BIJLAGE II bij het besluit d.d. 19 december 2012 tot toelating van het middel
Acticide BW 20, toelatingnummer 13925 N

RISKMANAGEMENT

3. Biocidal products. 4

4. Efficacy. 10

5. Human toxicology. 13

6. Environment 33

7. Conclusion. 56

8. Classification and labelling. 67

9. References. 75

1. Introduction

This assessment concerns the biocidal products based on the active substance 1,2-benzisothiazol-3(2H)-one (BIT). These applications have been submitted under the differentiated enforcement policy of biocides.

The assessment includes the following products:

Product	Applicant	PT	Application number
ACTICIDE BW 20	THOR GmbH	6	20120728 TBO
CANGUARD(TM) ULTRA BIT 20 LE Preservative	DOW Benelux B.V.	6, 13	20120668 TBO
Nipacide BIT 20	Clariant International Ltd	6, 9, 13	20120732 TBO
Nipacide BIT AS 20	Clariant International Ltd	6, 9, 13	20120730 TBO
Nuosept BIG-A	ISP Switzerland AG	6, 12, 13	20120733 TBO
Promex Clear	Prom Chem Ltd	6	20120689 TBO
Promex Na20S	Prom Chem Ltd	6	20120690 TBO
Rocima 640 Biocide	ROHM AND HAAS Europe Trading ApS	6, 13	20120667 TBO

The active substance 1,2-benzisothiazol-3(2H)-one (BIT) has been notified for product types 2, 6, 9, 11, 12 and 13. 1,2-Benzisothiazol-3(2H)-one has not been placed on annex 1 of Directive 98/8/EC yet.

2. Active substance

2.1 Identity of the active substance 1,2-benzisothiazol-3(2H)-one

General

Active substance (ISO Common Name)	BIT (non-ISO)
Name in Dutch	1,2-benzisothiazol-3(2H)-on

Identity

Chemical name (IUPAC)	1,2-benzisothiazol-3(2H)-one
Chemical name (CA)	1,2-benzisothiazolin-3-one
CAS No	2634-33-5
EC No	EINECS: 220-120-9
Other substance No.	-
Molecular formula	C₇H₅NOS
Molecular mass	151.19 g/mol
Structural formula

The active substance is not yet included in annex I of Directive 98/8/EC.

A CAR of the active substance is available (first draft, PT6, RMS ES, March 2012).

2.2 Physical and chemical properties of the active substance

2.2.1 1,2-benzisothiazol-3(2H)-one

Physical and chemical properties relevant to the risk assessment

Appearance	Solid white powder at ambient temperature (99.8%) Damp brown powder at ambient temperature (73.2%)
Surface tension	72.6 mN/m
Vapour pressure (Pa)	6.3 x 10^-5 Pa at 25°C
Henry’s law constant (Pa m³ mol ^-1)	7.4 × 10^-6 Pa m3 mol ^-1 at 20ºC
Solubility in water (g/L or mg/L)	pH 5 (4.8): 727 mg l^-1 at 10ºC pH 5 (4.8): 938 mg l^-1 at 20ºC pH 5 (4.8): 1196 mg l^-1 at 30ºC pH 7 (6.7): 1288 mg l^-1 at 20ºC pH 9 (9.1): 1651 mg l^-1 at 20ºC
Partition coefficient (log P_OW)	pH 5: 0.99 at 20ºC pH 7: 0.63 at 10ºC pH 7: 0.70 at 20ºC pH 7: 0.76 at 30ºC pH 9: -0.90 at 20ºC
Dissociation constant	Dissociation constant of the NH functional group:7.2
UV/VIS absorption (max.) (if absorption > 290 nm state e at wavelength)	4.29 at 224 nm No absorption above 290nm

Hazard identification for classification and labelling

Flammability

Flashpoint: Not applicable

Flammability: Not highly flammable

Auto-flammability: Not self-igniting

Oxidising properties

Not oxidising

Explosive properties

Not explosive

2.3 Analytical methods for the technical active substance

Adequate analytical methodology is available to determine the content of active substance and significant and/or relevant impurities in the technical active substance.

2.4 Conclusions active substance

The identity, physical and chemical properties and analytical methods of the active substance are sufficiently described.

3. Biocidal products

3.1 Identity of the biocidal poduct ACTICIDE BW 20

Name	ACTICIDE BW 20
Content active substance	200 g/kg pure 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	25, 30, 125 and 200 kg plastic drums (HDPE) and 1000 kg intermediate bulk containers (HDPE)

Physical and chemical properties of the biocidal product

Appearance	Beige dispersion with a mild odour
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint or Flammability	Not flammable (flash point > 60 °C)
pH 1% solution	1%: 4.8 pH (neat): 6.5
Relative density	1.0597
Storage stability/ Shelf life	9 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product

Preparation (principle of method)

HPLC-UV at 318nm

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product ACTICIDE BW 20

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.2 Identity of the biocidal poduct Canguard Ultra BIT 20 LE

Name	Canguard Ultra BIT 20 LE
Content active substance	20%w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	20kg HDPE pail 200 kg HDPE drum 1000kg HDPE IBC

Physical and chemical properties of the biocidal product Canguard Ultra BIT 20 LE

Appearance	Clear amber liquid without solids or precipitate
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	Not flammable (FP>60°C)
pH 1% solution	8.5
Relative density	1.17 at 20 °C
Storage stability/ Shelf life	12 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Canguard Ultra BIT 20 LE

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Canguard Ultra BIT 20 LE

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.3 Identity of the biocidal poduct Nipacide BIT 20

Name	Nipacide BIT 20
Content active substance	20% w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	25 L HDPE-jerrycan ; 200 L HDPE-drum ; 1000 L HDPE-IBC

Physical and chemical properties of the biocidal product Nipacide BIT 20

Appearance	Clear liquid with characteristic odour
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	Not flammable (FP>60°C)
pH 1% solution	12 – 13 (10g/L)
Relative density	Density: 1.21g/cm³
Storage stability/ Shelf life	12 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Nipacide BIT 20

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Nipacide BIT 20

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.4 Identity of the biocidal poduct Nipacide IT AS 20

Name	Nipacide IT AS 20
Content active substance	20%w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	25 L HDPE-jerrycan ; 200 L HDPE-drum ; 1000 L HDPE-IBC

Physical and chemical properties of the biocidal product Nipacide IT AS 20

Appearance	Clear liquid with characteristic odour
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	Not flammable (FP>60°C)
pH 1% solution	6 - 9 (10g/L)
Relative density	Density: 1.06g/cm³
Storage stability/ Shelf life	12 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Nipacide IT AS 20

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Nipacide IT AS 20

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.5 Identity of the biocidal poduct Nuosept BIG-A

Name	Nuosept BIG-A
Content active substance	19%w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	30kg or 60kg HDPE pail 250 kg HDPE drum 1000kg HDPE IBC

Physical and chemical properties of the biocidal product Nuosept BIG-A

Appearance	Clear yellowish viscose liquid
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	No flammable (FP>120°C)
pH 1% solution	12.5 4.6% alkalinity as NaOH
Relative density	D₄²⁰ = 1.14
Storage stability/ Shelf life	2 years in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Nuosept BIG-A

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Nuosept BIG-A

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.6 Identity of the biocidal poduct Promex Clear

Name	Promex Clear
Content active substance	9.0%w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	25kg HDPE drums 200 kg HDPE drums 1000kg HDPE steel reinforced IBC

Physical and chemical properties of the biocidal product Promex Clear

Appearance	Colourless liquid
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	Not flammable (FP>60°C)
pH 1% solution	10.5 – 11.5
Relative density	1.06
Storage stability/ Shelf life	12 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Promex Clear

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Promex Clear

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.7 Identity of the biocidal poduct Promex Na20S

Name	Promex Na20S
Content active substance	20%w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	25kg HDPE drums 200 kg HDPE drums 1000kg HDPE steel reinforced IBC

Physical and chemical properties of the biocidal product Promex Na20S

Appearance	Colourless liquid
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	Not flammable (FP>60°C)
pH 1% solution	8.8-9.2 (neat)
Relative density	1.06
Storage stability/ Shelf life	12 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Promex Na20S

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Promex Na20S

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

3.8 Identity of the biocidal poduct Rocima 640

Name	Rocima 640
Content active substance	20%w/w 1,2-benzisothiazol-3(2H)-one
Formulation type	AL
Packaging	20kg HDPE pail

Physical and chemical properties of the biocidal product Rocima 640

Appearance	Clear amber liquid without solids or precipitate
Explosive properties	Not explosive
Oxidising properties	Not oxidising
Auto-flammability	Not self-igniting
Flashpoint	Not flammable (FP>60°C)
pH 1% solution	Alkalinity: 2.41% as NaOH pH: 12-13 (10% solution)
Relative density	1.14 at 20 °C
Storage stability/ Shelf life	12 months in HDPE
Physical and chemical compatibility	Not applicable
Viscosity	Not applicable
Surface tension	Not applicable

Analytical methods for detection and identification

Analytical methods for analysis of the biocidal product Rocima 640

Preparation (principle of method)

HPLC-UV

Residue analytical methods

Adequate residue analytical methodology is available to monitor residues of the biocide taking into account all possible exposure scenarios and the toxicity of the active substance(s).

Conclusions biocidal product Rocima 640

The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described.

4. Efficacy

Function

Acticide BW20, Canguard Ultra Bit 20 Le, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A, Promex Clear, Promex NA20S, and Rocima 650 are preservative based on 1,2-Benz-isothiazolin-3-one, hereafter referred to as BIT. The products are intended for professional use only, although formulation to which these products are added are applied by non-professionals as well. Intended uses and organisms to control are summarised in Table W.1.

Table W.1. Intended use and concentrations active ingredients in products.

indented use	concentration in product
*Acticide BW 20*
control of bacteria, yeasts and fungi. The product will be used: - for the preservation of (water-based) paints, polymer dispersions, coatings, glues, detergents, lubricants, and additives for the production of paper, leather and textile (PT06)	200 g/kg
*Canguard Ultra Bit 20 Le*
control of bacteria and fungi. The product will be used: - for the preservation of water-based paints and coatings, glues and adhesives, households products such as detergents, polymer emulsions, mineral slurries used in the manufacture of paints and paper coatings, and printing inks (PT06); - for the preservation of metalworking fluids (PT 13).	200 g/kg
*Nipacide BIT 20*
control of bacteria, yeasts and fungi. The product will be used: - for the preservation of paints and coatings, glues and adhesives, and household products such as detergents (PT06); - for the preservation of textile, paper, rubber, and polymers (PT09); - for the preservation of leather during leather processing and storage (PT09); - for the preservation of metalworking fluids (PT 13).	200 g/kg

*Nipacide BIT AS 20*
control of bacteria, yeasts and fungi. The product will be used: - for the preservation of paints and coatings, glues and adhesives, and household products such as detergents (PT06); - for the preservation of textile, paper, rubber, and polymers (PT09); - for the preservation of leather during leather processing and storage (PT09); - for the preservation of metalworking fluids (PT 13).	200 g/kg
*Nuosept BIG-A*
in-can preservative for the control of bacteria in paints and coatings (PT06). Slimicide for paper processing and drilling fluids (PT12), and the control of bacteria and fungi in metalworking fluids (PT13).	190 g/kg
*Promex Clear*
in-can preservative for the control of bacteria and fungi in paints and coatings and their ingredients, water-based glues and adhesives and their ingredients, household detergents and washing aids, inks and water-based pigments, mineral slurries used in the manufacture of paints and paper coatings, additives for the production of paper, leather and textile, construction materials, pesticides, and drilling fluids during storage (PT06).	90 g/kg
*Promex NA20S*
in-can preservative for the control of bacteria and fungi in paints and coatings and their ingredients, water-based glues and adhesives and their ingredients, household detergents and washing aids, inks and water-based pigments, mineral slurries and fountain solutions used in the manufacture of paints and paper coatings, additives for the production of paper, leather and textile, construction materials, pesticides, drilling fluids during storage, and car care products (polishes) (PT06).	200 g/kg
*Rocima 650*
control of bacteria and fungi. The product will be used: - for the preservation of paints and coatings, glues and adhesives, household products such as detergents, polymer emulsions, mineral slurries used in the manufacture of paints and paper coatings, and printing inks (PT06); - for the preservation of metalworking fluids (PT 13).	200 g/kg

Mode of action

BIT has an antimicrobial action. The interaction of BIT with bacteria, fungus or yeast is influenced by the metabolic activity of the organisms (this has been demonstrated in the Gram-positive bacteria Staphylococcus aureus). BIT inhibits the oxidation of a number of carbohydrate substrates, which are transported across the cytoplasmic membrane by a process involving thiol dependent enzymes. In addition, BIT inhibits the oxidation of glycerol, which enters the cell by diffusion and also inhibits the utilisation of the electron transport chain by bacteria - possibly by action on the dehydrogenase enzymes. The inhibition of a number of these thiol-containing enzymes isolated from S. aureus supports this hypothesis. The interaction of BIT with the Gram- positive bacteria S. aureus is influenced by the metabolic activity of the organisms.

Enzymes dependent upon thiol groups for activity are affected by BIT and consequently inhibition of metabolic processes involving these enzymes is observed. A mechanism of antibacterial action such as this is unlikely to prove rapidly bactericidal; and is supported by the preservative rather than the disinfective action of BIT.

Resistance

BIT derives its antimicrobial activity from its ability to react with thiol compounds. Thiol compounds are found in cell membranes and serve important roles in various crucial metabolic activities such as transport of essential nutrients and minerals, respiration, excretion of waste products and many other membrane related processes. This mode of attack is fairly general and cannot be overcome by cells. Any possible method to overcome the ability of BIT to react with cell membranes has consequences that lead to slowing down of metabolism and contributes to eventual cell death. The thiol groups, found in many crucial enzymes responsible for driving many cellular processes, are also inhibited by BIT. Thus BIT has a principal mode of attack followed by a secondary inhibition of vital enzymes. This multiple attack mode precludes the possibility for organisms to develop mechanisms that can be passed on to future generations in the form of “resistance”.

Considering that the authorisation is done under article 121 of the WGB this is acceptable.

Conclusions

Considering that the evaluation is done under article 121 of the WGB and that the product has already been on the market for some time, it can be concluded that, when used in accordance with the proposed label (WG/GA):

- Acticide BW 20 is expected effective as a in-can preservative for the control of bacteria, yeasts and fungi in (water-based) paints, polymer dispersions, coatings, glues, detergents, lubricants, and additives for the production of paper, leather and textile (PT06);

- Canguard Ultra Bit 20 Le is expected effective as a (in-can) preservative for the control of bacteria and fungi in:

- water-based paints and coatings, glues and adhesives, households products such as detergents, polymer emulsions, mineral slurries used in the manufacture of paints and paper coatings, and printing inks (PT06);

- metalworking fluids (PT13).

- Nipacide BIT 20 and Nipacide BIT AS 20 is expected effective as a (in-can) preservative for the control of bacteria, yeast, and fungi:

- in paints and coatings, glues and adhesives, and household products such as detergents (PT06);

- on textile, paper, rubber, and polymers (PT09);

- on leather during leather processing and storage (PT09);

- in metalworking fluids (PT 13).

- Nuosept BIG-A is expected effective as:

- an in-can preservative for the control of bacteria in paints and coatings (PT06);

- a slimicide for paper processing and drilling fluids (PT12);

- a preservative for the control of bacteria and fungi in metalworking fluids (PT13).

- Promex Clear is expected effective as a in-can preservative for the control of bacteria and fungi in paints and coatings and their ingredients, water-based glues and adhesives and their ingredients, household detergents and washing aids, inks and water-based pigments, mineral slurries used in the manufacture of paints and paper coatings, additives for the production of paper, leather and textile, construction materials, pesticides, and drilling fluids during storage (PT06).

- Promex NA20S is expected effective as a in-can preservative for the control of bacteria and fungi in paints and coatings and their ingredients, water-based glues and adhesives and their ingredients, household detergents and washing aids, inks and water-based pigments, mineral slurries and fountain solutions used in the manufacture of paints and paper coatings, additives for the production of paper, leather and textile, construction materials, pesticides, drilling fluids during storage, and car care products (polishes) (PT06).

- Rocima 650 is expected effective as a (in-can) preservative for the control of bacteria and fungi in:

- paints and coatings, glues and adhesives, household products such as detergents, polymer emulsions, mineral slurries used in the manufacture of paints and paper coatings, and printing inks (PT06);

- for the preservation of metalworking fluids (PT 13).

5. Human toxicology

5.1 Human health effects assessment active substance

1,2 benzisothiazolone (BIT) is an existing active substance, not included in Annex I of 98/8/EC. An application for inclusion is submitted for BIT for which Spain is the Rapporteur Member State. A draft CAR is available for which the Ctgb has provided comments. The list of endpoints is based on data available with the Ctgb and has to be considered as preliminary.

When applied orally to rats BIT is easily absorbed and excreted mainly in urine (75-87%) within 24 hours. As 7-22% was found after cage washing, it is concluded that total oral absorption is about 100%. Metabolism includes thiazole ring opening and concomitant dioxidation or conjugation with methyl or glucuronyl. Dermal absorption is set at 27% based on in vitro data with human skin.

The acute oral LD₅₀ in rats was 606 mg BIT/kg bw. The dermal LD₅₀ in male and female rats was determined to be greater than 4500 mg BIT/kg bw. The inhalation LC₅₀ was 0.25 mg/L. The substance is not irritating to the skin, but a severe eye irritant. BIT was found to be a skin sensitizer in both LLNA and Buehler tests.

In a 90-day studies in rats mortalities, cardiopulmonary distress, behavioural CNS toxicity, decreased bodyweight, slightly lower albumin and total protein concentrations, stomach

alterations (hyperkeratosis, hyperplasia, erosions) were reported at the highest dose tested (65/50 mg/kg bw/day (M/F)). Local effects to the stomach (hyperkeratosis, hyperplasia, erosions) were seen at 10 and 25 mg/kg bw/day. In dogs (90-day feeding study), no treatment related adverse effects were seen at 11 and 37/38 mg/kg bw (M/F), while at the highest dose (109 mg/kg bw in males and 89 mg/kg bw in females) body weight loss, reduced food consumption and changes in blood calcium concentrations (females only) were observed. The NOAEL for systemic effects based on the rat study is set at 25 mg/kg bw/day.

BIT is not mutagenic when tested in in vitro and in vivo assays. In a developmental study with rabbits no developmental effects were found at the highest dose tested, 25 mg/kg bw/day. The NOAEL for maternal effects in this study (based on decreased body weight and food consumption) was 6 mg/kg bw. In a developmental study in rats decreased fetal body weight gain was found at 90 mg/kg bw. Maternal effects (including mortality) related to the irritant properties of BIT were reported at 30 mg/kg bw and above (NOAEL 10 mg/kg bw/day). No effects on reproductive performance were reported in a 2-generation study in rats at 50 mg/kg bw/day. The NOAEL for neonatal toxicity was 10 mg/kg bw based on increased mortality in the off-spring, which is at the same level where parental toxicity was observed (several deaths at 25 mg/kg bw related to irritant properties).

The AEL will be based on the lowest NOAEL available, 6 mg/kg bw/day in a developmental toxicity study in rabbits. Applying an assessment factor of 100 leads to an AEL of 0.06 mg/kg bw/day (3.6 mg/day based on a bodyweight of 60 kg).

Local effects

The AEL for local effects is based on the classification of BIT for sensitization with a specific concentration limit of ≥ 0.05%. Additional local effects in rats were found in oral studies and for local effects no route-to-route extrapolation is considered possible.

Data requirements active substance

No additional data requirements were identified.

5.2 Human exposure assessment active substance

5.2.1 Identification of main paths of professional exposure towards active substance from its use in biocidal product

Acticide BW 20 is a liquid and contains 20% BIT as active substance and the proposed field use is in:

PT 6 use as in-can preservative in washing and cleaning fluids, human hygienic products, detergents, fluids used in paper, textile and leather production, lubricants, glues and adhesives

Canguard Ultra Bit 20 Le is a liquid and contains 20% BIT as active substance.

The proposed field use is in:

PT 6 use as in can preservative for water based products (polymer emulsions used in interior and exterior paints and coatings, adhesives, printing inks, and water based household products, such as detergents and polishes, as well as mineral slurries used in the manufacture of paint and paper coatings).

PT13 use as a preservative in in water-based metalworking fluids (soluble oil, semi-synthetic and synthetic types), metal cleaners, and water-based hydraulic fluids..

Nipacide BIT 20 is a liquid and contains 19-21% BIT as active substance.

The proposed field use is in:

PT 6 use as in-can preservative for detergents, paints and coatings, glues and adhesives.

PT 9 use as a preservative for paper, textile, leather, rubber and polymerised materials.

PT13 use as a preservative for metalworking fluids (concentrate and end-product).

Nipacide BIT AS 20 is a liquid and contains 19-21% BIT as active substance.

The proposed field use is in:

PT 6 use as in-can preservative for detergents, paints and coatings, glues and adhesives.

PT 9 use as a preservative for paper, textile, leather, rubber and polymerised materials.

PT13 use as a preservative for metalworking fluids (concentrate and end-product).

Nuosept BIG-A is a liquid and contains 19% BIT as active substance.

The proposed field use is in:

PT 6 use as in-can preservative for paints and coatings.

PT12 use as a slimicide in paper industry and for drilling fluids in offshore applications

PT13 use as a preservative in metalworking fluids (concentrate and end-product)

Promex Clear is a liquid and contains 9% BIT as active substance.

The proposed field use is in:

PT 6 use as in-can preservative in paints and coatings (as well in raw materials), water-based adhesives (as well as raw materials), household cleaners and detergents, , inks and aqueous pigments, mineral slurries and fountain solutions used in paper industry, additives used in paper, leather and textile industry, building and construction compositions, pesticide formulations, drilling fluids,

Promex Clear is a liquid and contains 20% BIT as active substance.

The proposed field use is in:

Rocima 640 is a liquid and contains 20% BIT as active substance.

The proposed field use is in:

PT 6 use as in-can preservative for industrial water-based products: paints, polymer emulsions, coatings, mineral slurries used in the manufacture of paper coatings, adhesives, printing inks and household detergent products.

PT13 use as in metalworking fluids (soluble oil, semi-synthetic and synthetic types), metal cleaners, and water-based hydraulic fluids

5.2.2 Identification of main paths of professional exposure towards active substance from its use in biocidal product

An assessment of uses and exposure scenarios was made for the products. A summary of uses is given in Table T.1 below.

Table T.1 Summary of uses

	Concentra-tion a.s. in product	Use concentra-tion	PT	Application method	Fre-quency	Potential secondary exposure
ACTI-CIDE BW 20	200 g/kg BIT (20%)	0.4 g/kg 400 ppm	6¹	manual or automated dosing	once/ batch or contin-eous	Professionals, non-professionals and children during application of the products; by touching of treated surface/products and via textile and laundry (adults and children)
Can-guard Ultra Bit 20 Le Pre-servative	20% BIT	200-500 ppm	6¹	manual dosing dosing with a dosing device	30 min/day	Professionals, non-professionals and children during application of the products; by touching of treated surface/products and via textile and laundry (adults and children), consumers via food contact
		100-360 ppm	13¹	dosing with a dosing device metal working operations	30 min/week or 6 week period	by touching treated of surface/products (rinsing/cleaning not indicated in WG/GA)
Nipacide BIT 20	19-21% BIT	50-500 ppm	6¹	automated dosing device	once per batch	Professionals, non-professionals and children during application of the products; by touching of treated surface/products and via textile and laundry (adults and children)
		50-500 ppm	9¹	automated dosing device	once per batch	Bystanders during production; Adults and children by touching treated of surface/products via textile/ leather (adults and children)
		MWF concentrate 500-5000 ppm fluid (dilution 10-20 times) 50-500 ppm	13¹	automated dosing device	once per batch	by touching treated of surface/products (rinsing/cleaning not indicated in WG/GA)
Nipacide BIT AS 20	19-21% BIT	50-500 ppm	6¹	automated dosing device	once per batch	Professionals, non-professionals and children during application of the products; by touching of treated surface/products and via textile and laundry (adults and children)
		50-500 ppm	9¹	automated dosing device	once per batch	Bystanders during production; Adults and children by touching treated of surface/products via textile/ leather (adults and children)
		MWF concentrate 500-5000 ppm fluid (dilution 10-20 times) 50-500 ppm	13¹	automated dosing device metal working operations	once per batch	by touching treated of surface/products (rinsing/cleaning not indicated in WG/GA)
Nuosept BIG-A	19%	0.0095-0.0475% 95-475 ppm	6¹	manual dosing automated dosing device	once per batch, 2-3 batches/day < 1 min/day once per batch, 2-3 batches/day 10-20 min/day	Bystanders during production (4-6 h stirring/1-2h transfer); Professionals, non-professionals and children during application of the products; by touching of treated surface/products
		Paper industry 0.0095-0.0475% 95-475 ppm	12¹	automated dosing device/closed system (de)connection/sampling	shock dosing	Paper industry: Bystanders during production; Adults and children by touching treated of surface/products and consumers via food contact
		Off-shore 0.0095-0.0475% 95-475 ppm	12¹	manual dosing or automated dosing device sampling/analysis	mixing 1-3 x/day sampling 30 min 4x/day	off-shore: working at the drilling hole 60 min 3-5x/day (recirculating system)
		MWF fluid 0.0095-0.0475% 95-475 ppm	13¹	(de)connection of the dosing system mixing/sampling/ cleaning metal working operations	mounting hoses 5 min/d 20 min/day 2 hours/day	by touching treated of surface/products (rinsing/cleaning not indicated in WG/GA)
		MWF concentrate 0.38-0.76% 3800-7600 ppm MWF fluid (dilution 20 times) 0.019-0.038% 190-380 ppm	13¹	manual dosing automated dosing device metal working operations	once per batch, 2-3 batches/day < 1 min/day once per batch, 2-3 batches/day 10-20 min/day	Bystanders during production (4-6 h stirring/1-2h transfer); Professionals, non-professionals and children during application of the products; by touching of treated surface/pro-ducts
Promex clear	9%	0.01-0.05% 100-500 ppm	6¹	manual or automated dosing into closed system	5x/day	Professionals, non-professionals and children during application of the products; by touching of treated surface/products and via textile and laundry (adults and children)
Promex Na20S	20%	0.01-0.05% 100-500 ppm	6¹	manual or automated dosing into closed system	5x/day	Professionals, non-professionals and children during application of the products; by touching of treated surface/products and via textile and laundry (adults and children)
Rocima 640	20%	0.01-0.05% 100-500 ppm	6¹	manual or automated dosing	30 min/day	Professionals, non-professionals and children during application of the products; by touching of treated surface/pro-ducts and via textile and laundry (adults and children)
		0.01-0.036% 100-360 ppm	13¹	dosing with a dosing device metal working operations	30 min/week or 6 week period	by touching treated of surface/pro-ducts (rinsing/cleaning not indicated in WG/GA)

¹ Professional use

As the product is used by professionals, oral exposure is considered negligible. Respiratory and dermal exposure will be possible during mixing and loading of the formulation, (de)connection of the packages to the dosing device, mixing in the final product (e.g. paint) and during cleaning. However, as BIT has a low vapour pressure (1.1 x 10^-4 Pa at 20°C), inhalation exposure is considered negligible. For use in metal working fluids exposure of professionals in an industrial setting to BIT may possible during application of fluids containing Canguard Ultra Bit 20, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A or Rocima 640.

5.2.3 Identification of main paths of non-professional exposure towards active substance from its use in biocidal product

The products are intended for professional use only.

5.2.4 Indirect exposure as a result of use of the active substance in biocidal product

Secondary dermal and inhalation exposure after application of the formulations may be possible when working with treated products (professionals and non-professionals) or by touching treated materials (adults and children). Depending on the type of product (paints, plaster, glues, adhesives, detergents, coatings, polymer dispersions, starch, paper or metal working fluid), the active substances may be more or less incorporated into a matrix and consequently dermal exposure is expected to be more or less relevant. Inhalation exposure is considered negligible due to the low vapour pressure of BIT (1.1 x 10^-4 Pa at 20°C).

Specific exposure of adults and children to residues of BIT may be possible when wearing clothing washed with products containing BIT or textile/leather treated with Nipacide BIT 20 or Nipacide BIT AS 20.
As Acticide BW 20 is used in personal hygiene products, exposure of both adults and children may be possible when using soap, bath/shower gels, shampoo, tooth paste needs to be taken into consideration.

As Rocima 640, Nuosept BIG-A and/or Canguard Ultra Bit 20 Le treated products are used in paper production, the general public could be potentially exposed to BIT residues in food via migration from paper or cardboard used as “food contact material”.

5.3 Human health effects assessment product

5.3.1 Toxicity of the formulated product

Acticide BW 20

No studies with have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex I of CLP EC Regulation 1272/2008.

Canguard Ultra Bit 20 Le

No studies with Canguard Ultra Bit 20 Le have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

Nipacide BIT 20

No studies with Nipacide BIT 20 have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

Nipacide BIT AS 20

No studies with Nipacide BIT AS 20 have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

Nuosept BIG-A

No studies with Nuosept BIG-A have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

Promex clear

No studies with Promex clear have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

Promex Na20S

No studies with Promex Na20S have been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

Rocima 640

No studies with Rocima 640 been submitted and the classification and labelling of the formulation has been prepared based on the calculation method described in Annex II of Directive 1999/45/EC.

5.3.2 Data requirements formulated product

No additional data requirements are identified.

5.4 Risk characterisation for human health

5.4.1 Professional users

Mixing and loading

The professional user can be exposed to the products during mixing/loading, (de)connection of the dosing device and during cleaning. The concentration of the active substance in the undiluted formulations is higher than the classification limit for sensitization 0.05%. Therefore, it is recommended to wear suitable equipment to protect the skin during handling and/or use of the product (gloves and protective clothing).

In order to assess whether the PPE described above is also sufficient to protect against systemic exposure, a calculation for manual dumping of liquids with mixing and loading model 7 revised (TNsG part 2 page 144) is performed. In a worst case assumption it is assumed that a worker is exposed during 30 min. per day to a formulation used as in-can preservative containing 21% BIT. The AEL of 0.06 mg/kg bw/day is taken as starting point with the body weight of a professional user set at 60 kg. Dermal absorption is 27%. The total internal exposure is expected to be (0.43*21/100)*30*0.27= 0.73 mg/day.

Table T.2 Internal professional operator exposure to BIT and risk assessment for the use of 21% formulation

	Route	Estimated internal exposure ^a (mg /day)	Systemic AEL (mg/day)	Risk-index^b
Connecting/disconnecting vessels, no PPE
	Dermal	0.73	3.6	0.20

Route

Estimated internal exposure ^a (mg /day)

Systemic

AEL (mg/day)

Risk-index^b

Connecting/disconnecting vessels, no PPE

Dermal

0.73

3.6

0.20

Nipacide BIT 20, Nipacide BIT AS 20 and Nuosept BIG-A are concentrates that are further diluted before use. As gloves and protective clothing are prescribed based on the sensitisation properties of these formulations and as the worst-case internal exposure calculation by connecting/disconnecting vessel by using mixing/loading model 7 revised show that a safe use is calculated with gloves, no adverse health effects are expected for the protected (gloves &) professional user of Nipacide BIT 20, Nipacide BIT AS 20 and Nuosept BIG-A by pre-mixing/loading followed by mixing/loading.

On the basis of the above considerations, it can be concluded that the risk for the protected (gloves and protective clothing) professional user is acceptable.

Metal working fluids

For use in metal working fluids, exposure of professionals to BIT in an industrial setting may be possible during application of fluids containing Canguard Ultra Bit 20, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A or Rocima 640. To assess exposure the model from TNsG part 2 p.189 MWF Model 2 adopted by HEEG opinion dd 22-09-2008 was used.

Exposure of professionals to a solution containing 0.05% BIT after application of Nipacide BIT 20 or Nipacide BIT AS 20 during 4 hours per day is taken as the worst case starting point. Dermal absorption is set at 27%. Clothing penetration is set at 20% (HEEG 2009).

The metal fluids model indicates potential dermal exposures of 92 mg/min for body and 200 mg/min for hands. As BIT has a low vapour pressure (1.1 x 10^-4 Pa at 20°C), the inhalation exposure is considered negligible. Since inhalation exposure is expected to be negligible, this part of the model was not taken into account. Worker body weight is set at 60 kg. Internal exposure to BIT is calculated to be (200*0.0005*0.27*240)+ (92* 0.0005*0.27*240*0.2) = 7.1 mg/day.

The AEL of 0.06 mg/kg bw/day is used as starting point for the risk assessment.

Table T.2 Internal professional operator exposure to BIT and risk assessment for the use of Nuosept BIG-A in fluids used during metal working

	Route	Estimated internal exposure^a (mg /day)	Systemic AEL (mg/day)	Risk-index^b
MWF 0.05% BIT, no PPE
mixing/loading/ application ^c	Dermal	7.1	3.6	2.25
MWF 0.05% BIT, with PPE (gloves and coverall)
mixing/loading/ application ^c	Dermal	0.71	3.6	0.225

a Internal exposure was calculated with:

biological availability via the dermal route: 27 %

b The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c Exposure is estimated with MWF model (HEEG 2008).

d For dermal exposure, exposure of hands and of the body (with gloves and coverall, data from model reduced with factor 10) is combined.

On the basis of the above considerations, it can be concluded that the risk when applying the formulation Canguard Ultra Bit 20, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A or Rocima 640 in metal working fluids for the professional user is acceptable with the when using the appropriate PPE (gloves and coverall).

5.4.2 Non-professional users, including the general public

The products are for professional use only.

5.4.3 Indirect exposure as a result of use

Secondary dermal and inhalation exposure after application of the product may be possible when working with treated products (professionals and non-professionals) or by touching treated materials (adults and children). Depending on the type of product, the active substance may be more or less incorporated into a matrix and consequently dermal exposure is expected to be relevant or negligible. Inhalation exposure is considered negligible due to the low vapour pressure of BIT (1.1 x 10^-4 Pa at 20°C).

Dermal exposure of adults and children due to use of personal hygiene products and during wearing of clothing washed with treated detergents cannot be excluded. In addition, consumption of foods prepared on treated (e.g. painted) surfaces may lead to additional exposure

In a tiered approach the following scenarios are assessed:

Manual spray painting by professionals and non-professionals
Brush painting by professionals and non-professionals
Fluids in textile/leather production by professionals

PPE were not taken into account since it is not possible to prescribe PPE for secondary exposure.

In addition in a worst case approach the following scenarios were assessed related to exposure of consumers

Use of Acticide BW 20 as personal hygiene product (bath oil, soap, shampoo, toothpaste)
Dish washing
Contact to residual BIT in textiles after laundry by children
Consumption of food after contact with treated surfaces by adults and children
Contact with treated surfaces by children
Paper/board for food packaging

Professional and non-professional use

PT 6

Manual spray painting

Manual spray painting with paints containing BIT by professionals and non-professionals is considered to represent a worst case situation for exposure calculations. The maximum concentration BIT in paints is 0.05%.

A calculation was made using ConsExpo 4.1 based on the default scenario for paint spraying. Since inhalation exposure is expected to be negligible, this part of the model was not taken into account. It is assumed that professionals are exposed daily for 6 hours per day. Calculations were performed to assess the maximum concentration of BIT that could be present in a product in order to lead to safe use. PPE were not taken into account since it is not possible to prescribe PPE for secondary exposure.

The AEL of 0.06 mg/kg bw/day is taken as the starting point of the risk assessment. Dermal absorption is 27%.

dermal : point estimates

dermal load : 0,0099 mg/cm2

dermal external dose : 0,33 mg/kg

dermal acute (internal) dose : 0,0891 mg/kg

Internal daily exposure without PPE: 0.0891 mg/kg *60kg= 5.3 mg/day

This leads to a risk ratio of 5.3/3.6 = 1.49

On the basis of the above considerations, it can be concluded that the risk for the professional and non-professional user is not acceptable for spraying of paints containing 0.05% BIT. The safe concentration in paints and other products that are sprayed, was determined to be (0.05%/1.49) ≤0.033%.

Brush painting

Brush painting with paints containing BIT by professionals and non-professionals is considered to represent the second worst case situation for exposure calculations.

A calculation was made using ConsExpo 4.1 based on the default scenario for brush painting. Since inhalation exposure is expected to be negligible, this part of the model was not taken into account. It is assumed that professionals are exposed daily for 6 hours per day. PPE were not taken into account since it is not possible to prescribe PPE for secondary exposure.

The AEL of 0.06 mg/kg bw/day is taken as the starting point of the risk assessment. The dermal absorption is 27%.

dermal : point estimates

dermal load : 0,0027 mg/cm2

dermal external dose : 0,09 mg/kg

dermal acute (internal) dose : 0,0243 mg/kg

Internal daily exposure without PPE: 0.0234 mg/kg *60kg= 1.4mg/day

This leads to a risk ratio of 1.4/3.6= 0.39

On the basis of the above considerations, it can be concluded that the risk for the professional and non-professional user is acceptable for rolling/brushing paints containing 0.05% BIT.

Application in fluids in paper/textile/leather production

A calculation was made using dipping model 3 (TNsG 2002 part 2 page 169). Exposure of professionals to a solution of 0.05% during 4 hours per day is taken as the starting point. Dermal and inhalation absorption are both included in the model and set at 27 and 100 %, respectively.

Model 3 indicates potential dermal exposures of 7.49 mg/min for body, 0.34 mg/min hands (inside gloves) and 0.32 mg/min for feet inside shoes. Inhalation exposure is indicated to be 101 mg/m³. Worker body weight is set at 60 kg.

Based on the frequency of application, the long-term term AEL of 0.06 mg/kg bw/day is used as starting point for the risk assessment.

Table T.3 Internal professional operator exposure to BIT and risk assessment for the use of in 0.05% fluids used in the production of paper/textile/leather

	Route	Estimated internal exposure^a (mg /day)	Systemic AEL (mg/day)	Risk-index^b
Dipping, no PPE
mixing/loading/ application ^c	Dermal	0.07	3.6	0.02
	Respiratory	0.12	3.6	0.03
	Total	0.19	3.6	0.05

a Internal exposure was calculated with:

biological availability via the dermal route: 27 %

biological availability via the respiratory route: 100% (worst case)

b The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c Exposure is estimated with dipping model 3.

On the basis of the above considerations, it can be concluded that the risk when applying the formulations(0.05% solution) for the professional user is acceptable.

Conclusion PT 6

The secondary exposure of professionals and non-professionals working with products containing BIT is expected to lead to unacceptable risks for spraying applications of paints and coatings containing >0.033% IPBC (all formulations except Actide BW 20). For non-spraying applications of paints, coatings, plaster, sealant and fillers containing ≤0.05 % BIT (all formulations under evaluation) the risk for unprotected professionals and non-professionals is considered acceptable.

For use in fluids used in textile/leather production containing the products at concentrations as indicated in table T1, the risk due secondary exposure of unprotected professional and non-professional user to IPBC is considered acceptable.

Exposure of bystanders is in all cases expected to be lower than that of users of the products and the risk due to secondary exposure for bystanders is therefore considered acceptable.

PT9

The secondary exposure of professionals working with fibre, leather and plastics containing Nipacide BIT 20 and or Nipacide BIT 20 AS (maximum concentration BIT 0.05%) is expected to similar to that due to exposure to BIT in fluids used in paper/textile/leather production, as described under PT6. Therefore, the calculations described under PT6 are considered applicable for PT9.

On the basis of the above considerations, it can be concluded that the risk when applying Nipacide BIT 20 and or Nipacide BIT 20 AS in PT9 products for the unprotected professional and non-professional user is acceptable.

PT12

The secondary exposure of professionals in the paper industry is expected to be limited to exposure of co-workers and bystanders. The exposure is expected less than the calculated exposure as calculated under PT6 for use in fluids in paper production, as no direct contact with the working fluid is expected. Also in off-shore applications no direct contact is expected that would lead to a higher exposure than calculated under PT6.

PT13

Secondary exposure of co-workers and bystanders in the metal industry to fluids containing BIT cannot be excluded. It is expected that the exposure of the hands of the co-workers is negligible compared to exposure of hands of workers that are directly involved in metal working. Therefore a calculation is made based on the model from TNsG part 2 p.189 MWF Model 2 adopted by HEEG opinion dd 22-09-2008, to assess body exposure of co-workers. The metal fluids model indicates potential dermal exposures of 92 mg/min for body. Inhalation exposure is indicated to be 0.33 mg/m³. Worker body weight is set at 60 kg. In the current calculation the exposure of the hands of co-workers is set at 0 mg/min. Dermal absorption is set at 27%. Clothing penetration is set at 20% (HEEG 2009).

Exposure of co-workers to a solution containing 0.05% IPBC after application of Canguard Ultra Bit 20, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A or Rocima 640 during 4 hours per day is taken as the starting point.

The AEL of 0.06 mg/kg bw/day is used as starting point for the risk assessment.

Table T.4 Internal professional co-worker exposure to BIT and risk assessment for the use of Canguard Ultra Bit 20, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A or Rocima 640 in fluids used during metal working

	Route	Estimated internal exposure^a (mg /day)	Systemic AEL (mg/day)	Risk-index^b
MWF 0.05% BIT, no PPE
mixing/loading/ application ^c	Dermal	0.6	3.6	0.167
	Respiratory	0	3.6	0
	Total	0.6	3.6	0.167

a Internal exposure was calculated with:

biological availability via the dermal route: 27 %

biological availability via the respiratory route: 100% (worst case)

b The risk-index is calculated by dividing the internal exposure by the systemic AEL.

c Exposure is estimated with MWF model (HEEG 2008).

On the basis of the above considerations, it can be concluded that the risk when applying the formulation Canguard Ultra Bit 20, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A or Rocima 640 (at 0.05 %) for co-workers and bystanders is acceptable.

No additional secondary exposure is expected, as the products are mixed and used in industrial settings only.

Consumer use

Consumer exposure to products containing the formulations cannot be excluded.

Use of Acticide BW 20 as personal hygiene product (bath oil/foam, soap/douche gel, shampoo, toothpaste)

Exposure of consumers including children to personal hygiene products containing Acticide BW 20 cannot be excluded. Products contain at a maximum 0.02% BIT as the result of preservation with Acticide BW 20 and may be applied to the total body surface.

The use of shampoo containing 0.02% BIT is considered as during hair washing intensive contact with the skin is foreseen. Oral exposure during use of toothpaste containing Acticide BW20 as preservative is considered for both adults and children.

Douche gel/bath foam

A worst case scenario would be exposure to soap/douche gel, where direct contact of the total skin surface with the formulation is expected. Exposure to bath oil/bath foam is expected to be much lower as in this application further dilution of the product is foreseen.

A calculation was made using ConsExpo 4.1 based on the default scenario for cosmetics, showering using a liquid soap. Since inhalation exposure is expected to be negligible, this part of the model was not taken into account. It is assumed that the total body surface of adults and children is exposed daily (model assumes 329 times per year).

The AEL of 0.06 mg/kg bw/day is taken as the starting point of the risk assessment for adults and children. The dermal absorption is 27%. The body weight of an adult is 60 kg.

Dermal : point estimates

dermal load : 0,000597 mg/cm2

dermal external dose : 0,174 mg/kg

dermal acute (internal) dose : 0,047 mg/kg

This leads to a risk ratio of 2.82/3.6 = 0.78

For the exposure assessment of children, it is assumed that the amount of product/cm²body surface does not differ between adults and children and that the ratio body weight/body surface is 60/17400 for adults and 15/6030 for a small child (2-3 year, 15 kg) (TGD part 1 p. 236). This leads to a correction factor of 1.39 to be applied on the outcome of the model for adults as presented above.

A re-calculation of the dose for a child yields an exposure of 0.047*1.39= 0.05633 mg/kg bw. Based on a body weight of 15 kg total internal exposure is 0.98 mg/day.

The starting point is the AEL of 0.06 mg/kg bw/day multiplied with the body weight for a 2-3 year old child, i.e. 0.9 mg/dat

This leads to a risk ratio of 0.98/0.9 = 1.09

On the basis of the above considerations, it can be concluded that the risk for the use Acticide BW 20 in liquid soap is acceptable for adults only.

On the basis of the above considerations, it can be concluded that the risk for the use Acticide BW 20 in liquid soap is acceptable for adults and children.

Shampoo

A calculation was made using ConsExpo 4.1 based on the default scenario for cosmetics, shampoo. Since inhalation exposure is expected to be negligible, this part of the model was not taken into account. It is assumed that the head of adults and children is exposed daily (model 260 times/year).

The AEL of 0.06 mg/kg bw/day is taken as the starting point of the risk assessment for adults and children. The dermal absorption is 27%. The body weight of an adult is 60 kg.

Dermal : point estimates

dermal load : 0,0167 mg/cm2

dermal external dose : 0,369 mg/kg

dermal acute (internal) dose : 0,0997 mg/kg

This leads to a risk ratio of 5.98/3.6 = 1.66

For the exposure assessment of children, it is assumed that the amount of product/cm²body surface does not differ between adults and children. It is assumed that the ratio body weight/head surface is similar to the ratio body weight/body surface as indicated above. This leads to a correction factor of 1.39 to be applied on the outcome of the model for adults as presented above.

A re-calculation of the dose for a child yields an exposure of 0.0997*1.39= 0.139 mg/kg bw. Based on a body weight of 15 kg total internal exposure is 2.08 mg/day.

The starting point is the AEL of 0.06 mg/kg bw/day multiplied with the body weight for a 2-3 year old child, i.e. 0.9 mg/dat

This leads to a risk ratio of 2.08/0.9 = 2.31

On the basis of the above considerations, it can be concluded that the risk for the use Acticide BW 20 in shampoo is not acceptable for both adults and children.

Tooth paste

In addition to douche gel and shampoo, toothpaste may be an additional source of exposure to BIT. No dermal or inhalation exposure is expected, but oral exposure especially of children by ingestion of part of the tooth paste cannot be excluded. A calculation was made using ConsExpo 4.1 based on the default scenario for cosmetics, toothpaste (adults and children).

It is assumed that the bodyweight of an adult is 60 kg and that of a child 12.5 kg (default by model).

The AEL of 0.06 mg/kg bw/day is taken as the starting point of the risk assessment for adults and children. The oral absorption is set at 100%.

Adults

oral external dose : 0,000533 mg/kg

oral acute (internal) dose : 0,000533 mg/kg

This leads to a risk ratio of 0.000533*60/3.6 = 0.009

Children

Oral : point estimates

oral external dose : 0,017 mg/kg

oral acute (internal) dose : 0,017 mg/kg

This leads to a risk ratio of 0.017*15/0.9 = 0.14

Based on the above considerations it is concluded that the risk for the use Acticide BW 20 in tooth paste is acceptable for adults and children.

Adverse health effects as the result of the application of Acticide BW 20 in personal hygiene products cannot be excluded. Therefore, in the WG/GA the following text needs to be included: “niet gebruiken in persoonlijke verzorgingsproducten”.

Dish washing

Amateur/consumers use in-can preserved washing and cleaning fluids and detergents for laundry/surface cleaning/wiping and dish washing. The use of laundry and surface cleaning products by consumer is probably of limited duration and frequency. The hand dish washing products are applied more often (up to 21 times per week, i.e. 3 times per day, TGD on Risk Assessment, part 1, p. 239).Therefore, hand dish washing is a representative worst case for all consumer applications of washing and cleaning fluids and detergents. During the hand dish washing only dermal exposure is relevant as no aerosols are formed and BIT has a very low vapour pressure.

According to the TGD on Risk Assessment (part 1, p. 239) 3-10 g hand dish washing liquids are used per task which might take place up to 3 times per day. The highest amount of liquid (10 g) is diluted in 5 L water. The skin is exposed at hands (840 cm²) and forearms (1140 cm²). The thickness of the water film is 100 μm (0.01 cm, TGD on Risk Assessment, part 1, p. 223). The density of the wash solution is 1000 mg/cm³. The consumer wears no gloves during the dish washing. The concentration of BIT in the in-can preserved end-product is 0.05%.

Exposure calculation

Weight of wash solution on the exposed skin

(840 cm² + 1140 cm²) * 0.01 cm * 1000 mg/cm³ = 19800 mg

Amount of BIT in the wash solution on the exposed skin

19800 mg * 0.05 % * 10 g/5000 g = 0.0198 mg

Systemic exposure to BIT during single dish washing

0.0198 mg * 100 %/60 kg = 0.00033 mg/kg bw/day

Systemic exposure to BIT during 3 dish washings per day

3 * 0.00033 mg/kg bw/day = 0.00099 mg/kg bw/day

The exposure of a person to BIT when dish washing three times a day with hands is 0.00099 mg/kg bw/day. This is far below the AEL of 0.06 mg/kg bw/day.

Contact of child to residual BIT in textiles after laundry

Children may be exposed to BIT via the textiles. Although the concentration of BIT in the textiles is very low since laundry products are highly diluted, the dermal exposure is calculated for a child (35 kg) wearing a pullover with an area of 3540 cm2 (arms and trunk, TGD on Risk Assessment).

The exposure is calculated based on the considerations of HERA, 2005, Guidance Document Methodology. For 5 kg laundry, 150 g of product and 15 L of water are required (TGD on Risk Assessment, part 1, p. 239). The concentration of BIT in the product is 0.05%. The residues deposited on the clothes are 5 % (HERA, 2005). Fabric density is assumed at 20 mg/cm²(HERA, 2005). The weight fraction transferred from the fabric to the skin is 1 % (HERA, 2005). As very worst case assumption, the dermal penetration of the dry residues is set at 100%.

Exposure calculation

Amount of BIT depositing on the clothes:

150 g * 0.05 % * 5 % = 3.75 mg BIT in 5 kg laundry

Weight of pullover: 20 mg/cm² * 3540 cm² = 70800 mg

Amount of BIT on the pullover: 3.75 mg * 70800 mg/5 kg = 0.053 mg

Potential dermal exposure on the skin (transference from pullover):

0.053 mg * 1 % = 0.00053 mg

Systemic exposure of child to BIT:

0.00053 mg * 100 %/35 kg = 1.5*10^-5 mg/kg bw

The exposure of a child wearing a pullover washed with IPBC containing fluids is 1.5*10^-5 mg/kg bw. The exposure is far below the AEL of 0.06 mg/kg bw/day.

Consumption of food after contact with cleaned or painted surface

The following exposure assumptions are made:

An adult places a piece of meat (300 g, 150 cm²) on a cleaned surface.

For surface cleaning 60 g of in-can preserved liquid are diluted in 5 L (TGD on Risk Assessment, part 1, p. 239). The concentration of BIT in the in-can preserved cleaning liquid is 0.05 %. The film thickness of the washing solution on the surface is 100 μm before drying. After the solution has dried 2 % of the residues are dislodged (TNsG, part 2, p. 206). The density of the washing solution is 1000 mg/cm³. Oral absorption is 100%.

Exposure calculation

Amount of dislodged BIT in the meat:

60 g/5000 g * 0.05 % * 150 cm2 * 0.01 cm (100 μm) * 2 % * 1000 mg/cm3 = 0.00018 mg

Systemic exposure to BIT:

0.00018 mg/60 kg = 3.0*10^-6 mg/kg bw

The consumption of a piece of meat that was placed on a cleaned surface results in an exposure of 3.0*10^-6 mg/kg bw. This is far below the AEL of 0.06 mg/kg bw/day.

Contact of child to cleaned or painted surface or glues

Children may be secondary exposed to BIT when having contact to cleaned or painted surfaces and touch glues. The scenario for a painted surface is taken as the worst case approach.

A child (35 kg) has contact to a dried painted surface with 20 % of the area of one hand (200 cm2). As a worst case it is considered that the concentration of BIT at the surface is 0.05 % (see table T1). It is assumed that 2% of the substance on the surface (see TNsG on Human exposure, part 2, page 204) can be dislodged. The residual amount of BIT on the surface comes from a paint film with a thickness of 100 μm. A density of 1 g/mL is assumed. The dermal penetration of BIT in the dried solution is set at 100% as a very worst case assumption.

For an infant (10 kg) , it is additionally assumed that it licks its hands thereby ingesting 100% of the substance on its hands.

Child: Exposure calculations

BIT on hands:

0.05 % * 0.01 cm * 20 % * 200 cm2 * 1000 mg/cm3 * 2 % = 0.004 mg BIT on hands

systemic dose:

(0.004 mg IPBC on hands × 100% )/ 35 kg = 1.1*10^-4mg BIT/kg bw/day

Playing on painted surface results in an exposure of 1.1*10^-4 mg BIT/kg bw/day which is far below the AEL of 0.06 mg/kg bw/day (<0.2% of AEL).

Infant: exposure calculations

BIT on hands:

0.05 % * 0.01 cm * 20 % * 200 cm2 * 1000 mg/cm3 * 2 % = 0.004 mg BIT on hands

Systemic dose after dermal exposure:

(0.004 mg BIT× 100%)/ 10 kg = 0.0004 mg BIT/kg bw/day

Systemic dose after ingestion of BIT on hands:

(0.004 mg BIT on hands × 100%)/10 kg = 0.0004 mg BIT/kg bw/day

An infant playing on a painted surface has a maximum exposure of (0.0004 mg BIT/kg bw/day dermal exposure + 0.0004 mg IPBC/kg bw/day oral exposure =) 0.0008 mg BIT/kg bw/day which is equivalent to 1.3 % of the AEL.

Paper/board for food packaging

By using Canguard Ultra Bit 20 Le, Nuosept BIG-A and/or Rocima 640 treated fluids in paper production, the general public could be potentially exposed to BIT residues in food via migration of residues from paper or cardboard used as “food contact material”. The main requirements for the use as “food contact material” is established in REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. The principle underlying this Regulation is that any material or article intended to come into contact directly or indirectly with food must be sufficiently inert to preclude substances from being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in the composition of the food or

a deterioration in its organoleptic properties.

The regulation shall apply for the intended use of both products in the paper and cardboard industry.

Conclusion consumer exposure

Based on the above considerations, it is concluded that the risk for consumers (including infants and children) to products containing the formulations is considered acceptable with the exception of Acticide BW 20 when used in personal hygiene products.

5.4.4 Combined exposure

The formulations contain only one active substance, BIT, and it is not described that it should be used in combination with other formulations.

5.5 Overall conclusions for the aspect human health

Acticide BW 20

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Acticide BW 20 cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Acticide BW 20.

Indirect exposure

Based on the risk assessment, it can be concluded that adverse health effects are expected from indirect exposure to BIT as a result of use of Acticide BW 20 in personal hygiene products containing residues of BIT due to incorporation of Acticide BW 20. Therefore the following text needs to be added to the WGGA: “niet gebruiken in persoonlijke verzorgings producten”.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Acticide BW 20.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Acticide BW 20 cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.65 g/L of 0.165% Acticide BW 20 bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

Canguard Ultra Bit 20 Le

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Canguard Ultra Bit 20 Le cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Canguard Ultra Bit 20 Le.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Canguard Ultra Bit 20 Le.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Canguard Ultra Bit 20 Le cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.65 g/L of 0.165% Canguard Ultra Bit Le bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Nipacide BIT 20

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Nipacide BIT 20 cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Nipacide BIT 20.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Nipacide BIT 20.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Nipacide BIT 20 cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.57 g/L of 0.157% Nipacide BIT 20 bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

Nipacide BIT AS 20

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Nipacide BIT AS 20 cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Nipacide BIT AS 20.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Nipacide BIT AS 20.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Nipacide BIT AS 20 cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.57 g/L of 0.157% Nipacide BIT AS 20 bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

Nuosept BIG-A

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Nuosept BIG-A cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Nuosept BIG-A.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Nuosept BIG-A.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Nuosept BIG-A cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.74 g/L of 0.174% Nuosept BIG-A

bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

Promex clear

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Promex clear cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Promex clear.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Promex clear.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Promex clear cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 3.67 g/L of 0.367% Promex clear

bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

Promex Na20S

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Promex Na20S cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Promex Na20S.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Promex Na20S.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Promex Na20S cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.65 g/L of 0.165% Promex Na20S

bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

Rocima 640

For the unprotected professional operator, adverse health effects after dermal exposure to BIT as a result of the application of Rocima 640 cannot be excluded. Correct use of personal protective equipment (gloves and coverall) will reduce the dermal exposure and results in a sufficient reduction of the exposure to BIT for the application of Rocima 640.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Rocima 640.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Rocima 640 cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Indien het eindproduct meer dan 1.65 g/L of 0.165% Rocima 640

bevat moet de volgende zin op het label van het eindproduct moet worden opgenomen “niet toegestaan voor spraytoepassingen”.

6. Environment

6.1. Introduction

Authorisation is requested for the products ACTICIDE BW 20, CANGUARD(TM) ULTRA BIT 20 LE Preservative, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A, Promex Clear, Promex Na20S, Rocima 640 Biocide containing as active substance 1,2-benzisothiazol-3(2H)-one hereafter referred to as BIT. The biocidal product concerns preservatives for application in product types PT06 in-can preservatives in 15 different types of uses and PT09 product for the preservation of textile, paper, rubber, polymerised materials and leather intermediates, PT 12 slimicides used in the paper industry and PT13 preservatives in metal working fluids.

The biocides are added to intermediate and end-products professionally, but some treated products may be used by non-professionals as well. The intended uses are described in table E.1.

Table E.1. Intended uses.

nr	Product	Acticide BW20	Can-guard Ultra Bit 20 Le	Nipacide BIT 20 and Nipacide BIT AS 20	Nuosept BIG-A	Pro-mex Clear	Pro-mex Na20S	Roci-ma 640 Bio-cide
	Dosage product g/kg	0.5-2.0	1-2.5^c	0.25-2.5^a	0.5-2.5^b	1 – 5	0.5-2.5	0.5-2.5^c
	Range use concentration active substance (g/kg)	0.01-0.4	0.2 – 0.5	0.05– 0.5	0.095-0.475	0.1-0.5	0.1-0.5	0.1-0.5
	Use description
	PT6 In can preservatives in
1.01	Washing and cleaning products and detergents	●	●	●		●	●	●
1.02	Car wash fluids						●
1.03	Paints and coatings	●	●	●	●	●	●	●
1.04	Mineral slurries used in the manufacture of paint		●			●		●
1.05	Polymer dispersions	●	●			●	●	●
1.06	Glues and adhesives	●	●	●		●	●	●
1.07	Building and construction materials					●	●
1.08	Mineral slurries used in the manufacture of paper coatings.		●			●	●	●
1.09	Fountain solutions in the paper industry					●	●
1.10	Additives for the production of a. paper, b. leather and c. textile	●				●	●
1.11	Printing inks		●			●	●	●
1.12	Lubricants	●
1.13	Drilling fluids				●	●	●
1.14	Pesticides formulations					●	●
	PT9 preservative for
2.1	a. Textile, b. paper, c. rubber, d. polymerised materials			●
2.2	Leather intermediates			●
	PT12 Slimicide in
3	Installations in the paper industry				●
4	PT13 preservative in metalworking fluids (soluble oil, semi-synthetic and synthetic types), metal cleaners, and water-based hydraulic fluids		●	●	●			●

^a: Nipacide BIT (AS) 20: dosage in MWF concentrate is 2,5-25 g product/kg concentrate but is diluted further to reach a tank side concentration in the MWF of 0.05-0.5 g a.s./kg preserved product.

^b: Nuosept: dosage in MWF concentrate is 20-40 g product/kg concentrate but is diluted further to reach a tank side concentration in the MWF of 0.095-0.475 g a.s./kg preserved product.

^c: Canguard Ultra Bit 20 Le and Rocima 640 Biocide: MWF dosing is 0.5 to 1.8 kg preserved product and a tank side concentration of 0.1-0.36 g a.s./kg preserved product

6.2 Environmental profile of active substance

The predicted no effect levels (PNECs) based on the ecotoxicological data are presented in Table E.2a and b. BIT has a low potential for bioaccumulation due to low log Kow. Primary poisoning due to direct exposure to this product is not expected, therefore the risk to birds and mammals is relatively low and these PNECs are not presented.

Table E.2 PNECs for BIT

Compartment	Lowest endpoint	AF	PNEC	Test/species
Aquatic	NOEC: 0.0014 mg/L	10	0.14 µg/L	algae (Selenastrum capricornutum)
Sediment	NOEC: 11.7 mg/kg dwt	100	0.025 mg/kg wwt	Midge larvae (Chironomus riparius)
STP	EC₂₀: 3.3 g/L	20	0.17 mg/L	respiration rate
Marine water	NOEC: 0.002 mg/L	100	0.02 µg/L	algae (Selenastrum capricornutum)
Marine sediment	NOEC: 11.7 mg/kg dwt	1000	0.0025 mg/kg wwt	Midge larvae (Chironomus riparius)
Soil	LC50: 18.4 dwt	100	0.16 mg/kg wwt	Lettuce
Birds	-		-
Mammals	-		-

dwt: dry weight, wwt: wet weight, bw: body weight

6.3 Environmental exposure assessment

6.3.1 Chemistry and/or metabolism

Although BIT is classified as not readily biodegradable, the compound does show significant degradation in an STP simulation study, thereby forming several metabolites. Comparison of measured data with QSAR values of BIT showed that the EC50 0.028 mg/L of the most sensitive species Selenastrum is a factor of 10 lower than the QSAR EC50 (0.302 mg/L), thus the reliability of the QSAR calculations is questionable for the metabolites if they remain similar to the parent compound. QSAR L(E)C50 for the metabolites indicated a lesser or similar toxicity than the parent. No further ecotoxicity information on the metabolites is available. Even with the factor 10 found in the comparison between test result and QSAR, it is most likely that the metabolites have a lower toxicity than the parent, and therefore for the risk assessment it is assumed that the risk of BIT covers that of the metabolites as well.

6.3.2 Distribution in the environment

Various phases in the life cycle of a product may cause emissions and environmental exposure. In the risk assessment, emissions from the application phase, service life and waste phase of the product are considered. Emissions from active substance production and product formulation are not part of the risk assessment.

Emission of the active substance during the waste phase of end-product to which the products are added is not expected as the solid end-products are finally discharged as waste and usually burned in The Netherlands. Therefore, emission to the environment was only assess for the application phase and the service life phase in case of preservatives. Table E.3 summarises the receiving environmental compartments that have been identified as potentially exposed during the use of the product for the different applications.

Table E.3. Foreseeable routes of entry into the environment on the basis of the intended use.

	Main scenario	Environmental compartments and groups of organisms exposed
	Main scenario	STP	Freshwater¹	Saltwater¹	Soil^{2, 3}	Air	Birds and mam-mals
	PT6 In can preservatives in
1.01	Washing and cleaning products and detergents	++	++/+	+/- (Q)	++	+/++(Q)	-**
1.02	Car wash fluids	++	++/+	+/- (Q)	++	-	-**
1.03	Paints and coatings	++	+	- (Q)	++	-	-**
1.04	Mineral slurries used in the manufacture of paint	++	+	- (Q)	++	-	-**
1.05	Polymer dispersions	++	+	- (Q)	++	-	-**
1.06	Glues and adhesives	++	+	- (Q)	++	-	-**
1.07	Building and construction materials	++	+	- (Q)	++	-	-**
1.08	Mineral slurries used in the manufacture of paper coatings.	++	+	- (Q)	-	-	-**
1.09	Fountain solutions in the paper industry	++	+	- (Q)	-	-	-**
1.10	Additives for the production of a. paper, b. leather and c. textile	++	+	- (Q)	+	-	-**
1.11	Printing inks	++	+	- (Q)	-	-	-**
1.12	Lubricants
1.13	Drilling fluids	++	+	++	+	-	-**
1.14	Pesticides formulations	++	+	- (Q)	++	-	-**
	PT9 preservative for
2.1	a. Textile, b. paper, c. rubber, d. polymerised materials	++	+	- (Q)	+	-	-**
2.2	Leather intermediates	++	+	- (Q)	-	-	-**
	PT12 Slimicide in
3	Installations in the paper industry	++	+	- (Q)	-	-	-**
4	PT13 preservative in metalworking fluids (soluble oil, semi-synthetic and synthetic types), metal cleaners, and water-based hydraulic fluids	++	+	- (Q)	-	-	-**

++ Compartment directly exposed, + Compartment indirectly exposed, (+) Compartment potentially exposed (but unlikely significant concern due to a.s. hazard data and scale of exposure), - Compartment not exposed, (Q) Qualitative assessment, depending on application, ¹ Including sediment, ² Including groundwater, and soil

6.3.3. Predicted environment concentration calculations

Emission scenarios

For all intended uses, the predicted environmental concentrations (PECs) for BIT were calculated using European ESD models (see Table E.4.) with the exception of PT9 plant pot treatment and the use as a preservative in pesticide formulations. Predicted environmental concentrations were calculated using the ESD scenarios in EUSES 2.1.2 and/or in Excel. SimpleTreat was used to model the compounds’ behaviour in the STP and the concentrations in the STP’s effluent. Subsequent distribution in the environment was calculated according the Technical Guideline Document (TGD). The exposure was assessed by using the defaults unless otherwise noted. The use concentrations of the products are shown in Table E.1. Degradation of BIT is taken into account, thereby assuming that the metabolites formed are not contributing to the toxicity of BIT. Although this is a likely conclusion (see earlier discussion in section 6.3.1), this is however still under discussion in the EU.

Table E.4. Relevant exposure scenarios for the intended uses as

	application	scenario applied
1.01 1.02	PT06 - In-can preservation of water based detergents and laundry products including car wash fluids – domestic use (covering also detergents) (total emission for a city) and industrial use	ESD for washing detergents as presented in dCAR IPBC – PT06
1.03 1.04 1.05 1.06 1.07	PT06-Paints and coatings, also covering additives like slurries used for the production of paints and coatings, polymer dispersions, glues and adhesives and building materials - professional and non-professional use (outdoors)	ESD for PT08 wood preservatives (draft of 2010) and the ESD for PT10 masonry preservatives (2002)
1.08	PT06 – preservative for mineral slurries in the paper industry	ESD PT06/07/09 for paper coating and finishing. Ineris/EUBEES report 2001
1.09 1.10a 1.11	PT06 – fountain solutions and additives for paper production and printing ink	ESD PT06/07/09 for paper coating and finishing. Ineris/EUBEES report 2001
1.10b 2.2	PT6 Additives for the production of leather and PT9 Leather intermediates	ESD for PT09 – leather industry, Ineris 2001 with additional information from the OECD report 2004 ESD for leather industry
1.10c	Additives for the production of textile and textile end products	OECD 2004 ESD nr 7 on textile finishing industry. Outdoor use in tents (ctgb scenario)
1.12	Lubricants	**
1.13	Drilling fluids PT 6 - the prevention and/or control of slime growth on materials, equipments and structures, used in industrial processes for the off shore and on shore oil and gas exploration industry	CHARM model. (February 2005)
1.14	Pesticides formulations	Worst case repeated application to bare soil
3	PT 12 - the prevention and/or control of slime growth in the paper industry	ESD for PT12, EUBEES ESD (2003)
4	PT13 – conservation of metalworking fluids	ESD EUBees for PT13, metalworking fluids. ESD OECD 2011 for PT13, metalworking fluids.

** no calculations; as risk is considered to be similar to the PT13, conservation of metalworking fluids

PT06: Washing and cleaning products and detergents and Car wash fluids

Realistic worst case PT06 for household products is the use as a preservative in fabric softeners and laundry detergents. This model assumes that every household has a washing machine, with 4500 houses connected to the STP, that the washing machine runs once a day and that 150 ml product is used for one run. This model was presented in the dCAR of IPBC.

PT06: In-can preservation of paints and coatings including mineral slurries, polymer dispersions, glues and adhesives and building and construction materials

Leaching data for the active substance of the active substance from paints and coatings and other products was not supplied. Therefore, it was assumed that 100% leached during its total service life (leaching rates were similar for the initial (30 days) and longer assessment period (1795 days or 7200 days for construction materials) Realistic worst case scenarios to assess exposure resulting from outdoor application of paints and plasters on a local scale i.e. direct emission to soil and surface water from a single application or the emission to one STP is presented below:

- direct release to surface water: PT08 (version 2012, new draft ESD) offers a worst-case scenario for direct exposure to surface water by spilling during application of the paint and leaching to during service life which assumes that a bridge of 10 m² above a pond of 1000 m³ is painted by brushing;

- STP and indirect release to surface water: The scenario was adapted from PT10 which offers a scenario for treating masonry in cities where spills and precipitation containing the biocides (leaching) of 2000 houses is collected and discharged via the sewer system to an STP. Calculation were only made for façades (125 m²) and not for roofs as they are usually not painted. This scenario results in PECs for both STPs, and surface and sediment after purification;

- direct release to soils: PECs for soils were calculated by applying the brushing house scenario according to PT08. This scenario assumes that the soil (12.5 m³) adjacent of the façade (125 m²) is polluted by spilling during application and leaching during service life.

Because amateurs spill more paint (5%) than professionals (3%) during application, PECs were calculated for non-professional use as this covers the worst-case scenario. For paints and coatings a service life of 5 years (1825 days) for construction materials a service life of 20 years (7200 days) was considered. Degradation of the active substances was included for directly exposed water and soil.

PT06: mineral slurries and fountain solutions and printing ink in the paper industry and

PT12 slimicide in paper production installations

The risk of emission to the environment for mineral slurries was taken as a worst case for the preservation of mineral slurries and other water based fluids used in the paper industry. As mineral slurries are part of the coating and finishing process, the ESD on paper coating and finishing (Ineris/EUBEES 2001) has been used. This ESD presents a tonnage and a consumption model scenario. The consumption model provided in the ESD was used with daily paper production taken from the German survey (Table 3 in ESD) as that gave the highest local emission rates and was considered a realistic worst case emission scenario.

For the use as slimicide the EUBEES ESD document of 2003 was used assuming a shock dosing of 4 time a day.

PT09 preservative in paper.

No separate ESD was developed for this type of use. Identified uses are e.g. treated paper wraps for soap, but also the use in paper boxes for growing plants. At present the latter type of use is covered by the polymeric material scenario for emissions to soil during in service. The production phase is covered by the PT6 application in paper scenario.

PT6 Lubricants

Risk assessment is covered by the scenarios for metal working fluids and uses as pesticides preservation.

PT6 drilling fluids

The CHARM-model (Chemical Hazard Assessment and Risk Management, version 1.4, February 2005) offers various exposure scenarios for biocide use applied during offshore oil exploration, including exposure models for the use of chemicals in drilling mud. All default values were used, except for the depth of the marine water body: this was set to 20 meters as this is more appropriate for Dutch coastal waters.

PT6 Pesticides formulations

No scenario is available. As a worst case values on amounts of pesticides and frequencies of application were derived from questioning PPP experts and used as input for soil emission of the preservative.

PT6 and PT9 leather,

The products are only applied in the leather tanning process and not meant to preserve end-products such as clothing and sofas. The tannery’s waste water is mixed with other waste water streams from the tannery and via an on-site or industrial STP discharged to the surface water. Different fixation fractions occur during each process, from 0% fixation in the pre-soaking to 80% fixation during tanning (OECD ESD defaults). Therefore the fixation was set to 20% which is the average of the 4 phases identified in the standard EUBEES ESD.

PT6 and PT9 in rubber, polymer and textile

PT9 Polymer applications are covered by the assessment of outdoor use of polymeric materials in constructions. This is considered worst case also for uses in rubber and PT6 and PT9 applications in textile.

PT13

Exposure was estimated using the ESD for both water soluble lubricants and cooling lubricant emulsions representing the worst-case and realistic case, respectively. A tiered approach was used to assess the risks for metal working fluids. For Tier I, the EU BEES ESD (the standard ESD in the EU) was used which contains a worst case risk of metalworking fluids.

However, the ESD offers little information on the industry itself and how emissions take place to the environment nor its frequency. Therefore, as a Tier II, two scenarios were run based on the OECD 2011 ESD:

- For Tier IIa, the worst case emission for metal working fluids during metal grinding was calculated to assess the risk of a peak emission. Metal working fluids of the machines are replaced at the end of their service life. In general there are 48 machines which will be cleaned all 8 times a year. The worst case is if all machinery (48 per factory) is cleaned at once and the waste water is emitted at the same time to the STP. However, this would only result in peak emissions 8 times a year and thus is an intermittent release. Therefore for this scenario, the PNEC chronic was replaced by a PNEC intermittent release as it only occurs 8x a year that the MWF is replaced in a machine.

- For Tier IIb, the PEC was refined assuming that all the cleaning of the machines is evenly spread over the year. Added to that emission are all other potential emissions to the environment by other losses (spillages, MWF adsorbed to metal parts, etcetera).

In contrast to the ESD the OECD scenario does not distinguish between water soluble and water emulsifiable metalworking fluids. To be consistent with the EU methodology, the fraction of the biocide that adsorbs to the oil fraction according to the EU ESD was implemented in the OECD methodology.

6.4 Risk characterisation for the environment

For each relevant compartment, PECs are divided by PNECs. The risk is considered unacceptable when PEC/PNEC >1.

6.4.1. Aquatic compartment (incl. sediment) and STP

6.4.1.1. Water and sediment organisms and micro-organisms in the STP

The risk for the micro-organisms in STP was assessed using the PNEC of BIT and setting the degradation rate in the STP on 0.315 1/h (7.56 1/d) derived from an STP simulation study. This is considered acceptable because the concentrations in the influent are expected to be considerably below the EC50 to micro-organisms (in the range of 13 to 30 mg/L). , with the exception of PT12 applications. See further discussions on STP below.

6.4.2. Aquatic compartment (incl. sediment)

Direct exposure to surface water

Direct exposure to the surface water is only relevant when applied in paints, coatings, joint sealants and polymers (PT9) that are applied outdoors. The risk characterisation for the aquatic compartment (freshwater and sediment) receiving the active ingredients directly are presented in Table E.5.

Table E.7. PEC and PEC/PNEC ratios for direct exposure to fresh water and sediments.

Scenario	Dosage	fresh water		sediment
Scenario	Dosage	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
PT6 in paint, coatings, glues and adhesives
application phase	High dosage	4.90E-05	0.35	2.77E-04	0.011
service life phase
after the initial assessment period		6.51E-05	0.465	3.68E-04	<0.003
after the longer assessment period		1.03E-03	7.35	5.81E-03	0.233
Emission during application is prevented by risk mitigations
after the initial assessment period		1.61E-05	0.115	9.10E-05	0.004
after the longer assessment period		9.64E-04	6.88	5.45E-03	0.218

PT6 in paint, coatings, glues and adhesives
application phase	Low dosage	9.80E-06	0.070	5.54E-05	0.0022
service life phase
after the initial assessment period		1.30E-05	0.093	7.36E-05	<0.001
after the longer assessment period		2.06E-04	1.470	1.16E-03	0.0466
Emission during application is prevented by risk mitigations
after the initial assessment period		3.22E-06	0.023	1.82E-05	0.0008
after the longer assessment period		1.93E-04	1.376	1.09E-03	0.0436
Polymers, representing building and construction materials
after the initial assessment period	High dosage	1.16E-04	0.83	6.56E-04	0.026
after the longer assessment period		2.79E-02	199	1.58E-01	6.3
after the initial assessment period	Low dosage	2.32E-05	0.17	1.31E-04	0.01
after the longer assessment period		5.57E-03	39.80	3.15E-02	1.26

At both the proposed high and low dosages the PEC/PNEC ratios in freshwater are >1 after a longer assessment period. However, a risk to groundwater has also been identified (see section 6.4.3.1) and therefore the applications for these intended uses will be restricted to indoors only. Due to this restriction, also the direct emission to surface water will be prevented.

Table E.8. PEC and PEC/PNEC ratios for indirect exposure to fresh water and sediments of BIT for use in cleaning agents and detergents (PT06).

Scenario	Dosage	STP		fresh water		sediment
Scenario	Dosage	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
In-can preservation of cleaning agents and detergents (PT06)
Industrial areas
BIT	High dosage	7.72E-03	4.54E-02	7.70E-04	5.50	4.35E-03	0.174
	Low dosage	1.54E-03	9.08E-03	1.54E-04	1.10	8.70E-04	0.035
Institutional and domestic - Sanitary purposes
BIT	High dosage	1.93E-03	1.13E-02	1.92E-04	1.37	1.09E-03	0.044
	Low dosage	3.86E-04	2.27E-03	3.85E-05	0.27	2.18E-04	0.009
Hospitals
BIT	High dosage	2.89E-03	1.70E-02	2.89E-04	2.06	1.63E-03	0.065
	Low dosage	5.79E-04	2.06E-05	5.77E-05	0.41	3.26E-04	0.013
Wash detergents
BIT	High dosage	1.32E-02	7.76E-02	1.32E-03	9.40	7.44E-03	0.298
	Low dosage	2.64E-03	1.55E-02	2.63E-04	1.88	1.49E-03	0.060

All the proposed intended uses in detergents result in PEC/PNEC ratios >1 at the high dosages. In Institutional and domestic - sanitary purposes and hospital the lowest dosage is acceptable. Combined emissions, however will lead to a PEC/PNEC ratio >1. Therefore the use of BIT containing preservatives in washing and cleaning agents and detergents must be restricted to sanitary purposes with a maximum acceptable dosage of 0.2 g a.s./kg product. Wash detergents and treatment of industrial areas must be removed from the label.

Table E.9. PEC and PEC/PNEC ratios for indirect exposure to fresh water and sediments of BIT for use in paints (including mineral slurries), coatings, glues adhesives, polymer dispersions on houses in city, (PT06).

Scenarios	Dosage	STP		fresh water		sediment
Scenarios	Dosage	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
Paints and coatings glues adhesives, on houses in city, (PT06)
application phase*	High dosage	1.89E-04	0.001	1.89E-05	0.135	1.07E-04	0.004
service life phase
from recently painted houses		3.41E-05	<0.001	3.41E-06	0.024	1.92E-05	<0.001
from older houses		2.04E-03	0.012	2.04E-04	1.46	1.15E-03	0.046
from all houses		2.07E-03	0.012	2.07E-04	1.48	1.17E-03	0.046
total		2.26E-03	0.013	2.26E-04	1.61	1.28E-03	0.051

application phase*	Low dosage	3.78E-05	2.00E-04	3.78E-06	0.027	2.14E-05	0.001
service life phase
from recently painted houses		6.81E-06	<0.001	6.81E-07	0.005	3.85E-06	0.001
from older houses		4.08E-04	2.40E-03	4.07E-05	0.292	2.30E-04	0.009
from all houses		4.14E-04	2.40E-03	4.14E-05	0.296	2.34E-04	0.009
total		4.52E-04	2.60E-03	4.52E-05	0.322	2.56E-04	0.010

Polymers used on houses (PT9)
service life phase
from recently painted houses	High dosage	6.20E-05	<0.001	6.20E-06	0.044	3.50E-05	0.001
from older houses		1.49E-02	0.088	1.49E-03	10.6	8.41E-03	0.336
from all houses		1.49E-02	0.088	1.49E-03	10.6	8.44E-03	0.337
service life phase
from recently painted houses	Low dosage	1.24E-05	<0.001	1.24E-06	0.009	7.01E-06	<0.001
from older houses		2.98E-03	0.018	2.98E-04	2.12	1.68E-03	0.067
from all houses		2.99E-03	0.018	2.99E-04	2.12	1.69E-03	0.067

*: 1 house only

At both intended uses, the proposed high dosage results in PEC/PNEC ratios >1 in surface water. An acceptable risk is at a maximum acceptable dosage of 0.3 g/kg for paints and coatings. For polymers used outside, however, even at the lowest dosage a risk is identified, therefore this type of use must be removed from the label.

Use in PT12 and PT06 – Paper industry

Only the use in printing and writing paper and special and industrial paper (all types) provide a safe use for emissions to water at the highest dosage. A dosage of 0.1 g/kg is safe in surfaces water for all types of uses in mineral slurries for paper except for news print. It is expected that the use in fountain solutions and additives for paper production and printing ink is covered by the risk assessment of mineral slurries. Uncertainty, however, consists in the combined application in e.g. mineral slurries and other additives and ink. At present this is not accounted for. It is however likely that the emissions from these fluids only marginally increase the risk as the amount of mineral slurry used in the paper industry is much higher. Therefore also these applications are considered acceptable at the lowest proposed dosage of 0.1 g a.s/kg paper additive . Use as a slimicide does not result in a safe use and will therefore removed from the WGGA.

Table E.10 PEC and PEC/PNEC ratios for indirect exposure to fresh water and sediments of BIT for application in mineral slurries for paper (PT06) and as slimicide in the paper industry (PT12).

Compound	STP		fresh water		sediment
Compound	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
PT06: In-can preservative in mineral slurries for paper - High dosage
news print	2.08E-01	1.22	8.32E-04	5.94	5.71E-03	0.23
printing and writing paper	2.24E-02	0.13	8.96E-05	0.64	6.16E-04	0.02
printing and cardboard for packaging	1.17E-01	0.69	4.68E-04	3.34	3.22E-03	0.13
paper for sanitary and domestic use (tissue paper)	1.03E-01	0.60	4.11E-04	2.94	2.82E-03	0.11
special and industrial paper (all types)	3.46E-02	0.20	1.39E-04	0.99	9.51E-04	0.04
Flat cardboard	1.63E-01	0.96	6.50E-04	4.64	4.46E-03	0.18
corrugated cardboard	1.63E-01	0.96	6.50E-04	4.64	4.46E-03	0.18
PT06: In-can preservative in mineral slurries for paper - Low dosage
news print	4.16E-02	0.24	1.66E-04	1.19	1.14E-03	0.046
printing and writing paper	4.48E-03	0.03	1.79E-05	0.13	1.23E-04	0.005
printing and cardboard for packaging	2.34E-02	0.14	9.36E-05	0.67	6.43E-04	0.026
paper for sanitary and domestic use (tissue paper)	2.06E-02	0.12	8.22E-05	0.59	5.65E-04	0.023
special and industrial paper (all types)	6.93E-03	0.04	2.77E-05	0.20	1.90E-04	0.008
Flat cardboard	3.25E-02	0.19	1.30E-04	0.93	8.93E-04	0.036
corrugated cardboard	3.25E-02	0.19	1.30E-04	0.93	8.93E-04	0.036
PT12: Slimicide in the paper industry - High dosage
Shock treatment	416	2447	1.66	11885	9.37	375
PT12: Slimicide in the paper industry - Low dosage
Shock treatment	83.2	489	0.33	2377	1.87	75

PT12 slimicides in the oil and gas industry

Drilling fluids and drilling mud are used in the oil and gas drilling industry. Oil drilling and gas drilling occurs on land and off shore in the Netherlands. As the environmental risk assessment is significantly different between on land and off shore, these will be discussed separately.

On land

Water based mud used on land does not get directly disposed but is treated as it gets contaminated with oil. This waste falls under the Dutch waste water sector plan 58. The oil is extracted and used as fuel. The sediment fraction of the mud gets a thermal treatment or burned at a waste disposal. Any remaining BIT in these fractions is burned and is therefore eliminated. Waste water will be treated as chemical waste due to other contaminants present in the water, including persistent organic pollutants (Dutch waste water sector plan 58). During chemical treatment, it is likely that the degradation of BIT will approximate 67%, in line with results for the biodegradation test, but considering the amounts of product used, this will result in an unacceptable risk. Onshore use will be excluded from the lable...

Table E.11. PEC and PEC/PNEC ratios for micro-organisms in the STP and freshwater and sediment indirectly exposed

Compound	STP		freshwater		sediment
Compound	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
*PT6: (onshore, indirect exposure to freshwater, batchwise dosing)*
Drilling mud treatment	4.67E-01	2.75	4.67E-02	333	2.64E-01	10.6

Off shore

The CHARM model predicts a potential risk for BIT for marine species, see Table E.11. However, CHARM does not include degradation rate in sea water and has conservative water refreshing rates. MAMPEC model is deemed to be more realistic regarding water refreshing rates and was used for Tier II calculations. There are some conservative assumption in this calculation; lowest degradation rate was used of 29.3 days at 9 ˚C and that 20 platforms are located on 1 km². The risk to marine organisms is 1.30 and does exceed the risk limit when the highest dosage 0.5 g a.s./kg treated product is used. A maximal acceptable dose level can be calculated at 0.38 g a.s./kg treated product and the risk is thus considered acceptable for the intended use. As we have set the depth of the marine water for both gas and oil industries at 20 meters, the risk is similar for both industries. Therefore, the risk to marine organisms in the offshore use in oil and gas industry is considered acceptable if the maximum dosage is lowered to 0.38 g a.s/kg treated product.

Table E.12. PEC/PNEC ratios for the intended use PT12 – slimicides in the oil industry

Scenario	Dosage	PEC/PNEC ratios marine waters
		PEC mg/L	PNEC mg/L	PEC/PNEC
Drilling mud, all sections
Tier I – CHARM model	High dosage	6.25E-04	0.000014	44.6
Tier II – MAMPEC model 20 platforms per km²		1.82E-05	0.000014	1.30

PT06 and PT09, preservation of additives in textile and leather industry

The outcome of the risk assessment indicates that the use in additives and as preservative of textile will result in a release to surface water and causing a risk for water organisms at high and low dosage. Use in the textile industry as PT6 and PT9 application must be removed from the label.

Table E.13. Preservation of additives for the production of textile (PT6) and preservation of textile (PT9)

	STP		fresh water		sediment
	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
Fluids used in the textile industry – high dosage
production phase	8.88E-02	0.522	8.88E-03	63.4	5.02E-02	2.01
service life phase	6.60E-03	0.039	6.60E-04	4.71	3.73E-03	0.149
Fluids used in the textile industry – low dosage
production phase	1.78E-02	1.04E-01	1.78E-03	12.68	1.00E-02	0.40
service life phase	1.32E-03	7.80E-03	1.32E-04	0.94	7.46E-04	0.0298

The outcome of the risk assessment indicates that the use in additives and as preservative of leather intermediates will result in a release to surface water and causing a risk for water organisms. Lowering the maximum dose level to 0.18 g a.s./kg treated product results in an acceptable risk. Use as PT9 preservative in leather intermediates results in an unacceptable risk even at the lowest dose level. Use in the leather industry as PT9 application must be removed from the label.

Table E.14 Preservation of additives for the production of leather (PT6) and intermediates of leather (PT9)

Scenario	STP		fresh water		sediment
Scenario	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
PT6 applications in additives for curing, soaking or tanning in leather
High dose	1.37E-02	0.08	3.88E-04	2.77	3.86E-03	0.15
Low dose	2.73E-03	0.02	7.75E-05	0.55	7.72E-04	0.03
PT9 Application during curing, soaking or tanning to leather intermediates
High dosage	0.29	1.70	7.51E-03	53.68	4.25E-02	1.70
Low dosage	0.058	0.34	1.50E-03	10.74	8.49E-03	0.34

Preservative in metal fluids - PT13

Worst case risk of metalworking fluids is the use as water soluble fluids. The risk to micro-organisms is > 1, see Table E.15, and thus not considered acceptable. Also the risk of to aquatic organism is > 1 for the standard EU ESD (Tier I in Table).

The risk to micro-organisms in the STP remains > 1 with this refinement for both Tier II scenarios and thus considered unacceptable for batch wise emission. BIT can inhibit the degradation in an STP at higher concentrations in the STP which may be the case for this type of release from metal working fluids. This in fact indicates that the calculated PEC-PNEC ratios in surface water and sediment may be underestimated. Continuous release, however, shows an acceptable risk to micro-organisms, but in surface water the risk is still unacceptable. The same conclusion holds for lubricants used in the metal working industry.

Table E.15. PEC and PEC/PNEC ratios freshwater and sediment for uses in metal working fluids (OECD)

Scenario	STP		fresh water		sediment
Scenario	PEC (mg/L)	PEC/PNEC	PEC (mg/L)	PEC/PNEC	PEC (mg/kg wwt)	PEC/PNEC
Tier 1 - High dose
Emulsifiable metal working fluids	7.73E+00	45.5	7.72E-01	5517	4.37E+00	175
Water-soluble metal working fluids	3.09E+00	18.2	3.09E-01	2204	1.74E+00	7.3
*Tier IIa – OECD 2011,* *all machines cleaned at the same time* - high dose
Emulsifiable metal working fluids	1.24E+00	7.3	1.24E-01	886	7.01E-01	28
Water-soluble metal working fluids	2.48E+00	14.6	2.48E-01	1769	1.40E+00	56
*Tier IIb – OECD 2011, machines cleaned throughout year – high dose*
Emulsifiable metal working fluids	2.72E-02	0.16	2.72E-03	19.4	1.54E-02	0.614
Water-soluble metal working fluids	5.43E-02	0.319	5.43E-03	38.8	3.07E-02	1.23

6.4.1.3. Surface water intended for the abstraction of drinking water

BIT is included on the recommended list of biocides to be monitored for drinking water from surface water (RIVM, 2010). The RIVM, however, concludes that at present monitoring data are lacking. Furthermore RIVM signals that few data on biocides consumption are available. These data are needed to predict the concentrations in surface water. From this the Ctgb concludes that there are in this case insufficient indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. Thus the standards for surface water destined for the production of drinking water are met for all products.

6.4.2. Atmosphere

BIT has a vapour pressure of 2.76E-04 Pa, indicating that BIT is hardly volatile. AOPwin calculates for BIT a half life of 0.947 days in air (24hr day, 0.5*10⁶OH/cm³). This calculated half live is below the trigger of < 2 days that is used as cut off value to identify chemicals that could be of potential concern for long range transport through the atmosphere. The standards for atmosphere are met for all products.

6.4.3. Terrestrial compartment

6.4.3.1 Soil organisms and non target arthropods (including bees)

Direct emission to soil occurs if the active substances leach out of paints, coatings, polymeric materials or textiles to which the product is applied as a preservative. Other uses resulting in relevant emission to soil can be the use of BIT in lubricants and in pesticide formulations. Calculations were done for worst case application to polymeric materials and pesticides applied to bare land once a week.

Table E.15. PEC and PEC/PNEC ratios for soils (high dosage).

Compound	PEC (mg/kg wwt)	PEC/PNEC
outdoor use of treated polymers
application phase	not applicable
service life phase
after the initial assessment period	1.84E-03	0.012
after the longer assessment period	1.84E-03	0.012
Outdoor use of treated textile
Use as preservative of tents	5.94E-02	0.371
Preserved pesticide treatment
30 days after treatment	1.6E-04	0.00084

For BIT the PEC/PNEC ratios for soil is <1 (see table E.14) and therefore the risk to soil organisms is acceptable for all types of treated products leaching or emitted to soil.

6.4.3.2 Groundwater

Assessment of the drinking water criterion defines that the concentration of the active substance and the relevant metabolites in groundwater for the preparation of drinking water needs to be < 0.1µg/L.

The leaching from paints and coatings, polymeric material and textiles treated with the product or pesticides applications with the preservative can result in emission to soil and thus potentially to groundwater. The active substance is rapidly degraded in soil (half live is 0.56 days at 12 ˚C)and is not expected to reach ground water. Metabolites formed are less toxic but potentially reach ground water.

A best case was used for groundwater emission calculations, which is the use as a preservative in paints and coatings. To assess the emission to groundwater, it is assumed that there are 35 houses on 1 hectare of land and all treated with paint or coating containing BIT. Pore water concentrations estimations (Equilibrium partitioning estimation, TGD) were > 0.1 µg/L, therefore groundwater concentrations were modelled using PEARL 3.3.3. The expected groundwater concentrations were < 0.001 µg/L for BIT and thus the criteria for the exposure to groundwater have been met for BIT. The major metabolites Saccharin (SACH) and o-sulphobenzamide (SBAM), however, have a lower degradation rate. Assuming that these metabolites are inherently biodegradable, the scenario calculated the following concentrations in groundwater: SBAM 169 g/L and SACH 7.07 µg/L, which exceeds the 0.1 µg/L indicating the outdoor use of products treated with BIT must be removed from the label. Also the use in pesticides must be removed from the label, considering that the assessment done, is best case

6.4.3.3. Persistence in soil

The criteria for persistency in soil is that the degradation should be < 180 days at 12 ˚C in soil. BIT degrades rapidly in soil under aerobic conditions for which a half life of 0.56 days at 12˚C was observed. The soil degradation study at 20^oC indicated that after 100 days 40% of the active substance was transformed to CO₂. Recalculation to 12^oC this results in a degradation rate of 170 days. Therefore the standards for the persistency in soil have been met for BIT.

6.4.3. Non compartment specific effects relevant to the food chain

6.4.4.1. Bioconcentration

As the log K_ow of BIT is < 3 (log K_ow = 1.3 L/kg), the potential for bioaccumulation is considered low and no further assessment of secondary poisoning is deemed necessary for all products containing this substance.

6.4.4.2. Primary and secondary poisoning of birds and mammals

The low potential for bioaccumulation indicates that the risk for birds and mammals is low regarding secondary poisoning. Hence the product meets the standards for the risk to birds and mammals. Primary poisoning is not expected for the intended uses.

6.5. Measures to protect the environment (risk mitigation measures)

The legal Instructions for Use (WG/GA) of the products have been checked. No risk mitigations were proposed by the applicants. Restrictions in use and restrictions in maximum acceptable dosages must be implemented on the WG/GA of the different products.

6.6 Overall conclusion for the aspect Environment

An authorisation of a biocide in the Netherlands is only possible when the risks related to the product application are acceptable. An overview of the risks is shown in table E.12.

Based on the available data, it can be concluded that for all products restrictions must be included on the label and implemented. When these products used in accordance with the proposed label (WG/GA) they comply with the environmental standards when taking the following risk mitigation measure into account:

Acticide bw20: The WG/GA refers to detergents (not specified further), additive to leather and textile and lubricants (not specified further). These uses must be removed from the label as unacceptable risks have been identified for aquatic organisms.

Applications of in paints, coatings, polymers and glues require the following mitigations: Products to which Acticide bw20 are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings en polymeerdispersies) waaraan Acticide bw20 als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved paper additives is lowered from 1 to 0.5 g/kg to prevent potential unacceptable risks to aquatic organisms.

Canguard Ultra Bit 20 Le: The WG/GA refers to metalworking fluids. This use has to be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications of in paints, coatings, polymers, glues and adhesives require the following mitigations due to unacceptable risks to groundwater and aquatic organisms: Products to which Canguard Ultra Bit 20 Le are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings, lijm en kleefstoffen, polymeeremulsies en minerale slurries voor verven,) waaraan Canguard Ultra Bit 20 Le als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved household surface cleaning products for treatment of surfaces and in in-can preservative in mineral slurries for paper must be lowered to 0.2 g a.s./kg preserved products or 1 g Canguard Ultra Bit 20 Le/kg preserved product to prevent potential unacceptable risks to aquatic organisms.

Nipacide BIT 20: The WG/GA refers to metalworking fluids. This use has to be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications in paints, coatings, glues and adhesives, polymers and rubber require the following mitigations: Products to which Nipacide BIT 20 are added are restricted to in house use only due to unacceptable risks to groundwater and aquatic organisms. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings, lijm en kleefstoffen, polymeren en rubber) waaraan Nipacide BIT 20 als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved household surface cleaning products for treatment of surfaces and as preservative for paper must be lowered to 0.2 g a.s./kg preserved product or 1.0 g Nipacide BIT 20 /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

Nipacide BIT AS 20: The WG/GA refers to metalworking fluids. This use has to be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications of in paints, coatings, glues and adhesives, polymers and rubber require the following mitigations due to unacceptable risks to groundwater and aquatic organisms: Products to which Nipacide BIT AS 20 are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings, lijm en kleefstoffen, polymeren en rubber) waaraan Nipacide BIT AS 20 als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved household surface cleaning products for treatment of surfaces and as preservative for paper must be lowered to 0.2 g a.s./kg preserved product or 1.0 g Nipacide BIT AS 20 /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

Nuosept BIG-A: The WG/GA refers to metalworking fluids. This use has to be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications in paints, coatings, the following mitigations due to unacceptable risks to groundwater and aquatic organisms: Products to which Nuosept BIG-A are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings) waaraan Nuosept BIG-A als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

Additionally the use as slimicide in oil exploration must be restricted to off-shore only and he maximum dosage must be lowered to 0.38 g a.s./kg preserved product or 2.0 g Nuosept BIG-A /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

Promex Clear: The WG/GA refers to additives in the textile and leather industry and use in pesticides. These uses must be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications in paints, coatings, glues and adhesives, polymer emulsions, building and construction materials the following mitigations due to unacceptable risks to groundwater and aquatic organisms: Products to which Promex Clear are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings, lijmen en kleefstoffen en hulpstoffen hiervoor, polymeer emulsies, en bouw en constructie materialen) waaraan Promex Clear als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

Applications in household cleaning and washing products is restricted to surface treatment. Additionally the maximum dosage for in-can preserved household surface cleaning products and as preservative for paper must be lowered to 0.2 g a.s./kg preserved product or 2.2 g Promex clear /kg preserved product;

Additionally the use in drilling fluids for the oil and gas exploration must be restricted to off-shore only and the maximum dosage must be lowered to 0.38 g a.s./kg preserved product or 4.3 g Promex Clear /kg preserved product to prevent potential unacceptable risks to marine organisms.

Promex Na20S: The WG/GA refers to additives in the textile and leather industry and use in pesticides. These uses must be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications in paints, coatings, glues and adhesives, building and construction materials the following mitigations due to unacceptable risks to groundwater and aquatic organisms: Products to which Promex Clear are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings, lijmen en kleefstoffen en hulpstoffen hiervoor, bouw en constructie materialen) waaraan Promex Na20S als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

Additionally the use in drilling fluids for the oil and gas exploration must be restricted to off-shore only and the maximum dosage must be lowered to 0.38 g a.s./kg preserved product or 1.9 g Promex Na20S /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

Rocima 640 Biocide: The WG/GA refers to metalworking fluids. This use has to be removed from the label as unacceptable risks have been identified for aquatic organisms. Applications of in paints, coatings, glues and adhesives, polymers require the following mitigations: Products to which Rocima 640 Biocide are added are restricted to in house use only. Therefore the following restriction has been added to the label:

Op het etiket van producten (verven, coatings, lijm en kleefstoffen, polymeren) waaraan Rocima 640 Biocide als conserveermiddel is toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved household surface cleaning products and as preservative additives for paper must be lowered to 0.2 g a.s./kg preserved product or 1.0 g Rocima 640 Biocide /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

Based on the available data, it can be concluded that the products Acticide BW20, Canguard Ultra Bit 20 Le, Nipacide BIT 20, Nipacide BIT AS 20, Nuosept BIG-A, Promex Clear, Promex Na20S, Rocima 640 Biocide when used in accordance with the revised labels (WG/GA) comply with the environmental standards.

7. Conclusion

ACTICIDE BW 20

The proposed field of use of ACTICIDE BW 20 control of bacteria, yeasts and fungi

a. In detergents

b. In paints and coatings

c. In polymer dispersions

d. In glues and adhesives

e. In additives for production of paper

f. In additives for production of leather

g. In additives for production of textile

h. In lubricants

ACTICIDE BW 20 is intended for professional use only.

For application of ACTICIDE BW 20 in products described under a, f, g and h, it is concluded that adverse environmental effects cannot be excluded.

For application of ACTICIDE BW 20 in products described under b t/m e, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings and polymer dispersions to which ACTICIDE BW 20 is added to is restricted to indoors use only and the following restriction has been added to the label of paints, coatings and polymer dispersions to which ACTICIDE BW 20 is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved paper additives is lowered from 1 to 0.5 g/kg to prevent potential unacceptable risks to aquatic organisms.

For application of ACTICIDE BW 20 in products described under a t/m h it can be concluded that the risk when applying the formulation ACTICIDE BW 20 in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

Based on the risk assessment, it can be concluded that adverse health effects are expected from indirect exposure to BIT as a result of use of ACTICIDE BW 20 in personal hygiene products containing residues of BIT due to incorporation of Acticide BW 20.

Based on the risk assessment, it can be concluded that no adverse health effects are expected from indirect exposure to BIT as a result of use of Acticide BW 20.

For end-products containing >0.033% BIT, adverse health effects after spraying of products containing Acticide BW 20 cannot be excluded. Therefore, the following text in the WG/GA needs to be included: Op het etiket van producten welke ACTICIDE BW 20 in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, f, g and h, as mentioned above can not be authorised

· safe use and efficacy is demonstrated for all the other proposed uses, when used as described on the Legal Conditions for Use and the Directions for Use (WG/GA). The following warning sentences should be prescribed on the label:

1. Paints, coatings and polymer dispersions containing ACTICIDE BW 20 can only be used indoors: “Op het etiket van producten waaraan ACTICIDE BW 20 als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke ACTICIDE BW 20 in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

3. From the risk assessment use of appropriate PPE (gloves and coverall) for uses in industrial settings is concluded. These protection measures are already required due to classification and labelling of ACTICIDE BW 20.

CANGUARD(TM) ULTRA BIT 20 LE Preservative

The proposed field of use of CANGUARD(TM) ULTRA BIT 20 LE Preservative is the control of bacteria and fungi:

In washing products,

a. In cleaning products

b. In detergents

c. In paints and coatings

d. In mineral slurries used in the manufacture of paint

e. In polymer dispersions

f. In glues and adhesives

g. In mineral slurries used in the manufacture of paper coatings

h. In printing inkts

i. As preservative in metalworking fluids

CANGUARD(TM) ULTRA BIT 20 LE Preservative is intended for professional use only.

For application of CANGUARD(TM) ULTRA BIT 20 LE Preservative in products described under a, c and j, it is concluded that adverse environmental effects cannot be excluded.

For application of CANGUARD(TM) ULTRA BIT 20 LE Preservative in products described under b, d t/m i, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings, glues and adhesives, polymer dispersions and mineral slurries to which CANGUARD(TM) ULTRA BIT 20 LE Preservative is added to, is restricted to indoors use only and the following restriction has been added to the label of paints, coatings, glues and adhesives, polymer dispersions and mineral slurries to which CANGUARD(TM) ULTRA BIT 20 LE Preservative is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved household surface cleaning products for treatment of surfaces (b.) and in in-can preservative in mineral slurries for paper (h.) must be lowered to 0.2 g a.s./kg preserved products or 1 g CANGUARD(TM) ULTRA BIT 20 LE Preservative /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

For application of CANGUARD(TM) ULTRA BIT 20 LE Preservative in products described under a t/m j it can be concluded that the risk when applying the formulation CANGUARD(TM) ULTRA BIT 20 LE Preservative in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of CANGUARD(TM) ULTRA BIT 20 LE Preservative: Op het etiket van producten welke CANGUARD(TM) ULTRA BIT 20 LE Preservative in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, c and j, as mentioned above can not be authorised

1. Paints, coatings, glues and adhesives, polymer dispersions and mineral slurries containing CANGUARD(TM) ULTRA BIT 20 LE Preservative can only be used indoors: “Op het etiket van producten waaraan CANGUARD(TM) ULTRA BIT 20 LE Preservative als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke CANGUARD(TM) ULTRA BIT 20 LE Preservative in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Nipacide BIT 20

The proposed field of use of Nipacide BIT 20 is the control of bacteria, yeast and fungi:

a. In washing products,

b. In cleaning products

c. In detergents

d. In paints and coatings

e. In glues and adhesives

f. As preservative for textile

g. As preservative for paper

h. As preservative for rubber

i. As preservative for polymerised materials

j. As preservative for leather intermediates

k. As preservative in metalworking fluids

Nipacide BIT 20 is intended for professional use only.

For application of Nipacide BIT 20 in products described under a, c, f, j and k, it is concluded that adverse environmental effects cannot be excluded.

For application of Nipacide BIT 20 in products described under b, d, e, g t/m i, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings, glues and adhesives, polymer dispersions and rubber to which Nipacide BIT 20 is added to, is restricted to indoors use only and the following restriction has been added to the label of paints, coatings, glues and adhesives, polymer dispersions and rubber to which Nipacide BIT 20 is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

For application of Nipacide BIT 20 in products described under a t/m k it can be concluded that the risk when applying the formulation Nipacide BIT 20 in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of Nipacide BIT 20: Op het etiket van producten welke Nipacide BIT 20 in een concentratie van meer dan 1.57 g/L of 0.157% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, c, f, j and k as mentioned above can not be authorised

1. Paints, coatings, glues and adhesives, polymer dispersions and rubber containing Nipacide BIT 20 can only be used indoors: “Op het etiket van producten waaraan Nipacide BIT 20 als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke Nipacide BIT 20 in een concentratie van meer dan 1.57 g/L of 0.157% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Nipacide BIT AS 20

The proposed field of use of Nipacide BIT AS 20 is the control of bacteria, yeast and fungi:

a. In washing products,

b. In cleaning products

c. In detergents

d. In paints and coatings

e. In glues and adhesives

f. As preservative for textile

g. As preservative for paper

h. As preservative for rubber

i. As preservative for polymerised materials

j. As preservative for leather intermediates

k. As preservative in metalworking fluids

Nipacide BIT AS 20 is intended for professional use only.

For application of Nipacide BIT AS 20 in products described under a, c, f, j and k, it is concluded that adverse environmental effects cannot be excluded.

For application of Nipacide BIT AS 20 in products described under b, d, e, g t/m i, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings, glues and adhesives, polymers and rubber to which Nipacide BIT AS 20 is added to, is restricted to indoors use only and the following restriction has been added to the label of paints, coatings, glues and adhesives, polymers and rubber to which Nipacide BIT AS 20 is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The maximum dosage for in-can preserved household surface cleaning products for treatment of surfaces and as preservative for paper must be lowered to 0.2 g a.s./kg preserved product or 1.0 g Nipacide BIT AS 20 /kg preserved product to prevent potential unacceptable risks to aquatic organisms

For application of Nipacide BIT AS 20 in products described under a t/m k it can be concluded that the risk when applying the formulation Nipacide BIT AS 20 in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of Nipacide BIT AS 20: Op het etiket van producten welke Nipacide BIT AS 20 in een concentratie van meer dan 1.57 g/L of 0.157% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, c, f, j and k as mentioned above can not be authorised

1. Products containing Nipacide BIT AS 20 can only be used indoors: “Op het etiket van producten waaraan Nipacide BIT AS 20 als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke Nipacide BIT AS 20 in een concentratie van meer dan 1.57 g/L of 0.157% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Nuosept BIG-A

The proposed field of use of Nuosept BIG-A is the control of bacteria:

a. In paints and coatings

b. In drilling fluids

c. As slimicide in installations in the paper industry

and the control of bacteria, yeast and fungi:

d. As preservative in metalworking fluids

Nuosept BIG-A is intended for professional use only.

For application of Nuosept BIG-A in products described under c and d, it is concluded that adverse environmental effects cannot be excluded.

For application of Nuosept BIG-A in products described under a and b, it is concluded that adverse environmental effects are not to be expected, if the use of paints and coatings to which Nuosept BIG-A is added to, is restricted to indoors use only and the following restriction has been added to the label of paints and coatings to which Nuosept BIG-A is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

The use as slimicide in oil exploration must be restricted to off-shore only and the maximum dosage must be lowered to 0.38 g a.s./kg preserved product or 2.0 g Nuosept BIG-A /kg preserved product to prevent potential unacceptable risks to aquatic organisms.

For application of Nuosept BIG-A in products described under a t/m d it can be concluded that the risk when applying the formulation Nuosept BIG-A in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of Nuosept BIG-A: Op het etiket van producten welke Nuosept BIG-A in een concentratie van meer dan 1.74 g/L of 0.174% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses c and d as mentioned above can not be authorised

· The use as slimicide in oil exploration must be restricted to off-shore only

1. Op het etiket van verven en coatings waaraan Nuosept BIG-A als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke Nuosept BIG-A in een concentratie van meer dan 1.74 g/L of 0.174% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Promex Clear

The proposed field of use of Promex Clear is the control of bacteria and fungi:

a. In washing products,

b. In cleaning products

c. In detergents

d. In paints and coatings

e. In mineral slurries used in the manufacture of paint

f. In polymer dispersions

g. In glues and adhesives

h. In building and construction materials

i. In mineral slurries in the manufacture of paper coatings

j. In fountain solutions in the paper industry

k. In additives for production of paper

l. In additives for production of leather

m. In additives for production of textile

n. In painting inks

o. In drilling fluids

p. In pesticides formulations

Promex Clear is intended for professional use only.

For application of Promex Clear in products described under a, c, l, m and p, it is concluded that adverse environmental effects cannot be excluded.

For application of Promex Clear in products described under b, d t/m k, n and o, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings, glues and adhesives, polymer emulsions, building and construction materials to which Promex Clear is added to, is restricted to indoors use only and the following restriction has been added to the label of paints, coatings, glues and adhesives, polymer emulsions, building and construction materials to which Promex Clear is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

For application of Promex Clear in products described under a t/m q it can be concluded that the risk when applying the formulation Promex Clear in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of Promex Clear: Op het etiket van producten welke Promex Clear in een concentratie van meer dan 3.67 g/L of 0.367% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, c, l, m and p as mentioned above can not be authorised

· applications in household cleaning and washing products is restricted to surface treatment.

· the use in drilling fluids for the oil and gas exploration must be restricted to off-shore only

1. Paints, coatings, glues and adhesives, polymer emulsions, building and construction materials containing Promex Clear can only be used indoors: “Op het etiket van producten waaraan Promex Clear als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke Promex Clear in een concentratie van meer dan 3.67 g/L of 0.367% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Promex Na20S

The proposed field of use of Promex Na20Sis the control of bacteria and fungi:

a. In washing products,

b. In cleaning products

c. In detergents

d. In carwash products

e. In paints and coatings

f. In glues and adhesives

g. In building and construction materials

h. In mineral slurries in the manufacture of paper coatings

i. In fountain solutions in the paper industry

j. In additives for production of paper

k. In additives for production of leather

l. In additives for production of textile

m. In printing inks

n. In drilling fluids

o. In pesticides formulations

Promex Na20S is intended for professional use only.

For application of Promex Na20S in products described under a, c, k, l and o, it is concluded that adverse environmental effects cannot be excluded.

For application of Promex Na20S in products described under b, d t/m j, m and n, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings, glues and adhesives, building and construction materials to which Promex Na20S is added to, is restricted to indoors use only and the following restriction has been added to the label of paints, coatings, glues and adhesives, building and construction materials to which Promex Na20S is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

Additionally the use in drilling fluids for the oil and gas exploration must be restricted to off-shore only and the maximum dosage must be lowered to 0.38 g a.s./kg preserved product or 1.9 g Promex Na20S/kg preserved product to prevent potential unacceptable risks to aquatic organisms.

For application of Promex Na20S in products described under a t/m q it can be concluded that the risk when applying the formulation Promex Na20S in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of Promex Na20S: Op het etiket van producten welke Promex Na20S in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, b, k, l and o as mentioned above can not be authorised

· applications in household cleaning and washing products is restricted to surface treatment.

· the use in drilling fluids for the oil and gas exploration must be restricted to off-shore only

1. Paints, coatings, glues and adhesives, building and construction materials containing Promex Na20S can only be used indoors: “Op het etiket van producten waaraan Promex Na20S als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke Promex Na20S in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

Rocima 640 Biocide

The proposed field of use of Rocima 640 Biocide is the control of bacteria and fungi:

a. In washing products,

b. In cleaning products

c. In detergents

d. In paints and coatings

e. In mineral slurries used in the manufacture of paint

f. In polymer dispersions

g. In glues and adhesives

h. In mineral slurries in the manufacture of paper coatings

i. In printing inks

j. In metalworking fluids

Rocima 640 Biocide is intended for professional use only.

For application of Rocima 640 Biocide in products described under a, c and j, it is concluded that adverse environmental effects cannot be excluded.

For application of Rocima 640 Biocide in products described under b, d t/m i, it is concluded that adverse environmental effects are not to be expected, if the use of paints, coatings, glues and adhesives, polymers to which Rocima 640 Biocide is added to, is restricted to indoors use only and the following restriction has been added to the label of paints, coatings, glues and adhesives, polymers to which Rocima 640 Biocide is added: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

For application of Rocima 640 Biocide in products described under a t/m j it can be concluded that the risk when applying the formulation Rocima 640 Biocide in industrial settings for the professional user is acceptable with the application of the appropriate PPE (gloves and coverall).

To prevent human health risks, products containing >0.033% BIT are not allowed for spray applications. To avoid that products will be sprayed the following text has to be included on the WG/GA of Rocima 640 Biocide: Op het etiket van producten welke Rocima 640 Biocide in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

As a result of the assessment :

· uses a, b and j as mentioned above can not be authorised

· products containing Rocima 640 Biocide can only be used indoors

1. Paints, coatings, glues and adhesives, polymers containing Rocima 640 Biocide can only be used indoors: “Op het etiket van producten waaraan Rocima 640 Biocide als conserveermiddel wordt toegevoegd dient de volgende waarschuwingszin te worden opgenomen: “Met dit product behandelde materialen zijn uitsluitend geschikt voor binnengebruik en niet op plaatsen waar uitspoeling naar het riool optreedt en die niet met water worden afgenomen”.

2. Op het etiket van producten welke Rocima 640 Biocide in een concentratie van meer dan 1.65 g/L of 0.165% bevat moet de volgende zin op het label van het eindproduct worden opgenomen “Vanwege gezondheidsrisico’s product niet sprayen!”

8. Classification and labelling

ACTICIDE BW 20

Proposed for classification and labelling for the formulation based on Reg. (EC) 1272/2008:

The identity of all substances in the mixture that contribute to the classification of the mixture *:
-
Pictogram:	GHS05	Signal word:	Danger
	GHS07	Signal word:	Warning
	GHS09	Signal word:	Warning
H-statements:	H318	Causes serious eye damage
	H315	Causes skin irritation
	H317	May cause an allergic skin reaction
	H400	Very toxic to aquatic life
P-statements:	P273	Avoid release to the environment
	P280	Wear protective gloves/protective clothing/eye protection/ face protection.
	P303+P361+P353+P310	IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.
	P305+P351+P338+P310	IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.
Supplemental Hazard information:	-	-

Child-resistant fastening obligatory?	Not applicable
Tactile warning of danger obligatory?	Not applicable

* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

Remarks:
· P337+P313and P333+P313 are covered by the mandatory P310.

CANGUARD(TM) ULTRA BIT 20 LE Preservative

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
Sodium Hydroxide
Symbol:	C	Indication of danger:	Corrosive
	N	Indication of danger:	Dangerous to the environment
R phrases	R34	causes burns
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S28	After contact with skin, wash immediately with plenty of water
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
	S60	This material and its container must be disposed of as hazardous waste.
	S61	Avoid release to the environment.
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is stated in the LoEP and on the MSDS to be within 0.01 and 0.1 mg/L
· S60 and S61 are added based on the classification as R50
· S24/25 is not mandatory according to Directive 1999/45.

Nipacide BIT 20

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
Sodium Hydroxide
Symbol:	C	Indication of danger:	Corrosive
	N	Indication of danger:	Dangerous to the environment
R phrases	R35	Causes severe burns
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S28	After contact with skin, wash immediately with plenty of water
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
	S60	This material and its container must be disposed of as hazardous waste.
	S61	Avoid release to the environment.
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· S28 added based on R35 by the Ctgb to cover unforeseen situations (e.g. tearing of gloves)
· R35 is assigned based on the pH of the formulation.
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is stated in the LoEP and on the MSDS to be within 0.01 and 0.1 mg/L
· S60 and S61 are added based on the classification as R50
· S24 is not mandatory according to Directive 1999/45.

Nipacide BIT AS 20

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
-
Symbol:	Xi	Indication of danger:	Irritant
	N	Indication of danger:	Dangerous to the environment
R phrases	R38	Irritating to skin
	R41	Risk of serious damage to eyes
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S46	If swallowed, seek medical advice immediately and show this container or label
	S60	This material and its container must be disposed of as hazardous waste.
	S61	Avoid release to the environment.

Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· S46 is invariably assigned to formulations assigned with the mentioned R-phrase(s), intended for professional use only when this does not lead to more than six P-statements.
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is stated in the LoEP and on the MSDS to be within 0.01 and 0.1 mg/L
· S60 and S61 are added based on the classification as R50
· S24/25 is not mandatory according to Directive 1999/45.

Nuosept BIG-A

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
Sodium Hydroxide
Symbol:	C	Indication of danger:	Corrosive
	N	Indication of danger:	Dangerous to the environment
R phrases	R35	Causes severe burns
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S28	After contact with skin, wash immediately with plenty of water
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
	S60	This material and its container must be disposed of as hazardous waste.
	S61	Avoid release to the environment.
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is between 0.01 and 0.1 mg/L
· S60 and S61 are added based on the classification as R50
· S28 is added based on R35 by the Ctgb to cover unforeseen situations (e.g. tearing of gloves)
· S24 is not mandatory according to Directive 1999/45.

Promex Clear

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
Potassium Hydroxide
Symbol:	C	Indication of danger:	Corrosive
	N	Indication of danger:	Dangerous to the environment
R phrases	R35	causes severe burns
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S28	After contact with skin, wash immediately with plenty of water
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
	S60	This material and its container must be disposed of as hazardous waste.
	S61	Avoid release to the environment.
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· R35 assigned based on the pH of the formulation
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is stated on the MSDS to be within 0.01 and 0.1 mg/L (0.038 mg/L), which is in agreement with data available to the Ctgb
· S60 and S61 are added based on the classification as R50
· S24is not mandatory according to Directive 1999/45.

Promex Na20S

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
Tetramethylammonium Hydroxide
Symbol:	C	Indication of danger:	Corrosive
	N	Indication of danger:	Dangerous to the environment
R phrases	R20/21/22	Harmful by inhalation, in contact with skin and if swallowed.
	R34	causes burns
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S23	Do not breathe spray
	S26/28-NL	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
	S60	This material and its container must be disposed of as hazardous waste.
	S61	Avoid release to the environment.
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· S23 is added based on labelling with R20
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is stated on the MSDS to be within 0.01 and 0.1 mg/L (0.038 mg/L), which is in agreement with data available to the Ctgb
· S60 and S61 is added based on the classification as R50
· S24 is not mandatory according to Directive 1999/45.

Rocima 640 Biocide

Proposed for classification and labelling for the formulation based on 1999/45/EC:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances) *:
Sodium Hydroxide
Symbol:	C	Indication of danger:	Corrosive
	N	Indication of danger:	Dangerous to the environment
R phrases	R35	causes severe burns
	R43	May cause sensitization by skin contact
	R50	Very toxic to aquatic organisms
S phrases	S26	In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
	S28	After contact with skin, wash immediately with plenty of water
	S36/37/39	Wear suitable protective clothing, gloves and eye/face protection
	S45	In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)
	S60	This material and its container must be disposed of as hazardous waste
	S61	Avoid release to the environment.
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?		Not applicable
Tactile warning of danger obligatory?		Not applicable

* according to 1999/45/EC, article 10, point 2.3

Remarks:
· R50 added to the classification of the formulation. This is based on the EC50 of BIT in algae, which is stated in the LoEP and on the MSDS to be within 0.01 and 0.1 mg/L
· S60 and S61 are added based on the classification as R50
· S28 is added based on R35 by the Ctgb to cover unforeseen situations (e.g. tearing of gloves)

9. References

Consulted literature

PT06 Paper industry ESD	Supplement to the methodology for risk evaluation of biocides. Emission scenario document for biocides used paper coating and finishing (product type 6, 7 & 9). Institute National de l’Environment Industriel et des Risques. INERIS report DRC-01-25582-ECOT-CTi/VMi-n°01DR01183, Verneuil-en-Halatte, France, May 2001
PT08, ESD	Emission Scenario Document for Wood Preservatives. OECD Series on Emission Scenario Documents. Organisation for Economic Co-operation and Development, Paris, not dated
PT09 leather ESD	Supplement to the methodology for risk evaluation of biocides. Emission scenario document for biocides used as preservatives in the leather industry. Institute National de l’Environment Industriel et des Risques. INERIS report DRC-01-25582-ECOT-CTi-n°01DR0165, Verneuil-en-Halatte, France, May 2001.
PT09 leather OECD ESD	OECD Series on Emission Scenario Documents Number 8. Emission Scenario Document on leather processing. OECD report ENV/JM/MONO(2004)13. Organisation for Economic Co-operation and Development, Paris, June 2004
PT09 textile ESD	Supplement to the methodology for risk evaluation of biocides. Emission scenario document for biocides used as preservatives in the textile processing industry. Institute National de l’Environment Industriel et des Risques. INERIS report DRC-01-25582-ECOT-CTi/VMi-n°01DR0176, Verneuil-en-Halatte, France, November 2002
PT09 textile OECD ESD	OECD Series on Emission Scenario Documents Number 7. Emission Scenario Document on textile finishing industry. OECD report ENV/JM/MONO(2004)12. Organisation for Economic Co-operation and Development, Paris, June 2004
PT12	ESD PT 12, Harmonisation of Environmental Emission Scenarios for Slimicides. (product type 12). 2003
PT13	Supplement to the methodology for risk evaluation of biocides. Harmonisation of environmental emission scenarios for biocides used as metal working fluid preservatives (product type 13). Final report, Royal Haskoning, Nijmegen, The Netherlands, May 2003.
Rafoth et al., 2007	Rafoth et al., 2007. Journal of Chromatography A, 1164, 74–81
RIVM 2010	RIVM, 2010: Biociden in oppervlaktewater voor drinkwaterproductie, National institute for public health and the environment, RIVM-report 601712007/2010, Bilthoven, The Netherlands
TGD 2003	Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances; Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances; Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. Part II. European Commission Joint Research Centre, EUR 20418 EN/2, Ispra, Italy, 2003.

Appendix 1 by chapter 6

Local STP distribution and concentrations

Compound:	BIT

parameter	value	unit	s/o/p
Molecular weight	151.19	g mol^-1	s
Octanol-water partition coefficient (K_ow)	19.95	-	0
Vapour pressure at test temperature	0.000276	Pa	s
Test temperature varpour pressure	20	°C	s
Solubility	1183	mg L^-1	s
Test temperature solubility	20	°C	s
Henry constant at environmental temperature (H)	0.00	Pa m³mol^-1	s
Chemical class for Koc QSAR	*		p
Organic carbon-water partition coefficient (K_oc)	224.00	L kg_dwt^-1	p
Kp (raw sewage):	67.20	L kg_dwt^-1	p
Kp (activated sludge):	82.88	L kg_dwt^-2	p
Kp (settled sewage sludge):	67.20	L kg_dwt^-3	p
Kp effluent sewage sludge):	82.88	L kg_dwt^-4	p
Characterization of biodegradability	**		p
Rate constant for degradation in a STP	7.56	d^-1	p
Emission rate chemical:	50.059	kg d^-1	s

Remarks
Calculation are made by using default parameters for an STP.


Summary of distribution
To air	2.06E-05	%
To water	30.87	%
Via sludge	2.20
- primary sludge	1.96	%
- surplus sludge	0.24	%
Degraded	66.9	%

* QSAR was not used as an experimental Koc has been submitted; ** QSAR was not used because a STP simulation study has been submitted

werkzame stof:	gehalte:
1,2-benzisothiazool-3(2H)-on	200 g/kg

	in g van dit product / kg van het te conserveren product:
a.verven:	0,5 – 1 g/kg
b.coatings:	1 – 1,5 g/kg
c.polymeerdispersies:	1– 1,5 g/kg
d.lijmen (bijvoorbeeld zetmeel voor de productie van behanglijm: 2,0 g/kg): (bijvoorbeeld zetmeel voor de productie van behanglijm: 2,0 g/kg)	0,5 – 2,0 g/kg
e.hulp- en grondstoffen in de papierindustrie	0,5 g/kg

Gebruik als conserveermiddel van producten in verpakking of opslagvat :

De toevoeging kan geschieden in elk stadium van de productie van het product. Voor een optimale protectie wordt een zo vroeg mogelijke toevoeging aanbevolen.

1. Introduction

2. Active substance

3. Biocidal products

4. Efficacy

5. Human toxicology

6. Environment

7. Conclusion

9. References