HET COLLEGE VOOR DE
TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE I bij het besluit d.d. 11 mei 2012 tot toelating van het middel BIOBAN(TM) GA 50 Antimicrobial, toelatingnummer 13696 N
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het
gebruik als conserveermiddel in verpakking of opslagvat voor het bacterie- en
schimmelbestendig maken van de volgende industriële producten op waterbasis: wasverzachters, hechtmiddelen, latex en slurries gebruikt in de
papierindustrie en in verven.
De doseringen, inwerktijden
en het gebruik van het middel zoals aangegeven in de gebruiksaanwijzing moeten worden aangehouden.
Het middel is uitsluitend
bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Conserveermiddel
van producten op waterbasis (wasverzachters, hechtmiddelen, latex en slurries)
Het middel
wordt aan het product toegevoegd in één enkele dosis tijdens productie met
behulp van geautomatiseerde doseringssystemen. Het middel dient zodanig aan het
vloeibare eindproduct te worden toegediend dat een goede menging ontstaat.
Raadpleeg de
fabrikant voor het vaststellen van de optimale dosering voor de verschillende
te conserveren producten.
Dosering:
0,02-0,2% BIOBAN GA 50 Antimicrobial op basis van het watergehalte in het te
conserveren product.
Voorbeeld:
in het geval dat een middel 80% water bevat, komt een dosering van 0,02%
overeen met 1,6 g
BIOBAN GA 50 Antimicrobial in 10
kg eindproduct.
HET COLLEGE VOOR DE
TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II bij het besluit d.d. 11 mei 2012 tot toelating van het middel BIOBAN(TM) GA 50 Antimicrobial, toelatingnummer 13696 N
Contents Page
1 Introduction. 3
2 Identity. 3
3 Physical
and chemical properties. 6
4 Efficacy. 7
5 Human
toxicology. 10
6 Environment 17
7 Conclusion. 21
8 Classification and labelling. 22
9 References. 23
This
assessment concerns the biocidal products based on the active substances
ethanol and glutaraldehyde. These applications have been submitted under the
differentiated enforcement policy of biocides.
The
assessment includes the following
products:
|
Product
|
Applicant
|
PT
|
Application
number
|
|
Alcodes Wipes1
|
Ecolab B.V.
|
2, 4
|
20110076 TBR
|
|
BIOBAN GA 50
Antimicrobial2
|
DOW Benelux B.V.
|
3, 4, 6
|
20110116 TBR
|
1Based on ethanol and glutaraldehyde as active substances
2Based on glutaraldehyde as an active substance
The
active substance ethanol has been notified for product types 1, 2 and 4. The
active substance glutaraldehyde has been notified for product types
1-4, 6, 11 and 12. The active substances have not been placed on annex 1 of
Directive 98/8/EC
yet.
2.1
Ethanol
2.1.1
Identity of the active substance
2.1.1.1
Ethanol
General
|
Active substance (ISO
Common Name)
|
Ethanol (non-ISO)
|
|
Name in Dutch
|
Ethanol
|
Identity
|
Chemical name (IUPAC)
|
Ethanol
|
|
Chemical name (CA)
|
Ethanol
|
|
CAS No
|
64-17-5
|
|
EC No
|
200-578-6
|
|
Other substance No.
|
-
|
|
Molecular formula
|
C2H6O
|
|
Molecular mass
|
46.07
|
|
Structural formula
|
CH3-CH2-OH
|
The active substance is not
yet included in annex I of Directive 98/8/EC.
A CAR of the active
substance is available (RMS Greece, PT 1, 2, 4, first draft July 2007).
2.1.2 Physical and
chemical properties of the active substance
2.1.2.1
Ethanol
Physical and chemical properties relevant to the risk assessment
|
Appearance
|
Colourless clear liquid
|
|
Surface tension
|
21.82 - 21.97 mN/m
|
|
Vapour pressure (Pa)
|
5726 Pa at 19.6 °C
5903 Pa at 25 °C
|
|
Henrys law constant (Pa
m3 mol -1)
|
0.57 Pa x m3/mol
|
|
Solubility in water (g/L
or mg/L)
|
1000 g/L at 25 °C (ethanol is
indefinitely miscible with water
|
|
Partition coefficient
(log POW)
|
0.31
|
|
Dissociation constant
|
No dissociation within an environmentally relevant pH range.
|
|
UV/VIS absorption (max.)
(if absorption > 290 nm state e at wavelength)
|
No UV maximum >290 nm
|
Hazard identification for classification and labelling
|
Flammability
|
Flashpoint: Highly
flammable
Flammability: N/A
Auto-flammability: 363°C
|
|
Oxidising properties
|
Not oxidising
|
|
Explosive properties
|
Not explosive
|
2.1.3 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.
2.1.4 Overall conclusions
active substance
The identity, physical and
chemical properties and analytical methods of the active substance are
sufficiently described.
2.2
Glutaraldehyde
2.2.1
Identity of the active substance
2.2.1.1 Glutaraldehyde
General
|
Active substance (ISO Common Name)
|
Glutaric
aldehyde (non-ISO)
Glutaraldehyde
(non-ISO)
|
|
Name in Dutch
|
Glutaaraldehyde
|
Identity
|
Chemical name (IUPAC)
|
1,5-pentanedial
|
|
Chemical name
(CA)
|
Glutaraldehyde
|
|
CAS No
|
111-30-8
|
|
EC No
|
2032-856-5 (EINECS)
|
|
Other substance
No.
|
-
|
|
Molecular
formula
|
C5H8O2
|
|
Molecular mass
|
100.11
|
|
Structural
formula
|
|
The active substance
glutaric aldehyde is not yet included in annex I of Directive 98/8/EC.
A CAR of the active
substance is not yet available.
Glutaric aldehyde is not
produced in pure form, but always as a 50% technical concentrate. At higher
concentrations, the substance may polymerise.
2.2.2
Physical and chemical properties of the active
substance
Physical and chemical properties relevant to
the risk assessment
|
Appearance
|
Clear, colourless liquid (50%TK)
|
|
Surface tension
|
Not surface active
|
|
Vapour pressure (Pa)
|
44 Pa at 20
°C (50%TK)
|
|
Henrys law constant (Pa m3 mol -1)
|
0.0586 Pa.m3mol-1
|
|
Solubility in water (g/L or mg/L)
|
Readily soluble (> 250g/L)
|
|
Partition coefficient (log POW)
|
-0.3324 (independent on
pH)
|
|
Dissociation constant
|
No dissociation within an environmentally relevant pH range.
|
|
UV/VIS absorption (max.) (if absorption > 290 nm
state e at wavelength)
|
No significant absorption above 290nm
|
Hazard identification for classification and
labelling
|
Flammability
|
Flashpoint: > 60 °C
Flammability: N/A
Auto-flammability: 395 °C
|
|
Oxidising
properties
|
Not oxidising (TK)
|
|
Explosive
properties
|
Not explosive (TK)
|
2.2.3 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.
2.2.4 Overall conclusions active substance
The identity, physical and
chemical properties and analytical methods of the active substance are
sufficiently described.
3.1
Alcodes Wipes
3.1.1 Identity of the
biocidal poduct
|
Name
|
Alcodes Wipes
|
|
Content active
substance
|
Ethanol 76.8%
Glutaric
aldehyde 0.02%
|
|
Formulation type
|
XX (other)
|
|
Packaging
|
HDPE bucket
with 500 or 1000 towels
|
3.1.2 Physical and
chemical properties of the biocidal product
|
Appearance
|
Wet, non-woven, blue
wipes, alcohol like odour
|
|
Explosive properties
|
Not explosive
|
|
Oxidising properties
|
Not oxidising
|
|
Auto-flammability
|
< 400 °C
|
|
Flashpoint or
Flammability
|
FP: 17 °C
|
|
pH 1% solution
|
Neat: 7.16
1%: 6.31
|
|
Relative density
|
0.849 (T not stated)
|
|
Storage stability/ Shelf
life
|
5 months in HDPE
|
|
Physical and chemical
compatibility
|
Not applicable
|
|
Viscosity
|
Not applicable
|
|
Surface tension
|
Not applicable
|
3.1.3 Analytical methods
for detection and identification
3.1.3.1 Analytical methods
for analysis of the biocidal product
|
Preparation (principle of
method)
|
Pharmacopoeia method
(GC-FID.
Glutaric aldehyde: GC
|
3.1.3.2 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).
3.1.4 Overall conclusions
biocidal product
The identity, the physical and chemical
properties and the analytical methods of the biocidal product are sufficiently
described.
3.2 BIOBAN GA 50
Antimicrobial
3.2.1
Identity of the biocidal poduct
|
Name
|
BIOBAN GA 50
Antimicrobial
|
|
Content active
substance
|
50% pure a.s.
|
|
Formulation type
|
SL
|
|
Packaging
|
25 kg pails
(HDPE)
210 kg drums
(HDPE)
1040 KG IBC
(HDPE)
|
3.2.2
Physical and chemical properties of the biocidal
product
|
Appearance
|
Clear, colourless liquid
|
|
Explosive properties
|
Not explosive
|
|
Oxidising properties
|
Not oxidising
|
|
Auto-flammability
|
Not self-igniting
|
|
Flashpoint
|
FP > 60 °C
|
|
pH 1% solution
|
4.3 (1%)
Acidity: 0.08% as H2SO4
Neat pH 3 - 4.
|
|
Relative density
|
1.066 at 20 °C
|
|
Storage stability/ Shelf
life
|
12 months
|
|
Technical characteristics
|
Based on the composition
and intended use of the product, data is not considered required.
|
|
Physical and chemical
compatibility
|
Avoid contact with oxidisers and amines, strong
bases and acids.
Product is not intended for mixing with other
products.
|
|
Viscosity
|
Not applicable
|
|
Surface tension
|
Not applicable
|
3.2.3 Analytical methods
for detection and identification
3.2.3.1 Analytical methods
for analysis of the biocidal product
|
Preparation (principle of
method)
|
HPLC-UV
|
3.2.3.2 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).
3.2.4 Overall conclusions
biocidal product
The identity, the physical
and chemical properties and the analytical methods of the biocidal product are
sufficiently described.
4.1
Alcodes Wipes
Function
Alcodes
Wipes is a disinfectant (PT02 and PT04) based on ethanol (642 g/L; 76.8%) and
glutaraldehyde (0.17 g/L; 0.02%).
Alcodes
Wipes are soaked wipes and therefore ready-to-use.
Field of use envisaged
The
proposed field of use of Alcodes
Wipes is the control of
bacteria (excluding bacterial spores), yeasts and fungi on surfaces :
-
In
the cosmetic and pharmaceutical industry;
-
The
production, storage, and consumption area of food, feed and drinks.
These uses
are included in PT02 and PT04.
The product
is intended for professional use only.
Effects on target
organisms and efficacy
The
available information was sufficient to evaluate the efficacy of Alcodes Wipes, considering that the authorisation
is done under article 121 of the WGB. Several studies testing efficacy were
provided for Alcodes
Wipes, some were considered to be suitable and acceptable.
Quantitative suspension tests, quantitative surface tests and a
simulated use test with mechanical action following standard procedures have been done with the required
test organisms, the required interfering substance for soiling and the required
test temperature. The tests demonstrated efficacy against bacteria (exclusive
bacterial spores and mycobacteria) and yeasts at the use concentration (i.e.3,8
ml / wipe of standard version wipes and 7 ml / wipe of maxi-version wipes) and
a contact time of 1 minute. This complies with the intended use as specified on
the WG/GA.
No
acceptable efficacy test with fungi was provided, therefore the fungal claim
has to be removed from the WG/GA.
Evaluation of the
WG/GA
The
applicant has provided a Dutch WG/GA. This has been adapted to our standards.
For both versions of wipes, a separate WG/GA is available. Mycobacteria have to
be excluded from the bacterial claim as these organisms have not been tested in
efficacy tests. For fungi, efficacy was not proven. Therefore, the fungal claim
has to be removed from the WG/GA.
Mode of action
Ethanol exhibits an unspecific mechanism of effect. It affects the
outer cell membrane causing alteration of membrane fluidity and leakage, enters
the cytoplasm and destroys the inner structure of the cell molecules and of the
cytoplasm's proteins. This process (referred to as denaturation) and the
enzymes' coagulation leads to a loss of cellular activity resulting in the
cell's death. Ethanol rapidly inactivates the target micro-organisms without
time delay due to the unspecific mode of action (topical disinfectant).
The main target of aldehydes is the cell surface including the cell
wall and cell membrane. The cell is fixed by unspecific oxidising chemical
reactions between the aldehyde molecule and surface proteins but also chemical
reactions with nucleic acids can be observed. Aldehydes fix the cell structure and
cell metabolism and functions are blocked.
Resistance
The following information was provided by the
applicant. Resistances for Ethanol are not reported. As Ethanol is not specific
for just one cellular target but interferes with membrane integrity and denatures
proteins, the development of true resistances is not to be expected. Specific
resistances against glutaraldehyde have not yet been reported if the substance
is used in an adequate dosage and in an adequate way: Efficacy investigations
using Standard test procedures such as European Standards (EN phase-2-tests)
lead to application conditions in practice where micro-organisms are not able
to survive. However, disinfectant application solutions must be bio degradable
by environmental organisms e.g. in waste water, where they are diluted to a
suitable concentration. That's why a critical application concentration must be
applied which is usually obtained as a result of the above mentioned Standard
test procedures. If the substance is therefore used under adequate application
conditions (application concentration, contact time, one day shelf life of the
used solution, adequate treatment of disinfection equipment) microbial
resistance / tolerance against Glutaraldehyde have not been observed.
Considering
that the authorisation is done under article 121 of the WGB this is acceptable.
Conclusions
Based on
the data submitted and considering that the evaluation is done under article
121 of the WGB, it can be concluded that Alcodes Wipes, when used in accordance with the proposed
label (WG/GA), is effective in controlling bacteria (excluding bacterial spores
and mycobacteria) and yeasts on surfaces in
-
the
cosmetic and pharmaceutical industry;
-
the
production, storage, and consumption area of food, feed and drinks.
4.2
Bioban GA 50 Antimicrobial
Function
BIOBAN (TM) GA 50 Antimicrobial is a disinfectant (PT03 and PT04) and a
preservative (PT06, PT11 and PT13) based on Glutaraldehyde (50% w/w).
Field of use envisaged
The proposed field of use of BIOBAN (TM) GA 50 Antimicrobial is
- the control of bacteria and
viruses in animal housing and caging (PT03);
- the control of bacteria and
viruses on footwear of workers and on animals hoofs (PT03);
- the control of bacteria and
viruses on hatching eggs (PT03);
- the control of bacteria and
fungi on surfaces in places where food is processed and stored (PT04);
- the control of bacteria and
fungi on vessels and machinery used for food processing (PT04);
- in-can preservative of the
following water based products: fabric softeners, slurries, adhesives and
latexes & paints, by the control of deteriorating bacteria and fungi
(PT06);
- preservation of water used as a
solvent for extraction of sugar from sugar beets by the control of
deteriorating bacteria (PT11);
- preservation of metal working fluids
by the control of deteriorating bacteria and fungi in (PT13).
These uses are included in PT03, PT04, PT06, PT11 and PT13. The product
is intended for professional use only.
Effects on target organisms and efficacy
Several studies testing efficacy were
provided for BIOBAN (TM) GA 50 Antimicrobial, some
were considered suitable and acceptable. Quantitative suspension and surface
tests following EN standard procedures have been done with the required
standard organisms, the required interfering substance for soiling and the
required test temperature. The tests demonstrated efficacy against bacteria
(exclusive bacterial spores and mycobacteria) at a concentration of 0,40% w/w
of Bioban GA 50 (which is a 50% glutaraldehyde solution in water) at a contact
time of 30 minutes. This is in accordance with the proposed label (WG/GA). For
the intended uses as basic requirement efficacy against bacteria and yeasts is
set. However, no tests with yeasts are provided with the required soiling
circumstances for PT04 and with the required test temperature for PT 03.
Therefore the basic requirements of bactericidal and yeasticidal efficacy are
not satisfied for the PT03 and PT04 applications as disinfectant in animal
housing and caging, as disinfectant of footwear of workers, as disinfectant on
hatching eggs, and as disinfectant in places where food is processed and stored
and on vessels and food processing industry. These uses have to be removed from
the WG/GA. For the intended use of hoof disinfection a bactericidal claim is
sufficient, however no efficacy has been demonstrated at the required contact
time of maximum 5 minutes. Therefore, this use has also to be removed from the
WG/GA.
Evaluation of the WG/GA
The applicant has provided a Dutch WG/GA. This has been adapted to our
standards.
The following uses have to be removed:
- as disinfectant in animal
housing and caging and on footwear of workers, as no efficacy against
yeasts has been demonstrated at the required test temperature;
- as disinfectant of animal
hoofs, as no efficacy against bacteria has been demonstrated at the
required contact time;
- as disinfectant on hatching
eggs, as no efficacy against yeast has been demonstrated at the required contact
time and the required soiling conditions;
- as disinfectant on surfaces in
places where food is processed and stored, and on vessels and machinery
used for food processing, as no efficacy against yeast has been
demonstrated.
- preservation of water used as a
solvent for extraction of sugar from sugar beets by the control of
deteriorating bacteria (PT11), as the applicant decided to withdraw this
claim.
- preservation of metal working
fluids by the control of deteriorating bacteria and fungi in (PT13), as the
applicant decided to withdraw this claim.
Mode of action
Glutaraldehyde, the active ingredient in
BIOBAN GA 50 Antimicrobial, reacts with primary amines located in the cell
wall of the micro-organisms. The
reaction is known as cross-linking. These crossed-linked microbial cells can
not transport nutrients or perform any critical metabolic functions.
Glutaraldehyde also deactivates various membrane-bound enzymes. As a
consequence of these actions, the micro-organisms die. In viruses, the main
targets for Glutaraldehyde are nucleic acid, proteins and envelope constituents.
The established reactivity of Glutaraldehyde with proteins suggests that the
viral capsid or viral-specific enzymes are vulnerable to Glutaraldehyde
treatment.
Resistance
The applicant has stated that no development
of resistance is known or has been reported after several decades of use.
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 BIOBAN (TM) GA 50 Antimicrobial, when used in accordance with
the proposed label (WG/GA), may be expected to be effective as
- in-can preservative of the
following water based products: fabric softeners, slurries, adhesives and
latexes & paints, by the control of deteriorating bacteria and fungi
(PT06).
The following uses of BIOBAN (TM) GA 50 Antimicrobial have to be removed
from the WG/GA, as the applicant decided to withdraw these claims:
- preservation of water used as a
solvent for extraction of sugar from sugar beets by the control of
deteriorating bacteria (PT11);
- preservation of metal working
fluids by the control of deteriorating bacteria and fungi in (PT13).
The following uses of BIOBAN (TM) GA 50 Antimicrobial have to be removed
from the WG/GA as no efficacy data are provided to substantiate the claim:
- the control of bacteria and
viruses in animal housing and caging (PT03);
- the control of bacteria and
viruses on footwear of workers and on animals hoofs (PT03);
- the control of bacteria and
viruses on hatching eggs (PT03);
- the control of bacteria and
fungi on surfaces in places where food is processed and stored (PT04);
- the control of bacteria and
fungi on vessels and machinery used for food processing (PT04).
5.1 Human health effects
assessment active substance
Glutaraldehyde
Glutaraldehyde is an
existing active substance, not included in Annex I of 98/8/EG. An application
for inclusion is submitted, for which Finland
is the Reporting Member State.
This assessment is based on the physical chemical and toxicological data as
published by the Pest Management Regulatory Agency (PMRA) from Canada
on glutaraldehyde (September 2007), the Reregistration Eligibility Decision
(RED) report on glutaraldehyde (September 2007), published by the US
Environmental Protection Agency (US
EPA). In addition data from the draft CAR (April 2011) are used where data from
the other documents showed inconsistencies.
When glutaraldehyde is
applied dermally a large proportion of the dose retains in the skin. Dermal
absorption has set at 10% based on a weight of evidence approach (draft CAR).
Absorbed glutaraldehyde is rapidly eliminated, mainly via urine.
Oral LD50 values
reported for glutaraldehyde vary between 66 and 733 mg/kg bw. The LD50
for dermal toxicity > 1000 mg/kg bw (draft CAR). Glutaraldehyde is toxic via
the inhalation route (LC50 > 0.28-0.35 mg/L). Glutaraldehyde is
corrosive and a skin sensitizer.
Several subchronic oral,
dermal and inhalation toxicity studies were conducted with glutaraldehyde. The
critical effects reported were related to irritation/degeneration of tissues at
the entrance site. Similar findings were reported in chronic studies (oral and
inhalation). There was no evidence of carcinogenicity in rats or mice.
In vitro and in vivo studies investigating the genotoxic properties of
glutaraldehyde showed effects in in vitro
studies, but generally not in in vivo
studies. It is, however, unlikely that glutaraldehyde has genotoxic properties
(opinion of SCF 119th meeting, 1999).
No developmental or
reproductive toxicity was reported at and below maternally toxic doses.
Local effects
Due to its corrosive
properties, glutaraldehyde produces local effects after a single exposure (skin
and eye irritation) and repeated exposure (GI-tract irritation), therefore
local acceptable exposure levels (AELlocal) will be determined.
AELlocal dermal
From the human volunteer-
and occupational studies an NOEL of 0.2% glutaraldehyde was derived. For the
risk assessment an AELlocal dermal of 0.2% (without additional
assessment factors) will be used.
AELlocal inhalation
The Dutch Expert Committee
on Occupational Standards recommends a health-based occupational exposure limit
(HBR-OEL) for glutaraldehyde in the air of 0.4 mg/m3 as a ceiling
value (for 15 minutes), based on the sensory irritation, especially of the
eyes, nose and throat. Furthermore, because human data indicate that the
frequency of exposure is of relevance in the occurrence of sensory irritation
effects, the committee warrants an HBR-OEL of 0.08 mg/m3 as an
eight-hour time-weighted average concentration (8-h TWA) (Health Council of the
Netherlands, October 1993). For the risk assessment an AELlocal
inhalation of 0.08 mg/m3 will be used.
Data requirements active substance
No additional data
requirements are identified.
Ethanol
Ethanol is an existing
active substance, not included in Annex I of Directive 98/8/EC. This assessment
is based on the LoE submitted by the applicant, but also on public data from
previous evaluations made at Ctgb for ethanol. A draft CA-report is not yet
available.
For 2-Ethanol a EPA RED
(1995) and a DECOS evaluation (2006) are available.
List of Endpoints
In previous evaluations no
threshold values are set to be used for the risk assessment. Threshold values
were not required based on the representative use.
At the request of the
Minister of Social Affairs and Employment, the Health Council of the Netherlands
sets health-based recommended occupational exposure limits for chemicals in air
at the workplace in 2006. These recommendations are made by the Councils Dutch
Expert Committee on Occupational Standards (DECOS).
Epidemiological studies
suggest that consumption levels below 10-12 grams of ethanol per
day, will probably not cause liver cirrhosis. However, the Committee on Alcohol
consumption
and reproduction concluded
that at these consumption levels effects on fertility and development have been
reported. Even long term oral exposure to levels of 1-12 gram ethanol per day
might result in effects on the development (like increased incidence of
spontaneous abortion, foetal death, pre-term delivery and decreased length of
gestation) and fertility, according to the Committee on Alcohol consumption and
reproduction. Considering the fact that the maximal alcohol concentration in
blood after one (oral) drink is approximately 10-100 times higher than the
ethanol concentration in blood after inhalatory exposure to1300 mg/m3,
the committee was of the opinion that a HBC-OCRV (Health based calculated
occupational cancer risk value) of 1300 mg/m3 is low enough to
protect against these effects. Other toxic effect manifest after exposure to
higher exposure levels. DECOS calculates an HBC-OCRV of 1300 mg/m3,
resulting in a breast cancer risk of 4 additional death cases per 1000 (4*10-3)
deaths for 40 years.
In addition, DECOS
recommends a short term exposure limit (STEL) of 1900 mg/m3 twa 15
minutes and a skin notation. As dermal exposure can substantially contribute to
the body burden of ethanol, DECOS recommends a skin notation.
In the report was described
that as a worst case estimate, a penetration rate of 0.7 mg/cm2/h
can be used to calculate the internal dose after dermal exposure. From the
available meta-analysis and pooled studies, the committee concluded that
drinking of one glass of alcoholic beverage per day the internal intake will be
10 gram
ethanol.
Data requirements active substance
No additional data
requirements are identified.
5.2
Human exposure assessment active substance
5.2.1 General aspects
Alcodes Wipes are ready-to-use soaked wipes and contain ethanol (642 g/L)
and glutaraldehyde (0.17 g/L) as active substances. The proposed fields of use
are:
PT2: Surface disinfection in the food- and beverage industry
PT4: Surface disinfection in the cosmetic and pharmaceutical industry
BIOBANGA 50 Antimicrobial is a liquid an contains 50% glutaraldehyde.
After evaluation by the aspect Efficacy, the remaining field of use is:
PT6: In-can preservation of
fabric softeners, slurries, adhesives and latexes & paints
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 the evaluated uses
is given in Table T.1 below. For Bioban GA 50, the intended uses PT3, 4, 11 and PT13 were not
included in this evaluation as insufficient data on Efficacy were available to
substantiate claims for these product types, and several uses were withdrawn by
the applicant.
Table T.1 Summary
of uses
|
|
Concentration a.s. in product
|
Use concentration
|
PT
|
Application method
|
Frequency
|
Potential secondary exposure
|
|
Alcodes Wipes
|
Ethanol 642 g/l (76.80%)
Glutaraldehyde 0.17 g/l (0.02%)
|
Ethanol 642 g/l (76.80%)
Glutaraldehyde 0.17 g/l (0.02%)
|
21
|
Soaked wipe, surface disinfection, rubbing
surface (0.5-0.9 m2)
|
1-8 times per day
|
co-workers
|
|
Ethanol 642 g/l (76.80%)
Glutaraldehyde 0.17 g/l (0.02%)
|
Ethanol 642 g/l (76.80%)
Glutaraldehyde 0.17 g/l (0.02%)
|
41
|
Soaked wipe, surface disinfection, rubbing
surface (0.5-0.9 m2)
|
1-8 times per day
|
co-workers
|
|
BIOBANGA 50 Antimicrobial2
|
Glutaraldehyde
50%
|
Glutaraldehyde
0.01-0.1%
|
61
|
Automatic dosing
|
1-7 applications per week
|
Consumers:
contact with treated materials, e.g. hand washing, dishwashing, contact with
painted surfaces, or contact with paper.
|
1Professional
use
2 For Bioban GA 50, the intended uses
PT3, 4, 11 and PT13 were not included in
this evaluation as product types were withdrawn or insufficient data on
Efficacy were available to substantiate claims for these product types
Ethanol
Dermal exposure of
professionals to ethanol will be possible during use of the Alcodes Wipes,
during surface wiping, with a concentration of 76.80% ethanol.
Respiratory exposure to
ethanol during surface wiping cannot be excluded.
Glutaraldehyde
Dermal exposure of
professionals to glutaraldehyde will be possible during mixing and loading or
during wiping of surfaces.
Two scenarios will be
considered as a worst-case:
-
Mixing and loading of with BIOBANGA 50 Antimicrobial.
For mixing and loading a 50% concentration is considered.
-
Wiping of surfaces with
Alcodes Wipes with a concentration of 0.02% glutaraldehyde.
Inhalation exposure to
glutaraldehyde cannot be excluded based on the vapour pressure of glutaraldehyde.
The same scenarios as for dermal exposure will be considered as a worst-case.
As all products are used by trained professionals, oral exposure is considered
negligible.
5.2.3
Identification of main paths of non-professional
exposure towards active substance from its use in biocidal product
The formulations are for
professional use.
5.2.4
Indirect exposure as a result of use of the active
substance in biocidal product
Exposure scenarios for
secondary exposure are:
-
Co-worker dermal contact
with treated surfaces (76.80% ethanol and 0.02% glutaraldehyde) In the food-
and beverage industry and in the cosmetic and pharmaceutical industry, after
use of Alcodes Wipes, dermal contact with treated surfaces. It can be assumed
that dermal contact longer than a few seconds with the recently cleaned and wet
surfaces by co-workers is not to be expected.
-
BIOBAN GA 50 Antimicrobial
is used to control bacterial and fungal infestation of water based products
such as detergents & laundry additives, building materials (such as
concrete adhesives & adhesives), latex & paints, paper additives (such
as mineral slurries), printing inks and wipes.
Consumer dermal exposure might occur during hand washing, dishwashing,
contact with painted surfaces, or contact with paper. Both adults and children
may exposed dermally to the products. The maximum concentration in the products
is 0.1%. In addition, for children concomitant oral exposure via hand-mouth
contact may be possible.
Secondary inhalation
exposure to ethanol and glutaraldehyde are also considered, due to the vapour
pressure of both substances.
Since glutaraldehyde is a
highly reactive compound, the substance will rapidly degrade at the site of
first contact with organic matter. Therefore, accumulation of glutaraldehyde is
not expected after repeated exposure use of the products.
5.3
Human health effects assessment product
5.3.1 Toxicity of the
formulated product
Alcodes Wipes
No studies with Alcodes
Wipes 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.
The formulation Alcodes Wipes does not need
to be classified for acute oral, dermal and inhalation toxicity.
The formulation Alcodes
Wipes does not need to be classified for skin and eye irritation, and skin
sensitization.
BIOBAN GA 50 Antimicrobial
No studies with BIOBAN GA
50 Antimicrobial 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.
The formulation BIOBAN GA
50 Antimicrobial is classified with H301 Toxic if swallowed and H331 Toxic
if inhaled.
The formulation BIOBAN GA
50 Antimicrobial is classified with H314 Causes severe skin burns and eye
damage.
The formulation BIOBAN GA
50 Antimicrobial is classified with H317 May cause and allergic skin reaction,
and H334 May cause allergy or asthma symptoms or breathing difficulties if
inhaled.
BIOBAN GA 50 Antimicrobial
is classified with H335 May cause respiratory irritation.
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
Ethanol
Dermal exposure of
professionals to ethanol will be possible during use of the Alcodes Wipes,
during surface wiping, with a concentration of 76.80% ethanol. In addition,
respiratory exposure cannot be excluded, based on the vapour pressure of
ethanol.
For a product based on 84%
ethanol, meant for hygienic hand disinfection, a safe use was calculated (for
dermal and respiratory exposure of professionals in hospitals). It was assumed
that 108 ml of this product was rubbed into the dry hands as a worst-case
scenario. It was concluded that there was no additional risk for human health
when compared to the intake by drinking one alcoholic consumption and/or the
use of cosmetics as lotions and perfume.
Considering the
concentration of ethanol in Alcodes Wipes (76.80%), and based on the
anticipated exposure through wiping or foam spraying compared to already
authorized products based on ethanol, unacceptable health effects for the
professional user through use of Alcodes Wipes are not to be expected.
Glutaraldehyde
Considering standard
hygienic procedures in professional settings, oral exposure to Glutaraldehyde
can be excluded.
The AELlocal is
set at 0.2% Glutaraldehyde.
The concentration of the
active substance in Alcodes Wipes is 0.02%. Therefore, no adverse health
effects are to be expected after dermal exposure to glutaraldehyde after use of
Alcodes Wipes. The inhalation exposure is calculated using the TNsG model 1 for
manual surface disinfection and wiping surfaces.
A respiratory exposure of
0.046 mg/m3 is calculated, based on 10 minutes application per day.
Considering the HBR-OEL for glutaraldehyde of 0.4 mg/m3 as a ceiling
value (for 15 minutes), a safe use is considered for the exposure to
glutaraldehyde during the application of Alcodes Wipes.
BIOBANGA 50 Antimicrobial is added to the
system via an automated dosing system, therefore the professional user could be
inhalatory and dermally exposed to 50% glutaraldehyde during (un)connecting the
automated dosing system. In accordance to Table 3.2 of Regulation (EC)
1272/2008 formulations with ≥50% glutaraldehyde should be classified with
H301 Toxic if swallowed, H331 Toxic if inhaled and H314 Causes severe skin
burns and eye damage. Therefore, the professional user should wear suitable gloves,
protective clothing and eye/face protection.
During
connecting/disconnecting the exposure period will be very short, therefore
inhalatory exposure is expected to be very low and will not exceed the AELlocal
inhalation. Furthermore, chemical industries have to comply to the Dutch
Arbeidsomstandighedenregeling, which ensures that the unprotected worker is
not exposed to air concentrations glutaraldehyde exceeding the eight-hour
time-weighted average concentration (HBR-OEL of 0.08 mg/m3; Health
Council of the Netherlands, October 1993).
Considering standard
hygienic procedures in professional settings, oral exposure to Glutaraldehyde
can be excluded.
On the basis of the above
considerations, it can be concluded that the risk after exposure to Alcodes
Wipes for the unprotected professional user is acceptable.
On the basis of the above
considerations, it can be concluded that the risk after exposure to BIOBANGA 50 Antimicrobial for
the protected (suitable gloves, protective clothing and eye/face protection)
professional user is acceptable.
5.4.2
Non-professional users, including the general public
The formulations are for
professional use.
5.4.3
Indirect exposure as a result of use
In the food- and beverage
industry and in the cosmetic and pharmaceutical industry, after use of Alcodes
Wipes, dermal contact with treated surfaces might occur (76.80% ethanol and
0.02% glutaraldehyde). It can be assumed that dermal contact longer than a few
seconds with the recently cleaned and wet surfaces by co-workers is not to be
expected.
Exposure to both ethanol
and glutaraldehyde will be lower or maximally equivalent to professional
exposure. As no unacceptable health effects for the professional user were
concluded, a safe use can also be concluded for indirect exposure after use of
Alcodes Wipes.
Indirect exposure to
glutaraldehyde, might also occur after use of BIOBANGA 50 Antimicrobial in consumer products.
BIOBAN GA 50 Antimicrobial is used to control bacterial and fungal infestation
of water based products such as detergents & laundry additives, building
materials (such as concrete adhesives & adhesives), latex & paints,
paper additives (such as mineral slurries), printing inks and wipes.
The concentrations of
glutaraldehyde in the end-products (PT6) that were treated with the
formulations under evaluation are below the dermal AELlocal for
glutaraldehyde (0.2%). Therefore it can be concluded that secondary exposure of
professionals and non-professionals (adults and children) is negligible and not
expected to lead to local dermal effects.
Users of BIOBAN GA 50 Antimicrobial treated
products can be inhalatory exposed to maximally 0.1% glutaraldehyde.
Although pure gutaraldehyde
has relatively high volatility, the volatility of glutaraldehyde from aqueous
solutions containing this substance at low concentrations is relatively low,
based on the low Henrys law value (Henrys law value of 1x10-7
atm.m3/mole (worst-case)). The vaporisation of glutaraldehyde from
very diluted solutions found in end-use products is expected to be very low,
and therefore it is not expected that the exposure will exceed the AELlocal
inhalation of 0.08 mg/m3.
By using BIOBAN GA 50 Antimicrobial treated
fluids in paper production, the general public could be potentially exposed to
glutaraldehyde 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.
The concentrations of
glutaraldehyde in the end-products (PT6) that were treated with the
formulations under evaluation are below the AELlocal for
glutaraldehyde (0.2%). Therefore it can be concluded that secondary exposure of
professionals and non-professionals (adults and children) is negligible and not
expected to lead to local dermal effects.
Based on the above
considerations, it can be concluded no adverse health effects are expected for
indirect exposure of the (non-)professional users, including the general
public.
5.4.4 Combined exposure
Alcodes Wipes is a mixture
of 2 active substances. The combined toxicological effect of these active
substances has not been investigated with regard to repeated dose toxicity.
Both substances induce
different type of effects, and therefore the combined exposure to these active
substances will not lead to a different toxicological profile than the
profile(s) based on the individual substances.
5.5
Overall conclusions for the aspect human health
Alcodes Wipes
The proposed field of use
of Alcodes Wipes is:
PT2: Surface disinfection in the food- and beverage industry
PT4: Surface disinfection in the cosmetic and pharmaceutical industry
The product is intended for
professional use only.
As a result of the
assessment:
- A safe use is concluded for the unprotected professional during use
of Alcodes Wipes.
- A safe use is concluded for indirect exposure.
Overall a safe use is
concluded for the proposed use.
BIOBAN GA 50 Antimicrobial
An assessment was made for
PT6 only, as insufficient data were available for the evaluation of Efficacy
for the other uses (PT3, PT4 and PT13) .
The proposed field of used
assessed for BIOBAN GA 50
Antimicrobial is:
- PT6: In-can preservation of fabric
softeners, slurries, adhesives and latexes & paints
As a result of the
assessment:
- A safe use is concluded for the protected professional during
mixing and loading (suitable gloves, protective clothing and eye/face
protection)
- A safe use is concluded for indirect exposure.
Overall a safe use is
concluded for the proposed use in PT6.
6.1
Introduction
Authorisation is requested for the products Alcodes Wipes and Bioban GA 50.
Alcodes Wipes containing glutaraldehyde and ethanol as active substances.
Bioban GA 50 contains solely glutaraldehyde as active substance. The intended
and evaluated uses of the biocidal products are summarized in table E.1. For Bioban GA 50, the intended uses
PT3, 4, 11 and PT13 were not included in this evaluation as insufficient data
on Efficacy were available to substantiate claims for these product types, and
several uses were withdrawn by the applicant.
Table E.1. Intended uses of
Alcodes Wipes Alcodes Maxiwipes and Bioban
GA 50.
|
Product and intended use
|
Indoor/outdoor use
|
Professional/non-professional use
|
Glutaraldehyde
conc. g/L
|
ethanol
conc.
g/L
|
|
Alcodes Wipes
|
|
|
|
|
|
1
|
PT02: Disinfection of industrial areas surfaces
|
Indoor
|
Professional
|
0.17
|
642
|
|
2
|
PT04: Disinfection in food, drink and milk industries surfaces
|
Indoor
|
Professional
|
0.17
|
642
|
|
Bioban GA 50*
|
|
9
|
PT06
in can preservatives of water based laundry detergents, mineral slurries in
paper industry and paints, glues and adhesives and latex.
|
Indoors and outdoors use of the treated articles
|
The
end-products can be used by non-professional users/consumers.
|
0.1-1
|
-
|
* For Bioban GA
50, the intended uses PT3, 4, 11 and PT13 were not included in this evaluation
as insufficient data on Efficacy were available to substantiate claims for
these product types
6.2
Environmental profile of active
substance
Ethanol is present in Alcodes Wipes, for disinfection of
surfaces in PT02 and PT04. It is to be expected that most of the ethanol and
will evaporate and the main emission into the environment will be to air. The
risk to air is assessed in a qualitative manner and
therefore no PNECs are presented for ethanol.
The predicted no effect levels (PNECs) for
glutaraldehyde, based on the ecotoxicological data, are presented in Table E.2.
Glutaraldehyde has a low potential for bioaccumulation due to its low log Kow
(-0.52). Primary poisoning due to direct exposure to this product is not
expected (see section 6.3.2), therefore the risk to birds and mammals is
relatively low and these PNECs are not presented.
Table E.2. PNECs for
glutaraldehyde
|
Compartment
|
Lowest endpoint
|
AF
|
PNEC
|
Test/species
|
|
Aquatic
fresh water
|
NOEC 25
µg a.s./L
|
10
|
2.5 µg a.s./L
|
Freshwater algae
|
|
STP
|
LC50 = 510 mg a.s./L
|
100
|
0.51 mg a.s./L
|
Respiration
inhibition
|
6.3
Environmental exposure assessment
6.3.1
Chemistry and/or metabolism
Glutaraldehyde is a poly-aldehyde and ethanol
is a primary alcohol. No major persistent metabolites are known for ethanol.
Under anaerobic conditions, glutaraldehyde
is transformed to three major metabolites: compound A, 5-hydroxy-pentanal and
1,5-pentanediol. These metabolites will not be taken into account as EPI suite
calculations show that the toxicity of these compounds is lower than
glutaraldehyde. This is because these compounds are neutral organic compounds
(1,5-pentanediol) or a mono-aldehyde (5-hydroxy-pentanal), which show a lower
toxicity to aquatic organisms because glutaraldehyde is a poly-aldehyde. For
compound A it is also assumed that it is either a neutral organic compound or a
mono-aldehyde and thus less toxic than its parent. Furthermore, they are
predicted to be readily biodegradable just as glutaraldehyde under aerobic
conditions (EPI suite). The risk for these metabolites to the environment is
thus predicted to be much lower than glutaraldehyde, and degradation in
anaerobic conditions is not taken into account. Therefore the risk assessment
of glutaraldehyde covers the risk of its metabolites.
Possible pH effects in the environment were not
considered, because the STP and receiving environmental
compartments are expected to have sufficient buffering.
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. Table E.3 summarises the receiving environmental compartments that have
been identified as potentially exposed during the use of the products 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
|
|
STP#
|
Fresh-water*
|
Marine-water*
|
Soil**
|
Air
|
Birds
and mammals
|
|
PT02 - Disinfection of industrial areas surfaces
|
-
|
-
|
-
|
-
|
++
|
-
|
|
PT04 Disinfection in food, drink and milk
industries
|
-
|
-
|
-
|
-
|
++
|
-
|
|
PT06 In can preservatives laundry detergents
|
++
|
+
|
-
|
-
|
-
|
-
|
|
PT06 In can preservatives paints and
adhesives, mineral slurries in paints
|
-
|
(+)
|
-
|
(+)
|
+
|
-
|
|
PT06 In can preservatives mineral slurries in
paper industry
|
++
|
+
|
-
|
-
|
-
|
-
|
++ Compartment primarily exposed, + Compartment secondarily exposed
(surface water from STP discharge, vertebrates eating contaminated fish),
(+)Compartment potentially exposed, Compartment not exposed, (+)/- The
compartment is potentially exposed or not. This depends on the specific use and
the characteristics of the active substance, * Including sediment, ** Including
groundwater, bees and non-target arthropods, #In the Netherlands,
surplus sludge of public STPs is not applied for fertilization and soil
improvement of agricultural soil. Therefore, exposure of soil and groundwater
via STP surplus sludge application is not part of the risk assessment.
The main and major emission route for the
proposed use in product type PT02 and PT04, is release to air. The main
component of the product is ethanol and the product evaporates. Glutaraldehyde is a relatively volatile
substance (vapour pressure = 44 Pa at 20 ˚C), and thus it can be assumed
that glutaraldehyde will also evaporate with the
ethanol. Therefore there is only direct emission to air and no significant
emission to STP will occur.
As glutaraldehyde has a high vapour pressure,
it is assumed that the main exposure is to air of glutaraldehyde in paints and
adhesives and mineral slurries added to paints.
6.3.3
Predicted environment concentration
calculations
An overview of the chosen
models is given in Table E.4.
Table E.4. Relevant
exposure scenarios for the intended uses as in-can preservatives
|
application
|
scenario applied
|
|
In-can
preservation of water based detergents
and laundry products domestic use
(total emission for a city)
|
ESD for
washing detergents as presented in dCAR IPBC PT06
|
|
Paints
coatings, latexes and plasters, building materials - professional and
non-professional use (outdoors)
|
Not
assessed as emission is mainly to air due to relatively high volatility of glutaraldehyde
|
|
Mineral
slurries and fountain solutions for paper production
|
Exposure
is calculated according to the ESD for paper finishing products, Ineris 2001
|
6.4
Risk characterisation for the
environment
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 to STP and aquatic organisms (including sediment organisms) is
shown in Table E.3. The other intended uses do not have emission to STP or an
on site WWTP and will thus not indirectly emit to surface water. The risk
ratios for aquatic organisms and microorganisms in STP/WWTP are < 1 and thus the criteria for microorganisms in a STP and aquatic organisms have been
met.
Table E.3: Predicted emission rates to STP in
kg/day of glutaraldehyde for PT06 laundry detergents.
|
Compartment
|
PEC
|
PNEC
|
PEC/PNEC
|
units
|
|
PT06 laundry detergents
|
|
|
Aquatic
|
2.16E-03
|
0.0025
|
0.865
|
mg/L
|
|
STP
|
2.16E-02
|
0.51
|
0.042
|
mg/L
|
|
PT06 - mineral slurries in paper industry
|
|
|
Aquatic
|
2.04E-04
|
0.0025
|
0.082
|
mg/L
|
|
WWTP
|
5.11E-02
|
0.51
|
0.100
|
mg/L
|
6.4.1.2
Surface water intended for the
abstraction of drinking water
Ethanol and glutaraldehyde have been on the
Dutch market for > 3 years. From the general scientific knowledge collected
by the Ctgb about the products and their active substances, the Ctgb concludes
that there are in this case no concrete indications for concern about the
consequences of these products for surface water from which drinking water is
produced, when used in compliance with the directions
for use. Glutaraldehyde, ethanol nor their metabolites are on the
recommended list of biocides to be monitored for drinking water from surface
water (RIVM, 2010). The standards for surface water destined for the production
of drinking water are met for all products.
6.4.2 Atmosphere
Criteria for the examination of environmental
risks to air are not specified in the form of a numerical standard. The
assessment of potential impacts on air quality, yet, is aimed to minimize the
risk for stratospheric ozone depletion. As there are no indications that
glutaraldehyde nor ethanol contribute to depletion of the ozone layer
(calculated half lives are for both active substances below the trigger of <
2 days. Glutaraldehyde nor ethanol are listed as controlled substance listed in Annex I of Regulation (EC) No
1005/2009 of the European Parliament and thus the environmental risk to air is
considered acceptable.
6.4.3 Terrestrial compartment
6.4.3.1 Soil organisms and non target arthropods (including bees)
Bioban GA 50 is added as a preservative in
paints and latexes. Paints and latexes can be used outdoors and potentially
emit glutaraldehyde directly to soil or surface water. However, glutaraldehyde is a relatively volatile substance
(vapour pressure = 44 Pa at 20 ˚C), and thus it can be assumed that
glutaraldehyde will evaporate while the paint is applied and is drying. The
emission to soil is therefore expected to be negligible. There is no exposure expected to
soil for the PT02 and PT04 applications of Alcodes Wipes. Therefore the
products meet the criteria for soil organisms.
The risk to bees is considered acceptable as
ethanol and glutaraldehyde are not systemic pesticides in plants and emission
to soil is considered negligible.
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. Ethanol and glutaraldehyde have no emission to
soil and thus not to groundwater. Hence, the risk for groundwater is considered
acceptable for the intended uses.
6.4.3.3
Persistence in soil
Exposure to soil is not expected for
ethanol and glutaraldehyde by the intended uses. Hence, the criteria for the persistency in soils are met.
6.4.4
Non compartment specific effects
relevant to the food chain
6.4.4.1
Bioconcentration
Ethanol and glutaraldehyde have low potentials
for bioaccumulation due to their low log Kow (0.31 and -0.52).
6.4.4.2
Primary and secondary poisoning of
birds and mammals
The low BCF (see
above) indicates that the risk for birds and mammals is low regarding secondary
poisoning. Hence the products meet 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)
Alcodes
Wipes
The applicant did not include any risk
mitigation measures for the environment in the draft proposed label (WG/GA) and
PGB-PUB. Additional risk mitigation measures are not required, considering that
risks to the environment are acceptable for the intended uses.
BIOBAN GA 50
Antimicrobial.
The applicant has added the following
unnecessary sentence to the draft WG/GA:
Dit materiaal is
zeer giftig voor Daphnia; voorkom verontreiniging van oppervlaktewater.
This sentence will be removed. Additional risk mitigation measures are not required, considering that
risks to the environment are acceptable for the intended uses.
6.6
Overall conclusion for the aspect
environment
All intended uses show acceptable risks to the
environment and no additional risk mitigation measures are needed. Therefore,
when used in accordance with the legal Instructions for Use (WG/GA), the products Alcodes Wipes and Bioban GA 50 with active
substances glutaraldehyde either or not in combination with ethanol, comply with the
environmental standards and will not cause unacceptable effects to the
environment.
Alcodes Wipes
it can be concluded that Alcodes Wipes, when used in accordance with the proposed label (WG/GA), is effective
in controlling bacteria (excluding bacterial spores and mycobacteria) and
yeasts on surfaces in
-
the
cosmetic and pharmaceutical industry;
-
the
production, storage, and consumption area of food, feed and drinks.
Overall a safe use is concluded for the
product. All intended uses show acceptable risks to the environment and no
additional risk mitigation measures are needed.
BIOBAN GA 50 Antimicrobial
BIOBAN (TM) GA 50 Antimicrobial, when used in
accordance with the proposed label (WG/GA), is
expected to be effective as an in-can preservative of the following
water based products: fabric softeners, slurries, adhesives and latexes&
paints, by the control of deteriorating bacteria and fungi (PT06).
Several other uses in the original application
were removed from the WGGA since the product types were withdrawn by the
applicant (PT11 and PT13) or requested efficacy data were not provided (PT03
and PT04).
Overall a safe use is concluded for the proposed use in PT6, the product complies with the environmental standards and will not cause unacceptable
effects to the environment..
8.1
Alcodes Wipes
|
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:
|
F
|
Indication of danger:
|
Highly flammable
|
|
|
|
Indication of danger:
|
|
|
|
|
Indication of danger:
|
|
|
R phrases
|
R11
|
Highly flammable
|
|
S phrases
|
S16
|
Keep away from sources of
ignition No smoking.
|
|
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
8.2
BIOBAN
GA 50 Antimicrobial
|
The identity of all substances in the mixture that
contribute to the classification of the mixture *:
|
|
.............
|
|
Pictogram:
|
GHS05
|
Signal word:
|
Danger
|
|
|
GHS06
|
Signal word:
|
Danger
|
|
|
GHS08
GHS09
|
Signal word:
|
Danger
Warning
|
|
H-statements:
|
H301
|
Toxic if
swallowed
|
|
|
H331
|
Toxic if
inhaled
|
|
|
H314
|
Causes
severe skin burns and eye damage
|
|
|
H317
|
May
cause an allergic skin reaction
|
|
|
H334
|
May
cause allergy or asthma symptoms or breathing difficulties if inhaled
|
|
|
H335
|
May cause
respiratory irritation
|
|
|
H400
|
Very
toxic to aquatic life
|
|
P-statements:
|
P260
|
Do
not breathe dust/fume/gas/mist/vapours/spray
|
|
|
P280
|
Wear
protective gloves/protective clothing/eye protection/face protection
|
|
|
P285
|
In
case of inadequate ventilation wear respiratory protection
|
|
|
P301 +
P330 + P331+P310
|
IF
SWALLOWED: rinse mouth. DO NOT induce vomiting and immediately call a POISON CENTER or doctor/physician
|
|
|
P303 +
P361 + P353 +P310
|
IF
ON SKIN (or hair): Remove/Take off immediately all contaminated clothing .
Rinse skin with water/shower and 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 and immediately
call a POISON CENTER or doctor/physician
|
|
|
P273
|
Avoid release to the environment
|
|
Supplemental
Hazard information:
|
none
|
sentence
|
|
Child-resistant
fastening obligatory?
|
|
|
Tactile warning of danger obligatory?
|
|
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
|
Remarks:
|
|
·
P304+ P340 not included as not highly recommended
|
|
·
P430 + P233 not included as formulation is not volatile
|
|
|
|
ESD PT06
|
Ineris, 2001; 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 lEnvironment Industriel et des Risques.
INERIS report DRC-01-25582-ECOT-CTi/VMi-n°01DR01183, Verneuil-en-Halatte, France,
May 2001
|
|
HERA 2005
|
Human and Environmental
Risk Assessment on Ingredients of Household cleaning products. Guidance
Document Methodology. 2005
|
|
Regulation (EC)
no 1005/2009
|
Regulation (EC) No
1005/2009 of the European Parliament and the Council of 16 September 2009 on
substances that deplete the ozone layer.
|
|
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
|
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 I to chapter 6. EUSES and Excel calculations
STP modelling
|
Local STP distribution and concentrations
|
|
|
|
|
|
|
|
|
Compound:
|
glutaraldehyde
|
|
|
|
|
|
|
|
|
parameter
|
value
|
unit
|
s/o/p
|
|
|
Molecular weight
|
100.11
|
g mol-1
|
s
|
|
|
Octanol-water partition coefficient (Kow)
|
0.4365
|
-
|
s
|
|
|
Vapour pressure at test temperature
|
44
|
Pa
|
s
|
|
|
Test temperature varpour pressure
|
20.1
|
°C
|
s
|
|
|
Solubility
|
405500
|
mg L-1
|
s
|
|
|
Test temperature solubility
|
20
|
°C
|
s
|
|
|
Henry constant at environmental temperature (H)
|
0.01
|
Pa m3 mol-1
|
s
|
|
|
Chemical class for Koc QSAR
|
Non hydrophobics
|
|
p
|
|
|
Organic carbon-water partition coefficient (Koc)
|
6.80
|
L kgdwt-1
|
p
|
|
|
Kp (raw sewage):
|
2.04
|
L kgdwt-1
|
p
|
|
|
Kp (activated sludge):
|
2.52
|
L kgdwt-2
|
p
|
|
|
Kp (settled sewage sludge):
|
2.04
|
L kgdwt-3
|
p
|
|
|
Kp effluent sewage sludge):
|
2.52
|
L kgdwt-4
|
p
|
|
|
Characterization of biodegradability
|
Readily biodegradable
|
|
p
|
|
|
Rate constant for degradation in a STP
|
24
|
d-1
|
p
|
|
|
Emission rate chemical:
|
2.0205
|
kg d-1
|
s
|
|
|
|
|
|
|
|
|
Remarks
|
|
|
|
|
|
Calculation are made by using default parameters for an STP.
|
|
|
|
|
|
|
|
|
|
Summary of distribution
|
|
|
|
|
|
To air
|
0.00
|
%
|
|
|
|
To water
|
12.7
|
%
|
|
|
|
Via sludge
|
0.06
|
|
|
|
|
- primary sludge
|
0.1
|
%
|
|
|
|
- surplus sludge
|
0.0
|
%
|
|
|
|
Degraded
|
87.3
|
%
|
|
|
|
|
|
|
|
|
|
Concentrations
|
|
|
|
|
|
In air
|
9.03E-10
|
g m-3
|
|
|
|
Dry swage sludge
|
1.64E+00
|
mg kg-1
|
|
|
|
primary sludge:
|
2.06E+00
|
mg kg-1
|
|
|
|
surplus sludge:
|
3.23E-01
|
mg kg-1
|
|
|
|
Effluent (total)
|
1.28E-01
|
mg L-1
|
|
|
|
dissolved
|
1.28E-01
|
mg L-1
|
|
|
|
associated
|
9.69E-06
|
mg L-1
|
|
|
|
In solids effluent
|
3.23E-01
|
mg kg-1
|
|
|
|
|
|
|
|
|
|
PEC for micro-organisms in the STP
|
1.28E-01
|
mg L-1
|
|
|
|
|
|
|
|
|
|
Calculations are made for an STP with primary settler (9-box). The
model is based on SimpleTreat 3.1
|
|
|
|
s: parameters is required
|
|
|
|
|
|
o: output
|
|
|
|
|
|
p: default value chosen from pick-up list
|
|
|
|
|
|
|
|
|
|
|
Emission to STP calculations
of glutaraldehyde
Emission of
glutaraldehyde from its intended use as a preservative in mineral slurries in
the paper industry
|
Code in ESD
|
description
|
unit
|
Input
|
source
|
|
|
volume of a.i. per kg water
|
mg/L water
|
1000
|
PGB
|
|
|
volume of a.i. per kg mineral slurry
|
mg/ kg slurry
|
300
|
PGB
|
|
|
fraction mineral clay per
tonne paper
|
|
0.1
|
Public
information
|
|
Qsubst
|
quantity of active substance applied per kg of paper
|
[kg a.s./kg]
|
0.00003
|
|
|
-
|
type of paper produced
|
[-]
|
|
|
|
Qpaper
|
quantity of coated paper produced per day
worst case -
News print
|
[kg/d]
|
449000
|
|
|
Fbroke
|
fraction of coated broke produced compared to
overall production
|
[-]
|
0.2
|
|
|
Ffix
|
fixation fraction
|
[-]
|
0
|
|
|
Fclosure
|
degree of closure of the water system
|
[-]
|
0.75
|
|
|
Output
|
|
|
|
|
|
Elocal3,water
|
local emission of active substance to waste water
|
[kg a.s./d]
|
2.02E+00
|
|
Emission of
glutaraldehyde from its intended use as a preservative in washing detergents
|
consumption model wash detergents
|
|
|
|
|
Number of households per STP (eq)
|
|
4000
|
|
|
fraction of house holds having a washing machine
|
|
1
|
suggested D
|
|
washing machines using detergent with PT02 or PT06 claim
|
4000
|
O
|
|
concentration of disinfectant/preservative
|
kg/L
|
0.00100
|
S
|
|
Amount of liquid used in washing machine
|
L
|
0.150
|
HERA TGD (2005), Appendix F, page 85
|
|
number of washing events per day of washing machine
|
|
0.57
|
HERA TGD (2005), Appendix F, page 85
|
|
Penetration factor of disinfectant
|
Fpenetr
|
0.5
|
D
|
|
litres used per day
|
|
342
|
litres/day
|
|
total of active substance per day
|
|
0.342
|
kg/day
|
