File No: NA/720
27 October 2000
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION
AND ASSESSMENT SCHEME
FULL PUBLIC REPORT
-D-galactopyranuronic acid, O-6-deoxy--L-galactopyranosyl-13-O--D-
galactopyranosyl-13-, homopolymer (9CI)
(Biosaccharide Gum-1)
This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals
(Notification and Assessment) Act 1989 (the Act) and Regulations. This legislation is an Act of the
Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment
Scheme (NICNAS) is administered by the National Occupational Health and Safety Commission
which also conducts the occupational health & safety assessment. The assessment of environmental
hazard is conducted by the Department of the Environment and the assessment of public health is
conducted by the Department of Health and Aged Care.
For the purposes of subsection 78(1) of the Act, copies of this full public report may be inspected by
the public at the Library, National Occupational Health and Safety Commission, 92-94 Parramatta
Road, Camperdown NSW 2050, between the following hours:
Monday - Wednesday 8.30 am - 5.00 pm
Thursday 8.30 am - 8.00 pm
Friday 8.30 am - 5.00 pm
Copies of this full public report may also be requested, free of charge, by contacting the
Administration Coordinator on the fax number below.
For enquiries please contact the Administration Coordinator at:
Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW 2050, AUSTRALIA
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA
Telephone: (61) (02) 9577 9514 FAX (61) (02) 9577 9465
Director
Chemicals Notification and Assessment
TABLE OF CONTENTS
FULL PUBLIC REPORT ......................................................................................................................3
1. APPLICANT..............................................................................................................................3
2. IDENTITY OF THE CHEMICAL ............................................................................................3
3. PHYSICAL AND CHEMICAL PROPERTIES........................................................................4
4. PURITY OF THE CHEMICAL ................................................................................................5
5. USE, VOLUME AND FORMULATION .................................................................................6
7. PUBLIC EXPOSURE................................................................................................................8
8. ENVIRONMENTAL EXPOSURE ...........................................................................................8
Release ...........................................................................................................................................8
Fate.................................................................................................................................................9
9. EVALUATION OF TOXICOLOGICAL DATA......................................................................9
9.1 Acute Toxicity ...................................................................................................................9
9.1.1 Oral Toxicity................................................................................................................10
9.1.2 Skin Irritation ...............................................................................................................10
9.1.3 Eye Irritation ................................................................................................................11
9.2 Overall Assessment of Toxicological Data......................................................................12
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS.........................................................12
11. ASSESSMENT OF ENVIRONMENTAL HAZARD.........................................................12
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS.........................................................................................................................................13
13. RECOMMENDATIONS.....................................................................................................14
14. MATERIAL SAFETY DATA SHEET ...............................................................................15
15. REQUIREMENTS FOR SECONDARY NOTIFICATION ...............................................15
16. REFERENCES ....................................................................................................................15
MSDS...................................................................................................................................................18
NA/720
FULL PUBLIC REPORT
-D-galactopyranuronic acid, O-6-deoxy--L-galactopyranosyl-13-O--D-
galactopyranosyl-13-, homopolymer (9CI)
(Biosaccharide Gum-1)
1. APPLICANT
Marigny (Australasia) Pty Ltd of 266 Bay Road, SANDRINGHAM VIC 3191 (ACN 004 191
673) has submitted a Limited Notification statement in support of their application for an
assessment certificate for the biopolymer, Biosaccharide Gum ?1.
No application was made by the notifier for any information relating to the notified
biopolymer to be exempt from publication in the Full Public Report and Summary Report.
2. IDENTITY OF THE CHEMICAL
-D-galactopyranuronic
Chemical Name: acid, O-6-deoxy--L-
galactopyranosyl-13-O--D-galactopyranosyl-13-,
homopolymer (9CI)
Chemical Abstracts Service
194237-89-3
(CAS) Registry No.:
Biosaccharide Gum-1
Other Names:
Fucogel 1000PP (aqueous solution that contains the
Marketing Name:
notified biopolymer at 1%)
(C6H12O6)x (C6H12O6)y (C6H10O7)z
Molecular Formula:
where (L-Fructose)x + (D-Galactose)y + (Galacturonic
acid)z 105 (see comments below)
Structural Formula:
COOH
CH2OH
O
O
O OH
OH
CH3
OH O
O
O
HO
OH
OH
O
FULL PUBLIC REPORT 17 July 2000
NA/720 Page 3 of 18
20 000
Molecular Weight:
Method of Detection
Infrared (IR) analysis
and Determination:
Major IR absorbance peaks were located between 1 600
Spectral Data:
to 700 cm-1
Comments on Chemical Identity
The notified biopolymer is composed of disaccharides, (L-fructose and D-galactose) and
galacturonic acid.
No molecular formula for the notified biopolymer was provided. The absence of information
on the ratio of disaccharide to galacturonic acid prevented an independent determination of a
molecular formula for the biopolymer for this assessment.
3. PHYSICAL AND CHEMICAL PROPERTIES
Pale yellow, slightly opalescent, viscous solution
Appearance at 20癈 & 101.3 kPa:
Not determined
Boiling/Melting Point:
1.00 g/cm3
Density:
Not determined
Vapour Pressure:
Not determined
Water Solubility:
Not determined
Partition Co-efficient
(n-octanol/water):
Not determined
Hydrolysis as a Function of pH:
Not determined
Adsorption/Desorption:
Not determined
Dissociation Constant:
Not determined
Flammability Limits:
Not determined
Autoignition Temperature:
Not determined
Explosive Properties:
Not determined
Reactivity/Stability:
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NA/720 Page 4 of 18
Comments on Physico-Chemical Properties
Other than a measurement of density no other investigation of physico-chemical properties
were conducted on the notified biopolymer.
Based on its high molecular weight and polysaccharide nature, the notified biopolymer is
expected to have low vapour pressure.
In the absence of physico-chemical data, the notifier has commented as follows:
The notified biopolymer is expected to be very soluble in water.
Hydrolysis of the notified biopolymer is not expected to occur in the environmental pH range
due to the presence of stable glycosidic linkages. The literature indicates that abiotic
breakdown of the glycosidic linkages is only expected to occur in the presence of an acid
catalyst in aqueous solution where water is present in excess.
The n-octanol partition coefficient is expected to be low. The notified biopolymer is
expected to partition to water due to its anticipated water solubility.
The notified biopolymer is not expected to sorb strongly to soil, sediments or organic
material due to its anticipated water solubility.
The galacturonic acid component of the notified biopolymer has a carboxylic acid group
which has the potential to dissociate.
4. PURITY OF THE CHEMICAL
>99%
Degree of Purity:
Hazardous Impurities:
Chemical name: Heavy metals (unidentified)
CAS No.: Not assigned
0.002
Weight percentage:
Chemical name: Arsenic
CAS No.: 7440-38-2
0.0002
Weight percentage:
R23/25 - Toxic by inhalation and if swallowed
Toxic properties:
(NOHSC 1999)
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NA/720 Page 5 of 18
Non-hazardous Impurities
None
(> 1% by weight):
Fucogel 1000PP contains the notified biopolymer at 1%
Additives/Adjuvants:
(aqueous solution) and is preserved with
Phenoxyethanol (1%) and Phenonip (<0.3%).
Chemical name: 2-Phenoxyethanol
CAS No.: 122-99-6
Phenonip is comprised of:
Chemical name: Methylparaben
CAS No.: 99-76-3
Chemical name: Ethylparaben
CAS No.: 120-47-8.
Chemical name: Propylparaben
CAS No.: 94-13-3
Chemical name: Butylparaben
CAS No.: 94-26-8
Chemical name: Isobutylparaben
CAS No.: 4247-02-3
5. USE, VOLUME AND FORMULATION
The notified biopolymer will not be manufactured in Australia. It will be imported as a
component (1%) of an aqueous solution, Fucogel 1000PP at approximately 50 kg per annum
over the next five years in 25 kg plastic containers.
Fucogel 1000PP is an additive used in the formulation of skin moisturisers at concentrations
of up to 5% (0.05% notified biopolymer).
Formulation of the finished moisturiser involves transfer of the notified biopolymer solution
at the final stage of manufacture to other ingredients contained within a steam-jacketed,
enclosed mixing vessel. The notifier states that the formulation process is automated.
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6. OCCUPATIONAL EXPOSURE
Tabulated below is the maximum potential exposure duration of workers to the notified
biopolymer and the personal protective equipment required to be worn by them during the
performance of their tasks.
Category of Nature of Work Done Maximum Personal Protective Equipment &
Worker Potential Engineering Controls
Exposure
Storeworker Storage & transfer of 25 0.5 hour/day; Safety glasses, overalls & gloves;
kg containers. 12 days/year.
Compounder Dispensing of 2 hours/day; Safety glasses, overalls & gloves;
biopolymer solution 24 days/year. Exhaust ventilation/dust
into mixing vessel & extractors.
cleaning of equipment.
Linesetter Setting, monitoring & 0.5 hour/day; Safety glasses, overalls & gloves;
maintaining filling line. 24 days/year. Exhaust Ventilation.
Laboratory Sampling & testing of 0.5 hour/day; Safety glasses, overalls & gloves;
Technician the biopolymer solution 24 days/year. Laboratory fume hoods.
prior to compounding.
Transport and Storage
The notified biopolymer solution is transported in hermetically sealed 25 kg containers. No
exposure is anticipated during transport except in the event of a spill. One storeworker is
responsible for delivery receipt and transfer of the containers to the storage area by forklift.
Formulation
Blending
Up to three compounders are involved in the formulation process. Within the dispensary, the
notified biopolymer solution is weighed out by a compounder, then manually transferred to
the 3 000 kg mixing vessel which already contains the other ingredients.
Packaging
At the end of the compounding process the mixing vessel is sealed to prevent contamination.
The finished product (containing the notified biopolymer at 0.05%) is transferred to the
packaging line where one linesetter feeds the product into the filler, which transfers the end
use product to 50 mL jars.
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Clean - up
After filling, the empty vessel is cleaned before returning to the manufacturing area. A third
compounder steam cleans the vessel in the wash bay and stores it for future use. This
compounder is also responsible for washing of the 25 kg containers prior to disposal.
Quality Control Analysis
Sampling of the biopolymer solution is performed by two laboratory technicians in a
segregated, quarantine area of the store. Testing of samples is undertaken in the chemical
laboratory.
7. PUBLIC EXPOSURE
Exposure of the public to the notified biopolymer is via cosmetic use. The notifier estimates
that consumers will use the product once every 2 to 3 days, and therefore be exposed to 0.25
g of the biopolymer per application of skin moisturiser, equivalent to about 0.1 g per day.
Spillage of Fucogel 1000PP during transport will be controlled by following the
recommended spill procedures given in the Material Safety Data Sheet (MSDS), which
recommends that spillages should be collected by aspiration or absorption of the material
onto sand or sawdust for disposal by incineration.
8. ENVIRONMENTAL EXPOSURE
Release
The notified biopolymer will be formulated at a factory site in Melbourne. Release of the
notified biopolymer is expected to occur during formulation activities such as dispensing,
mixing, quality testing, packaging and equipment and drum cleaning. Release is expected to
total approximately 5% (2.5 kg) of total import volume. All liquid waste and spills are
contained and directed to the in-house effluent plant. The effluent treatment process is a
batch process involving 10 000 litres per treatment cycle. During this process the alkaline
effluent is adjusted to a pH range of 6-10 using 32% (v/v) HCI. Ammonia stripping via
aeration/evaporation is another feature of this process. The treated water is then released to
the Melbourne Waste Water Treatment Plant.
The amount of end use product remaining as residues in the retail jars will depend on the
design of the containers. The most likely container residue level is 5% volume, representing
release of approximately 5% of import volume (2.5 kg) per annum. Retail containers will be
disposed of to landfill through domestic garbage services.
The majority of release of the notified biopolymer is expected to be associated with end use
of the consumer product. The high molecular weight of the notified biopolymer suggests that
it will not pass biological membranes and will therefore remain on the skin to be
subsequently washed off and into the sewer. The notified biopolymer has the potential to be
degraded on the skin by bacteria but it is not known what percentage will be broken down
and absorbed. Consequently, the Predicted Environmental Concentration (PEC) estimate
FULL PUBLIC REPORT 17 July 2000
NA/720 Page 8 of 18
assumes all of the notified biopolymer applied to the skin will be washed off (see
Environmental Hazard section).
Fate
The polysaccharide nature of the compound suggests at least inherent biodegradability.
Glycosidic linkages between individual units of the biopolymer are likely to be stable to
abiotic degradation under normal environmental pH, but under extreme pH these linkages
may be destroyed. However the biopolymer has the potential to be readily degraded by
bacteria and other microflora in the pH range of 4-9.
Notified biopolymer released to the sewer is expected to remain in solution rather than be
removed during primary treatment. During biological or secondary treatment, the notified
biopolymer is expected to be oxidised and degraded by anaerobic and aerobic
microorganisms and ultimately mineralised to carbon dioxide and water.
The high anticipated solubility indicates the notified biopolymer may leach rapidly in landfill.
However, the notified biopolymer is expected to be degraded by soil borne bacteria. Any
undegraded biopolymer in landfill may eventually be transported to the aquatic compartment.
Due to the high molecular weight and anticipated high water solubility, the biopolymer is not
expected to bioaccumulate or persist.
9. EVALUATION OF TOXICOLOGICAL DATA
The following tests were conducted on Fucogel 1000 (also known as Bioeurope 856), which
is an aqueous solution that contains the notified biopolymer at 1% and the preservatives,
Phenopip (phenoxy ethanol and parabens at 0.6%).
9.1 Acute Toxicity
Summary of the acute toxicity of Fucogel 1000
Test Species Outcome
Acute oral toxicity Mouse LD50 not established
Skin irritation Rabbit Slight irritant
Eye irritation Rabbit Slight irritant
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9.1.1 Oral Toxicity (Universite D'Aix Marseille 1992)
Species/strain: Mouse/OFI albino
Number/sex of animals: 10/group
Observation period: 8 days
Method of administration: Oral gavage: 200, 500, 1 00 and 1 000 mg/kg
Test method: Not stated
Mortality: There were 2 deaths in the 1 000 mg/kg group and 3 deaths
in the 1 500 mg/kg group. Also reported were 3 deaths in
the control group.
Clinical observations: Not reported
Morphological findings: Not reported
LD50: Not established
Comment: The study summary reports an LD50 of > 1 500 mg/kg bw.
However, on the basis of deaths occurring in control animals
with no explanation offered and in the absence of
commentary on morphological findings this assessment
rejects the quoted LD50 and concludes that an LD50 cannot
be established.
9.1.2 Skin Irritation (Universite D'Aix Marseille 1992)
Species/strain: Rabbit/albino
Number/sex of animals: 6, sex not specified
Observation period: 3 days
Method of administration: Not satisfactorily described except that the test substance
was applied in a volume of 0.5 mL to scarified and non-
scarified zones on the sides of animals.
Test method: Not stated
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Draize scores:
Time after Animal #
treatment 1 2 3 4 5 6
(days)
Erythema &
oedema
a
1 1 1 1 0 0 0
2 NR NR NR NR NR NR
3 1 1 0 0 0 0
a
see Attachment 1 for Draize scales. NR ?not reported.
Comment: Only an approximate assessment of the skin irritation effect
of the notified biopolymer can be made on the basis of the
quality of the data provided. The irritation scores for
erythema and oedema were provided as combined scores,
and the 48-hour observation point was not included. It was
therefore not possible to calculate the mean scores for skin
irritation from this study.
Result: The poor reporting quality of the study permits only an
approximate assessment of eye irritation potential to be
made. The available evidence suggests that the notified
biopolymer solution may be a slight irritant to the skin of
rabbits.
9.1.3 Eye Irritation (Universite D'Aix Marseille 1992)
Species/strain: Rabbit/albino
Number/sex of animals: 3, sex not specified
Observation period: 7 days
Method of administration: 0.1 mL of test substance instilled into the right eye of each
animal
Test method: Not stated
Comment: No accurate assessment of the ocular irritation potential of
the notified biopolymer can be made because no scores for
ocular lesions were given for the first three days of
observation. The report mentions conjunctival irritation in
all three animals one hour after instillation, with slight
oedema in one animal, with no evidence of any lesions by
the fourth day.
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Result: The poor reporting quality permits only an approximate
assessment of eye irritation potential to be made. The
available evidence suggests that the biopolymer solution
may be slightly irritating to the eyes of rabbits.
9.2 Overall Assessment of Toxicological Data
Toxicological data on the notified biopolymer are not available. However, the notifier
provided findings on acute oral toxicity, and skin and eye irritation on Fucogel 1000 an
aqueous solution that contains the notified biopolymer at 1% and less than 1% preservative.
Interpretation of the results from these studies is hampered by the fact that the tests were not
conducted according to established test guidelines and only summary reports were provided
with very little detail given on methodology and test findings.
An acute oral LD50 could not be determined on the basis of mortality in the control group.
Irritation studies gave insufficient information to accurately determine the potential to
adversely affect the skin and eyes but the available evidence suggests that only a slight
reaction was elicited in both, with notified biopolymer solution.
Hazard Classification
On the basis of the limited data provided no determination of hazard can be made for Fucogel
1000PP against the NOHSC Approved Criteria for Classifying Hazardous Substances
(NOHSC 1999)
10. ASSESSMENT OF ENVIRONMENTAL EFFECTS
No ecotoxicological data were provided.
11. ASSESSMENT OF ENVIRONMENTAL HAZARD
The notified biopolymer is unlikely to present a hazard to the environment when formulated
as described and used in the indicated manner. The great majority of the biopolymer will go
through the sewerage system where it is expected to undergo biodegradation to carbon
dioxide and water.
While no data are readily available for the biopolymer or related polymers neither the
biopolymer or its degradation products are likely to be toxic to aquatic organisms. In any
case all releases of the biopolymer will be widespread and diffuse at very low concentrations
(see below).
This assessment assumes the cosmetic product will be sold throughout Australia,
consequently release will be widespread and diffuse. The following assumptions are held in
calculating the PEC: the formulation containing the new biopolymer is used nationwide; all is
released to the sewer system; 150 L of waste water are generated each day by each person;
and that the biopolymer remains in the water column.
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Import rate 50 kg per annum
Release rate 50 kg per annum
Population (national) 18 000 000
Volume of sewerage per annum 18 000 000 x 150 L
0.051 礸/L
Mean concentration in sewage per day
0.0051 礸/L
PEC*
*On release to receiving waters (after treatment at the sewage treatment plant), it is assumed
that the effluent is diluted by a factor of 10.
Many monosaccharides such as galactose and fructose act as substrates for both fermentation
and respiratory metabolism (Zubay 1983). For this reason, and provided levels of release
remain low, the notified biopolymer is not expected to be toxic and the risk posed to the
aquatic environment is considered to be low.
12. ASSESSMENT OF PUBLIC AND OCCUPATIONAL HEALTH AND SAFETY
EFFECTS
Summary reports on an acute oral toxicity study and skin and eye irritant studies were
provided for an aqueous solution containing the notified biopolymer at 1% and preservatives
at less than 1%. An LD50 for acute oral toxicity cannot be established on the basis of
mortality in the control group. The descriptive findings indicate slight skin and eye irritancy
in animals. Interpretation of the study results is severely hindered by the poor reporting
quality of the studies and an assessment of hazard of the notified biopolymer against the
NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC 1999) is not
possible.
Occupational Health and Safety
The formulation and final packaging of skin moisturisers containing the notified biopolymer
(at 0.05%) occurs within an automated and partially enclosed system. Tasks requiring
manual operations, such as handling of the 25 kg import containers containing the notified
biopolymer (at 1%), weighing and addition of the notified biopolymer to mixing vessels and
sampling for quality control purposes, could give rise to drips, spills and splashes.
Contamination of the workplace atmosphere with aerosols of the notified biopolymer is not
expected given the viscous nature of the polysaccharide and the presence of ventilation
systems throughout the plant. The notifier states that all workers at the formulation site are
required to wear coveralls, gloves and safety glasses, thereby limiting the occurrence of skin
and eye contact. Formulation of the moisturisers is done batch wise and occurs about twice
per month. Under the conditions described, exposure to the diluted notified biopolymer
during manual tasks is expected to be intermittent and the potential risk of skin and eye
irritant effects low. Other activities where exposure to the notified biopolymer could occur
are during rinsing of the import containers for disposal and cleaning of plant equipment.
FULL PUBLIC REPORT 17 July 2000
NA/720 Page 13 of 18
However, the biopolymer is present in very dilute form (<1.0%) and the level of exposure is
considered negligible.
Public Health
Exposure of the public to the notified biopolymer via cosmetic use is estimated to be 0.25 g
of the notified biopolymer per application of skin moisturiser, equivalent to about 0.1 g per
day. Since the biopolymer is present at a low final concentration in the finished product
(0.05%), it is unlikely to pose a significant risk to the public when used in the proposed
manner.
13. RECOMMENDATIONS
To minimise occupational exposure to the notified biopolymer, the following guidelines and
precautions should be observed:
Workers should receive regular instruction on good occupational hygiene practices in
?br>
order to minimise personal contact, and contamination of the work environment with
Biosaccharide Gum-1 and products that contain it.
Personal protective equipment (PPE) should be used where exposure to Biosaccharide
?br>
Gum-1 and products that contain it occurs. Workers should be trained in the proper
fit, correct use and maintenance of their PPE. Guidance in the selection, personal fit
and maintenance of PPE can be obtained from:
Protective eyewear: AS 1336 (SAA 1994);
AS/NZS 1337 (SAA/SANZ 1992).
Chemical impermeable AS 3765.2 (SAA 1990).
clothing:
Impermeable gloves: AS 2161.2 (SAA/SANZ 1998).
Occupational footwear: AS/NZS 2210 (SAA/SANZ 1994).
A copy of the MSDS should be easily accessible to employees.
?br>
If products containing the notified biopolymer are hazardous to health in accordance with the
NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC 1999),
workplace practices and control procedures consistent with State and territory hazardous
substances regulations must be in operation.
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NA/720 Page 14 of 18
14. MATERIAL SAFETY DATA SHEET
The MSDS for the notified biopolymer was provided in a format consistent with the National
Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC 1994).
This MSDS was provided by the applicant as part of the notification statement. It is
reproduced here as a matter of public record. The accuracy of this information remains the
responsibility of the applicant.
15. REQUIREMENTS FOR SECONDARY NOTIFICATION
Under the Act, the Director of Chemicals Notification and Assessment, must be informed if
any of the circumstances stipulated under subsection 64(2) of the Act arise, and secondary
notification of the notified chemical may be required. No other specific conditions are
prescribed.
16. REFERENCES
NOHSC (1994). National Code of Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(1994)]. Canberra, Australian Government Publishing Service.
NOHSC (1999). Approved Criteria for Classifying Hazardous Substances
[NOHSC:1008(1999)]. Canberra, AusInfo.
NOHSC (1999). List of Designated Hazardous Substances [NOHSC:10005(1999)].
Canberra, AusInfo.
SAA (1990). Australian Standard 3765.2-1990, Clothing for Protection Against Hazardous
Chemicals Part 2 Limited Protection Against Specific Chemicals. Sydney, Standards
Association of Australia (SAA).
SAA (1994). Australian Standard 1336-1994, Eye Protection in the Industrial Environment.
Sydney, Standards Association of Australia (SAA).
SAA/SANZ (1992). AS/NZS 1337-1992, Australian/New Zealand Standard Eye Protectors
for Industrial Applications. Sydney/Wellington, Standards Association of Australia/Standards
Association of New Zealand (SAA/SANZ).
SAA/SANZ (1994). Australian/New Zealand Standard 2210-1994, Occupational Protective
Footwear. Sydney/Wellington, Standards Association of Australia/Standards Association of
New Zealand (SAA/SANZ).
SAA/SANZ (1998). Australian/New Zealand Standard 2161.2-1998, Occupational Protective
Gloves, Part 2: General Requirements. Sydney/Wellington, Standards Association of
Australia /Standards Association of New Zealand (SAA/SANZ).
FULL PUBLIC REPORT 17 July 2000
NA/720 Page 15 of 18
Universite D'Aix Marseille (1992). Acute Oral Toxicity - Bioeurope 856 (Summary Report -
English translation). Marseille.
Universite D'Aix Marseille (1992). Eye Irritation Study - Bioeurope 856 (Summary Report -
English translation). Marseille.
Universite D'Aix Marseille (1992). Primary Skin Irritation Study - Bioeurope 856
(Summary Report - English translation). Marseille.
Zubay, G. (1983). Biochemistry. Part II. Carbohydrate Metabolism and Chemical Energy,
Addison-Wesley Publishing Co.
FULL PUBLIC REPORT 17 July 2000
NA/720 Page 16 of 18
Attachment 1
The Draize Scale (Draize, 1959) for evaluation of skin reactions is as follows:
Erythema Formation Rating Oedema Formation Rating
No erythema 0 No oedema 0
Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1
Well-defined erythema 2 Slight oedema (edges of area well- 2
defined by definite raising
Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3
Severe erythema (beet redness) 4 4
Severe oedema (raised more than 1 mm
and extending beyond area of exposure)
The Draize scale (Draize et al., 1944) for evaluation of eye reactions is as follows:
CORNEA
Opacity Rating Area of Cornea involved Rating
No opacity 0 none 25% or less (not zero) 1
Diffuse area, details of iris clearly 1 slight 25% to 50% 2
visible
Easily visible translucent areas, details 2 mild 50% to 75% 3
of iris slightly obscure
Opalescent areas, no details of iris 3 Greater than 75% 4
visible, size of pupil barely discernible moderate
Opaque, iris invisible 4 severe
CONJUNCTIVAE
Redness Rating Chemosis Rating Discharge Rating
Vessels normal 0 none No swelling 0 none No discharge 0 none
Vessels definitely 1 Any swelling above 1 slight Any amount different 1 slight
injected above normal slight normal from normal
More diffuse, deeper 2 mod. Obvious swelling with 2 mild Discharge with 2 mod.
crimson red with partial eversion of lids moistening of lids and
individual vessels not adjacent hairs
Swelling with lids half-
easily discernible
closed 3 mod. Discharge with 3 severe
Diffuse beefy red 3 severe moistening of lids and
Swelling with lids half- hairs and considerable
closed to completely 4 severe area around eye
closed
IRIS
Values Rating
Normal 0 none
Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight
No reaction to light, haemorrhage, gross destruction 2 severe
MSDS
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