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EC number: 405-290-6 | CAS number: 12036-37-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation / corrosion
The test material was determined to be non-irritating and non-corrosive according to Draize. The study assessed the irritancy potential of a test material following a single, 4-hour, semi-occluded application to intact rabbit skin. (OECD Guidelines for Testing of Chemicals 1981, No. 404 "Acute Dermal Irritation/Corrosion" and Annex V Method B4 of EEC Commission Directive 84/449/EEC).
Eye irritation
The test material produced a maximum group mean score of 7.3 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra scoring system. However the reactions seen were not sufficient to warrant classification. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as method B5 in Annex V of EEC Commission Directive 84/449/EEC.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 March 1989 - 10 March 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read across to a similar substance. Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Justification for type of information:
- See read-across justification in Section 13.
- Reason / purpose for cross-reference:
- other: Target substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Accredited breeders; not otherwise specified.
- Age at study initiation: 12 – 20 weeks
- Weight at study initiation: 2.0 – 3.5 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum (Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK or suitable alternative)
- Water (e.g. ad libitum): ad libitum tap water from automatic mains.
The diet and water are routinely analyses and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 – 21 °C
- Humidity (%): 40 – 75 %
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of test material moistened with 0.5 mL of distilled water and applied to 1 intact site of each rabbit.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- PROCEDURE
Method of Application: Test material introduced under gauze patch (2.5 x 2.5 cm) and secured on shorn skin by a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent interference the trunk of each animal wrapped in elasticated corset (TUBIGRIP) for duration of exposure period.
Exposure Period: 4 hours after which dressings removed and application sites decontaminated by cotton wool soaked with water or suitable solvent.
OBSERVATIONS
Skin Evaluation: Scored according to the method of Draize (1959)
Intervals: One hour after removal of patches and approximately 24, 48 and 72 hours later. If no adverse skin reactions at 72 hours, the study is complete. If irritation is persistent, additional observations will be made on days 7 and 14 as necessary to assess reversibility or irreversibility of effects observed. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects seen
- Irritant / corrosive response data:
- Corrosive effects noted in 0 animals, test material therefore classified as non-corrosive
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Non-irritant
- Executive summary:
The test material was determined to be non-irritating and non-corrosive according to Draize. The study assessed the irritancy potential of a test material following a single, 4-hour, semi-occluded application to intact rabbit skin. (OECD Guidelines for Testing of Chemicals 1981, No. 404 "Acute Dermal Irritation/Corrosion" and Annex V Method B4 of EEC Commission Directive 84/449/EEC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 March 1989 - 17 March 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across to similar substance. Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Justification for type of information:
- See read-across justification in Section 13.
- Reason / purpose for cross-reference:
- other: Target substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.59 – 2.94kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet (e.g. ad libitum): ad libitum. Free access to food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14 - 18°C
- Humidity (%):60 - 65% relative
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): give 12 hours continuous light and 12 hours darkness - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- The test material (100 mg) was placed into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The upper and lower eyelids were held
together for about one second immediately after application, to prevent loss of the test material, and then released. - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- For the purpose of this study the test material was used as supplied.
The identification and stability of the test material were not determined.
Procedure
Immediately before commencement of the test, both eyes of the three provisionally selected test rabbits were examined for evidence of ocular irritation or defect using the light source from a standard ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.
On the day of the test each animal was held firmly but gently until quiet. The test material (100 mg) was placed into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes.
The initial pain reaction was assessed for each animal, immediately after dosing, according to a six point scale.
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment, according to the numerical evaluation developed by Draize J.H. 1959, Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"). Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.
No evidence of ocular irritation was noted at the 72-hour observation and the study was terminated.
Interpretation of Results
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the total score was calculated as follows:
Total score for conjunctivae = (A + B + C) x 2
Total score for iris = D x 5
Total score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962 13 281 - 289 was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the total scores for the cornea, iris and conjunctivae for each of the 1, 24, 48 and 72-hour observations for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean overall score for 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean overall score for 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: Mean overall score for 24, 48 and 72 h
- Score:
- 0.34
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean overall score for 24, 48 and 72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- other: Mean overall score for 24, 48 ad 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight to moderate initial pain was noted following treatment. No adverse corneal or iridial effects were noted.
Moderate conjunctival irritation was noted in two treated eyes one hour after treatment. Minimal conjunctival irritation was noted in one treated eye at this time and in all treated eyes at the 24-hour observation.
All treated eyes appeared normal at the 48-hour observation. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 7.3 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra scoring system. However the reactions seen were not sufficient to warrant classification.
- Executive summary:
The test material produced a maximum group mean score of 7.3 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra scoring system. However the reactions seen were not sufficient to warrant classification. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as method B5 in Annex V of EEC Commission Directive 84/449/EEC.
Reference
Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
25 Male (IPR = 2) |
102 Female (IPR = 3) |
89 Female (IPR = 2) |
|||||||||
Time After Treatment |
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
CORNEA E = Degree of opacity F = area of opacity |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE A = Redness B = Chemosis C = Discharge |
2 1 0 |
1 0 0 |
0 0 0 |
0 0 0 |
2 1 1 |
1 1 0 |
0 0 0 |
0 0 0 |
2 1 1 |
1 0 0 |
0 0 0 |
0 0 0 |
Score (A + B + C) x 2 |
6 |
2 |
0 |
0 |
8 |
4 |
0 |
0 |
8 |
2 |
0 |
0 |
Total Scores |
6 |
2 |
0 |
0 |
8 |
4 |
0 |
0 |
8 |
2 |
0 |
0 |
Key: h = hour(s)
IPR = initial pain reaction
Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores at: |
|||
1 hour |
24 hours |
48 hours |
72 hours |
|
25 Male 102 Female 89 Female |
6 8 8 |
2 4 2 |
0 0 0 |
0 0 0 |
Group Total |
22 |
8 |
0 |
0 |
Group Mean Scores |
7.3 |
2.7 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
The key study was conducted in accordance with GLP and the
standardised guidelines OECD Guidelines for Testing of Chemicals 1981,
No. 404 "Acute Dermal Irritation/Corrosion" and Annex V Method B4 of EEC
Commission Directive 84/449/EEC. It was awarded a reliability score of 2
in accordance with the principles of Klimisch (1997) due to the fact
that the study is being used in a read-across capacity. The test was
conducted on the analogous substance Zinc Hydroxystannate. The results
are considered to be representative of the registered material.
Justification for selection of eye irritation endpoint:
The key study was conducted in accordance with GLP and the
standardised guidelines OECD Guidelines for Testing of Chemicals (1987)
No. 405 "Acute Eye Irritation/Corrosion" referenced as method B5 in
Annex V of EEC Commission Directive 84/449/EEC. It was awarded a
reliability score of 2 in accordance with the principles of Klimisch
(1997) due to the fact that the study is being used in a read-across
capacity. The test was conducted on the analogous substance Zinc
Hydroxystannate. The results are considered to be representative of the
registered material.
Justification for classification or non-classification
Skin Irritation/Corrosion
The test material was determined to be non-irritating and non-corrosive according to the Draize scale. In accordance with Annex I, Regulation 1272/2008, the test material does not require classification as it does not meet the criteria.
Eye Irritation
The test material produced a maximum group mean score of 7.3 and was described as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra scoring system. However the reactions seen were not sufficient to warrant classification in accordance with Annex I, Regulation 1272/2008.
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