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EC number: 287-007-4 | CAS number: 85408-46-4
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- 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
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- 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
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.Therefore the test subsatnce is to be considered as non-irritant to the skin of rabbits.
The primary-irritation index, which serves as a measure of the acute eye irritation, was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae. The findings were reversible within 2 days.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: single housing in V2A wire cages
- Diet: NAFAG (Gossau SG, rabbit food), ad libitum
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and slightly scarified on the left side
- Vehicle:
- other: Polyethylene glycol (PEG 400)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50 % polyethylene glycol suspension - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6 (3 males / 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5*2.5 cm (on both sides)
- Type of wrap if used: The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h and 72 h after application
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h and 72 h after application
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single housing in V2A wire cages
- Diet: NAFAG (Gossau SG) rabbit food ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- single treatment (30 seconds)
- Observation period (in vivo):
- The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.
SCORING SYSTEM:
on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: days 1,2,3,4,7 after application
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: days 1,2,3,4,7 after application
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: days 1,2,3,4,7 after application
- Score:
- 0.2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation/corrosion potential of the test substance was assessed in an equivalent to OECD 404 study. The test was conducted to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian strain were shaved on the whole back and flanks two days before treatment with an electric clipper.
The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was-applied to each side in quantities of 0.5 g. Before application a 50% polyethylene glycol suspension (PEG 400) was made. The gauze patches were removed 24 hours after the application. The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. The erythema and edema score was 0, respectively.
Additionally, the potential of the test substance to induce eye irritation was determined in a study equivalent to OECD 405. The substance was tested for its irritating effect on the eyes of 6 rabbits (3 males/3 females) of the Russian strain. The procedure adopted was the technique described in the"Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae. The findings were reversible within 2 days.
Justification for classification or non-classification
Based on the available information classification for skin or eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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