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EC number: 243-855-7 | CAS number: 20506-24-5
- 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
In a primary skin and eye irritation study, no skin or eye irritating effects were observed in six English Silver rabbits. (BASF, 1972)
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- other: polyethylene glycol
- Controls:
- other: Untreated skin served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- see observation period; no washing was done
- Observation period:
- 72 hours
- Number of animals:
- 6 (3x shaved; 3x abraded)
- Details on study design:
- TEST SITE
- Area of exposure: whole back and flanks
- coverage: 2.5x2.5 cm gauze patch soaked with the test substance
- Type of wrap if used: plastic film fixed with adhesive tape
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite
raising 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scarified skin
- Irritant / corrosive response data:
- No irritating effects were seen in any of the six animals.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the U.S Association of Food and Drug Officials (AFDO)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: English Silver
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: individually
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- see observation period; washing out was conducted for 3/6 animals after 30 sec.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 mL lukewarm water
- Time after start of exposure: 30 sec
SCORING SYSTEM: According to Draize et al. (1959)
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: unrinsed
- Irritant / corrosive response data:
- A conjunctival effect was only observed in one animal when rinsing the eye. No other irritating parameters were detected. The irritation index was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae.
- Interpretation of results:
- GHS criteria not met
Reference
Eyes not rinsed:
Rabbit 4 | Rabbit 5 | Rabbit 6 | |||||||
Days after application | Cornea | Iris | Conjunctiva | Cornea | Iris | Conjunctiva | Cornea | Iris | Conjunctiva |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation
In a primary skin irritation, 0.5 g of the test substance suspended in polyethylene glycol was applied to the intact and abraded skin of 6 English Silver rabbits (3/sex) (BASF, 1972). All animals were shaved and half of them were slightly scarified at the shaved skin site. The test substance was applied for 24 hours under an occlusive dressing. The animals were then observed for 72 hours. Irritation was scored by the method of Draize.
No irritations were observed either on the intact or the abraded skin sites. Therefore the substance is not regarded as irritating to the skin.
Eye Irritation
In a primary eye irritation study, 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the right eye of 6 English Silver rabbits (3/sex) (BASF, 1972). The test substance was not washed out in 3 of the 6 and the left eye served as a control. Animals were observed for a period of 7 days. Irritation was scored by the method of Draize et al.(1959) after 24 hours, 72 hours and 3, 4 and 7 days.
No irritating effects in the form of corneal opacity, iritis, conjunctival redness and chemosis were observed in all six animals after 24 and 72 hours. Conclusively the test substance is not regarded as irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Non GLP study. Meets general scientific standards.
Justification for selection of eye irritation endpoint:
Non GLP study. Meets general scientific standards.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled for eye and skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for eye and skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
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