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EC number: 278-115-2 | CAS number: 75199-13-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 August to 15 August, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disperse Yellow 231
- IUPAC Name:
- Disperse Yellow 231
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.28 to 3.28 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum; Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, UK
- Water: ad libitum; mains drinking water
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 21 °C
- Humidity: 65 - 68 %
- Air changes: 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12 controlled by a time switch
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- fur of the dorsal/flank areas was closely clipped using veterinary clippers approximately 24 hours before the test
- Vehicle:
- water
- Remarks:
- slightly moistened with 0.5 ml distilled water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount applied: 0.5 g in 0.5 ml distilled water
- Negative control: untreated surrounding skin - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after removal of substance
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area
- Type of coverage if used: 2.5 × 2.5 cm gauze patch, secured with surgical adhesive tape (Blenderm; ca. 25 × 40 mm); then the trunk of the animal was wrapped in elasticated corset (Turbigrip)
REMOVAL OF TEST SUBSTANCE
- Removal: gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after removal of patch/test item
SCORING SYSTEM:
- Method of calculation: Draize, J. H. (1959) "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", as follows:
Erythema and Eschar Formation:
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema Formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approximately 1 mm)
4 - Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Very slight erythema was noted in all three animals at 1 hour after removal of the substance. Only one animal still showed slight erythema at 24 hours after exposure, which was reversible within 48 hours after exposure.
No oedema was observed. - Other effects:
- Faint yellow coloured staining of the treatment sites was noted in all three animals which lasted until the end of the study period.
Any other information on results incl. tables
Table 1: Individual daily and individual mean scores for dermal irritation/corrosion.
Skin reaction | Reading (hours) | Individual scores | ||
#1 | #2 | #3 | ||
Erythema/eschar formation | 1 | 1s | 1s | 1s |
24 | 0s | 1s | 0s | |
48 | 0s | 0s | 0s | |
72 | 0s | 0s | 0s | |
total (24, 48, 72 h) | 0 | 1 | 0 | |
mean (24, 48, 72 h) | 0.0 | 0.3 | 0.0 | |
Oedema formation | 1 | 0 | 0 | 0 |
24 | 0 | 0 | 0 | |
48 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | |
total (24, 48, 72 h) | 0 | 0 | 0 | |
mean (24, 48, 72 h) | 0.0 | 0.0 | 0.0 |
s = faint yellow-coloured staining over the test site not affecting evaluation of erythema
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- The test item was very slightly irritating to rabbit skin until 24 hours; skin was stained slightly yellow locally.
- Executive summary:
The potential skin irritation/corrosion of the test item was evaluated in an experimental study according to a method based on the OECD guideline 404 (1981). The dorsal fur of three New Zealand White rabbits was clipped free of hair and 0.5 mg of test item moistened with 0.5 ml of distilled water was applied under a gauze. After four hours, the substance was removed with cotton and water, and observations of erythema and oedema were recorded at 1, 24, 48 and 72 hours after exposure.
Very slight erythema was noted in all three animals 1 hour after exposure. Only one animal still showed slight erythema 24 hours after exposure, which was reversible within 48 hours. No oedema was observed. Faint yellow coloured staining of the treatment sites was noted in all three animals which lasted until the end of the study period. The mean (24, 48 and 72 h) irritation scores for (i) erythema and (ii) oedema were subsequently calculated to be (i) 0 in two animals and 0.33 in one animal, and (ii) 0 in all animals.
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