Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-127-2 | CAS number: 71873-51-3
- 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:
- October from 19th to 26th, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acid Yellow 218
- IUPAC Name:
- Acid Yellow 218
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, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old.
- Weight at study initiation: 2.24 - 2.37 kg
- Housing: individually housed in suspended metal cages.
- Diet: free access to food (Rabbit Diet, Preston Farmers Limited, Nerv Leake, Boston, Lincolnshire, U.K. and Spillers Rabbit Diet, Daigety Agriculture Ltd., Almondsbury, Bristol) was allowed throughout the study.
- Water: free access to mains drinking water.
- Acclimation period: minimum acclimatisation period of five days.
- Health check: on the day before the test each of a group of rabbits was clipped free of fur from the dorsal/ flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Relative humidity: 47 - 65 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of test material were moistened with 0.5 ml of distilled water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 1 female and 2 males
- Details on study design:
- TEST SITE
- Area of exposure: test item was introduced under a 2.5 cm × 2.5 cm gauze patch and placed in position on the shorn skin.
- Type of wrap if used: the patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm × 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
Approximately one hour following the removal of the patches and 24, 48 and 72 hours later, the test sites were examined. An additional observation was made on day 7 to assess the reversibility of the skin reactions.
SCORING SYSTEM
The test sites were examined for evidence of primary irritation and scored according to scale decribed in the 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".
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar fornation (injuries in depth) 4
Oedema formatíon
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Faint yellow-coloured staining caused by the test material was noted at two treated skin sites during the study. It did not affect evaluation of skin responses.
Very slight erythema was noted at all treated skin sites 1, 24 and 48 hours after patch removal and continued to be noted at two treated skin sites at the 72-hour observation.
Very slight oedema was noted at two treated skin sites one hour after patch removal.
All treated skin sites appeared normal at the 7-day observation.
The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.
Any other information on results incl. tables
Individual reactions
Animal | Reaction | 1 hrs | 24 hrs | 48 hrs | 72 hrs | 7 days | Mean 24/48/72 hrs |
28 female | Erythema/Eschar | 1 STA | 1 STA | 1 STA | 1 STA | 0 | 1.00 |
39 male | Erythema/Eschar | 1 | 1 | 1 | 0 | 0 | 0.67 |
68 male | Erythema/Eschar | 1 STA | 1 STA | 1 STA | 1 STA | 0 | 1.00 |
28 female | Oedema | 1 | 0 | 0 | 0 | 0 | 0.00 |
39 male | Oedema | 0 | 0 | 0 | 0 | 0 | 0.00 |
68 male | Oedema | 1 | 0 | 0 | 0 | 0 | 0.00 |
STA: faint yellow-coloured staining caused by the material
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
The study was performed to assess the irritancy potential of the test material following a single, 4-hour, semi-occluded application to the intact rabbit skin. The method used followed OECD guideline 404.
Faint yellow-coloured staining caused by the test material was noted at two treated skin sites during the study. It did not affect evaluation of skin responses.
Very slight erythema was noted at all treated skin sites 1, 24 and 48 hours after patch removal and continued to be noted at two treated skin sites at the 72-hour observation. Very slight oedema was noted at two treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 7-day observation.
The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.
Conclusion
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.