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EC number: 228-359-0 | CAS number: 6245-60-9
- 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations" Title 16 , Sections 1500.41"
- Principles of method if other than guideline:
- 0.5 g of the test item were applied to clipped and abraded skin of 6 rabbits. The duration of the application was 24 hours and the readings were performed after 1 and 48 hours and 7 days.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acid Red 042
- IUPAC Name:
- Acid Red 042
- 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
-Weight at study initiation: between 2 .5 kg and 3 .5 kg
-Housing: individual cages measuring 540 X 360 X 315 mm or in restraining devices which allow the back of the animal to be treated.
-Diet: 200 g of food is provided per animal per day in the form of granules (Granulés Lapin "entretien" SANDERS)
-Water: ad libitum
ENVIRONMENTAL CONDITIONS
-Temperature: 22 °C ± 2 °C
-Humidity: 55 % ± 20 %
-Air changes: 12 change per hour
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount: 0.5 g per area and animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 1, 48 hours and 7 days
- Number of animals:
- Six male rabbits
- Details on study design:
- TEST SITE
- Area of exposure:
clipped: 14 cm x 14 cm
abraded: the right flank is scarified with a sterile scalpel blade, making three parallel superficial incisions 2 cm long and 0.5 cm apart .
- % coverage: 2 cm²
- Type of wrap if used: gauze pad consisting of sterile, hydrophilic gauze of four layers. The material to be tested and the gauze pads are kept in contact with the skin by a patch (NEODERMOTEST ROC) consisting of a central, circular disc of 22 mm diameter with a surrounding, adhesive, hypoallergenic, perforated plaster 10 mm wide. An adhesive tape 6 cm wide is wound around the animal to complete the fixing of the patches .
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
yes, surplus material which had not penetrated the skin was removed with a sterile gauze soaked in warm water.
- Time after start of exposure: 24 hours
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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: clipped skin
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5 ,#6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: clipped skin
- Other effects:
- The purple colour of the test substance made the macroscopic examination of the erythema inaccurate. Reading was made 1 hour later, after removing the surplus material, but remains more or less imprecise.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The substance was found to be not irritating for rabbit skin.
- Executive summary:
The skin irritation test was performed to rabbit skin according to the Code of Federal Regulations" Title 16, Sections 1500.41". 0.5 g of the test item were applied to clipped and abraded skin of 6 rabbits. The duration of the application was 24 hours and the readings were performed after 1 and 48 hours and 7 days.
The purple colour of the test substance made the macroscopic examination of the erythema inaccurate at 1 hour-observation. The erythema and the oedema scores were calculated following the mean values after 24/48/72 h. For the scores at 48 h the greater value observed during the test was considered, as no observation was performed at this time-point. The erythema scores (mean values 24/48/72 hours) were 0.67 in four animals (animals #1,#3, #4 and #5), 1.33 in animal #2 and 0 in animal #6. The oedema scores (mean values 24/48/72 hours) were 0 in all animals.
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