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Diss Factsheets
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EC number: 227-876-9 | CAS number: 6021-61-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Disperse Red 054
- IUPAC Name:
- Disperse Red 054
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Health check: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- other: DMSO
- Remarks:
- test item was prepared immediately before dosing
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1.0 ml of the solution.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Three males and three females
- Details on study design:
- TEST SITE
- Area of exposure: test item was introduced under a square patch of surgical gauze, measuring 6.5 cm^2.
- Type of wrap if used: the animals were immobilzed with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.
SCORING SYSTEM
After 24 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulation, title 16, Section 1500.41.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritation parameter:
- edema score
- Basis:
- animal: 6/6
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Remarks:
- in none of the animals
- Irritant / corrosive response data:
- The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Six rabbits (three males and three females) were used to test the skin irritation potential of the substance. The abraded and intact skin of rabbits was treated with 1.0 ml of test solution. The irritation was measured by patch test technique on the intact skin. After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
The irritation score was 0.0 and the substance has been judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.
Conclusion
The scoring system criteria used to record the severity of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC 1272/2008).
None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).
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.
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