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EC number: 275-912-7 | CAS number: 71720-84-8
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- The procedure employed was that described by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41.
- GLP compliance:
- no
- Remarks:
- pre GLP
Test material
- Reference substance name:
- Acid Green 040
- IUPAC Name:
- Acid Green 040
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact skin
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of test item were mixed with 0.5 ml of distilled water
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- six rabbits
- Details on study design:
- TEST SITE
- Area of exposure: two slngle layers thick moinstoned with test item were introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch.
- Type of wrap if used: the entire trunk of the animal was wrapped with an impervious material such as rubberized cloth.
SCORING SYSTEM
Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skinat 24 hours and 72 hours. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Slmilarly, add the values for oedema formation at 24 hours and at 72 hours for intact and abraded skln (four values). The total of the eight values is divlded by four to give the primary irritation score.
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
Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema ( ratsed approximately I milllmeter) 3
Severe oedema (raised more than 1 miillimeter and extending beyond the area of exposure) 4
Classification system recommended by the ETAD subcommittee for Toxicology:
0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant
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:
- none of the animals showed any observable response
- 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:
- none of the animals showed any observable response
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the 72 hours observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not irritating
- Executive summary:
Primary irritation to the skin was assayed following the procedures prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41. 0.5 g of test item were rnixed with 0.5 ml of distilled water before application to the skin. The primary irritation was measured by a patch technique on both abraded and intact skin of albino rabbits.
None of the animals showed any observable response to treatment throughout the 72 hours observation period.
Conclusion
The scoring system criteria used to record the hardness 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) No 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) No 1272/2008.
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