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EC number: 247-640-9 | CAS number: 26381-41-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from opinions on health and safety risks (chemical, biological, mechanical and other physical risks)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- EC Number:
- 247-640-9
- EC Name:
- [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 26381-41-9
- Molecular formula:
- C19H21N4O.Cl
- IUPAC Name:
- 8-[(4-aminophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Basic Brown 16- Molecular formula (if other than submission substance): C19-H21-N4-O.Cl - Molecular weight (if other than submission substance): 356.855- Smiles notation (if other than submission substance): c1(\N=N\c2ccc(cc2)N)c2cc([N+](C)(C)C)ccc2ccc1O.[ClH-]- Substance type: Organic - Physical state: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No details available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact left flank
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g of C 009 moistened with 0.1 ml of purified water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3 (1 male and 2 females)
- Details on study design:
- SCORING SYSTEM:mean erythema/eschar score and mean oedema score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: erythema/eschar score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: no signs of irritation
- Irritation parameter:
- other: mean oedema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: no signs of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hrs
- Reversibility:
- no data
- Remarks on result:
- other: slight brown staining was observed.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Reversibility:
- no data
- Remarks on result:
- other: slight brown staining was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the study considered Basic Brown 16 to be not irritating to rabbit skin.
- Executive summary:
The test substance was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately.
The mean erythema/eschar score and the mean oedema score was 0 for all three animals.The application of Basic Brown 16 to the skin resulted in no signs of irritation. However slight brown staining of the treated skin produced by the test item was observed in all animals at the 1 and 24-hour reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Thus based on the experimental observation and result it is concluded that the test substance Basic Brown 16 is not irritating to rabbit skin.
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