Registration Dossier
Registration Dossier
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EC number: 201-346-7 | CAS number: 81-39-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- No guideline followed but method is comparable to OECD TG 404 in principle.
- Deviations:
- yes
- Remarks:
- No guideline followed but method is comparable to OECD TG 404 in principle.
- Principles of method if other than guideline:
- 0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
- Cas Number:
- 81-39-0
- Molecular formula:
- C24H18N2O2
- IUPAC Name:
- 3-methyl-6-[(4-methylphenyl)amino]-3H-naphthol[1,2,3-de]quinolone-2,7-dione
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Macrolex Rot 5B
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Body weight between 2.3 and 2.8 kg; 6 male and 6 female rabbits.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml test item (50% test item 50% water)
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 6 male and 6 female
- Details on study design:
- 0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Other effects:
- no effect on clinical observations, feed intake, body weight development
Any other information on results incl. tables
No irritation was observed on the intact and scarificed skin at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No adverse effects observed. Not irritating.
- Executive summary:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize. No irritation was observed on the intact and scarificed skin at any time point.
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