Registration Dossier
Registration Dossier
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EC number: 221-375-9 | CAS number: 3081-14-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
- Reference Type:
- publication
- Title:
- Acute Toxicologic Evaluation of N,N'-Bis(1,4-dimethylpentyl)-p-phenylene diamine
- Author:
- Bomhard, E. et al.
- Year:
- 1 996
- Bibliographic source:
- J. Am. Coll. Toxicol. 15 (Suppl. 1), p. S73
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period 7 days because no skin irritating effects observed
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
- EC Number:
- 221-375-9
- EC Name:
- N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine
- Cas Number:
- 3081-14-9
- Molecular formula:
- C20H36N2
- IUPAC Name:
- N1,N4-bis(5-methylhexan-2-yl)benzene-1,4-diamine
- Details on test material:
- Vulkanox 4030 purity: 93.9%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 h
- Observation period:
- up to 7 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: at 24 and 48 h evaluation not possible due to the intensive coloration by the test substance
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: at 24 and 48 h evaluation not possible due to the intensive coloration by the test substance
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects
Any other information on results incl. tables
Evaluation of skin erythema was not possible during the first 48 hours (two animals) / 72 hours (one animal) due to the intense coloration by the test substance. Nevertheless, no other inflammatory signs (e.g. oedema formation) became apparent within this period and no irritant effects were observed after 72 hours and 7 days respectively. Therefore, the authors concluded that a significant irritant effect of the test substance to the skin may be excluded.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The skin irritating potential of 77PD was evaluated in a GLP and OECD guideline study (TG 404) in New Zealand White rabbits (Bayer AG 1990). 500 mg of the test substance was applied under semi-occlusive conditions onto the clipped intact skin of 3 female rabbits for an exposure period of 4 hours. Evaluation of skin irritation was made 1 hour, 24 hours, 48 hours, 72 hours and seven days after termination of exposure. The degree of skin irritation was recorded as specified by DRAIZE and any additional serious lesions or toxic effects were also recorded. Evaluation of skin erythema was not possible during the first 48 hours (two animals) and 72 hours (one animal) due to the intense coloration by the test substance. Nevertheless, no other inflammatory signs (e.g. oedema, formation) became apparent within this period and no irritant effects were observed after 72 hours and 7 days respectively. The authors concluded that therefore a significant irritant effect of 77PD to the skin may be excluded.
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