Registration Dossier
Registration Dossier
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EC number: 207-529-8 | CAS number: 479-27-6
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The test substance 1,8-naphylenediamine was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on male guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 %
The test concentrations were determined in a dose finding assay. - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1992. At this time an OECD guideline for a LLNA was not available.
- Species:
- guinea pig
- Strain:
- other: Bor: DHPW
- Sex:
- male
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 % - Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 % - No. of animals per dose:
- Test substance group: 20 animals
Control group: 10 animals - Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 19.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 16.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 12.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- sensitising
- Executive summary:
The test substance 1,8-naphylenediamine was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on male guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 %
After the challenge with a 50% suspension 100% of the animals revealed a positive reaction, and after the challenge with a 25% suspension 80% of the animals revealed a positive reaction. In the control group no reaction was observed.
Therefore a classification as Xi, R43 (GHS: Skin Sens.1B) ist justified.
Reference
After the provocation with a 50% suspension 100% of the animals revealed a positive reaction, and after the provocation with a 25% suspension 80% of the animals revealed a positive reaction. In the control group no reaction was observed. The test item was formulated in polyethyleneglycol 400.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The test substance 1,8-naphylenediamine was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on male guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5 %
Topical induction: 50 %
Challenge: 50% and 25 %
After the challenge with a 50% suspension all animals revealed a positive reaction, and after the challenge with a 25% suspension 80% of the animals revealed a positive reaction. In the control group no reaction was observed.
Therefore a classification as Xi, R43 (GHS: Skin Sens.1B) ist justified.
Migrated from Short description of key information:
In a valid study 1,8-naphthylenediaminewas tested in a guinea pig maximisation test (GPMT) as described by Magnusson and Kligman
Justification for selection of skin sensitisation endpoint:
Key study used
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
no data
Justification for classification or non-classification
In the skin sensitization test according Magnusson and Kligman, after the challenge with a 50% suspension 100% of the animals revealed a positive reaction, and after the challenge with a 25% suspension 80% of the animals revealed a positive reaction. In the control group no reaction was observed.
Therefore a classification as Xi, R43 (GHS: Skin Sens.1B) ist justified.
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