Registration Dossier
Registration Dossier
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EC number: 203-581-0 | CAS number: 108-42-9
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 m-chloroaniline was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5 %
Topical induction: 50 %
1. Challenge: 50 %
2. Challenge: 25% and 12% - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Bor:DHPW
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 %
Topical induction: 50 %
1. Challenge: 50 %
2. Challenge: 25% and 12% - Route:
- epicutaneous, semiocclusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 %
Topical induction: 50 %
1. Challenge: 50 %
2. Challenge: 25% and 12% - No. of animals per dose:
- Three goups of experimental animals were randomly established for the main test:
One test substance group consisting of 20 animals (no 21 to 40) and 2 control groups consisting of 10 animals each (no 1 to 10, and 11 to 20) - Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 19.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 13.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: reddening + edema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: reddening + edema.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- reddening + edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: reddening + edema.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
The test substance m-chloroaniline was evaluated for potential skin sensitizing properties in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs. The following test compound concentrations were used in this test:
Intradermal induction: 5%, Topical induction: 50%, 1st Challenge: 50 %, 2nd Challenge: 25% and 12%.
Under the condition of the maximisation assay, m-chloroaniline is positive. Based on these data a classification as R43 (GHS: Skin Sens. 1B; H317) is justified.
Reference
After the 1st challenge, 95% of the test group animals and 70% of the control animals revealed skin changes on the application area of the test substance.
After the 2nd challenge, the 25% and the 12% test solution provokes skin changes on 70% and 15% on the test group animals, respectively. The animals of the control group showed no reactions.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The following test compound concentrations were used in this test:
Intradermal induction: 5%, Topical induction: 50%, 1st Challenge: 50 %, 2nd Challenge: 25% and 12%.
After the 1st challenge, 95% of the test group animals and 70% of the control animals revealed skin changes on the application area of the test substance.
After the 2nd challenge, the 25% and the 12% test solution provokes skin changes on 70% and 15% on the test group animals, respectively. The animals of the control group showed no reactions.
Migrated from Short description of key information:
The test substance m-chloroaniline was evaluated for potential skin sensitizing properties according OECD 406 in a maximisation test as decribed by Magnusson and Kligman. The test was performed on female guinea pigs.
Justification for selection of skin sensitisation endpoint:
key study is used
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data
Migrated from Short description of key information:
No data
Justification for classification or non-classification
On the basis of the positive GPMT (guinea pig maximisation test) a classification as R 43 (GHS: Skin Sens.1B; H317) is justified.
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