Registration Dossier
Registration Dossier
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EC number: 201-756-6 | CAS number: 87-60-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented Study according to guideline and under GLP-conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 3-chloro-o-toluidine
- EC Number:
- 201-756-6
- EC Name:
- 3-chloro-o-toluidine
- Cas Number:
- 87-60-5
- Molecular formula:
- C7H8ClN
- IUPAC Name:
- 3-chloro-2-methylaniline
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-Wight Hoe-Strain DHPK (SPFLac)
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- for induction and first challenge, petrolatum in second challenge
- Concentration / amount:
- Cannot be standardized for the Buehler test. Established in preliminary tests.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- for induction and first challenge, petrolatum in second challenge
- Concentration / amount:
- Cannot be standardized for the Buehler test. Established in preliminary tests.
- No. of animals per dose:
- 20
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- Erythema, dry-rough skin, fine scales
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Erythema, dry-rough skin, fine scales.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
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