Registration Dossier
Registration Dossier
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EC number: 204-280-7 | CAS number: 118-83-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- 5-chloro-α,α,α-trifluoro-2-nitrotoluene
- EC Number:
- 204-280-7
- EC Name:
- 5-chloro-α,α,α-trifluoro-2-nitrotoluene
- Cas Number:
- 118-83-2
- Molecular formula:
- C7H3ClF3NO2
- IUPAC Name:
- 4-Chloro-1-nitro-2-(trifluoromethyl)benzene
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Vaseline white DAB
- Concentration / amount:
- 25%, 5%, 1% in Vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline white DAB
- Concentration / amount:
- 25%, 5%, 1% in Vaseline
- No. of animals per dose:
- 2
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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