Registration Dossier
Registration Dossier
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EC number: 213-313-4 | CAS number: 936-49-2
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:
- 2 (reliable with restrictions)
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- non-LLNA method experimental result was already available
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 1st: Induction .1 % intracutaneous
2nd: Induction 3 % occlusive epicutaneous
3rd: Challenge 1 % occlusive epicutaneous - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 1st: Induction .1 % intracutaneous
2nd: Induction 3 % occlusive epicutaneous
3rd: Challenge 1 % occlusive epicutaneous - No. of animals per dose:
- 20 animals for test
10 animals for control - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
RESULTS OF TEST - Sensitization reaction: 0/20 animals positive at 24 hours and at 48 hours = no sensitization no animals positive in control group - Clinical signs: 1st induction, FCA application sites: severe erythema and edema, slight to severe necroses 1st induction, vehicle + test substance application sites: distinct erythema and edema 1st induction, vehicle application sites: slight erythema 2nd induction, test and control groups: some FCA injection sites bleeding, wounds from scratching; crust formation within 24 hours - Other: Mean body weight gain 124.8 g in test group, 120.1 g in control group = expected range
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
According to the available study the substance is not sensitising
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