Registration Dossier
Registration Dossier
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EC number: 200-922-5 | CAS number: 75-98-9
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Magnusson and Kligman method
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Adequate in vivo study already available.
Test material
- Reference substance name:
- Pivalic acid
- EC Number:
- 200-922-5
- EC Name:
- Pivalic acid
- Cas Number:
- 75-98-9
- Molecular formula:
- C5H10O2
- IUPAC Name:
- 2,2-dimethylpropanoic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.05% w/v
Topical induction: 25% w/v
Topical challenge: 10% w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Intradermal induction: 0.05% w/v
Topical induction: 25% w/v
Topical challenge: 10% w/v
- No. of animals per dose:
- 20, 10 male, 10 female
5 male controls, 5 female controls
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Dose level:
- 2 x 0.1 ml of 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Dose level: 2 x 0.1 ml of 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Dose level:
- 2 x 0.1 ml of 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Dose level: 2 x 0.1 ml of 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was not a skin sensitizer in guinea pigs.
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