Registration Dossier
Registration Dossier
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EC number: 202-496-6 | CAS number: 96-29-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- The study was conducted according to generally valid procedures and according to GLP guidelines. All parameters described are closely related or comparable to guideline methods. Study was summarized in documents published from OECD SIDS program. However, original company divested this business to another company and neither has a copy of the original report.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed prior to the implementation of the LLNA method.
Test material
- Reference substance name:
- Butanone oxime
- EC Number:
- 202-496-6
- EC Name:
- Butanone oxime
- Cas Number:
- 96-29-7
- Molecular formula:
- C4H9NO
- IUPAC Name:
- (NE)-N-butan-2-ylidenehydroxylamine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- 4% intracutaneous
100% epicutaneous (occlusive)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50%
- No. of animals per dose:
- 10
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: specifics not reported
- Group:
- test chemical
- Dose level:
- 4% intracutaenous induction, 100% epicutaneous induction, 50% epicutaneous challenge
- No. with + reactions:
- 7
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1B based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- Under the conditions of this study, MEKO induced a sensitization rate of 70% in the guinea pig.
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