Registration Dossier
Registration Dossier
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EC number: 203-631-1 | CAS number: 108-94-1
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
- Principles of method if other than guideline:
- The Guinea pig maximization test. Curr. Probl. Derm. 14, 59-106 (Karger, Basel)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performance before finalization of OECD guideline for LLNA.
Test material
- Reference substance name:
- Cyclohexanone
- EC Number:
- 203-631-1
- EC Name:
- Cyclohexanone
- Cas Number:
- 108-94-1
- Molecular formula:
- C6H10O
- IUPAC Name:
- cyclohexanone
- Details on test material:
- TS-Freetext:
Cyclohexanone
CAS No.: 108-94-1
Constituent 1
- Specific details on test material used for the study:
- pure Cyclohexanone (Fluka) as well as two batches of a cyclohexanone resin were tested.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- intradermal: 8 %, epicutaneous: 25 %
Challenge
- Concentration / amount:
- Challenge concentrations Cyclohexanone: 5%, 10% and 5%
- No. of animals per dose:
- 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% ; 10% and 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%, 10% and 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
2 sensitization experiments were carried out with 2 batches of Cyclohexanone resin. The 1st batch showed a sensitizing potential, while the 2nd only gave a statistically significant difference at the 24 h reading and at a challenge concentration of 10%. A GPMT with cyclohexanone did not reveal any allergenic potential.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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