Registration Dossier
Registration Dossier
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EC number: 241-318-1 | CAS number: 17283-81-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This guinea pig maximisation test is sufficient to conclude about the sensitization potential of Dihydro ionone beta. Therefore an LLNA study was not required.
Test material
- Reference substance name:
- 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one
- EC Number:
- 241-318-1
- EC Name:
- 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one
- Cas Number:
- 17283-81-7
- Molecular formula:
- C13H22O
- IUPAC Name:
- 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)butan-2-one
- Reference substance name:
- rel-4-((1R,6R)-2,2,6-trimethylcyclohexyl)butan-2-one
- Cas Number:
- 60761-23-1
- Molecular formula:
- C13H24O
- IUPAC Name:
- rel-4-((1R,6R)-2,2,6-trimethylcyclohexyl)butan-2-one
- Test material form:
- liquid
Constituent 1
impurity 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- male
- Details on test animals and environmental conditions:
- Age at deliver: 4-6 weeks
Body weight 289-380g
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- No. of animals per dose:
- 5 animals in the control group
10 animals in the test group - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle (PEG 400)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle (PEG 400)
- No. with + reactions:
- 0
- Total no. in group:
- 5
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
None of the control and test animals showed skin reactions after the challenge with the test article concentration of 1% in PEG040.
Based on the findings in the report, in guinea pigs, Dihydro Ionone Beta is considered not to be a skin sensitizer.
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