Registration Dossier
Registration Dossier
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EC number: 209-269-0 | CAS number: 564-20-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2006 - January 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: standard RIPT protocol
- Version / remarks:
- the study was performed according to ICH Guideline E6 for Good clinical practice and requirements provided for in 21 CFR parts 50 and 56.
- GLP compliance:
- no
- Remarks:
- GCP compliance
- Type of study:
- patch test
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- EC Number:
- 209-269-0
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- Cas Number:
- 564-20-5
- Molecular formula:
- C16H26O2
- IUPAC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
Constituent 1
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 63 qualified subjects, male and female, ranging age from 20 to 78 years were selected for the evaluation. 52 subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Results and discussion
- Positive control results:
- N/A
In vitro / in chemico
- Other effects / acceptance of results:
- Observations remained negative throughout the test interval.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g of the test material
- No. with + reactions:
- 0
- Total no. in group:
- 52
- Clinical observations:
- no skin reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- there was no skin reaction in any of the subjects
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.2 g of the test material
- No. with + reactions:
- 0
- Total no. in group:
- 52
- Clinical observations:
- no skin reaction observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- there was no skin reaction in any of the subjects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material did not indicate a potential for dermal irritation or allergic contact sensitization.
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