Registration Dossier
Registration Dossier
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EC number: 947-279-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb - April 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Open Epicutaneous Test (OET)
- GLP compliance:
- no
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Sufficient information is available from the OET study, therefore it is not necessary to conduct an LLNA.
Test material
- Reference substance name:
- rel-(3R,3aS,7S,8aS)-3,6,8,8-tetramethyl-2,3,4,7,8,8a-hexahydro-1H-3a,7-methanoazulene
- Cas Number:
- 22567-43-7
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(3R,3aS,7S,8aS)-3,6,8,8-tetramethyl-2,3,4,7,8,8a-hexahydro-1H-3a,7-methanoazulene
- Reference substance name:
- rel-(3R,3aR,7R,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Cas Number:
- 1404220-60-5
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(3R,3aR,7R,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Reference substance name:
- rel-(3R,3aS,7S,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Cas Number:
- 65450-98-8
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(3R,3aS,7S,8aS)-3,8,8-trimethyl-6-methyleneoctahydro-1H-3a,7-methanoazulene
- Reference substance name:
- rel-(1R,9S,E)-4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Cas Number:
- 17627-40-6
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,9S,E)-4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Reference substance name:
- rel-(1aR,4aR,8aR)-2,4a,8,8-tetramethyl-1,1a,4,4a,5,6,7,8-octahydrocyclopropa[d]naphthalene
- Cas Number:
- 32435-95-3
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1aR,4aR,8aR)-2,4a,8,8-tetramethyl-1,1a,4,4a,5,6,7,8-octahydrocyclopropa[d]naphthalene
- Reference substance name:
- 1,8-dimethyl-4-(propan-2-ylidene)spiro[4.5]dec-7-ene
- Molecular formula:
- C15H24
- IUPAC Name:
- 1,8-dimethyl-4-(propan-2-ylidene)spiro[4.5]dec-7-ene
- Reference substance name:
- 1-methyl-4-(1,2,2-trimethylcyclopentyl)benzene
- Cas Number:
- 51773-81-0
- Molecular formula:
- C15H22
- IUPAC Name:
- 1-methyl-4-(1,2,2-trimethylcyclopentyl)benzene
- Test material form:
- liquid
- Details on test material:
- UVCB
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
- Specific details on test material used for the study:
- Cedrene Washed: Batch 9000368155
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: GOHI (SPF)
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 100ul
- Day(s)/duration:
- 5 days a week (Monday to Friday) for 4 consecutive weeks.
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 25ul
- Day(s)/duration:
- 2 weeks
- Adequacy of challenge:
- other: 3%, 1%, 0.3% and 0.1%
- No. of animals per dose:
- 6 animals per treatment group (including 6 animals in the control group).
- Challenge controls:
- Challenge reactions were assessed at 24hr and 48hr after application.
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- NA
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 840
- Group:
- test chemical
- Dose level:
- 0.1, 0.3, 1 and 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 840
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 840
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not determinable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Cedrene washed when applied at the concentrations of 30% and 10% in ethanol, induced slight to severe cutaneous responses accompanied by dry scaling during the induction phase of the study. The test article, however, did not induce any skin reactions as such in the test or contorl animals during the challenge phase of the experiment when applied at the concentrations 3% or lower.
Based on the above experimental data, it is concluded that the topically applied Cedrene washed when used under the conditions of this study (<3%) did not induce skin sensitization in the guinea pig. Considering the predictive value of the guinea pig skin sensitization test it can be assumed that cutaneous exposure to Cedrene washed at the concentrations of equal to or lower than 3% in ethanol is unlikely to give rise to skin sensitization in man.
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