Registration Dossier
Registration Dossier
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EC number: 947-279-3 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1999
- 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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study follows the principles of the method outlined by Ames et al. (1975)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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 9000343808
Method
Species / strain
- Species / strain / cell type:
- other: TA1535, TA97, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 50, 158, 500, 1580 and 5000ul
Top dose based on the results of the range-finder. - Vehicle / solvent:
- Ethanol
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA1535, TA97, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Executive summary:
Cedrene Washed did not induce any dose related increase of the number of revertant colonies / plate in any of the 5 tester strains.
Therefore, it can be concluded that Cedrene washed is devoid of mutanic activity in the Ames test under the described experimental conditions.
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