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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:
1999
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
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
Constituent 4
Chemical structure
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
Constituent 5
Chemical structure
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
Constituent 6
Chemical structure
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
Constituent 7
Chemical structure
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
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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