Registration Dossier

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. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
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.