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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: other guideline: EC Directive 2000/32, B13/14 OECD 471, 1997
GLP compliance:
yes
Type of assay:
other: not available

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) Escherichia coli WP2uvrA
Metabolic activation system:
S9 liver homogenate of rat induced with Aroclor 1254.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 10 ... 5000 μg/plate
Vehicle / solvent:
Solvent: ethanol

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Additional information on results:
Observations:
The bacterial background lawn was not reduced at all concentrations tested and no biologically relevant decrease in the number of revertants was observed. The presence of 5 and 10% (v/v) liver microsomal activation did not influence these findings. T-7479 did not induce a dose-related, two-fold increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Remarks on result:
other: Test system: preliminary test

Applicant's summary and conclusion

Conclusions:
Interpretation of results
negative with metabolic activation
negative without metabolic activation