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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
and EC Commission Directive 2000/32/EC Annex 4D-B.13/14. Mutagenicity - Reverse mutation test in bacteria. No. L 136/57.
Deviations:
no
Remarks:
No deviations from the protocol
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, Escherichia coli,strain WP2 uvrA (pKM101),
Metabolic activation system:
Phenobarbital/5,6-benzoflavone induced rat liver S9.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate
Vehicle / solvent:
Solvent: Dimethyl sulphoxide

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
No evidence of mutagenic activity in this bacterial system
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
No evidence of toxicity was noted at any of the test concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
No evidence of mutagenic activity in this bacterial system
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
No evidence of toxicity was noted at any of the test concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
It is concluded that Trimofix O showed no evidence of
mutagenic activity in this bacterial system under the test
conditions employed.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

It is concluded that Trimofix O showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
Executive summary:

It is concluded that Trimofix O showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.