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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
Study period:
1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD guideline for the testing of chemicals. Proposal for replacement of guideline OECD 471 & 472 (1997) - Bacterial reverse mutation test
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA 40 CFR 799: 799.9510 TSCA bacterial reverse mutation test (1997)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
See attachment
Type of assay:
bacterial reverse mutation assay

Test material

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S-9.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation):
First test: 5, 15, 50, 150, 500, 1500, 5000 µg/plate Second test: 1.5, 5, 15, 50, 150, 500, 1500 µg/plate

Concentration range in the main test (without metabolic activation):
First test: 5, 15, 50, 150, 500, 1500, 5000 µg/plate
Second test: 1.5, 5, 15, 50, 150, 500, 1500 µg/plate
Vehicle / solvent:
Dimethyl sulphoxide

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
In the first test, toxicity was observed towards all the tester strains at 5000 and 1500 µg/plate and towards CM891 at 500 µg/ml.
In the second test (in which the 5000 µg/plate dose level was omitted), toxicity was observed towards all tester strains at 1500 µg/plate and towards CM891 at 500 µg/plate.
No evidence of mutagenic activity was seen at any dose level of the test substance in either mutation test.
Remarks on result:
other: other: Main test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

Cl-TTA Solid shows no evidence of mutagenic activity in this bacterial system.

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