Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vitro
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:
- 1 998
- 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
Constituent 1
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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