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EC number: 205-218-1 | CAS number: 135-76-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Supporting study:
The Ames test was carried out with the test item using Salmonella typhimurium strains TA 98, TA 100. The test was performed with and without matabolic activation. The concentrations were 0-10000 (0, 50, 100, 500, 1000, 5000, 10000) µg/plate.
Supporting study:
The substance did not show any mutagenic effect under test conditions.
The test item was tested with S. typhimurum TA1535, TA1537, TA1538, TA98, or TA100 with and without male rat Aroclor S9 mix.
The test item was non mutagenic in plate incorporation test at 5000 mcg, and liquid preincubation test at 1000 mcg.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (Only 2 strains were tested)
- Principles of method if other than guideline:
- Method: preincubaton
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100.
- Metabolic activation:
- with and without
- Metabolic activation system:
- -S9 and +S9 were tested.
- Test concentrations with justification for top dose:
- 0-10000 (0, 50, 100, 500, 1000, 5000, 10000) ug/plate were tested
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100,
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.
- Executive summary:
The Ames test was carried out with the test item using Salmonella typhimurium strains TA 98, TA 100. The test was performed with and without matabolic activation. The concentrations were 0-10000 (0, 50, 100, 500, 1000, 5000, 10000) µg/plate.
The substance did not show any mutagenic effect under test conditions.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Justification for type of information:
- Information form a scientific publication.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Tested only: Salmonella typhimurium TA1535, TA1537, TA1538, TA98, or TA100
- Principles of method if other than guideline:
- The Salmonella typhimurium tester strains TA1535, TA1537, TA1538, TA98, and TA100 were grown in nutrient broth shaken for 14 h at 370C. The plate incorporation assays were performed as described by Ames et al. with the modifications of Andrews et al.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Provided by Adrian B. Leatherman of the Food and Drug Administration, Washington DC.
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98, or TA100 with and without male rat Aroclor S9 mix
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Maximum non toxic dose that was nonmutagenic: Plate incorporation test: 5000 mcg, and liquid preincubation test 1000 mcg.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- Maximum non toxic dose that was nonmutagenic: Plate incorporation test: 5000 mcg, and liquid preincubation test 1000 mcg.
- Conclusions:
- The test item was non mutagenic in plate incorporation test at 5000 mcg, and liquid preincubation test at 1000 mcg.
- Executive summary:
The test item was tested with S. typhimurum TA1535, TA1537, TA1538, TA98, or TA100 with and without male rat Aroclor S9 mix.
The test item was non mutagenic in plate incorporation test at 5000 mcg, and liquid preincubation test at 1000 mcg.
Referenceopen allclose all
The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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