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EC number: 425-450-9 | CAS number: 294-90-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in vitro: Key study (001). Test method according to 92/69/EWG, B.14. GLP study.
Gene mutation in vitro: Key study (002). Test method according to 92/69/EWG, B.14 and OECD 471 guidelines. GLP study.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.14 (Ames-Test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not used
- Metabolic activation:
- with and without
- Metabolic activation system:
- "DEUSTCH" Leberhomogenat von mit Aroclor 1254 behandelten Ratten. "ENGLISH" Liver homgenat from Aroclor 1254 treated rats.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 3 ... 3330 μg/plateConcentration range in the main test (without metabolic activation): 3 ... 3330 μg/plate
- Vehicle / solvent:
- Solvent: DMSO
- Key result
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate)
- Key result
- Species / strain:
- other: As specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate)
- Key result
- Species / strain:
- other: As specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1000 μg/plate)
- Additional information on results:
- None
- Remarks on result:
- other: Preliminary test
- Conclusions:
- Under the test conditions, the test substance is not mutagenic in the tested TA 98,100, 1535 and 1537 Salmonella typhimurium strains.
- Executive summary:
The test substance mutagenicity study was performed according to the 92/69/EWG, B.14 (Ames-Test) Guideline under GLP conditions.
Several concentrations of test substance ranging from [3 -3330 μg/plate] were tested in TA 98,100, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation ( Liver homgenat from Aroclor 1254 treated rats ).
Under the test conditions, the test substance is not mutagenic in the tested TA 98,100, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation. Test substance caused cytotoxic effect at concentrations >1000µg/plate.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: 2000/32/EG, B.14 (Ames-Test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not used
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): .03 ... 5000 μg/plateConcentration range in the main test (without metabolic activation):.03 ... 5000 μg/plate
- Vehicle / solvent:
- Solvent: Ethanol
- Key result
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>=3 μg/plate))
- Key result
- Species / strain:
- other: As specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> =33μg/plate)
- Additional information on results:
- None
- Remarks on result:
- other: Main test
- Conclusions:
- Under the test conditions, the test substance is not mutagenic in the tested TA 98,100, 102, 1535 and 1537 Salmonella typhimurium strains.
- Executive summary:
The test substance mutagenicity study was performed according to the 92/69/EWG, B.14 (Ames-Test) and OECD 471 Guideline under GLP conditions.
Several concentrations of test substance ranging from [.03 -5000 μg/plate] were tested in TA 98, 100, 102, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation ( Liver homgenat from Aroclor 1254 treated rats ).
Under the test conditions, the test substance is not mutagenic in the tested TA 98, 100, 102, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation. Test substance had cytotoxic effect with metabolic activation in concentrations >= 3µg plate and without metabolic activation at concentrations >=33µg/plate.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Gene mutation in vitro: Key study (001). Test method according to 92/69/EWG, B.14. GLP study. Several concentrations of test substance ranging from [3 -3330 μg/plate] were tested in TA 98,100, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation ( Liver homgenat from Aroclor 1254 treated rats ).
Under the test conditions, the test substance is not mutagenic in the tested TA 98,100, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation. Test substance caused cytotoxic effect at concentrations >1000µg/plate.
Gene mutation in vitro: Key study (002). Test method according to 92/69/EWG, B.14 and OECD 471 guidelines.GLP study. Several concentrations of test substance ranging from [.03 -5000 μg/plate] were tested in TA 98, 100, 102, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation ( Liver homgenat from Aroclor 1254 treated rats ).
Under the test conditions, the test substance is not mutagenic in the tested TA 98, 100, 102, 1535 and 1537 Salmonella typhimurium strains with and without metabolic activation. Test substance had cytotoxic effect with metabolic activation in concentrations >= 3µg plate and without metabolic activation at concentrations >=33 µg/plate.
Justification for selection of genetic toxicity endpoint
No study was selected, both scored negative on mutagenic activity.
Justification for classification or non-classification
Based on the available informartion, test substance does not have mutagenic activity.
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