Registration Dossier
Registration Dossier
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EC number: 430-050-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial reverse mutation assay: Negative result obtained with and without metabolic activation.
In vitro mammalian cytogenicity: No genotoxicity was observed with and without metabolic activation. No cytotoxicity was observed up to precipitating concentrations.
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: Salmonella typhimurium, strains TA1535, TA1537, TA98, TA100. Escherichia coli WP2uvrA (pKM101) bacteria
- Metabolic activation system:
- Liver S9 derived from phenobarbital/B-napthoflavone-induced Sprague Dawley rats.
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 100 ... 5000 μg/plateConcentration range in the main test (without metabolic activation): 100 ... 5000 μg/plate
- Vehicle / solvent:
- Solvent: Dried dimethylsulphoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 μg/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 μg/plate)
- Additional information on results:
- Observations:None.
- Remarks on result:
- other: other: preliminary test Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):negative with metabolic activationnegative without metabolic activation
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Cytogenetics)
- GLP compliance:
- yes
- Type of assay:
- other: in vitro mammalian cytogenicity (B10)
- Species / strain / cell type:
- mammalian cell line, other: Peripheral Human lymphocytes
- Remarks:
- mammalian cell line
- Metabolic activation system:
- Liver S9 derived from phenobarbital/B-naphthoflavone-induced Sprague Dawley rats
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 1 ... 1000 μg/mlConcentration range in the main test (without metabolic activation): 1 ... 1000 μg/ml
- Vehicle / solvent:
- Dried dimethylsulphoxide
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hoursExposure period (without metabolic activation): 20 hoursFixation time:20 and 44 hours from start of exposure period to fixation
- Species / strain:
- mammalian cell line, other: Peripheral Human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Additional information on results:
- Observations:Precipitation was observed at 75μg/ml and above in thepresence of S9 and at 25μg/ml and above in the absence ofS9. Consequently, the highest concentrations selected forchromosomal aberration analysis were 100μg/ml and 25μg/ml inthe presence and absence of S9 respectively.
- Conclusions:
- Interpretation of results (migrated information):negative with metabolic activationnegative without metabolic activation
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
Justification for classification or non-classification
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