Registration Dossier
Registration Dossier
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EC number: 931-195-9 | CAS number: -
Toxicological information
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the three types of in vitro study, the substance is considered to be not mutagenic.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- 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:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- n/a
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9-mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 200 µg/ml
Concnetration range in the main test (without metabolic activation): 10 ... 200 µg/ml - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Details on test system and experimental conditions:
- Fixation time (start of exposure up to fixation or harvest of cells):
With metabolic activation: 7, 18 and 28 hr
Without metabolic activation: 7, 18 and 28 hr
Second experiment: without metabolic activation: 28 hr - Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Treatment with concentrations higher than 25.0 µg/ml reduced the plating efficiency of the V79 cells. Also the mitotic index was reduced after treatment with the highest scorable concentration at all fixation intervals in the absence of S9-mix. In the presence of S9-mix a reduction was observed at interval 18 hr.
- Conclusions:
- Negative with and without metabolic activation
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9-mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 10 ... 200 µg/ml
Concnetration range in the main test (without metabolic activation): 10 ... 200 µg/ml - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Details on test system and experimental conditions:
- - Expression time (cells in growth medium): 7 days with and without metabolic activation
- Fixation time (start of exposure up to fixation or harvest of cells): 8 days with and without metabolic activation - Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Treatment with concentrations higher than 25.0 µg/ml reduced the plating efficiency of the V79 cells. Also the mitotic index was reduced after treatment with the highest scorable concentration at all fixation intervals in the absence of S9-mix. In the presence of S9-mix a reduction was observed at interval 18 hr.
- Conclusions:
- Negative with and without metabolic activation
- Endpoint:
- in vitro gene mutation study in bacteria
- 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: Guidelines issued by EA/MHW/MITI (1986) and the Ministry of Labour of Japan
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- bacteria, other: S. Typhimurium TA98, TA100, TA1535, TA1537, E. Coli WP2 uvrA-
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix Rat liver induced with phenobarbital (4 days 0.03-0.06 g/kg BW) and 5,6-benzoflavon (1 day 0.08 g/kg BW)
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation) 10 ... 1250 µg/plate
Concentration range in the main test (without metabolic activation) 10 ... 313 µg/plate - Vehicle / solvent:
- Dimethylsulphoxide
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 µg/plate
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- The substance shows no mutagenic tendencies in this assay.
- Executive summary:
Limited data provided by ECHA. Not possible to make further conclusions.
Referenceopen allclose all
In this assay the test substnace was specially shielded from UV light during all phases of the study.
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
Based on the available data, no classification for genetic toxicity is required for the registered substance.
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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