Registration Dossier
Registration Dossier
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EC number: 429-040-0 | CAS number: 272460-97-6
Toxicological information
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Studies conducted to recognised testing guidelines with GLP certification.
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 without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- 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
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver homogeneate fraction
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 5 ... 500 µg/plate
Concentration range in the main test (without metabolic activation): 5 ... 500 µg/plate - Vehicle / solvent:
- Solvent: DMSO
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 500 µg/plate.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 5000 µg/plate)
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Additional information on results:
- Observations:
At the concentration range investigated, ESACURE 1001 did not show any mutagenic activity with or without the addition of S9 liver homogeneate fraction. - Conclusions:
- Interpretation of results (migrated information):
- Negative with metabolic activation
- Negative without metabolic activation - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 tissue homogenate with protein content ca.37.1 mg/ml and Aminopyrine demethylase activity (uM/g liver/5 min, formadeyde production) ca.3.89
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 25 ... 100 µg/ml
Concentration range in the main test (without metabolic activation): 25 ... 100 µg/ml - Vehicle / solvent:
- DMSO
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 3 hours
Exposure period (without metabolic activation): 20 hours - Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- other: >= 100 µg/ml
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- other: >= 25 µg/ml
- Additional information on results:
- Observations:
No statistically significant increase in the incidence of cells bearing aberrations including and excluding gaps, compared with the relevant control values, was observed at any dose level selected for the scoring in the absence or presence of S9 metabolism.
The positive controls Cyclophoshamide and Mitomycin-C shown a statistically significant increase of aberrant cells confirmed the correct functioning of the assay system. - Conclusions:
- Interpretation of results (migrated information):
- Negative with metabolic activation
- Negative 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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
