Registration Dossier
Registration Dossier
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EC number: 946-849-9 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- other: read across from supporting substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- refer to confidential details on test material
- IUPAC Name:
- refer to confidential details on test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S.Typhimurium TA98, TA100, TA1535, TA1537, E. Coli WP2 and WP2 uvrA
- Metabolic activation system:
- S9 mix rat
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33 ... 5000 μg/plateConcentration range in the main test (without metabolic activation): 33 ... 5000 μg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 ug/plate
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 5000 ug/plate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative with metabolic activationnegative without metabolic activationThe substance was tested for genetic toxicity in vitro following OECD 471 (Ames test). Under the experimental conditions the substance did not show any mutagenic properties.
- Executive summary:
The substance was tested for genetic toxicity in vitro following OECD 471 (Ames test). Under the experimental conditions the substance did not show any mutagenic properties.
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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