Registration Dossier
Registration Dossier
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EC number: 482-390-6 | 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- other: part of the SNIF file, no further data
- Rationale for reliability incl. deficiencies:
- other: Part of the SNIF file, which was accepted by the UK national authority for NONS
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Ames)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA-
- Metabolic activation system:
- Phenobarbitone/ beta-naphthoflavone induced rats liver
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Tetrahydrofuran
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 1500 µg/plate
Results and discussion
Test resultsopen allclose all
- 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:
The test material caused no visible reduction in the growth
of the background lawn at any dose level.
A precipitate (oily in appearance) was observed at and above
1500 micrograms per plate, this did not prevent the scoring
of revertant colonies.
No significant increases in the frequency or revertant were
recorded for any of the bacterial strains, with any dose of
the test material, either with or without metabolic
activation. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Part of the SNIF file, which was accepted by the UK national authority for NONS
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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