Registration Dossier
Registration Dossier
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EC number: 402-670-3 | CAS number: 106797-53-9 DAROCUR (R) 2959; DAROCUR 2959
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD 471 and 472, Directive 84/449/EEC, B13 and B14 and compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- not specified
- 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
Test material
- Reference substance name:
- 2-hydroxy-4'-hydroxyethoxy-2-methylpropiophenone
- EC Number:
- 402-670-3
- EC Name:
- 2-hydroxy-4'-hydroxyethoxy-2-methylpropiophenone
- Cas Number:
- 106797-53-9
- Molecular formula:
- C12H16O4
- IUPAC Name:
- 2-hydroxy-4'-hydroxyethoxy-2-methylpropiophenone
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: bacteria (other): Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, E.Coli: WP2, WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomal fraction (S9 mix)
- Test concentrations with justification for top dose:
- Concentration ragne in the main test (with metabolic activation): 50... 10000 ug/plate
Concentration range in the main test (without metabolic activation): 50... 10000 ug/plate - Vehicle / solvent:
- Solvent: Dimethyl sulfoxide (DMSO)
Results and discussion
Test results
- Species / strain:
- other: bacteria (other): Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, E.Coli: WP2, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Additional information on results:
- Observations:
No evidence of induction of point mutations in presence or absence metabolic activation - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test substance was not mutagenic to bacteria under the conditions of the test.
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