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EC number: 202-496-6 | CAS number: 96-29-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 482 (Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells In Vitro)
- GLP compliance:
- yes
- Type of assay:
- other: Damage and Repair, Unscheduled DNA Synthesis in mammalian cells in vitro
Test material
- Reference substance name:
- Butanone oxime
- EC Number:
- 202-496-6
- EC Name:
- Butanone oxime
- Cas Number:
- 96-29-7
- Molecular formula:
- C4H9NO
- IUPAC Name:
- (NE)-N-butan-2-ylidenehydroxylamine
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- hepatocytes: male Fischer F344 rats
- Test concentrations with justification for top dose:
- 1500, 500, 150, 50 and 15 pg/ml
- Vehicle / solvent:
- - Vehicle: water
- Justification for choice of solvent/vehicle:based on a solubility and stability determination of the test article and compatibility with the target cells
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Details on test system and experimental conditions:
- - Exposure duration: 18-20 hours
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 150 cells total (50 per replicate)
DETERMINATION OF CYTOTOXICITY
- Method: other: LDH determinations of media
OTHER: nuclear grains were counted in fifty cells in random areas on each of three coverslips for a total of 150 cells per treatment. The net nuclear counts were determined by counting three nucleus-sized areas adjacent to each nucleus and subtracting the average cytoplasmic count from the nuclear count. Replicative synthesis was identified by nuclei completely blackened with grains and such cells were not counted. Nuclei exhibiting toxic effects of treatment, such as dark or uneven staining, disrupted membranes, or irregular shape, were not counted - Evaluation criteria:
- If the mean net nuclear count was increased by at least five counts over the vehicle control, the results for a particular dose level were considered significant. A test article was judged positive if it induced a dose-related response and at least one dose produced a significant increase in the average net nuclear grains when compared to that of the vehicle control. In the absence of a dose response, a test article which showed a significant increase in the mean net nuclear grain count in at least two successive doses was considered positive.
Results and discussion
Test results
- Species / strain:
- hepatocytes: male F344 rats
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 and 1500 pg/ml
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The results of the UDS assay indicate that under the test conditions, the test article did not cause a significant increase in the unscheduled DNA synthesis as measured by the mean number of net nuclear grain counts (i.e., an increase of at least 5 counts over the vehicle control), at any dose level. In this study the positive control, DMBA, induced a significant increase in the mean number of net nuclear grain counts over that in the vehicle control. All criteria for a valid test were met. Therefore, the test article is considered to be negative in this study
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