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EC number: 209-750-5 | CAS number: 592-34-7
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP compliant, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , an additional tester strain (TA102 or E.coli) is lacking and only one positive control used to test efficacy of the S9-mix.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Butyl chloroformate
- EC Number:
- 209-750-5
- EC Name:
- Butyl chloroformate
- Cas Number:
- 592-34-7
- Molecular formula:
- C5H9ClO2
- IUPAC Name:
- butyl carbonochloridate
- Details on test material:
- - Name of the test substance used in the study report: chloroformic acid butylester
- Appearance, consistency: Colorless liquid
- Storage: 4°C
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9 fraction
- Test concentrations with justification for top dose:
- - TA1535: 0.0005 - 5.0 µL/plate
- TA100, TA1537, TA98: 0.0005 - 0.5 µL/plate - Vehicle / solvent:
- ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation for all strains
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg
- Positive control substance:
- other: N-methyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without metabolic activation for strains TA 100 and TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 10 µg
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- Without metabolic activation for strain TA 98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 µg
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation for strain TA 1537
- Details on test system and experimental conditions:
- - METHOD OF APPLICATION: preincubation
- DURATION: Preincubation period: 20 min; Exposure duration: 48 h
- NUMBER OF REPLICATIONS: 3 test plates per dose or per control
- DETERMINATION OF CYTOTOXICITY: decrease in the number of his+ revertants, reduced his- background growth - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (compared to control values)
- dose-response relationship
- reproducibility of the results
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Solubility: Complete solubility of the test substance in ethanol.
- A clear bacteriotoxic effect was observed at doses of about ≥ 0.005 µL/plate (without S-9 mix) and from about 0.2 - 0.3 µL/plate onward (with S-9 mix).
- With the positive reference compound DIMCA the expected positive reaction was demonstrated both with and without 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
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