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EC number: 224-644-9 | CAS number: 4435-53-4
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: Guideline study. No restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-methoxybutyl acetate
- EC Number:
- 224-644-9
- EC Name:
- 3-methoxybutyl acetate
- Cas Number:
- 4435-53-4
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 3-methoxybutyl acetate
- Reference substance name:
- butoxyl
- IUPAC Name:
- butoxyl
- Details on test material:
- - Name of test material (as cited in study report): butoxyl
- Physical state: light liquid
- Analytical purity: 99.7%
- Composition of test material, percentage of components: 99.5% butoxyl, 0.2% methoxybutanol, <0.1% n-Butylacetat
- pH value in water: 7
- Melting point: <-80°C
- Boiling point: 167-171°C
- Storage condition of test material: dark at room temperature
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA1535, TA1537, TA98, TA100 and TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 0, 4, 20, 100, 500, 2500 and 10000 µg/plate in experiment 1 and 0, 4, 20, 100, 500, 2500 and 5000ug/plate in experiment 2
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 and TA1535; without S9
Migrated to IUCLID6: 1 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537; without S9
Migrated to IUCLID6: 50 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 and TA1538; without S9
Migrated to IUCLID6: 2.5 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA98, TA100, TA1535, TA1537 and TA1538; with S9
Migrated to IUCLID6: 10 µg/plate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene 0.5 or 1 µg/plate
- Remarks:
- TA98, TA100, TA1535, TA1537 and TA1538; with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Tested at doses of 4 to 10000 µg/plate in the first experiment and 4 to 5000 µg/plate in the second experiment.
DURATION
- Expression time (cells in growth medium): 48 hours at 37°C in the dark
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: reduced rate of spontaneously occurring colonies/visible thinning of the bacterial lawn
- Tested at doses of 4 to 10000 µg/plate - Evaluation criteria:
- A significant increase in the number of revertant colonies was considered indicative of a mutagenic effect.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA1535, TA1537, TA98, TA100 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Butoxyl was not mutagenic in the absence or in the presence of an exogenous metabolizing system. - Executive summary:
Butoxyl was not toxic or mutagenic at doses up to 5000 µg/plate to S.typhimurium strains TA100, TA1535, TA1537, TA1538 or TA98 with or without S9 mix.
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