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Toxicological information

Genetic toxicity: in vitro

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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:
1992
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

Constituent 1
Chemical structure
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
Constituent 2
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

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.