3-methoxybutyl acetate

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:

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

Test material information

Constituent 1

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

Controls

Controls 1

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

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

TA1537; without S9

Migrated to IUCLID6: 50 µg/plate

Controls 3

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

Controls 4

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

Controls 5

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.