3-methylbutan-1-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Zur Toxikologie zweier haeufig nachgewiesener MVOCs: 1-Octen-3-ol und 3-Methyl-l-butanol.

Author:

Seidel HJ and Plappert U

Year:

1999

Bibliographic source:

Umweltmed Forsch Prax 4: 285-288

Materials and methods

Principles of method if other than guideline:

The study was conducted according to the method described by Bradley M O et al. (1981). Mutat. Res. 87: 81-142.

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-methylbutan-1-ol

EC Number:

204-633-5

EC Name:

3-methylbutan-1-ol

Cas Number:

123-51-3

Molecular formula:

C5H12O

IUPAC Name:

3-methylbutan-1-ol

Details on test material:

- Name of test material (as cited in study report): 3-methyl-1-butanol
- source: Fluka

Method

Target gene:

HPRT

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-treated rat liver S9-mix

Test concentrations with justification for top dose:

0, 45.5, 455, 1820, 4550, 6370 µg/ml

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO (1% maximal concentration)
- Justification for choice of solvent/vehicle: was shown to produce no genetic toxicity effect

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

with metabolic activation Migrated to IUCLID6: 0.05 mM

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without metabolic activation Migrated to IUCLID6: 0.5 mM

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: 2000000 cells overnight in 10 ml medium
- Exposure duration: 2 hours
- Expression time (cells in growth medium): 4 aliquots of 250 cells for 7 days; the plating efficiency 1 (PE1) was determined at the end of the expression time.
- Selection time (if incubation with a selection agent): 5 aliquots of 200000 cells in 6-thioguanine-containing medium (10µg/ml) for 6 days; the plating efficiency 2 (PE2) was determined at the end of the selection time.

SELECTION AGENT (mutation assays): 6-thioguanine

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency

Evaluation criteria:

The test substance was classified as mutagen if the spontaneous mutation rate was 3-fold higher than the control. The relative mutation frequency was the fraction of mutant colonies at "plating effeciency 2" (PE2).

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

cytotoxicity from 500 µg/ml onwards; 700 µg/ml caused complete cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

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