4-methylpentan-2-ol

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

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guidelines

Data source

Reference

Reference Type:

publication

Title:

The Results of Microbial Mutation Test for Forty-Three Industrial Chemicals

Author:

Shimizu H, Suzuki Y, Takemura N, Goto S, & Matsushita H

Year:

1985

Bibliographic source:

Jpn. J. Ind. Health., Vol. 27, pp 400-419

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-methylpentan-2-ol

EC Number:

203-551-7

EC Name:

4-methylpentan-2-ol

Cas Number:

108-11-2

Molecular formula:

C6H14O

IUPAC Name:

4-methylpentan-2-ol

Details on test material:

- Name of test material (as cited in study report): 4-Methyl-2-pentanol
- Analytical purity: 98%

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA 1538, TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Polychlorinated biphenyl-induced rat liver (S9)

Test concentrations with justification for top dose:

1, 5, 10, 50, 100, 500, 1000, or 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

- DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: See Table 1

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes at 37 ºC
- Exposure duration: 48 hours at 37 ºC

NUMBER OF REPLICATIONS: Tests were performed in duplicate

Evaluation criteria:

The number of revertant colonies on each plate was scored.

Statistics:

None performed (number of revertant colonies were counted).

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA 1538, TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

- Growth inhibition was observed at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

- Growth inhibition was observed at 5000 µg/plate

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

Executive summary:

MIBC was tested in a non-GLP study (equivalent to OECD guideline 471) at doses of 0, 1, 5, 10, 50, 100, 500, 1,000, or 5,000 µg/plate in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in Escherichia coli WP2 uvr A both in the presence and absence of exogenous metabolic activation (polychlorinated biphenyl-induced rat liver S9) (Shimizuet al., 1985). Incubations at each concentration were done in duplicate; however, an independent repeat experiment was not performed. Dimethyl sulfoxide (DMSO) was used as the vehicle and positive controls were included in all incubations. Growth inhibition was observed at 5,000 µg/plate; however, no increase in the reverse mutation rate were observed at any MIBC concentration in any of the tester strains either in the presence or absence of metabolic activation. Incubation with positive control substances in the absence or presence of metabolic activation resulted in anticipated increases in the reverse mutation rate.