2-methyl-1-heptanol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (limited reporting).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

OECD Guidelines recommend using TA 102 or E. coli to detect cross-linking/oxidising agents.

Principles of method if other than guideline:

An in-house protocol similar to OECD No. 471

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Lorol C8 (tradename)
- Substance type: monoconstituent substance
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9

Test concentrations with justification for top dose:

4, 20, 100, 500, and 2500 µg/plate

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Water/Tween 80

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (5 µg/plate), sodium azide (1 µg/plate), 4-nitro-o-phenylenediamine (40 µg/plate)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: Four per dose level.

Evaluation criteria:

No data

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: 2500 µg/plate for all strains, 500 µg/plate for some strains (see text)

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not reported

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- With metabolic activation: Total inhibition of bacterial growth at 2500 ug/plate for all strains tested; also at 500 ug/plate for strains TA1537, TA1538 and TA98.
- Without metabolic activation: Total inhibition of bacterial growth at 2500 ug/plate for all strains tested; also at 500 ug/plate for strains TA1538 and TA98.

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 with and without activation

In a reliable study, using a method similar to OECD test guideline 471, C8 alcohol Lorol C8 at concentrations up to 2500 µg/plate did not increase the reverse mutation rate in five histidine dependent bacterial strains of Salmonella typhimurium, in the presence or absence of a mammalian liver metabolic activation system (S9). Cytotoxicity was observed at the highest concentration tested.