Octan-1-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

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

Test material information

Constituent 1

Reference substance name:

Octan-1-ol

EC Number:

203-917-6

EC Name:

Octan-1-ol

Cas Number:

111-87-5

Molecular formula:

C8H18O

IUPAC Name:

octan-1-ol

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

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 and 2500 μg/plate with and without metabolic activation

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

2500 μg/plate

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 2500 μg/plate

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 μg/plate with metabolic activation and 2500 μg/plate with and without metabolic activation

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 and 2500 μg/plate with and without metabolic activation

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: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

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.

Executive summary:

In a bacterial mutagenicity study, S. typhimurium cells TA 98, TA 100, TA 1535, TA 1537, and TA 1538 were exposed to 4, 20, 100, 500, and 2500 µg/plate of test material, without or with metabolic activation.

There was no increase in the reverse mutation rate in the five histidine dependent bacterial strains. Cytotoxicity was observed at the highest concentration. The study concludes that the test material is negative for mutagenicity to bacterial cells under the conditions of the study. The study was conducted according to a protocol similar to OECD TG 471, and in compliance with GLP.