3,7-dimethyloctane-1,7-diol

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:

1982-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Study of artificial flavouring substances for mutagenicity in the Salmonella/microsome, Basc and micronucleus tests

Author:

Wild D, King MT, Gocke E & Eckhardt K

Year:

1983

Bibliographic source:

Food Chem Toxicol. 1983 Dec;21(6):707-19

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

up to 3600 µg/plate with and without S-9 mix
Positive controls: sodium azide and benzo[a]pyrene
Results that met the following additional criteria were regarded as positive: reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloctane-1,7-diol

EC Number:

203-517-1

EC Name:

3,7-dimethyloctane-1,7-diol

Cas Number:

107-74-4

Molecular formula:

C10H22O2

IUPAC Name:

3,7-dimethyloctane-1,7-diol

Test material form:

liquid

Specific details on test material used for the study:

Supplier: ICN, ICNK &K: Plainview, NY, USA

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

up to 3600 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

Details on test system and experimental conditions:

not further specified

Evaluation criteria:

Results that met the following additional criteria were regarded as positive: reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency

Statistics:

not further specified

Results and discussion

Test results

Key result

Species / strain:

other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.

Executive summary:

The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.