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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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.