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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

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:
Not applicable
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C8-18 and C18-unsatd.
EC Number:
266-929-0
EC Name:
Fatty acids, C8-18 and C18-unsatd.
Cas Number:
67701-05-7
Molecular formula:
Not available for this UVCB constituent
IUPAC Name:
C8-18 and C18-unsatd. fatty acyl
Details on test material:
- Name of test material (as cited in study report): Edenor K 8-18(CAS N° 67701-05-7, EC N° 266-929-0)



Method

Target gene:
No data
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
4, 20, 100, 500 and 2,500 µg/plate
Vehicle / solvent:
Water with Tween 80
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the substance fatty acids, C8-18 and C18-unsatd. was found to be non-mutagenic in Salmonella typhimurium bacteria reverse mutation assay.
Executive summary:

A study was conducted to determine the mutagenic potential of the constituent ‘Fatty acids, C8 -18 and C18 -unsatd.’ in a bacterial gene mutation assay with Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100. The test was conducted on agar plates in the absence or presence of S-9 mix. Suspensions of the substance were freshly prepared in water with Tween 80 before use at concentrations of 4, 20, 100, 500 and 2,500 µg/plate. Under the test conditions, ‘the substance fatty acids, C8 -18 and C18 -unsatd. was found to be non-mutagenic in Salmonella typhimurium bacterial reverse mutation assay (Gloxhuber and Wallat, 1982).