Squalene-rich fraction obtained from vegetable oil deodorizer distillate by transesterification, crystallisation and vacuum distillation

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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 / strain

Species / strain 1

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 2

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 results

Test results 1

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

Test results 2

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).