Fatty acids, C16-18, sodium salts

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Laurinsäure (98 - 100%)

IUPAC Name:

Laurinsäure (98 - 100%)

Details on test material:

no data

Method

Target gene:

TA1537: his C 3076; rfa; uvrB- frame shift mutations
TA 98: his D 3052; rfa; uvrB- (pKM101) frame shift mutations
TA 1538: his D 3052; rfa; uvrB- frame shift mutations
TA1535: his G 46; rfa; uvrB- base-pair substitutions
TA 100: his G 46; rfa; uvrB (pKM101) base-pair substitutions

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 2

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

4, 20, 100, 500 and 2500 µg substance /plate

Vehicle / solvent:

Solvent used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine, sodium azide for test without S-9 mix; 2-aminoanthracene for test with S-9 mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: the test was conducted on agar plates

Evaluation criteria:

no data

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 100, TA 1535, TA 1537, TA 1538, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not examined

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used with and without S9 mix.
Therefore, Edenor C 12 98/100 % is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.

Executive summary:

This study was performed to investigate the potential of Edenor C 12 98/100 % to induce gene mutations according to the plate incorporation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100.

The assay was performed with and without metabolic activation.

The test article was tested at the following concentrations:

4, 20, 100, 500 and 2500 µg/plate

No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Edenor C12 98/100% at any dose level, neither in the presence nor absence of metabolic activation (S9 mix).

Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

Therefore, Edenor C 12 98/100 % is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.