Fatty acids, C9-13-neo-

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study according to appropriate guidelines, GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Neodecanoic acid

EC Number:

248-093-9

EC Name:

Neodecanoic acid

Cas Number:

26896-20-8

Molecular formula:

C10H20O2

IUPAC Name:

neodecanoic acid

Details on test material:

- Name of test material (as cited in study report): versatic 10
- Physical state: clear liquid

Method

Target gene:

N/A

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9 - no additional details

Test concentrations with justification for top dose:

Toxicity assay:
100, 33.33, 11.11, 3.70, 1.23 microliters/plate

Mutegenicity assays
Test #1 - 1000, 333.33, 111.11, 37.04, 12.35 micrograms/plate
Test #2 - 1500, 500, 166.67, 55.56, 18.52 micrograms/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: sodium azide, 9-aminoacridine, 2-nitrofluorene, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period: 72 hours

Evaluation criteria:

His+ revertants were counted

Statistics:

None performed

Results and discussion

Test results

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:

cytotoxicity

Remarks:

Only at the highest doses tested

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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

Versatic 10 does not induce genotoxicity in bacteria in the Ames assay

Executive summary:

Versatic 10 (neodecanoic acid) was examined for mutagenic activity in the Ames test using the histidine-requiringSalmonella typhimuriummutant strains TA 1535, TAA 1537, TA 98, and TA 100. A liver fraction of Aroclor-induced rats for metabolic activation (S9) was used.

 

Versatic 10 was tested at five different dose levels ranging from 6.17 to 1000 ug/plate, in the absence of S9 mix, and from 18.52 to 1500 ug/plate in the presence of S9 mix. Higher dose levels were toxic. Negative and positive controls were run concurrently with the test substance.

 

In both the absence and presence of the S9-mix in all strains, the test substance did not cause a two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background spontaneous reversion rate observed with the vehicle, together with evidence of a dose-response. The positive controls gave results as expected.   

 

It is concluded that the results obtained in the various TA strain, with and without metabolic activation, indicate Versatic 10 is not mutagenic.