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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Reference substance name:
Neodecanoic acid
EC Number:
248-093-9
EC Name:
Neodecanoic acid
Cas Number:
26896-20-8
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

Mutagenicity 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.