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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: Study was conducted according to a GLP, O.E.C.D. Testing Guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Method

Target gene:
histidine operon
Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 rat liver homogenate
Test concentrations with justification for top dose:
0, 5.0 ul, 8.9 ul, 15.8 ul, 28 ul and 50.0 ul plate
Vehicle:
Corn Oil
Controls
Negative controls:
no
Solvent controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: 9-aminoacrimide, 4-nitro-o-phenylenediamine, 2-anthramine
Details on test system and conditions:
The plate incorporation version of the assay was conducted. Rat liver S9 homogenate, in KC1 buffer, prepared from Aroclor 1254-induced male Sprague-Dawley rats was obtained from Molecular Toxicology, Inc., College Park, Maryland. It was stored frozen in liquid nitrogen and was thawed and used to prepare an S9 mixture immediately before the chemical exposure step of each assay. The specific test method has been described in detail (Ames et al., 1975; Maron and Ames, 1983). The plate incorporation assay for each sample was performed in the following way. To a sterile 13 X 100-mm test tube placed in a 45°C heating block, the following were added: 2.0 ml of 0.615% agar containing 0.5% NaCl, 0.05 mM histidinebiotin solution, Vogel-Bonner medium E, and 20% glucose; 0.1 ml of indicator organisms (about 108 bacteria); 0.5 ml of the metabolic activation mixture or buffer; and the appropriate amount of vinyl neononanoate , positive control, or solvent control. This mixture was stirred gently and then poured on a plate containing about 30 ml of minimal glucose agar plus biotin, obtained from Molecular Toxicology, Inc., College Park, Maryland. After the top agar had set, the plates were placed in Plexiglas boxes which were sealed then incubated at 37°C for 48 hours. The number of histidine independent revertant colonies on each plate was then counted using an Artek 982B colony counter.


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Evaluation criteria:
The data generated are considered acceptable if controls are within expected ranges as reported in the literature and if a sufficient number of nontoxic concentrations have been tested to determine if the test material is capable of inducing a dose-related mutagenic response.

• Positive. The test material is considered mutagenic for a strain and condition if a statistically significant dose-related increase in the number of revertants is observed or if a reproducible and statistically significant positive response is observed for at least one of the concentrations of the test material.

• Negative. A test material is considered negative if neither criteria for a positive response is met. If a negative response in the initial assay is not reproduced, the test material may be evaluated as inconclusive or positive, depending upon the conditions of testing in the repeat assay.
Statistics:
No data

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:
yes
Remarks:
at highes dose (50 ul pure)
Vehicle controls valid:
yes
Negative controls valid:
no
Positive controls valid:
yes
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 the absence and presence of metabolic activation, vinyl neononanoate failed to induce a reproducible, statistically significant or biologically relevant increase in mutation frequencies in any of the five strains of Salmonella typhimurium. Therefore, vinyl neononanoate was negative in the Salmonella typhimurium histidine reversion test in the presence and absence of metabolic activation. Therefore, vinyl neononanoate does not induce gene-mutation under the conditions of this test.

Executive summary:

Vinyl neononanoate was evaluated for ability to induce gene-mutation in vitro in a GLP, O.E.C.D. 471 Testing Guideline study using the plate incorporation method. In the absence and presence of metabolic activation, vinyl neononanoate failed to induce a reproducible, statistically significant or biologically relevant increase in mutation frequencies in any of the five strains of Salmonella typhimurium. Therefore, vinyl neononanoate was negative in the Salmonella typhimurium histidine reversion test in the presence and absence of metabolic activation. Therefore, vinyl neononanoate does not induce gene-mutation under the conditions of this test.