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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-propylvaleronitrile
EC Number:
236-338-2
EC Name:
2-propylvaleronitrile
Cas Number:
13310-75-3
Molecular formula:
C8H15N
IUPAC Name:
2-propylpentanenitrile

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from rats pretreated with Aroclor 1254
Test concentrations with justification for top dose:
5, 16, 50, 160, 500, 1600 and 5000 μg/plate
Vehicle / solvent:
dimethyl sulfoxide (DMSO)
Controls
Untreated negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
mitomycin C
other: 6-Chloro-9-(3-[2-chloro ethylamino]propylamino)-2- methoxyacridine] dihydrochloride and 2-aminoanthracene
Evaluation criteria:
A test article is considered to have induced a positive response in the bacterial reverse mutation test when at least two of the following criteria were fulfilled:
• the test article induces at least a two-fold increase in the number of revertant colonies for one or more dose levels for Salmonella typhimurium strains TA98, TA100 and TA102 or at least a three-fold increase in the number of revertant colonies for one or more dose levels for Salmonella typhimurium strains TA1535 and TA1537;
• the increase is dose-related;
• the increase number of revertant colonies is reproducible;
• the number of revertant colonies exceeds the upper value of the range of historical negative control data.
Moreover, biological significance needs to be discussed, taking into consideration the criteria mentioned above.
If the above criteria are not fulfilled, the test article was then considered negative.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA 1535, TA1537, TA 98, TA 100, TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Cytotoxicity was observed in the presence and absence of metabolic activation at dose levels >=1600 to 5000 µg/plate depending on the strain.

Applicant's summary and conclusion

Conclusions:
In conclusion, under the experimental conditions of the study, 2-propylvaleronitrile was found negative in the bacterial reverse mutation test conducted on Salmonella typhimurium strains TA100, TA1535, TA1537, TA98, and TA102 in the presence and absence of metabolic activation, at dose levels up to 5000 μg/plate

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