2-propylvaleronitrile

Genetic toxicity: in vitro

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

Test material information

Constituent 1

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