Benzenepropanenitrile, 2-chloro-.beta.-oxo-

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

Study period:

25 July - 31 August 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and in accordance with several internationally achnowledged guidelines for the testing of chemicals.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Chlorobenzoylacetonitril

IUPAC Name:

Chlorobenzoylacetonitril

Test material form:

other: solid

Details on test material:

Name: Chlorobenzoylacetoniril
Batch No. 46
Physical state: solid
Colour: yellow
Molecular weight: 179.61 g/mol
Purity: > 99%
Storage: in original container at 4°C

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 100 and TA 98

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

10, 31.6, 100, 316.2, 1000, 2500 and 5000 microgram/plate, each was concentration was used in triplicate.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: NaN3; 4-NOPD; 2-AA

Remarks:

all used without metabolic activation, except 2-AA

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation
DURATION
- Preincubation period: 10h
- Exposure duration: 48h


NUMBER OF REPLICATIONS: 3 per concentration

Evaluation criteria:

A test item is considered mutagenic if:
-A dose-related increase in the number of revertants occur and/or:
-A reproducible biologically relevant positive response for at least one of the test points occurs in at least one strain with or withour metabolic activation.

Statistics:

The mutation factor is calculated by dividing the mean value of the revertant counts through the mean values of the solvent control.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 100 and TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

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 with metabolic activation
negative without metabolic activation

The test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.