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Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
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

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.