(RS)-2-methyl-4-oxo-3-(prop-2-en-1-yl)cyclopent-2-en-1-yl (1R)-cis,trans-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 27, 2006 - June 7, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-methyl-4-oxo-3-(prop-2-en-1-yl)cyclopent-2-en-1-yl (1R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate

EC Number:

687-634-7

Cas Number:

231937-89-6

Molecular formula:

C19H26O3

IUPAC Name:

2-methyl-4-oxo-3-(prop-2-en-1-yl)cyclopent-2-en-1-yl (1R)-2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropane-1-carboxylate

Test material form:

liquid: viscous

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

Test concentrations with justification for top dose:

200 microg/plate and 400 microg/plate in the absence and presence of metabolic activation, respectively, for all strains - based on cytotoxicity (inhibition of background bacterial lawn and reduction in number of colonies).

Vehicle / solvent:

DMSO

Controls

Controls 1

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other:

Controls 2

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

mitomycin C

Controls 3

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Controls 4

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Controls 5

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 4

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Test results 5

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Applicant's summary and conclusion

Conclusions:

Exposure up to 200 microg/plate in the absence and 400 microg/plate of test material in the presence of metabolic activation did not reveal any mutagenic effect when compared with the concurrent vehicle controls in the tester strains TA1537, TA1535, TA98, TA100 and TA102.

Executive summary:

Before conducting the mutagenicity test, the test material was evaluated for its possible cytotoxicity. Based on the results, 200 microg/plate and 400 microg/plate hence 200 microg/plate were selected as the highest concentrations to be tested in the absence and presence of metabolic activation respectively for all strains.
The test material was evaluated for its possible mutagenic effect at 6 dose levels in the absence and presence of metabolic activation. Duplicate plates were maintained for each test concentration of test material, negative, vehicle and positive controls. Two trials were conducted.