2,6,6-trimethylcyclohex-2-ene-1,4-dione

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study performed according to OECD and GLP guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

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:

2,6,6-trimethylcyclohex-2-ene-1,4-dione

EC Number:

214-406-2

EC Name:

2,6,6-trimethylcyclohex-2-ene-1,4-dione

Cas Number:

1125-21-9

Molecular formula:

C9H12O2

IUPAC Name:

2,6,6-trimethylcyclohex-2-ene-1,4-dione

Method

Target gene:

hisG46, hisD6610, hisD3052, hisG46, hisG428

Species / strain

Species / strain / cell type:

other: TA97, TA98, TA100, TA102, TA1535

Additional strain / cell type characteristics:

other: rfa, delta-uvrB, pKM101, pAQ1

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 15.8, 50, 158, 500, 1580, 5000 ug/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

mitomycin C

other: 2-Aminoanthracene

Results and discussion

Test results

Species / strain:

other: TA97, TA98, TA100, TA102, TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

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'.

Any other information on results incl. tables

-

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

It can be concluded that neither Ketoisophorone per se, nor any of the metabolites formed by the metabolising system, is
mutagenic in the Ames test under the described experimental conditions.

Executive summary:

Ketoisophoron was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a

preincubation modification assay were performed in absence and in presence of an exogenous metabolic activation system (S9).

Five Salmonella typhimurium tester strains (TA15 35, TA97, TA98, TA10 0, and TA10 2) were employed. The activity of the

SS-mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment.

Ketoisophorone was dissolved in DMSO. No precipitation was observed when aliquots

were added to the aqueous medium up to the generally recommended maximal dose level of 5000 ug/plate. The dose range of 50 to 5000 ug/plate was chosen for both versions of the test. The compound did not induce toxicity except for some reduction of background growth in strains TA1535, TA100 and TA102 in the preincubation test (-S9) at the test concentration of 5000 ug/plate.

No increase in the number of revertant colonies was apparent for any of the five tester strains after treatment with Ketoisophorone.

Thus it can be concluded that neither the substance per se, nor any of the metabolites formed by the metabolising system, is mutagenic in the Ames test under the described experimental conditions.