α,2,2,6-tetramethylcyclohexene-1-butyraldehyde

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:

September 25th, 2003 to October 27th, 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial forward mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

α,2,6,6-tetramethyl-2-cyclohexene-1-butyraldehyde

EC Number:

277-458-5

EC Name:

α,2,6,6-tetramethyl-2-cyclohexene-1-butyraldehyde

Cas Number:

73398-85-3

Molecular formula:

C14H24O

IUPAC Name:

2-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)butanal

Constituent 2

Reference substance name:

α,2,6,6-tetramethylcyclohexene-1-butyraldehyde

EC Number:

282-993-2

EC Name:

α,2,6,6-tetramethylcyclohexene-1-butyraldehyde

Cas Number:

84518-22-9

Molecular formula:

C14H24O

IUPAC Name:

2-methyl-4-(2,6,6-trimethylcyclohex-1-en-1-yl)butanal

Specific details on test material used for the study:

Test material name (as stated in the report): Cetonal
Batch No.: 9000503780
Expiry date: February 09, 2015

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:

See below the "Any other informtaion on materials and methods " boxe

Vehicle / solvent:

Distilled water and DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9,10-dimethylbenzanthracene

Controls 3

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Controls 4

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Controls 5

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cumene hydroperoxide

Results and discussion

Test results

Key result

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

In the toxicity test, the test item was assayed at a maximum dose level of 5000 microf/plate and at four does levels spaced at approximately half - log intervals: 1580, 500, 158 and 50 microg/plate. Toxicity as indicated by the thinning of the background lawn and/or reduction in revertant numbers was observed with TA1537 and TA100 both in the absence and presence of S9 metabolic avctivation and with TA102 in its absence. With TA100 tester strain the toxic effects were not dose related but evident at all dose levels.

Dose levels used with all tester strains were selected on the basis of the results obtained in an additional experiment where the dose range assayed proved to be too toxic. Toxicity as indicated by thinning of the background law and reduction in revertant numbers was observed at higher dose levels with all tester strains both in the absence and presence of S9 metabolic activation. No increase in revertant numbers were observed at any concentrations assays.

Applicant's summary and conclusion

Conclusions:

It is concluded that the test item CETONAL does not induce reverse mutation in Salmonella Typhimurium under the reported experimental conditions.