Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

EC Number:

916-807-4

Molecular formula:

C13H20O

IUPAC Name:

Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

Test material form:

liquid

Specific details on test material used for the study:

- Appearance at ordinary temperature: Transparent liquid
- Stability: Stable in room temperature

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital and 5,6-benzoflavone induced rat liver

Test concentrations with justification for top dose:

Without metabolic activation (µg/plate): 0.610, 1.22, 2.44, 4.88, 9.77, 19.5, 39.1 (E. Coli only), 78.1(E. Coli only)
With metabolic activation (µg/plate): 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, (E. Coli only) 313 (E. Coli only)
Highest dose based on results preliminary tests.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

sodium azide

other: ICR-191, 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 3 for vehicle control, 2 for test substance treatment groups and positive controls

DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertant colonies

Evaluation criteria:

The test substance was judged to be positive when the number of revertant colonies increased to twice or more that in the negative control in a concentration-dependent manner and also the reproducibility of the test results was obtained. In all other cases, it was judged to be negative.

Statistics:

Any statistical methods were not used.

Results and discussion

Test results

Key result

Species / strain:

bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

- Dose Finding Test-I: The number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was observed at 19.5 µg/plate or more in TA 100, TA 1535, TA 98 and TA 1537 without S9 mix, at 78.1 µg/plate or more in WP2uvrA without S9 mix, at 78.1 µg/plate or more in TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 313 µg/plate or more in WP2uvrA with S9 mix. The precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.
- Dose Finding Test-II: The number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was observed at 19.5 µg/plate in TA 100, TA 1535, TA 98 and TA 1537 without S9 mix, at 39.1 µg/plate or more in WP2uvrA without S9 mix, at 78.1 µg/plate in TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 156 µg/plate or more in WP2uvrA with S9 mix. The precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.
- Main Test: The number of revertant colonies in the test substance treatment groups was less than twice that in the solvent control. The bacterial growth inhibition was observed at 19.5 µg/plate in TA 100, TA 1535, TA 98 and TA 1537 without S9 mix, at 39.1 µg/plate or more in WP2uvrA without S9 mix, at 78.1 µg/plate in TA 100, TA 1535, TA 98 and TA 1537 with S9 mix, and at 156 µg/plate or more in WP2uvrA with S9 mix. The precipitation of the test substance was not observed at any doses in the groups of with and without S9 mix.