Cyclohex-3-ene-1-carbaldehyde

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

only four S. typhimurium tester strains used

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only four S. typhimurium tester strains used

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohex-3-ene-1-carbaldehyde

EC Number:

202-858-3

EC Name:

Cyclohex-3-ene-1-carbaldehyde

Cas Number:

100-50-5

Molecular formula:

C7H10O

IUPAC Name:

cyclohex-3-ene-1-carbaldehyde

Details on test material:

Tetrahydrobenzaldehyde, purity: 96.5%

Method

Target gene:

Ames assay

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

up to 5000 µg/plate

Controls

Untreated negative controls:

other: within historical control data range

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: -S9: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine; +S9: 2-aminoanthracene

Details on test system and experimental conditions:

Ames test

Results and discussion

Test results

Species / strain:

S. typhimurium, other: tester strains: TA 1535, TA 100, TA1537 and TA 98 bacteria

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

Toxic effects of the test substance tetrahydrobenzaldehyde were observed at 5000 µg/plate in the plate incorporation test. No mutagenicity of the test substance was noted in any of the tester strains evaluated up to 5000 µg/plate in the plate incorporation test with and without metabolic activation. In the pre-incubation assay toxicity of the test substance was observed at 900 µg/plate and higher. No mutagenic effects of the test substance were observed in the pre-incubation assay in any of the tester strains evaluated with and without metabolic activation.

Applicant's summary and conclusion

Executive summary:

An Ames test with S.typhimurium strains TA 100, TA 1535, TA 98 and TA 1537 was conducted with tetrahydrobenzaldehyde in a study design similar or equivalent to OECD Guideline 471 (Bacterial Reverse Mutation Assay)
in vitro gene mutation study in bacteria.

Tetrahydrobenzaldehyde was tested in concentrations of up to 5000 μg/plate. 

The test substance tetrahydrobenzaldehyde was negative in the bacterial mutation assay with and without metabolic activation.