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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, comparable to guideline study with acceptable restrictions (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

Constituent 1
Chemical structure
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:
other: Salmonella typhimurium TA 1535, TA 100, TA1537 and TA 98
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:
IUCLID4 Type: Ames test

Results and discussion

Test results
Species / strain:
S. typhimurium, other: tester strains: TA 1535, TA 100, TA1537 and TA 98
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
Remarks on result:
other: other: Salmonella typhimurium tester strains: TA 1535, TA 100, TA1537 and TA 98
Remarks:
Migrated from field 'Test system'.

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:

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