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EC number: 250-078-7 | CAS number: 30168-23-1
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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde
- EC Number:
- 250-078-7
- EC Name:
- 4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde
- Cas Number:
- 30168-23-1
- Molecular formula:
- C14H20O
- IUPAC Name:
- 4-[(8Z)-tricyclo[5.2.1.0^{2,6}]decan-8-ylidene]butanal
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Dupical
Extremely pale yellow liquid
Batch: 788005171001
Storage: Room temperature in the dark.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitone and beta-naphthoflavone
- Test concentrations with justification for top dose:
- The dose range for the dose range finder test was determined in a preliminary toxicity assay and ranged between 0.5 and 1500 ug/plate, depending on strain type and S9 exposure.
The experimental was repeated on a separate day using similar dose ranges as the range finding test. - Vehicle / solvent:
- Dimethyl sulphoxide (DMSO)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 3 day
NUMBER OF REPLICATIONS: 3 plate per concentration - Rationale for test conditions:
- As per OECD guideline
- Evaluation criteria:
- Dose related increase in revertant frequency over the dose range.
Biological relevance of the results. - Statistics:
- As per the UKEMS evaluation if required.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- 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 applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
- Executive summary:
The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF. It also meets the requirements of the OECD guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Comission Directive 2000/32/EC and USA, EPA (TSCA) OPPTS harmonised guidelines.
Methods: Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test material using the Ames plate incorporation method at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolishing system (10% liver S9 in standard co-factors). The dose range for the range-finding test was determined in a preliminary toxicity assay and ranger between 0.5 and 1500 micrograms per plate, depending on strain type and S9 exposure. The experiment was repeated on a separate day using similar dose ranges as the range-finding test, fresh cultures of the bacterial strains and fresh test material formulations.
Additional dose levels were included to allow for test material induced toxicity, ensuring that at leat four non-toxic doses were achieved.
Results: The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9 -mix were validated.
The test material caused a visible reduction in the growth of the bacterial background lawn to all of the bacterial strains initially at 150 and 50 micrograms per plate, with and without S9 respectively. The test material was, therefore, tested up to its toxic limit. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9 -mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
Conclusion: The test material was considered to be non-mutagenic under the conditions of this test.
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