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Registration Dossier
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EC number: 257-840-8 | CAS number: 52314-67-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic Toxicity study for Cyclohexene by Bacterial reverse mutation assay
- Author:
- National Institute of Technology and Evaluation
- Year:
- 2 017
- Bibliographic source:
- Japan chemicals collaborative knowledge database (J-check), 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan) and OECD Test Guideline 471
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of Cyclohexene in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia
coli WP2 uvrA. - GLP compliance:
- not specified
- Type of assay:
- bacterial forward mutation assay
Test material
- Reference substance name:
- Cyclohexene
- EC Number:
- 203-807-8
- EC Name:
- Cyclohexene
- Cas Number:
- 110-83-8
- Molecular formula:
- C6H10
- IUPAC Name:
- Cyclohexene
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): Cyclohexene
Molecular form; C6H10
Constituent 1
- Specific details on test material used for the study:
- Details on test material
- Name of test material (as cited in study report): Cyclohexene
Molecular form; C6H10
Purity: 98.63 wt%
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA.
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver, induced with phenobarbital and 5, 6-benzoflavone
- Test concentrations with justification for top dose:
- -S9 mix; 0, 19.5, 39.1, 78.1, 156, 313, 625, 1250 mg/plate (TA100,TA1535, TA98, TA1537)
-S9 mix; 0, 78.1, 156, 313, 625, 1250, 2500, 5000 mg/plate (WP2 uvrA)
+S9 mix; 0, 19.5, 39.1, 78.1, 156, 313, 625, 1250 mg/plate (all strains) - Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: Ethanol
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- sodium azide
- other: -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide (TA100, TA98 and WP2 uvrA), 2-Methoxy-6-chloro-9-[3-(2- chloroethyl)-aminopropylamino] acridine¡¦2HCl (TA1537) ,+S9 mix; Benzo[a]pyrene (TA100, TA98, TA1537) and 2- Aminoanthracene (TA1535 and WP2 uvrA)
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: Pre-incubation method
Other: 3 plates per test were observed. - Rationale for test conditions:
- Not specified.
- Evaluation criteria:
- To evaluate the histidine revertant /plate
- Statistics:
- Not specified
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Not specified.
- Remarks on result:
- other: No mutagenic effect were observed.
Applicant's summary and conclusion
- Conclusions:
- Cyclohexene (110-83-8) was evaluated for its mutagenic potential in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA. The test result was considered to be negative in the presence and absence of metabolic activation.
- Executive summary:
Cyclohexene was assessed for its possible mutagenic potential. For this purpose Bacterial reverse mutation assay was performed according toGuidelines for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan) and OECD Test Guideline 471 on Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichiacoli WP2 uvrA. The test material was exposed in the presence and absence of S9 at different concentration. No mutagenic effects were observed in any strain. Therefore Cyclohexene was considered to be non mutagenic in the presence and absence of metabolic activation. Hence test substance cannot be classified as gene mutant in vitro.
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