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Toxicological information

Genetic toxicity: in vitro

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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:
2017
Bibliographic source:
Japan chemicals collaborative knowledge database (J-check), 2017

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Details on test material
- Name of test material (as cited in study report): Cyclohexene
Molecular form; C6H10
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:
other: TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA.
Details on mammalian cell lines (if applicable):
Not applicable.
Additional strain 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:
Vehicle
- Vehicle(s)/solvent(s) used: Ethanol
Controls
Negative controls:
not specified
Solvent 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 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:
other: TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic effect were observed.
Additional information on results:
Not specified.

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.