Registration Dossier
Registration Dossier
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EC number: 203-807-8 | CAS number: 110-83-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse 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:
- - Analytical purity:98.63%
- Impurities (identity and concentrations):Benzene 0.799%, Cyclohexane 0.526%, Water 0.003%, BHT(2,6-Di-tert-butyl 4-methylphenol) 0.01% (as antioxidant)
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 : 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(s)/solvent(s) used: ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9 mix (TA100, TA98, TA1537)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix (TA1535)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: AF-2 (2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- without S9 mix (TA100, TA98, Escherichia coli WP2 uvrA)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2AA (2-aminoanthracene)
- Remarks:
- with S9 mix (TA1535, Escherichia coli WP2 uvrA)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191 (2-methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine 2HCl
- Remarks:
- without S9 mix (TA1537)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No mutagenic activity was found in the S. typhimurium and E. coli strains. Toxicity was not observed in any strain, with or without metabolic activation. - Executive summary:
- No mutagenic activity was found in the S. typhimurium and E. coli strains.
Toxicity was not observed in any strain, with or without metabolic
activation.
Genetic effects:
Salmonella typhimurium TA100, TA1535, TA98, TA1537+ ? - Without metabolic activation: [ ] [ ] [*] With metabolic activation: [ ] [ ] [*] Genetic effects:
Escherichia coli WP2 uvrA
+ ? - Without metabolic activation: [ ] [ ] [*] With metabolic activation: [ ] [ ] [*]
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