Registration Dossier
Registration Dossier
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EC number: 473-370-8 | CAS number: -
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:
- 06 February 2007 to 19 February 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 473-370-8
- EC Name:
- -
- Cas Number:
- 13304-62-6
- Molecular formula:
- C10 H11 N O
- IUPAC Name:
- N-benzylprop-2-enamide
1
Method
- Target gene:
- His+ (S. typhimurium), Trp+ (E. coli)
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:
- Type and composition of metabolic activation system:
- source of S9 : liver of phenobarbital/beta-naphthoflavone (80/100 mg/kg bw) treated rats
- method of preparation of S9 mix (10 mL): A mixture of 30 mg NADP and 15.2 mg glucose-6-phosphate dissolved in 5.0-5.5 mL Milli-Q water, 2 mL 0.5 M sodium phosphate buffer, 1 mL 0.08 M MgCl2 and 1 mL 0.33 M KCl was filter (0.22 um) sterilized. To this 0.5 to 1 mL S9 homogenate was added
- concentration or volume of S9 mix and S9 in the final culture medium : experiment 1 5%, experiment 2 10% - Test concentrations with justification for top dose:
- experiment 1: 3, 10, 33, 100, 333, 1000, 3330 and 5000 ug/plate with and without metabolic activation (evaluated concentrations 100-5000 ug/plate)
experiment 2: 100, 333, 1000, 3330 and 5000 ug/plate with and without metabolic activation
Maximum concentration based on the absence of toxicity (bacterial background lawn, size of micro colonies and number of revertants) and precipitate in a dose range finding study in TA100 and TA98 at 3, 10, 33, 100, 333, 1000, 3330 and 5000 ug/plate with and without metabolic activation - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplcate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density: 1.0E09 cells/mL
- Test substance in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 hours
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition; size of micro-colonies and number of revertants
METHODS FOR MEASUREMENTS OF GENOTOXICIY :
TA100 number of revertants >2 times vehicle control
TA98, TA1535, TA1537 and Wp2uvrA number of revertants >3 times vehicle control
Negative response confirmed in separate experiment
- Evaluation criteria:
- TA100 number of revertants >2 times vehicle control
TA98, TA1535, TA1537 and Wp2uvrA number of revertants >3 times vehicle control
Negative response confirmed in separate experiment - Statistics:
- NA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- 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
- Remarks:
- within historical control ranges
- Positive controls validity:
- valid
- Remarks:
- within historical control ranges
- Species / strain:
- S. typhimurium TA 1537
- 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
- Remarks:
- within historical control ranges
- Positive controls validity:
- valid
- Remarks:
- within historical control ranges
- Species / strain:
- S. typhimurium TA 98
- 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
- Remarks:
- within historical control ranges
- Positive controls validity:
- valid
- Remarks:
- within historical control ranges
- Species / strain:
- S. typhimurium 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
- Remarks:
- within historical control ranges
- Positive controls validity:
- valid
- Remarks:
- within historical control ranges
- 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
- Remarks:
- within historical control ranges
- Positive controls validity:
- valid
- Remarks:
- within historical control ranges
Any other information on results incl. tables
see attached document
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in bacteria with and without metabolic activation
- Executive summary:
The substance (in DMSO) was tested in the Ames test in Salmonella typhimurium strains TA 1535, TA1537, TA98 and TA100 and in E.coli strain WP2uvrA at concentrations of 3 to 5000 ug/plate with and without metabolic activation.
No cytotoxicity or precipitate was observed up to 5000 ug/plate. The number of revertants was not increased in any of the evaluated concentrations (100 -5000 ug/plate). Vehicle and positive controls included gave results within the historical control ranges. An independent repeat with the same evaluated concentrations gave a similar result.
It is therefore concluded that the substance is not mutagenic in bacteria with and without metabolic activation.
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