Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 473-370-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.