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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-574-4 | CAS number: 64-04-0
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenethylamine
- EC Number:
- 200-574-4
- EC Name:
- Phenethylamine
- Cas Number:
- 64-04-0
- Molecular formula:
- C8H11N
- IUPAC Name:
- 2-phenylethanamine
- Test material form:
- liquid
- Details on test material:
- Name of the test substance used in the study report: 2-Phenylethylamin
Purity: 99 .7 area % (GC)
Constituent 1
Method
- Target gene:
- S. typhimurium and 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:
- Aroclor-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 20 ug - 5000 ug/plate (standard plate test and preincubation test)
- Vehicle / solvent:
- Due to the limited insolubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoquanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine and N-ethyl-N'-nitro-N-nitrosoquanidine
- Details on test system and experimental conditions:
- Standard plate test
Salmonella typhimurium:
Test tubes containing 2-ml portions of soft agar (overlay agar), which consists of 100 ml agar (0 .6 % agar + 0 .6% NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants : 0 .5 mM histidine + 0 .5 mM biotin) are kept in a water bath at 45°C, and the remaining components are added in the following order :
0.1 ml test solution or vehicle; 0.1 ml fresh bacterial culture; 0.5 ml S-9 mix (in tests with metabolic activation) or 0.5 ml phosohate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
Composition of the minimal glucose agar : 980 ml aqua dest.; 20 ml Vogel-Bonner E medium; 15 g Difco bacto agar; 20 g D-glucose, monohydrate. After incubation at 37°C for 48 - 72 hours in the
dark, the bacterial colonies (his* revertants) are counted.
Escherichia coli:
Test tubes containing 2-ml portions of soft agar (overlay agar), which consists of 100 ml agar (0 .6% agar + 0 .6% NaCl) and 10 ml amino acid solution (minimal amino acid solution for the determination of mutants : 0 .5 mM tryptophan) are kept in a water bath at 45°C, and the remaining components are added in the following order : 0 .1 ml test solution or vehicle; 0 .1 ml fresh bacterial cultur e
0 .5 ml S-9 mix (in tests with metabolic activation) or 0 .5 ml phosphate buffer (in tests without metabolic activation). After mixing, the samples are poured onto minimal agar plates within approx . 30 seconds.
The composition of the minimal agar (SAl selective agar) is based on the description of Green, M .H .L . and Muriel, W .J . (5), with the exception of solution E (tryptophan solution), which has previously been added to the soft agar : 300 ml solution B (agar ); 100 ml solution A (saline solution); 8 ml solution C (glucose solution); 10 ml solution D (casein solution). After incubation at 37°C for 48 - 72 hours in the dark, the bacterial colonies (trp* revertants) are counted.
Preincubation test
0 .1 ml test solution or vehicle, 0 .1 ml bacterial suspension and 0 .5 ml S-9 mix are incubated at 37°C for the duration of about 20 minutes using a shaker. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx. 30 seconds. After incubation at 37°C for 48 - 72 hours in the dark, the bacterial colonies are counted. - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met :
• A dose-related and reproducible increase in the number of revertant colonies, i .e . about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
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:
- other: A bacteriotoxic effect was observed in the standard plate test from about 2500 ug/plate onward.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A bacteriotoxic effect was observed in the standard plate test from about 2500 ug/plate onward.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental conditions chosen here.
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.