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EC number: 206-080-5 | CAS number: 299-42-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, restriction in design (only one positive control used to test efficacy of the S9-mix), but adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , only one positive control used to test efficacy of the S9-mix
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- , only one positive control used to test efficacy of the S9-mix
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [R-(R*,S*)]-α-(1-aminoethyl)benzyl alcohol
- EC Number:
- 207-755-7
- EC Name:
- [R-(R*,S*)]-α-(1-aminoethyl)benzyl alcohol
- Cas Number:
- 492-41-1
- IUPAC Name:
- 2-amino-1-phenylpropan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): (-)-Norephedrin S krist.
- Appearance, consistency: white crystals
- Storage: Room temperature (protected from light)
Constituent 1
Method
- Target gene:
- - S. typhimurium: His-locus
- E. coli: Trp-locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 mix
- Test concentrations with justification for top dose:
- - Experiment 1 and 2: 20, 100, 500, 2500, 5000 µg/plate
- Experment 3: 4, 20, 100, 500, 1000 µg/plate - Vehicle / solvent:
- - Vehicle/solvent used: water
- Justification for choice of solvent/vehicle: due to the good solubility of the test substance in water, water was selected
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- TA: 2.5 µg/plate, E.coli: 60 µg/plate
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg/plate
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- TA 1535, TA 100; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5 µg/plate
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- E.coli WP2 uvrA; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- TA 98; without metabolic activation
- Details on test system and experimental conditions:
- EXPERIMENT 1
- METHOD OF APPLICATION: in agar (plate incorporation)
- DURATION: Exposure duration: 48 - 72 h
- NUMBER OF REPLICATIONS: 3 test plates per dose or per control
- DETERMINATION OF CYTOTOXICITY: Toxicity detected by a: decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), reduction in the titer
EXPERIMENT 2 and 3
- METHOD OF APPLICATION: preincubation
- DURATION: Preincubation period: 20 min; Exposure duration: 48 - 72 h
- NUMBER OF REPLICATIONS: 3 test plates per dose or per control
- DETERMINATION OF CYTOTOXICITY: Toxicity detected by a: decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), reduction in the titer - Evaluation criteria:
- - The test chemical is considered positive in this assays 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.
- A test substance is generally considered nonmutagenic in this test if: The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.
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:
- cytotoxicity
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no test substance precipitation was found
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Standard plate test: A slight increase in the number of revertants and/or a slight reduction in the titer was occasionally observerd in the standard plate test depending on the strain and test conditions at doses ≥2500 µg/plate.
- Preincubation test: In the preincubation assay bacteriotoxicity (reduced background growth, decrease in the number of revertant, slight reduction in the titer) was observed depending on the strain and test conditions from about 2500 µg/plate onward. - 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
It is concluded that there is no evidence of induction of gene mutations by the test substance and its metabolites in the strains of S. typhimurium and E. coli used. - Executive summary:
In a GLP compliant mutagenicity test, performed according to OECD guideline 471, 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) and one E. Coli strain (WP2 uvrA) were used to test the mutagenic potential of the test substance both with and without metabolic activation. Three experiments were performed. In the first experiment: a standard plate test strains were exposed to 0, 20, 100, 500, 2500, and 5000 µg/plate. The second and third experiment were preincubation tests. In the second test strains were exposed to 0, 20, 100, 500, 2500, and 5000 µg/plate and in the third test strains were exposed to 0, 4, 20, 100, 500 and 1000 µg/plate. No precipitation of the test substance was found. A bacteriotoxic effect was observed under all test conditions at concentrations ≥2500 µg/plate. An increased in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
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