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EC number: 200-074-6 | CAS number: 50-98-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP non-guideline study, published, acceptable for assessment Read across from CAS 134-72-5 As the toxicity of (-)-Ephedrine- Hydrochloride is predominantly mediated by the alkaloid with its phenethylamine skeleton read across to Ephedrine sulfate has been done and is scientifically justified.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chromosome Aberrations In Vitro Related to Cytotoxicity of Nonmutagenic Chemicals and Metabolic Poisons
- Author:
- Hilliard A.C.
- Year:
- 1 998
- Bibliographic source:
- Environmental and Molecular Mutagenesis 31 :316-326
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate
- EC Number:
- 205-154-4
- EC Name:
- Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate
- Cas Number:
- 134-72-5
- Molecular formula:
- C10H15NO.1/2H2O4S
- IUPAC Name:
- 2-(methylamino)-1-phenylpropan-1-ol sulfate (2:1) (salt)
- Reference substance name:
- Ephedrine sulfate
- IUPAC Name:
- Ephedrine sulfate
- Details on test material:
- - Name: Ephedrine sulfate
- Supplier: Sigma, st. Lois. MO
Constituent 1
Constituent 2
Method
- Target gene:
- no data
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Cloned Chinese hamster ovary cells (CHO-W-BI) were cultured in Mc-Coy's 5a medium with 10% fetal calf serum, L-glutamine, and antibiotics
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from male SD rats induced with phenobarbital/ß-napthoflavone
- Test concentrations with justification for top dose:
- 0 ; 6; 8 and 10 mM (corresponding to 0 ; 1.58 ; 2.11 and 2.63 mg/L),
with and without metabolic activation. - Vehicle / solvent:
- - Vehicle/solvent used: water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 h
- Expression time (cells in growth medium): 17 h
- Fixation time (start of exposure up to fixation or harvest of cells): 2-3 h before trypsonozation
SPINDLE INHIBITOR (cytogenetic assays): 0.1 µg/ML Colcemid
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: no data
NUMBER OF CELLS EVALUATED: 200
DETERMINATION OF CYTOTOXICITY
- Method: other: cell count
For each treatment. 200 metaphase cells containing 19-23 chromosomes were scored for CHO cells and 100 cells containing 45-49 chromosomes were scored for TK6, unless aberration frequencies were high or few cells were available for analysis due to mitotic suppression .Gaps (achromatic region less than or equal to the width of a chromatid), polyploid and endoreduplicated cells, and pulverized chromosomes were noted but not included in structural aberration totals . - Evaluation criteria:
- A test is considered positive if there is a statistically significant increase (P < 0 .05) over concurrent controls in the percentages of cells with chromosomal aberrations at two separate concentrations of test article, with about 50 % cytotoxicity, or a reproducible increase at one dose level .
- Statistics:
- The analysis is a pairwise comparison of the percentage of cells with aberrations a each dose level with the controls by Fisher's exact test, with the P values adjusted for multiple comparisons against a common control by the method of Dunnett [1955].
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- no data
- Remarks on result:
- other: strain/cell type: Chinese hamster Ovary (CHO-W-Bl)
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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