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EC number: 205-154-4 | CAS number: 134-72-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, similar to guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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:
- bis([(1R,2S)-1-hydroxy-1-phenylpropan-2-yl](methyl)azanium) sulfate
- Details on test material:
- - Name of the test substance used in the study report: (-)-Ephedrin-Sulfat
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: mean group weight females 170-186 g, males 171-191 g
- Fasting period before study: 16 hours (water was still available)
- Housing: 5 animals per cage, stainless steel wire mesh cages, Type DK-III (Becker & Co., Castrop-Rauxel
- Diet: ad libitum, Kliba-labordiaet (FA. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Justification for choice of vehicle: The aqueous formulation corresponds to the physiologial medium.
- Concentrations used (w/v): 0.68, 1, 1.47, 2.15, 3.16, 4.64
- Administration volume (mL/kg): 10 - Doses:
- 68.1, 100, 147, 215, 316, 464 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration (at least once each working day). A check for moribund and dead animals was made twice each working day and once on public holidays. Body weight was determined before the test and at day 7, 9, and 13.
- Necropsy of survivors performed: yes; Withdrawal of food 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 368 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 464 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 189 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was observed within 1 day after exposure.
- No mortality observed in animals exposed to 68.1 or 100 mg/kg bw.
- 4 out of 10 animals died exposed to 147 mg/kg bw (1 male and 3 females).
- 4 out of 10 animals died exposed to 215 mg/kg bw (all females).
- 3 out of 10 animals died exposed to 316 mg/kg bw (1 male and 2 females).
- 6 out of 10 animals died exposed to 464 mg/kg bw (1 male and 5 females). - Clinical signs:
- other: - Excitation and piloerection observed in male and female animals exposed to 68.1 mg/kg bw. - Dyspnea, excitation, staggering, piloerection, and a poor general state observed in male and female animals exposed to 100 mg/kg bw. - Dyspnea, apathy (male only
- Gross pathology:
- - Animals that died: lung: edematous, focal hyperemia.
- Sacrificed animals: no abnormalities detected.
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this test, the LD50 was determined to be 189 mg/kg bw.
- Executive summary:
Five Wistar rats per sex per dose were exposed, in a acute oral toxicity study similar to OECD guideline 401, to 68.1, 100, 147.0, 215, 316, and 464 mg/kg bw of the test substance, dissolved in water, via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Several clinical signs were observed such as dyspnea, apathy, excitation, abnormal position, staggering, tremors, twitching, tonus of the jaws, tonic convulsions, piloerection, exophthalmos, salivation, imbalance, and a poor general state. These effects were absent after 2 days. Upon necropsy edematous lungs and focal hyperemia were observed in animals that died. The LD50 was determined to be 189 and more than 464 mg/kg bw for females en males, respectively.
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