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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information from a published industry source (NTP), restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Ten Fischer 344/N rats were given diets containing 0, 125, 250, 500, 1000, or 2000 ppm of the test substance. Animals were observed twice per day and weighed once per week. After an exposure period of 13 weeks, animals were necropsied, blood was taken for the determination of packed cell volume and pupil diameters were measured.
- GLP compliance:
- no
- 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 test material (as cited): L-ephedrine sulfate
- Lot No.: 926EW
- Purity: >99%
- Storage: in the dark at 25°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Portage, MI)
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: group mean males 129 - 158 g and females 109 - 115 g
- Housing: 5 animals per cage, Polycarbonate cages (Hazleton Systems, Inc., Aberdeen, MD), Reeman Spun-bonded polyester filters (Snow Filtration, Cincinnati, OH); Aspen wood chips as bedding.
- Diet: ad libitum, NIH 07 Rat and Mouse Ration (Zeigler Bros., Garners, PA)
- Water: ad libitum, Automatic watering system (Edstrom Idnustries, Waterford, WI)
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26.6
- Humidity (%): 20 - 48
- Air changes (per hr): 120
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 1979-12-31 to 1980-04-04
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Premix mixed with feed in a twin-shell blender for 5 min with intensifier bar and then 10 min without intensifier bar
- Maximum storage time: 14 days
- Storage temperature of food: Room temperature - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
125, 250, 500, 1000, 2000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
Males: 4.6, 9.6, 22.2, 43.4, 87.4 mg/kg bw/day (mean)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
Females: 8.1, 16.6, 35.6, 67.2, 144.9 mg/kg bw/day (mean)
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- - CAGE SIDE OBSERVATIONS AND DETAILED CLINICAL OBSERVATIONS: twice daily
- FOOD CONSUMPTION AND COMPOUND INTAKE: measured once a week. Food consumption for each animal determined and divided by final body weight to estimate the daily intake of the test substance in mg/kg body weight/day
- BODY WEIGHT: measured once a week.
- OPHTHALMOSCOPIC EXAMINATION: Pupil diameter measured at the end of the study. - Sacrifice and pathology:
- - Necropsy and histologic exam performed on all animals. Tissues examined: tissue masses, regional lymph node, blood smear, skin, mandibular lymph node, mammary gland, salivary gland, thigh muscle, sciatic nerve, bone marrow, costochondral junction (rib), thymus, larynx, trachea, lungs and bronchi, heart, thyroid gland, parathyroids, esophagus, stomach, duodenum, jejunum, ileum, colon, rectum, mesenteric lymph node, liver, gallbladder, pancreas, spleen, kidneys, adrenal glands, urinary bladder, seminal vesicles/prostate/tested or ovaries/uterus, nasal cavity, brain, pituitary gland, eyes, external and middle ear and spinal cord.
- Adrenal gland and heart weight measured for control and highest dose groups. - Other examinations:
- Determination of packed cell volume. Blood was taken from the external jugular vein at the scheduled kill.
- Statistics:
- t-test was used to compare packed cell volumes and organ weights of the controls with animals exposed to the test substance.
Results and discussion
Results of examinations
- Details on results:
- MORTALITY AND CLINICAL SIGNS
- No mortality observed in all exposed animals.
- No mortality observed in the control group.
- Animals that received 2000 ppm were hyperexitable and had rough coats.
BODY WEIGHT AND WEIGHT GAIN
- Final mean body weights of rats that received 1,000 or 2,000 ppm were 20% and 23% lower than those of the controls for males and 10% and 17% lower for females.
- The mean final body weights for males were 359, 347, 339, 315, 286, and 277 g for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The mean final body weights for females were 201, 189, 184, 184, 180, and 167 g for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The mean body weight gains for males were 218, 189, 199, 186, 146, and 142 g for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The mean body weight gains for females were 90, 80, 74, 73, 68, and 52 g for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
FOOD CONSUMPTION AND COMPOUND INTAKE
- Feed consumption by dosed and control groups was generally comparable.
- The mean feed consumption of males in week 6 was 15.1, 14.2, 14.4, 15.4, 14.1, and 12.7 g per animal per day for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The mean feed consumption of males in week 12 was 14.8, 12.9, 13, 14, 12.4, and 12.1 g per animal per day for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The mean feed consumption of females in week 6 was 9.7, 9.3, 8.6, 8.9, 8.8, and 8.5 g per animal per day for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The mean feed consumption of females in week 12 was 12.7, 12.2, 12.2, 13.1, 12.1, and 12.1 g per animal per day for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
OPHTHALMOSCOPIC EXAMINATION
- The mean pupil diameters for dosed and control animals were comparable.
- The pupil diameter, right and left combined, of males was 1.46, 1.46, 1.29, 1.26, 1.06, and 1.49 mm for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
- The pupil diameter, right and left combined, of females was 1.04, 1.34*, 1.01, 0.86, 1.01, and 0.97 mm for the control, 125, 250, 500, 1000, and 2000 ppm exposed animals respectively.
* = statistically significant difference compared to the control group (p<0.05).
ORGAN WEIGHTS
- The mean adrenal gland weights of males were 39.9 and 37.9 mg for the control and 2000 ppm exposed animals respectively.
- The relative adrenal gland weights of males were 1.11 and 1.37 for the control and 2000 ppm exposed animals respectively, which is a statistically significant difference (p<0.01).
- The mean heart weights of males were 0.828 and 0.772 g for the control and 2000 ppm exposed animals respectively.
- The relative heart weights of males were 2.3 and 2.79 for the control and 2000 ppm exposed animals respectively.
- The mean adrenal gland weights of females were 51.3 and 37.1 mg for the control and 2000 ppm exposed animals respectively, which is a statistically significant difference (p<0.01).
- The relative adrenal gland weights of females were 2.55 and 2.27 for the control and 2000 ppm exposed animals respectively.
- The mean heart weights of females were 0.66 and 0.451 g for the control and 2000 ppm exposed animals respectively, which is a statistically significant difference (p<0.01).
- The relative heart weights of females were 3.27 and 2.69 for the control and 2000 ppm exposed animals respectively.
GROSS PATHOLOGY and HISTOPATHOLOGY
No compound related histopathological effects were observed.
OTHER FINDINGS: Packed cell volume
- The mean packed cell volume of male rats that received 2,000 ppm was 6% greater than that of the controls
- The mean packed cell volume in males was 47.1 and 49.7 % for the control and 2000 ppm exposed animals respectively, which is a statistically significant difference (p=0.004)
- The mean packed cell volume in females was 46.2 and 46.6 % for the control and 2000 ppm exposed animals respectively.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 500 other: ppm (nominal in diet)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Lower body weights of 10% and 17% for males and 20% and 23% for females compared to the control, at 1000 and 2000 ppm, and the clinical signs observed at 2000 ppm.
- Dose descriptor:
- NOAEL
- Effect level:
- 22 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Clinical signs and lower final body weights in comparison with controls.
- Dose descriptor:
- NOAEL
- Effect level:
- 35 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Clinical signs and lower final body weights in comparison with controls
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a 90-day oral repeated dose toxicity study in Fischer 344/N rat exposed via diet, the NOAELs were determined to be 500 ppm (nominal in diet); 22 mg/kg bw/day (actual ingested for males) and 35 mg/kg bw/day (actual ingested for females).
- Executive summary:
Ten Fischer 344/N rats were given diets containing 0, 125, 250, 500, 1000, or 2000 ppm of the test substance. Animals were observed twice per day and weighed once per week. After an exposure period of 13 weeks, animals were necropsied, blood was taken for the determination of packed cell volume and pupil diameters were measured. None of the rats died before the end of the studies. Final mean body weights of rats that received 1000 or 2000 ppm were 20% and 23% lower than those of the controls for males and 10% and 17% lower for females. Feed consumption by dosed and control groups was generally comparable. Rats that received 2000 ppm were hyperexcitable and had rough coats. No compound-related histopathologic effects were observed. The mean pupil diameters for dosed and control animals were comparable. The mean packed cell volume of male rats that received 2000 ppm was 6% greater than that of the controls. The relative adrenal gland weight of male rats that received 2000 ppm was significantly greater than that of the controls, and the adrenal gland weight and heart weight of female rats that received 2000 ppm were significantly lower than those of the controls. Based on the a lower body weights compared to controls and clinical signs observed the NOAELs were determined to be 500 ppm (nominal in diet), 22 mg/kg bw/day (actual ingested for males) and 35 mg/kg bw/day (actual ingested for females).
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