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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
Carcinogenicity
Administrative data
Description of key information
Under the conditions of the test, there was no evidence of carcinogenicity for F334/N rats or B6C3F1 mice of either sex receiving 125 or 250 ppm ephedrine sulfate in diet for 2 years.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Since there is no evidence for a carcinogenic potential, ephedrine sulphate does not have to be classified as being carcinogenic in accordance with Directive 67/548/EEC (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
Additional information
In a chronic carcinogenicity study (NTP 1986), ephidrine sulfate was administered by diet to F344/N rats and B6C3F1 mice at concentrations of 0, 125 or 250 ppm for 103 weeks (50 animals/sex/group). Doses are based on 13-week studies (the major response that occurred during the 13-week studies was compound-associated reduction in weight gain). In the 2 year study performed prior to GLP, the estimated average amount of ephedrine sulfate consumed per day was 4 mg/kg bw/day and 9 mg/kg bw/day for low dose and high dose male rats, 5 mg/kg bw/day and 11 mg/kg bw/day for female rats, 14 mg/kg bw/day and 29 mg/kg bw/day for male mice, and 12 mg/kg bw/day and 25 mg/kg bw/day for female mice. Survival of exposed female rats during the 2-year study was greater than that of the controls (control, 27/50; low dose, 39/50; high dose, 39/50) ; survival of exposed male rats, male mice, and female mice was comparable to that of controls. Throughout most of the study period, mean body weights of rats of each sex receiving diets containing the test substance were lower than those of controls (about 10%). The average daily feed consumption was 94% and 92% that of the controls for low dose and high dose males and 92% and 89% for females. Throughout most of the study period (after week 10 of the study time), mean body weights of mice of each sex receiving diets containing the test substance were lower than those of controls (at high doses up to ca. 20%). The average daily feed consumption by both dosed male mouse groups was 100% that of the controls and by low dose and high dose female mice, 97% and 94% that of the controls. At necropsy, the following tissues were examined: gross lesions, skin, mandibular lymph node, mammary gland, salivary gland, thigh muscle, sciatic nerve, sternebrae, vertebrae or femur including marrow, costochondral junction (rib), oral cavity, thymus, larynx and pharynx, trachea, lungs and bronchi, heart and aorta, thyroid gland, parathyroids, esophagus, stomach, duodenum, jejunum, tongue, gallbladder (mice only) regional lymph nodes, ileum, colon, cecum, rectum, mesenteric lymph node, liver, pancreas, spleen, kidneys, adrenal glands, seminal vesicles, prostate, testes, epididymis or ovaries, uterus, nasal cavity and nasal turbinates, brain, pituitary gland, spinal cord, eyes, and preputial or clitoral gland. Neoplasms that occurred in this study with rats were not considered to be related to administration of ephedrine sulfate. With regard to neoplasms in male mice, generally the incidences in the low and high dose groups were comparable with the incidences of the control group. Neoplasms that occurred in female mice were not considered to be related to administration of ephedrine sulfate. Thus, at the doses tested, there was no evidence of increased incidence of carcinogenesis. Under the conditions of this study, the NOAEL was >9 mg/kg bw/day (male rats), >11 mg/kg bw/day (female rats), >29 mg/kg bw/day (male mice) and >25 mg/kg bw/day (female mice) for carcinogenicity.
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