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EC number: 240-085-3 | CAS number: 15956-58-8
- 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:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: To GLP, studies performed according to peer-reviewed methods.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NTP peer-reviewed methods
- Principles of method if other than guideline:
- Male and female rats were fed diets containing varying concentrations of MnSO4 for 103 weeks.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Manganese sulphate monohydrate
- IUPAC Name:
- Manganese sulphate monohydrate
- Details on test material:
- - Name of test material (as cited in study report): manganese (II) sulphate monohydrate
- Physical state: crystalline, solid
-Appearance: white, slightly efflorescent
- Analytical purity: 97.7 ± 0.4%
- Impurities (identity and concentrations): sodium (640 ppm), potassium (120 ppm) and silicon (160 ppm).
- Stability under test conditions: No bulk stability studies were performed.
- Storage condition of test material: Bulk chemical was stored in the dark at room temperature.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were approximately 41 days old at the start of the study.
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1500, 5000, 15000 ppm, equivalent to 0, 60, 200 or 615 mg/kg in male and 0, 70, 230 or 715 mg/kg in females
Basis:
nominal in diet
- No. of animals per sex per dose:
- 70 male and 70 female rats per group
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- All animals were observed twice daily. Clinical findings were recorded weekly for the first 13 weeks and monthly thereafter.
- Sacrifice and pathology:
- All animals were necropsied. At necropsy all organs were examined for gross lesions and all major tissues were fixed and preserved for histopathological examinations.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 72.8 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Mn
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 83.7 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Mn
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- food intake and concentration in diet
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 230 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- food consumption and concentration in feed
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
CLINICAL SIGNS AND MORTALITY: Survival of male rats exposed to 15000 ppm was significantly lower than that of the controls. This was attributed to increased incidences of advanced renal disease relating to the ingestion of MnSO4.
BODY WEIGHT AND WEIGHT GAIN: The final mean bodyweight of male rats exposed to 15000 ppm was 10% lower than that of the controls. The mean body weights of all the other exposed groups were similar to the controls.
HAEMATOLOGY AND CLINICAL CHEMISTRY: No differences in haematology and clinical parameters attributable to the ingestion of MnSO4 were observed.
TISSUE MANGANESE CONCENTRATIONS: At both the 9 and 15 month interim evaluations, tissue concentrations of manganese were significantly elevated in the livers of male and female rats exposed to 5000 and 15000 ppm, with an accompanying depression of hepatic iron.
GROSS PATHOLOGY: The ingestion of diets containing 15000 ppm MnSO4 was associated with a marginal increase in the average severity of nephropathy in male rats. In these rats, lesions associated with renal failure, uremia, and secondary hyperparathyroidism were observed.
No increased incidence of neoplasms in male or female rats was attributed to ingestion of MnSO4.
Applicant's summary and conclusion
- Conclusions:
- MnSO4 is relatively non-toxic at the doses examined, and the parameters assessed in the study, over a 2 year period of exposure, via the oral route.
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