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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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:
- key study
- Study period:
- 90 days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- US National Toxicity Programme study
- Justification for type of information:
- Published data on key component of the substance
The substance dissociates in water under environmental conditions and an assessment of toxicity can be performed by considering the key dissociated ions present in water.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Meeting international guidelines as required 1993
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Manganese sulphate
- EC Number:
- 232-089-9
- EC Name:
- Manganese sulphate
- Cas Number:
- 7785-87-7
- Molecular formula:
- MnO4S
- IUPAC Name:
- Manganese sulphate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Technical grade, ca 97%
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- Feeding at 0, 1600, 3130, 6250, 12500 or 25000 ppm in diet
(equivalent range 110 to 1700 mg/kg males / 115 to 2000 mg/kg in females - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Metal content as Mn
- Duration of treatment / exposure:
- 90 days, daily feeding
- Frequency of treatment:
- Daily - feeding
- No. of animals per sex per dose:
- 10 male and 10 female
- Control animals:
- yes, plain diet
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- Clinical findings recorded weekly,
Feed consumption recorded weekly by cage.
Rats weighed at the beginning and weekly thereafter.
At the end of the exposure period, blood was collected for analysis - Sacrifice and pathology:
- Full necropsy on all animals.
Organs were weighed.
Complete histopathological examination performed on control and high-dose animals.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males in a mid-treatment group had lower body weight gain than control animals or those in other groups
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Nutrophil counts were significantly higher in all male groups.
Lymphocyte counts were significantly lower in the three highest dose groups.
In females: leukocyte counts were significantly lower in the three highest dose groups.
A significant increase in the haematocrit and erythrocyte counts occurred in males exposed to the three highest dose levels. - Clinical biochemistry findings:
- no effects observed
- Endocrine findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- Fron clinical and cage-observation
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Some mid-treatment groups had lower liver weights than control animals or those in other groups
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Minor incidental changes not considered significant and apparently not treatment related
- Neuropathological findings:
- not examined
- Description (incidence and severity):
- Minor incidental changes not considered significant and apparently not treatment related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No significant toxicity observed
No clear treatment -related findings
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 2 000 OB/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 700 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 570 OB/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Mn
- Sex:
- male
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No significant adverse effects observed. Minor blood chemistry effects considered adaptive changes to balance in physiological essential elements.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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