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Diss Factsheets
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EC number: 227-873-2 | CAS number: 6018-92-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Long term toxicologic assessment of nickel in rats and dogs.
- Author:
- Ambrose, A. M. et al.
- Year:
- 1 976
- Bibliographic source:
- Journal of Food Science and Technology 13, 181-187
- Reference Type:
- secondary source
- Title:
- Nickel Sulphate, CAS-No.: 7786-81-4, EINECS-No.: 232-104-9, RISK ASSESSMENT Final version March 2008, Chapters 0, 1, 2, 4, 5, 6 & 7 – human health only
- Author:
- Danish Environmental Protection Agency
- Year:
- 2 008
- Bibliographic source:
- European Union Risk Assessment Report
Materials and methods
- Principles of method if other than guideline:
- An oral three-generation study in rats was performed, however, examinations were limited. Various indices were calculated (for details see below).
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 10101-97-0
- EC Number:
- 600-152-3
- Cas Number:
- 10101-97-0
- IUPAC Name:
- 10101-97-0
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- IUPAC Name:
- nickel(2+) sulfate
- Reference substance name:
- nickel (II) sulfate hexahydrate
- IUPAC Name:
- nickel (II) sulfate hexahydrate
- Details on test material:
- - Name of test material (as cited in study report): nickel sulfate hexahydrate containing 22.3% nickel by analysis
- Molecular formula (if other than submission substance): NiSO4X6H2O
- Physical state: fines
- Analytical purity: no data
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: albino Wistar derived
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Albino Farms, Red Bank, New Jersey
- Age at study initiation: (P) 4 wks; (F1) 2 wks
- Housing: Rats were individually caged.
- Diet (e.g. ad libitum): Radiston Purina, St. Louis, Missouri
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): Stock aqueous solutions of nickel sulfate hexahydrate were prepared in appropriate concentrations so that the addition of 100 mL for each 6 kg of diet resulted in the desired nickel content. Addition of nickel solutions were thoroughly blended into the diet by mixing in a rotary-type blender. - Details on mating procedure:
- - M/F ratio per cage: 1:1
- After successful mating each pregnant female was caged (how): individually in a breeding cage
- Any other deviations from standard protocol: Male rats of each group were rotated to a different female on each of three successive 7-day periods. On the 20th mating day alle males were removed. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 11 weeks prior to mating
- Frequency of treatment:
- continuously for 11 weeks; for F1 litters the treament started after weaning
- Details on study schedule:
- The parent generation (F0) was mated for F1 litters (For procedure refer to "Details on mating procedure"). Following weaning of F1 litters, surviving F0 rats were sacrificed and autopsied. For the production of F2 and F3 litters, the same procedure was followed.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 250, 500 and 1000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 30 (20 were used for mating procedures)
- Control animals:
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- Weekly body weight records were obtained, except during mating through weaning of litters.
- Litter observations:
- Litters containing more than 10 offsprings were reduced to 10 on day 5.
- Postmortem examinations (offspring):
- Gross observations on all offspring.
Histopathologic studies were performed on 10 male and 10 female F3 weanlings from each diet level. Tissues included: heart, spleen, kidneys, liver, testes, lung, urinary bladder, stomach, small and large intestine, skeletal muscle, brain, skin, bone marrow, pituitary, thyroid, adrenal, pancreas and gonad - Reproductive indices:
- fertility index=(pregnancies/matings)x100
gestation index=(liiters cast/pregancies)x100 - Offspring viability indices:
- viability index=(live pups at day 5/live pups born)x100
lactation index=(weaned/live pups-dicard on day 5)x100
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- 1 000 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: probably corresponding to 52-80 mg Ni/kg bw/day for nickel sulphate
- Remarks on result:
- other: Generation: all (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: body weight
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Body weights of the F0 rats were slightly decreased at the high dose only, with an average decrease of 13% reported for males and 8% reported for females. The fertility index was slightly lower at 250 and 1000 ppm in the F1 generation, and at 1000 ppm in the F2 generation (around 60% compared to 70-79% in the controls), however, the differences were not statistically significant. The fertility index in exposed animals was similar to control values at the high dose in F1, F2 a and b as well as in F3 a and b.
Applicant's summary and conclusion
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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