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Diss Factsheets
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EC number: 242-533-3 | CAS number: 18721-51-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given
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
- Objective of study:
- other: distribution and excretion
- Principles of method if other than guideline:
- Two year feeding-study in dogs. Within this study, tissue storage of nickel as well as nickel excretion in the urine and feces were examined.
- GLP compliance:
- no
Test material
- Reference substance name:
- nickel sulphate hexahydrate
- IUPAC Name:
- nickel sulphate hexahydrate
- Details on test material:
- - Name of test material (as cited in study report): nickel sulfate hexahydrate
- Molecular formula (if other than submission substance): NiSO4x6H2O
- Analytical purity: no data
- Composition of test material, percentage of components: 22.3% nickel
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: about 6 months
- Housing: individually
- Individual metabolism cages: no
- Diet (e.g. ad libitum): finely ground dog kibbled meal (Radiston Purina, St. Louis, Missouri)
- Water (e.g. ad libitum): water was mixed in the diet
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): daily
- Mixing appropriate amounts with (Type of food): Nickel sulfate was added to the basic diet in amounts calculated to yield the required dose. Weighed amounts of feed, 400 g/d through the first 22 weeks and 450 g/d thereafter, moistened and thoroughly mixed with an equal weight of water, were offered to the dogs.
- Duration and frequency of treatment / exposure:
- daily for 2 years
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 1000 and 2500 ppm
In week two, the high concentration was adjusted to 1500 ppm because auf severe gastrointestinal effects (emesis, salivation, gastrointestinal irritation). At two-week intervals this dietary nickel level was again raised to 1700, 2100 and 2500 ppm, without any effects.
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- yes, plain diet
- Details on study design:
- Feed consumed was recorded daily and body weights were recorded weekly.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces
- Time and frequency of sampling: At approx. 12 months, one week collections of excreta were made on one dog of each sex and dose level for analyses of nickel content. During the 23rd and 24th months, one week collections were made on two dogs of each sex and diet level, and three successive weekly collections were made from two other dogs of each sex and diet level. The sixth dog of each sex on each of the nickel-containing diets for 24 months returned to the control diet. Two successive one-week collections of excreta were made following passage of charcoal-marked feces.
At autopsy, specimens of bone, liver, kidney, lung, skeletal muscle and fat were taken from each dog for nickel analysis. Feces were oven-dried and ground and tissue nickel was determined on wet basis (spectrophotometric method of Alexander et al. 1946).
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Tissue analyses on bone, liver, kidney, lung, skeletal muscle and fat indicated limited retention of Ni. Highest values found were for kidney (4-7 ppm in dogs recieving 2500 ppm), and in one dog 1.6 ppm was found after withdrawal of nickel-containing diet for two weeks.
- Details on excretion:
- Approx. 1 to 3% of the ingested nickel was excreted in the urine.
Data on excretion in feces showed variable amounts of Ni, inconsistent with the amounts in diet and ingested.
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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