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Diss Factsheets
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EC number: 242-522-3 | CAS number: 18718-11-1
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Distribution of various nickel compounds in rat organs after oral administration.
- Author:
- Ishimatsu S, Kawamoto T, Matsuno K, Kodama Y.
- Year:
- 1 995
- Bibliographic source:
- Biol. Trace Elements Res. 49 (1): 43 – 52.
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A particular Test Guideline was not specified in the study.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- NiSO4
- IUPAC Name:
- nickel(2+) sulfate
- Reference substance name:
- 22.3% Ni
- IUPAC Name:
- 22.3% Ni
- Reference substance name:
- Wako Pure Chem. Ind., Japan
- IUPAC Name:
- Wako Pure Chem. Ind., Japan
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulphate hexahydrate
- Molecular formula (if other than submission substance): Not different than submission substance
- Molecular weight (if other than submission substance): Not different than submission substance
- Smiles notation (if other than submission substance): Not different than submission substance
- InChl (if other than submission substance): Not different than submission substance
- Structural formula attached as image file (if other than submission substance): Not different than submission substance
- Analytical purity: 22.3% Nickel
- All other details on the test material was not reported or is not applicable.
- Other: A solubility test was performed. Three hundred milligrams of each compound was put into 50 mL of distilled water and saline.
The suspension was shaken for 1 wk at 37°C and filtered through a filter paper (Toyo filter paper, No. 5C, Ams., Japan) and
a membrane filter (pore size 0.22 um). The Ni concentration of the filtrate was determined by an atomic absorption spectrophotometry (Hitachi
Polarized Zeeman Effect Atomic Absorption Spectrophotometer, Model Z-8000, Ams., Japan).
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kyudo Co., Ltd. (Ams., Japan).
- Age at study initiation: 10 wk of age
- Weight at study initiation: 200 g
- Fasting period before study: Not reported
- Housing: Glass metabolic cages
- Individual metabolism cages: Yes
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: 2 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 5% starch saline solution
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Each Ni compound containing 10 mg of Ni was dissolved in a 5% starch saline solution and the solution was administered by gavage to the experimental animals. The control group was also given a 5% starch saline solution.
DIET PREPARATION
- Rate of preparation of diet (frequency): Not reported
- Mixing appropriate amounts with (Type of food): Not reported
- Storage temperature of food: Not reported
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not reported
- Concentration in vehicle: 10 mg of Ni was dissolved in a 5% starch saline solution
- Amount of vehicle (if gavage): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported
HOMOGENEITY AND STABILITY OF TEST MATERIAL: Not reported - Duration and frequency of treatment / exposure:
- One dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 mg of Ni
- No. of animals per sex per dose / concentration:
- 8 males/group
- Control animals:
- yes
- Positive control reference chemical:
- None
- Details on study design:
- - Dose selection rationale: Not reported
- Rationale for animal assignment (if not random): Not reported - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, Distribution)
- Tissues and body fluids sampled: The lungs, liver, kidneys, spleen, pancreas, heart, brain, and blood were taken as samples for the
determination of Ni. The Ni concentration in the sample solution was determined by a flameless atomic absorption spectrophotometry.
- Time and frequency of sampling: 24 h after the administration.
METABOLITE CHARACTERISATION STUDIES: Not applicable
TREATMENT FOR CLEAVAGE OF CONJUGATES (if applicable): Not applicable - Statistics:
- Student's T-test
Results and discussion
- Preliminary studies:
- Solubilities:
Ni-metal - 3.57 ug/ml in saline, 1.13 ug/ml in distilled water
NiSO4 - 32.4 g/100 g (reference value)
NiCl2 - 42.3 g/100 g (reference value)
Ni(NO3)2 - 54.3 g/100 g (reference value)
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The absorbed fraction in the rats given scarcely soluble compounds, was estimated to be 0.09% for the Ni-Metal group and 10-34% for the NiSO4,
NiCl2, and Ni(NO3)2 groups. NiCl2 absorption was 9.8%.
Following administration of a single dose of 10 mg nickel (nickel sulphate in 5% starch saline solution) by gavage to male Wistar rats, the absorbed fraction was 11% 24 hours after oral administration. - Details on distribution in tissues:
- Ni Organ Concentrations: Significantly higher concentrations were found in the lungs, kidneys, and pancreas for the Ni-metal group.
Ni concentrations in all organs in the rats given NiSO4, NiCl2, and Ni(NO3)2 were significantly higher than those in the control rats.
Ni Distribution: About 84-87% of the Ni amount was found in the kidneys for the NiCl2 and NiSO4. The ratio in the kidneys for the Ni(NO3)2 and Ni-M groups was 73, and 51%, respectively.
On the other hand, the Ni amount in the liver was higher than that in the kidneys for the NiO(G) group, showing similar results as the control group. The ratio of Ni in the kidneys depended on the solubility of the administered Ni compound.
Transfer into organs
- Test no.:
- #1
- Transfer type:
- other: kidney and lung
- Observation:
- distinct transfer
- Remarks:
- significantly different than control
- Details on excretion:
- In the preliminary experiment soluble Ni compounds were excreted within 72 hours after the oral administration.
24 hours after oral administration NiCl2 was measured in the urine at 914 ug.
Toxicokinetic parameters
- Toxicokinetic parameters:
- other: none reported
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- not applicable
Applicant's summary and conclusion
- Conclusions:
- Following administration of a single dose of 10 mg nickel (nickel sulphate in 5% starch saline solution) by gavage to male Wistar rats, the absorbed fraction was 11% 24 hours after oral administration.
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
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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