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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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
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:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- According to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
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
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulfate 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
- Physical state: blue-grean appearance
- Impurities: Co 8 ppm, Na 3 ppm, Fe 2 ppm, Mg 0.7 ppm, Ag 0.2 ppm
- Purity: 99.99+%
- Lot No.: 02221PQ
- Source: Sigma Aldrich
- Other details not reported or not applicable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC, USA.
- Age at study initiation: 8 weeks
- Weight at study initiation: 239-267 g
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study: not reported
- Housing: 2 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64 - 79 deg F
- Humidity (%): humidity 30-70%
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle.
IN-LIFE DATES: From: April 21, 2003 To: Aug. 2003
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Cell culture control water
- Lot No: 017156 and 01100526 - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: each day the test article was prepared by adding to the vehicle. Formulations held at room temperature.
Animals were dosed by oral gavage once daily for three consecutive days to six males per dose level. The dose levels were 125, 250, or 500 mg/kg/day.
DIET PREPARATION
- not applicable - Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- Once daily
- Post exposure period:
- 24 hours after 3rd dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
125, 250, 500 mg/kg-d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide was used as the positive control administered by oral gavage dissolved in deionized water at a dose of 60 mg/kg
Examinations
- Tissues and cell types examined:
- Animals were euthanized approximately 24 hours after the third dose for extraction of bone marrow.
Blood was also collected prior to euthanization.
Nickel in bone marrow and blood was analyzed by AAS. - Details of tissue and slide preparation:
- Following centrifugation to pellet the marrow, the supernatant was spread on slided fixed with methanol and stained in acridine orange, dried, and analyzed under fluorescent microscopy.
- Evaluation criteria:
- Slides were scored for micronuclei and to determine the PCE to NCE cell ratio. The percent micronucleated cells was determine by analyzing micronuclei from at least 2000 PCEs per animal. The criteria were those of Schmid 1976.
- Statistics:
- Data analysis was conducted using ANOVA
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 125-1750 mg/kg-day
- No cytotoxicity observed at 750 or 1000 mg/kg-day. Mean PCE:NCE ratios were 0.32 and 0.64 compared to 0.81 (control)
- Other: the maximum tolerated dose was estimated at 500 mg/kg-day
RESULTS OF DEFINITIVE STUDY
Clinical signs of toxicity were noted in all treatment animals including hypoactivity, salivation, black feces, irregular respiration, squinted/closed eyes.
No mortality occurred.
Nickel did not significantly increase micronucleated PCEs at any dose level. Nickel was not significantly cytotoxic to bone marrow at any dose level.
Dose-dependent nickel concentrations were detected in plasma and bone marrow samples.
The author's suggest the results support the non-genotoxic mode of action for soluble nickel.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test article, nickel sulfate hexahydrate, was evaluated as negative in the rat bone marrow micronucleaus assay under the conditions of this assay. - 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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