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EC number: 206-761-7 | CAS number: 373-02-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 7 - September 10, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- publication
- Title:
- Acute Oral Toxicity of Nickel Compounds
- Author:
- Henderson RG, Durando J, Oller A, Merkel DJ, Marone PA, and Bates HK.
- Year:
- 2 012
- Bibliographic source:
- Regul Toxicol and Pharmacol (doi.org/10.1016/j.yrtph.2012.02.002)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Nickel di(acetate)
- EC Number:
- 206-761-7
- EC Name:
- Nickel di(acetate)
- Cas Number:
- 373-02-4
- Molecular formula:
- Ni(CH3CO2)2
- IUPAC Name:
- nickel di(acetate)
- Details on test material:
- - Name of test material (as cited in study report): Nickel acetate tetrahydrate
- 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
- Substance type: Pure product
- Physical state: liquid (60% w/v in distilled water)
- Physical description: Green, solid (crystals)
- Analytical purity: 100%
- Stability: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: stored under nitrogen
- Other details on test material not reported or not applicable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Ace Animals, Inc., Boyertown, PA on July 22 and August 5, 2008.
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 184-220 grams
- Fasting period before study: not reported
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum (Purina Rodent Chow #5012)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10-28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 63-86%,
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE: 60% w/w mixture in distilled water
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg - Doses:
- 175, 550, 2000 mg/kg
- No. of animals per sex per dose:
- 2-4 per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: Following administration, each animal was returned to its designated cage. Feed was replaced approximately 3-4 hours after dosing. Observed up to 14 days.
- Frequency of observations and weighing: days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight measured - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- 95% CL:
- 191.7 - 1 680
- Mortality:
- 175 mg/kg: 0/2
550 mg/kg: 2/4
2000 mg/kg: 2/2 - Clinical signs:
- other: 175 mg/kg: There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior. 550 mg/kg: Prior to death, these animals were hypoactive. One surviving female exhibited piloerection following test substance administration, but recov
- Gross pathology:
- 175 mg/kg: no gross abnormalities were noted
550 mg/kg: Gross necropsy of the decedents revealed red intestines. No gross abnormalities were noted for the euthanized animals when necropsied at the conclusion of the 14-day observation period.
2000 mg/kg: Gross necropsy of the decedents revealed red intestines. - Other findings:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- The acute oral LD50 of Nickel acetate tetrahydrate in female rats was estimated to be 550 mg/kg-bw (95% CI 191.7-1,680). A NOAEL of 175 mg/kg bw (or 42 mg Ni/kg bw/day) was observed.
- Executive summary:
Eurofins Product Safety Laboratory (EPSL, 2008) reported the findings of the acute oral toxicity of nickel acetate tetrahydrate as determined by the acute toxicity up and down procedures in rats (carried out according to OECD Test # 425 guidelines and using GLP standards). The purpose of the study was to determine the potential for nickel acetate tetrahydrate to produce toxicity from a single oral gavage dose, and to estimate a LD50 for the test compound. The authors stated that females were chosen for the study, as they are typically more sensitive to the toxicity of test chemicals than males.
Eight healthy, female rats were used for the study. A default starting dose level of 175 mg/kg nickel acetate tetrahydrate (60% w/w mixture in distilled water) was administered to one animal by gavage. The decision to proceed with dosing the next animal was based on survival of the previous animal, following administration of the test compound. Using this procedure, seven additional rats were administered 175 (1 rat), 550 (4 rats) or 2,000 mg/kg (2 rats) of the test compound. For 14 days after dosing, or until death occurred, rats were observed at least once per day for signs of gross toxicity, behavioral changes and mortality. Body weights were documented at various times: prior to dosing, day 7and day 14 (termination), following dosing, or post-mortem. Necropsies were conducted on all animals. No effects were observed in the animal exposed to 175 mg/kg. Of the four rats exposed to 550 mg/kg, two animals died within 3 hours (prior to death these animals exhibited hypoactivity) and exhibited red intestines upon necropsy. Aside from piloerection in one of the two surviving animals, no other effects were noted. In the 2,000 mg/kg dose group, both animals died within 1 day, displayed hypoactivity, hunched posture, and red intestines upon necropsy. The authors estimated that the acute oral LD50 of nickel acetate tetrahydrate was 550 mg/kg, with an approximate 95% confidence interval of 191.7-1,680 mg/kg. STUDY RATED BY AN INDEPENDENT REVIEWER
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