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Diss Factsheets
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EC number: 236-068-5 | CAS number: 13138-45-9
- 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)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions. The report lacked information on environmental conditions and dose volume administered.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Similar to OECD 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
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:
- 98.8%
- IUPAC Name:
- 98.8%
- Reference substance name:
- NiPERA.
- IUPAC Name:
- NiPERA.
- Details on test material:
- - Name of test material (as cited in study report): Nickel Sulfate Hexahydrate (10101-97-0)
- 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
- Analytical purity: 98.8%
- Impurities (identity and concentrations): Cu <0.001%, Fe 0.001%, Zn 0.003%
- Other details not reported or not applicable
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA, USA.
- Age at study initiation: young adult
- Weight at study initiation: Fasted body weights ranged from 249.8-285.8 g for males and 216.8-222.4 g for females.
- Fasting period before study: yes, the night prior
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days prior to testing.
ENVIRONMENTAL CONDITIONS: controlled, no details
IN-LIFE DATES: not reported
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- Two studies were conducted, an initial dose range-finding study and a subsequent main study.
The dose levels chosen for the main study, based on the results of the range-finding study, were 100, 178, 316, 562, and 1000 mg/kg.
VEHICLE: water
- Concentration in vehicle: not reported
- Amount of vehicle (if gavage): 20 ml
MAXIMUM DOSE VOLUME APPLIED: 10 g test article in 20 ml diluent
- Doses:
- 100, 178, 316, 562, and 1000 mg/kg
- No. of animals per sex per dose:
- 10 (5 males and 5 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were observed frequently for signs of toxicity or mortality and body weights were measured on days 0 (i.e., test initiation), 8, and 15, or at death.
- Necropsy of survivors performed: yes, surviving animals were sacrificed on day 15, and all animals were necropsied and examined for abnormalities.
- Other examinations performed: clinical signs and body weight - Statistics:
- Acute oral toxicity values (w/ 95% confidence limits) were calculated from the mortality data using the method of Miller and Tainter (1944).
Dose-mortality curves were plotted (normal log graph).
Results and discussion
- Preliminary study:
- A range finding study was performed, dose/mortality after 8 days:
100 mg/kg = 0/4
266 mg/kg = 1/4
707 mg/kg = 4/4
1880 mg/kg = 4/4
5000 mg/kg = 4/4
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 300 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 325 mg/kg bw
- 95% CL:
- 121 - 529
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 275 mg/kg bw
- 95% CL:
- 140 - 410
- Mortality:
- Cumulative mortality observed (number of mortalities observed/total number of animals tested), by nominal dose administered:
100 mg/kg: 0/5 males; 0/5 females
178 mg/kg: 0/5 males; 1/5 females (death occurred on day 1)
316 mg/kg: 2/5 males; 3/5 females (deaths occurred on day 1)
562 mg/kg: 5/5 males; 5/5 females (deaths occurred by day 5)
1000 mg/kg: 5/5 males; 5/5 females (deaths occurred by day 2) - Clinical signs:
- other: Symptoms observed in more than one animal/dose group were decreased activity (all dose groups) and ataxia (316, 562, and 1000 mg/kg groups).
- Gross pathology:
- Necropsy findings were negative, except for the 562 and 1000 mg/kg dose groups where bloodlike viscous liquid was found in the
intestines of 1-2 animals/dose group. - Other findings:
- none reported
Any other information on results incl. tables
A NOAEL of 22 mg Ni/kg/day (100 mg NiSO4.6H2O/kg/day) was observed.
Applicant's summary and conclusion
- Conclusions:
- Oral LD50 was 72 mg Ni/kg (325 mg NiSO4.6H2O /kg) (males) and 61 mg Ni/kg (275mg NiSO4.6H2O/kg) (females). A NOAEL of 22 mg Ni/kg/day (100 mg NiSO4.6H2O/kg/day) was observed.
- Executive summary:
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
The acute toxicity of the test substance was determined by oral administration to male and female Sprague Dawley rats. Test animals were
obtained from Charles River Breeding Laboratories, Inc., Wilmington, MA, USA. Animals were individually housed, provided food and water ad
libitum, and acclimatized for at least 5 days prior to testing. The test substance was dissolved in water.
Two studies were conducted, an initial dose range-finding study and a subsequent main study. Animals were fasted overnight prior to initiationof the main study. The dose levels chosen for the main study, based on the results of the range-finding study, were 100, 178, 316, 562, and 1000 mg/kg.
Groups of 10 animals (5 males and 5 females) received a single oral dose of one of the test substance concentrations.
Animals were observed frequently for signs of toxicity or mortality and body weights were measured on days 0 (i.e., test initiation), 8, and 15,or at death. Fasted body weights ranged from 249.8-285.8 g for males and 216.8-222.4 g for females. Surviving animals were sacrificed on day 15,
and all animals were necropsied and examined for abnormalities. Acute oral toxicity values (w/ 95% confidence limits) were calculated from the
mortality data using the method of Miller and Tainter (1944). Dose-mortality curves were plotted (normal log graph).
Cumulative mortality observed (number of mortalities observed/total number of animals tested), by nominal dose administered:
100 mg/kg: 0/5 males; 0/5 females
178 mg/kg: 0/5 males; 1/5 females (death occurred on day 1)
316 mg/kg: 2/5 males; 3/5 females (deaths occurred on day 1)
562 mg/kg: 5/5 males; 5/5 females (deaths occurred by day 5)
1000 mg/kg: 5/5 males; 5/5 females (deaths occurred by day 2)
Symptoms observed in more than one animal/dose group were decreased activity (all dose groups) and ataxia (316, 562, and 1000 mg/kg groups).Mean body weights of surviving rats increased during the 15-day study period. Necropsy findings were negative, except for the 562 and 1000
mg/kg dose groups where bloodlike viscous liquid was found in the intestines of 1-2 animals/dose group.
Acute oral toxicity (LD50) values (95% confidence limits), by sex tested:
LD50 (males): 325 (121-529) mg/kg bw
LD50 (females): 275 (140-410) mg/kg bw
LD50 (both sexes): 200 (101-299) mg/kg bwSTUDY 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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