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EC number: 232-104-9 | CAS number: 7786-81-4
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not reported
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: oral exposure cannot be ruled out
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of nickel sulfate on male rats.
- Author:
- Mathur, A.K., K.K. Datta, S.K. Tandon, and T.S.S. Dikshith.
- Year:
- 1 977
- Bibliographic source:
- Bulletin of Environmental Contamination and Toxicology. 17(2):241-248.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A particular Test Guideline was not specified in this study.
- GLP compliance:
- not specified
- 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
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: obtained from Industrial Toxicology Research Centre (Lucknow, India)
- Age at study initiation: not reported
- Weight at study initiation: 160 +/- 10 g
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-27 deg C
- Humidity (%): 60-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: saline
- Details on exposure:
- TEST SITE
- Area of exposure: A 4x4-cm patch of fur was shaved on the lateroabdominal area of each animal.
- % coverage: not reported
- Type of wrap if used: patch
- Time intervals for shavings or clipplings: shaved on the lateroabdominal area of each animal.
REMOVAL OF TEST SUBSTANCE: not reported
TEST MATERIAL
Appropriate amounts of the test substance were dissolved in normal saline to prepare nominal test concentrations of 40, 60, and 100 mg Ni/kg.
Animals in Group 1 were treated dermally with 40 mg Ni/kg; Group 2 with 60 mg Ni/kg; Group 3 with 100 mg Ni/kg; and Group 4 (control group)
with 0.25 ml untreated saline. The test and control concentrations were administered at a volume of 0.25 ml. Dermal applications continued daily
for the entire 30-day exposure period.
VEHICLE: normal salive
USE OF RESTRAINERS FOR PREVENTING INGESTION: not reported - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not reported
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
40, 60, and 100 mg Ni/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 8
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no other details reported
- Positive control:
- none reported
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: not reported
BODY WEIGHT: Yes
- Time schedule for examinations: not reported
-Other examinations not reported - Sacrifice and pathology:
- GROSS PATHOLOGY/HISTOPATHOLOGY: After 15 days of treatment, 4 animals from each group were sacrificed, with the remaining 4 animals sacrificed at the end of the 30-day exposure period. Gross and histopathological examinations of the skin, liver, kidney, and testis of each animal were conducted.
- Other examinations:
- none reported
- Statistics:
- none reported
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
No mortality or symptoms of poisoning were noted during the exposure period.
GROSS PATHOLOGY:
There were no gross changes to the liver, skin, kidneys, or testis of the exposed rats, after either 15- or 30-days of exposure.
The results of microscopic examination of the skin, liver, kidneys, and testis of exposed rats are summarized by treatment group:
DERMAL EXAMINATIONS:
Group 1 (40 mg Ni/kg): Day 15 - all tissues normal. Day 30 - slight hyperkeratinization and distortion of the epidermis was noted. No
abnormal changes to the liver or testis.
Group 2 (60 mg Ni/kg): Day 15 - testis and skin normal; liver hepatocytes swollen with some degeneration. Day 30 - tubular damage, degenerated
sperm, and edematous fluid in testis; slight distortion and hyperkeratinization of the skin; focal necrosis, dilatation of the sinusoids, and
vacuolation of the liver.
Group 3 (100 mg Ni/kg): Day 15 - testis normal; distortion of the dermis and epidermis of the skin; liver hepatocytes swollen with some
degeneration. Day 30 - increased tubular degeneration and edema of the testis, necrotic tubules with a few giant cells in one rat, and
distortion of the seminiferous tubules; atrophy or acanthosis of the epidermis, epidermal cells disordered, increasing hyperkeratinization;
focal necrosis, dilatation of the sinusoids, and vacuolation of the liver.
Group 4 (control; 0.25 ml saline): Days 15 and 30 - all tissues normal. Based on the results presented, there is evidence that the test substance
was absorbed through intact skin. Testicular changes were observed at an application of >= 60 mg Ni/kg, after exposure for 30 days. Minor
changes to the liver and skin were observed at 60 and 100 mg Ni/kg, respectively, following 15 days of continuous exposure. Microscopic
changes to the testis, liver, and skin became more severe following 30 days of continuous exposure.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 40 other: mg Ni/kg
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were no clinical symptoms of poisoning or mortality among experimental animals due to the dermal application of nickel sulphate. No gross changes were noticed in the skin, liver, kidney or testis of rats painted with nickel sulphate. There was no liver enlargement and the weight of liver showed no significant difference from those of controls. The testis did not show any marked atrophy or hypertrophy. The colour and weight of testes did not differ significantly from those of controls.
The results of microscopic examination on skin, liver and testis of control animals and those of 40, 60 and 100 mg Ni/kg groups after 15 and 30 days of exposure to nickel demonstrated that a NOAEL of 40 mg Ni/kg existed for effects on skin testis, and liver of nickel sulfate painted rats. No abnormality was observed in kidney of nickel sulphate treated rats.
Only males were included in the study. Exposure via the oral route of exposure could not be ruled out, preventing a conclusive assessment of the NOAEL for dermal exposure, based on these results. In addition, only selected endpoints were measured. Effects on body weights are unknown. Due to the limitations of the study a clear NOAEL for dermal exposure cannot be derived from this study.
Applicant's summary and conclusion
- Conclusions:
- In the study, 40 mg Ni/kg bw/day was a NOAEL for liver and testis degenerative changes, and a LOAEL for local effects on the skin. This study has limitations in experimental design and reporting. E.g., the group size in the study is small, only male animals were included, and only a limited number of organs were examined. Information on food intake and body weight were not given in the publication.
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust Summary for Mathur et al.(1977):
Appropriate amounts of the test substance were dissolved in normal saline to prepare nominal test concentrations of 40, 60, and 100 mg Ni/kg. Male
albino rats (160 +/- 10 g), obtained from Industrial Toxicology Research Centre (Lucknow, India), were divided into 4 groups of 8. A 4x4-cm patch
of fur was shaved on the lateroabdominal area of each animal. Animals in Group 1 were treated dermally with 40 mg Ni/kg; Group 2 with 60 mg Ni/kg;
Group 3 with 100 mg Ni/kg; and Group 4 (control group) with 0.25 ml untreated saline. The test and control concentrations were administered
at a volume of 0.25 ml. Dermal applications continued daily for the entire 30-day exposure period. The test was conducted under constant
conditions of temperature (25 +/- 2 deg. C) and relative humidity (60-70%). Animals were observed for mortality.
After 15 days of treatment, 4 animals from each group were sacrificed, with the remaining 4 animals sacrificed at the end of the 30-day exposureperiod. Gross and histopathological examinations of the skin, liver, kidney, and testis of each animal were conducted.
No mortality or symptoms of poisoning were noted during the exposure period.
There were no gross changes to the liver, skin, kidneys, or testis of the exposed rats, after either 15- or 30-days of exposure.
The results of microscopic examination of the skin, liver, kidneys, and testis of exposed rats are summarized by treatment group:
Group 1 (40 mg Ni/kg): Day 15 - all tissues normal. Day 30 - slight hyperkeratinization and distortion of the epidermis was noted. No abnormal changes to the liveror testis.
Group 2 (60 mg Ni/kg): Day 15 - testis and skin normal; liver hepatocytes swollen with some degeneration. Day 30 - tubular damage, degeneratedsperm, and edematous fluid in testis; slight distortion and hyperkeratinization of the skin; focal necrosis, dilatation of the sinusoids, and vacuolation of the liver.
Group 3 (100 mg Ni/kg): Day 15 - testis normal; distortion of the dermis and epidermis of the skin; liver hepatocytes swollen with somedegeneration. Day 30 - increased tubular degeneration and edema of the testis, necrotic tubules with a few giant cells in one rat, and
distortion of the seminiferous tubules; atrophy or acanthosis of the epidermis, epidermal cells disordered, increasing hyperkeratinization;
focal necrosis, dilatation of the sinusoids, and vacuolation of the liver.
Group 4 (control; 0.25 ml saline): Days 15 and 30 - all tissues normal.
Based on the results presented, there is evidence that the test substance was absorbed through intact skin. Testicular changes were observed at anapplication of >= 60 mg Ni/kg, after exposure for 30 days. Minor changes to the liver and skin were observed at 60 and 100 mg Ni/kg, respectively,
following 15 days of continuous exposure. Microscopic changes to the testis, liver, and skin became more severe following 30 days of continuous exposure.
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