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Diss Factsheets
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EC number: 909-803-9 | CAS number: -
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Study period:
- 1960-1962 (in-life phase)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study in accordance with generally accepted methods, but limited level of parameters examined and data reported
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A limited set of investigations (siblings gross observation, F3 weanlings histopathology) were conducted for evaluation of teratologic effects as part of this 3-generation study.
- GLP compliance:
- no
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Nickel sulfate hexahydrate fines containing 22.3% nickel by analysis (theoretically 22.32%) served as the test material in this study.
Test animals
- Species:
- rat
- Strain:
- other: Wistar-derived
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Albino Farms, Red Bank, New Jersey, USA
- Age at study initiation: (P) 4 wks
- Weight at study initiation: (P) 56-65 g
- Fasting period before study: No data
- Housing: individually caged
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet: ad libitum, Radlston Purina, St. Louis, Missouri, USA
- Water: ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
No details provided
IN-LIFE DATES: From: 1960 To: 1962
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Radlston Purina feed
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): Finely ground laboratory chow served as the basic diet. Stock aqueous solutions of nickel sulfate hexahydrate were prepared in appropriate concentrations so that the addition of 100 mL for each 6 kg of diet resulted in the desired nickel content, respectively. Additions of nickel solutions were thoroughly blended into the diet by mixing in a rotary-type blender.
- Storage temperature of food: No data - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 7 days
- Proof of pregnancy: No data
- Further matings after two unsuccessful attempts: No
- After successful mating each pregnant female was caged: individually
- Any other deviations from standard protocol: On the 20th mating day all males were removed. - Duration of treatment / exposure:
- 11 weeks prior to mating, during mating, gestation, and lactation
- Frequency of treatment:
- Daily
- Duration of test:
- Approximately 2 years (3 generations)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 500 and 1000 ppm
Basis:
nominal in diet
equivalent to 0, 22.5, 45 and 90 mg/kg bw nickel, respectively
- No. of animals per sex per dose:
- 30
- Control animals:
- yes, plain diet
- Details on study design:
- No further details provided
Examinations
- Maternal examinations:
- Weekly body weight records were obtained, except during mating through weaning of litters.
Records were maintained of mating and number of pregnancies.
Following weaning of F/1b litters, surviving F/0 rats were sacrificed and autopsied.
Records were maintained of litters cast (alive and dead), pups in litter at 1, 5, and 21 days (weaning), and total weight of the litter at weaning.
At weaning of F/2b rats, F/1b parents were sacrificed and autopsied. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: No
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: No
- Number of early resorptions: No
- Number of late resorptions: No - Fetal examinations:
- Gross observations at necropsy were performed for all 3 generations.
Histopathologic examinations were performed on 10 male and 10 female F/3b weanlings from each diet level. Absolute and relative organ-to-body weight ratios for heart, spleen, kidneys, liver, and testes were analysed statistically. Tissues preserved in formalin for histopathologic study were in addition to the above: lung, urinary bladder, stomach, small and large intestine, skeletal muscle, brain, skin, bone marrow, pituitary, thyroid, adrenal, pancreas, and gonad. - Statistics:
- No data
- Indices:
- The following indices were calculated for each generation:
- Fertility (F.l.) = (pregnancies/matings) x 100
- Gestation (G. I.) = (litters cast/pregnancies) x 100
- Viability (V.I.) = (live pups at day 5/live pups born) x 100
- Lactation (L.I.) = (weaned/live pups-discards on day 5) x 100 - Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes. Remark: decreased body weight at 1000 ppm (90 mg/kg nickel)
Details on maternal toxic effects:
Rats on 1000 ppm (90 mg/kg nickel) exhibited slightly lower body weights. The average decrease in body weight did not exceed 8% for females.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects. Remark: up to 1000 ppm (90 mg/kg nickel) throughout the 3 generations
Details on embryotoxic / teratogenic effects:
Gross observations on siblings cast, at all dietary levels of nickel through three generations showed no teratogenic effects. Histopathologic findings on F/3b weanlings, 10 of each sex on each dietary level, were entirely negative.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 ppm (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the absence of abnormalities in pups throughout 3 generations, the NOAEL for teratogenicity can be set at 1000 ppm (90 mg/kg nickel).
- Executive summary:
In a 3-generation study, Wistar-derived rats were fed with 0, 250, 500, or 1000 ppm of nickel sulfate hexahydrate (equivalent to 0, 22.5, 45, or 90 mg/kg of nickel, respectively).
In the parental generation, body weights for rats on 250 and 500 ppm diets (22.5 and 45 mg/kg nickel, resp.), before mating and at weaning of respective litters, were not adversely affected, but rats on 1000 ppm (90 mg/kg nickel) exhibited slightly lower body weights. The average decrease in body weight did not exceed 8% for females.
Gross observations on siblings cast, at all dietary levels of nickel through three generations showed no teratogenic effects. Histopathologic findings on F/3b weanlings, 10 of each sex on each dietary level, were entirely negative.
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