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EC number: 234-829-6 | CAS number: 12035-72-2
- 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:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for publication.
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:
- Negative test for transplacental carcinogenicity of nickel subsulfide in Fischer rats
- Author:
- Sunderman FW, McCully KS, and Rinehimer LA
- Year:
- 1 981
- Bibliographic source:
- Res. Comm. Chem. Path. Pharm. 31: 545-554
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Developmental toxicity of nickel subsulfide (Ni3S2) was examined by i.m. administration of Ni3S2 (20 mg) to 8 pregnant Fischer rats on day 6 of gestation.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Trinickel disulphide
- EC Number:
- 234-829-6
- EC Name:
- Trinickel disulphide
- Cas Number:
- 12035-72-2
- Molecular formula:
- Ni3S2
- IUPAC Name:
- (trinickel-1-ylidene)-1λ⁴-disulfene
- Details on test material:
- - Name of test material (as cited in study report): nickel subsulfide (alpha-Ni3S2)
- Physical state: particulate
- Other: median particle diameter < 2 um; provided by INCO Ltd., Toronto, Canada
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA
- Age at study initiation: 120 - 150 days at time of breeding; offspring studied from birth
- Housing: dams housed singly in polypropylene cages
- Diet (e.g. ad libitum): Purina rat chow ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- other: penicillin
- Details on exposure:
- The test group of 8 pregnant dams was injected i.m. with 20 mg Ni3S2 in 0.2 ml of penicillin vehicle on day 6 of gestation. The i.m. injections were performed with a 20 gauge needle deep into the musculature of the right thigh.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:3
- Length of cohabitation: 4pm to 8am
- Further matings after two unsuccessful attempts: no data
- Verification of same strain and source of both sexes: no data
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Single i.m. injection of dam on gestational day 6
- Frequency of treatment:
- Once
- Duration of test:
- Approximately 26 months
- No. of animals per sex per dose:
- 8 dams
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dams delivered their litters on days 21 or 22 of gestation. The 8 litters of the control dams contained an average of 8.8 pups (SD ±1.5; range = 7 to 11). The 8 litters of Ni3S2-treated dams contained an average of 7.5 pups (SD ± 2.2; range = 2 to 10; 0.10 > P > 0.05 versus controls by Student's t test). The pups were weaned at 4 weeks, and no more than 8 offspring/litter were included in the carcinogenesis test. The rats that were observed for tumor development comprised 53 offspring of control dams (29 males, 24 females) and 50 offspring of Ni3S2-treated dams (17 males, 33 females). The rats were weighed and examined at biweekly intervals. The rats either died spontaneously or were killed when they had become so cachectic that they could not move around in their cages, and hence could not obtain food or water. The study was terminated at approximately 26 months. Complete autopsies were performed, including examination of the brain. Tissue specimens were fixed in 10% neutral buffered formalin, and paraffin embedded sections stained with hematoxylin and eosin for examination by light microscopy.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: No data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: No data
- Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No data
- Skeletal examinations: No data
- Head examinations: No data - Statistics:
- Body weights of rats in test and control groups were compared by Student's t test; mortality data in the test and control, groups were compared by the Mann-Whitney U test; tumor incidences in the test and control groups were compared by Fisher's exact test.
- Indices:
- Not applicable
- Historical control data:
- Not applicable
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:not examined
Details on maternal toxic effects:
Not applicable
Effect levels (maternal animals)
- Dose descriptor:
- dose level:
- Effect level:
- 20 other: mg Ni3S2/dam
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
There was no significant difference between the litter sizes of control vs. treated rats (0.1 > p > 0.05; Student's t-test). No congenital malformations were observed in pups of control dams or Ni3S2-treated dams. The body weights of progeny of treated dams were significantly lower than progeny of control dams. Sex-specific mortality rates did not differ between progeny of treated vs. control dams. There was no significant difference in tumor incidence between progeny of treated (4/33 female; 0/17 male) vs. control (4/24 females; 1/29 males) dams.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Age Number Body weights (grams, mean +/- SD)
Category (months) of rats Males Females
Progeny of 6 53 (29 M, 24 F) 288 +/- 32 172 +/- 11
Control Dams 12 48 (25 M, 23 F) 325 +/- 40 198 +/- 10
18 33 (14 M, 19 F) 330 +/- 44 212 +/- 10
Progeny of 6 50 (17 M, 33 F) 264 +/- 30* 167 +/- 15
Treated Dams 12 46 (16 M, 30 F) 302 +/- 44# 191 +/- 13#
18 36 (11 M, 25 F) 291 +/- 33* 197 +/- 19*
* = p < 0.05 vs. control progeny
# = p < 0.01 vs. control progeny
Applicant's summary and conclusion
- Conclusions:
- Intramuscular administration of 20 mg Ni3S2 to pregnant rats resulted in lower progeny body weights relative to progeny of control dams. This exposure had no significant effect upon litter size, the development of congenital malformations, or progeny mortality rates.
- Executive summary:
Sunderman et al. (1981) studied the potential for Ni3S2 to induce transplacental carcinogenicity by exposing 8 pregnant Fischer rats on day 6 of gestation to 20 mg Ni3S2 via i.m. injection into the right thigh; control dams received a similar injection of a penicillin vehicle. Gestation day 0 was determined when the presence of sperm was observed in vaginal smears following the cohousing of 3 female rats with 1 male rat. There were 50 offspring (17 males, 33 females) born to Ni3S2-treated dams and 53 offspring (29 males, 24 females) of control dams. The only notable effect observed was lower progeny body weights relative to progeny of control dams; no treatment-related effects on litter size, the development of congenital malformations, progeny mortality rates, or incidences of non-neoplastic lesions or tumors in the progeny were noted. The results of this particular gestational exposure design indicated that Ni3S2 was not embryotoxic or teratogenic, although the decrease in progeny body weight relative to control suggests some degree of developmental toxicity is associated with Ni3S2. See the Carcinogenicity Section for findings related to carcinogenicity in progeny. STUDY RATED BY AN INDEPENDENT REVIEWER
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