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EC number: 234-454-8 | CAS number: 12004-35-2
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with CAS number 1313-99-1. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Comparative Carcinogenic Effects of Nickel Subsulfide, Nickel Oxide, or Nickel Sulfate Hexahydrate Chronic Exposures in the Lung
- Author:
- Dunnick JK, Elwell MR, Radovsky AE, Benson JM, Hahn FF, Nikula KJ, Barr EB, Hobbs CH
- Year:
- 1 995
- Bibliographic source:
- CANCER RESEARCH. 55: 5251-5256
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Nickel monoxide
- EC Number:
- 215-215-7
- EC Name:
- Nickel monoxide
- Cas Number:
- 1313-99-1
- IUPAC Name:
- oxonickel
- Details on test material:
- - Name of test material (as cited in study report): NiO
- Substance type: green; formed at 1350 C (Cas NO. 1313-99-1)
- Analytical purity: > 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Housing: Hazleton 2000 whole-body chambers
- Diet (e.g. ad libitum): ad libitum during non-exposure periods
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hr dark, 12 hr light
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no data
- Remarks on MMAD:
- MMAD / GSD: MMAD = 2.2-2.5 um
GSD = 1.8 - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Multitiered inhalation chambers, H-2000
- System of generating particulates/aerosols: NiO aerosols were generated 4' fluid bed generators
- Air change rate: flow through the chamber was 12 ± 2 air changes/h
- Method of particle size determination: Aerosol size was determined using cascade impactors
TEST ATMOSPHERE
- Brief description of analytical method used: Aerosol concentration was determined by taking three 2-h filter samples throughout the exposure day.
Real-time determination of aerosol concentration was made using real time aerosol monitor-model S units.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Aerosol concentration was determined by taking three 2-h filter samples throughout the exposure day.
Real-time determination of aerosol concentration was made using real time aerosol monitor-model S units. - Duration of treatment / exposure:
- 6 hr/day
- Frequency of treatment:
- 5 d/wk, 2 yr
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.62 mg NiO/m3
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1.25 mg NiO/m3
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
2.5 mg NiO/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- 50 males, 50 females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: based on previous 13-week study (Dunnick et al., 1989)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: every 4 weeks
BODY WEIGHT: Yes
- Time schedule for examinations: every 4 weeks
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: Lung Ni burden - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organ weights: lung, thymus, liver, right kidney, brain, right testes or ovary
HISTOPATHOLOGY: Yes. Complete histopathology was performed on high-exposure and control groups and to a no-effect level in target tissues. Including: gross lesions and tissue masses, adrenals, bone (vertebra with spinal cord and femur with bone marrow), brain, epididymus, esophagus, heart, small intestine (duodenum, jejunum, ileum), large intestine (cecum, colon, rectum), islets of pancreas, kidneys, larynx, liver, lung, lymph nodes (bronchial, mandibular, mediastinal, mesenteric), mammary gland, nasal turbinates, pancreas, parathyroid gland, pituitary gland, preputial or clitoral gland (in rats) prostate or uterus, salivary glands, seminal vesicles, skin, spleen, stomach (including forestomach and glandular portions), testes or ovaries, thymus, thyroid gland, trachea, and urinary bladder. - Other examinations:
- lung Ni concentration
- Statistics:
- Tests of significance included pairwise comparisons of each exposed group with controls and a test for overall exposure-related trends. Organ and body weight data were analyzed using parametric multiple comparison procedures, and lung burden data were analyzed using nonparametric multiple comparison methods. The reported values were considered significant at the P < 0.05 level.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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 specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
-
ORGAN WEIGHTS
By 7 months, lung weight was significantly increased in females and males at 0.62 mg/m3 and 1.2 mg/m3, respectively.
HISTOPATHOLOGY: NON-NEOPLASTIC
Noncarcinogenic effects included alveolar/bronchiolar (A/B) hyperplasia, inflammation, fibrosis, and lymphoid hyperplasia of the lung-associated lymph nodes.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
See Section 7.7
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 0.62 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: At the 0.62 mg/m3 dose, 15/53 male rats survived t and 26/53 female rats survived with significant increased lung weight. Adenoma and carcinoma occurrence was not different than for control animals.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Absolute Lung Weight (grams) | ||||
NiO mg/m3 | 0 | 0.62 | 1.2 | 2.5 |
Male - 7 mo | 1.72 | 1.85 | 2.46* | 2.59* |
Male- 15 mo | 2.2 | 2.15 | 3.30* | 4.09* |
Female - 7 mo | 1.14 | 1.31* | 1.65* | 1.78* |
Female - 15 mo | 1.56 | 1.79 | 2.41* | 3.02* |
* = significantly different from control
Applicant's summary and conclusion
- Conclusions:
- Noncarcinogenic effects included alveolar/bronchiolar (A/B) hyperplasia, inflammation, fibrosis, and lymphoid hyperplasia of the lung-associated lymph nodes. In addition, lung weight was increased by 7 months.
- Executive summary:
As part of a study on the toxicity and carcinogenicity of NiSO4, Ni3S2 and NiO, Dunnick et al. (1995) described the toxicity of inhaled green NiO in F344/N rats exposed for 6 hr/d, 5 d/wk, for 2 years (0.62, 1.25, and 2.5 mg/m3; 0.5, 1.0, 2.0 mg Ni/m3). Chamber concentrations and aerosol size were determined analytically (MMAD: 2.4 μm; GSD 2.2). Noncarcinogenic effects examined included clinical signs, body and organ weights, tissue histopathology, and lung burden. (note: carcinogenic effects and lung burden are described in the Carcinogenicity and Basic Toxicokinetics sections, respectively). No significant differences in mortality were observed between control and treated animals. Bodyweights of exposed animals were said to be within 5-10% of control animals and were not considered characterized as adverse effects. Lung weights in exposed animals were greater than controls and were considered to be due to inflammatory responses. By 7 months, lung weight was significantly increased in females and males at 0.62 mg/m3 and 1.2 mg/m3, respectively. At 15 months, significant differences were observed at 1.2 mg/m3 in both sexes. Noncarcinogenic effects included alveolar/bronchiolar (A/B) hyperplasia, inflammation, fibrosis, and lymphoid hyperplasia of the lung-associated lymph nodes. Pigment was observed in the lungs of animals exposed to NiO, and was thought to be deposited Ni. This investigation was part of a comprehensive bioassay conducted by the National Toxicology Program (1996). STUDY RATED BY AN INDEPENDENT REVIEWER
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