Registration Dossier
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EC number: 231-111-4 | CAS number: 7440-02-0
- 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

Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 25, 1985 to April 8, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions.
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:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Guideline:
- other: not reported
- Principles of method if other than guideline:
- Principles of method not described. Details of test methods described throughout the following sections.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- nickel metal
- IUPAC Name:
- nickel metal
- Reference substance name:
- Nickel
- EC Number:
- 231-111-4
- EC Name:
- Nickel
- Cas Number:
- 7440-02-0
- Molecular formula:
- Ni
- IUPAC Name:
- nickel
- Reference substance name:
- Nickel powder
- IUPAC Name:
- Nickel powder
- Reference substance name:
- Sherritt Gordon Mines Ltd., Fort Saskatchewan, Alberta, Canada.
- IUPAC Name:
- Sherritt Gordon Mines Ltd., Fort Saskatchewan, Alberta, Canada.
- Details on test material:
- - Name of test material (as cited in study report): Nickel powder
- Physical state: powder
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Stability under test conditions: not specified
- Storage condition of test material: not provided
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: young adult (approximately 8 weeks of age)
- Weight at study initiation: 205-237 grams
- Fasting period before study: not reported
- Housing: Individually housed in wire mesh bottom cages. All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23.
- Diet (e.g. ad libitum): Food (NIH 07 Open Formula, certified rodent diet, Zeigler Brothers, Inc., Gardner, PA) was suppied fresh each week (ad libitum) except during the exposure period.
- Water (e.g. ad libitum): Fresh tap water was suppied each week (ad libitum) except during the exposure period.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C) and Humidity (%): All animals were housed in environment-controlled rooms with temperature and relative humidity regulated as per "Guide for the Care and Use of Laboratory Animals".
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12 hour light-dark cycle
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: not applicable
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A 128 L acrylic (plexiglass), portable chamber designed by the FDRL scientific staff.
- Exposure chamber volume: 128L
- Method of holding animals in test chamber: individually caged during exposure
- Source and rate of air: Transvector jet (Model 901, Vortec Corporation, Cincinnati, OH), 100 L/minute
- Method of conditioning air: An air treatment system (Charles Spengler and Associates, Cincinnati, OH) constructed of a glass fiber pre-filter, Micretain(r) HEPA filter, and an activated charcoal bank
- System of generating particulates/aerosols: NBS-II dust generator (BGI, Inc., Waltham, MA) using an air inlet port.
- Method of particle size determination: A multijet cascade impactor (Model 02-200, In-Tox Products, Albuquerque, Nl'1).
- Treatment of exhaust air: Vented via an air treatment system (Charles Spengler and Associates, Cincinnati, OH)
- Temperature in air chamber during exposure: 19oC (initial) , 23oC (final)
- Humidity in air chamber during exposure: 49% (initial) , 29% (final)
- Pressure in air chamber during exposure: not provided
TEST ATMOSPHERE
- Brief description of analytical method used: Test atmosphere temperature and relative humidity were taken at initiation, once during and at the conclusion of exposure, using a Taylor wet bulb/dry bulb hygrometer placed within the chamber. The instrument was modified so that chamber air was drawn over the wet bulb at the time of reading.
- Samples taken from breathing zone: no
VEHICLE: Not applicable
PARTICLE SIZE ANALYSIS
Particle size analysis was performed twice during the exposure using a multijet cascade impactor (Model 02-200, In-Tox Products, Albuquerque, Nl'1). Stages one to seven of the impactor were fitted with pre-weighed stainless steel impaction substrates. Stage eight (final filter stage) was fitted with a pre-weighed cellulose filter membrane (Gelman Type A/E, 47 mm, Triacetate, 99.7% efficient at 0.3 micrometers). Chamber air was drawn through the impactor at a rate of 20 L/minute. The change in weight (mg) of each substrate was determined subsequent to sampling. The cumulative percent of aerosol collected through each stage was determined.
EXPOSURE DETAILS
- Rationale for the selection of the exposure concentration: The nominal Nickel Powder exposure concentration was calculated by dividing the net weight of test article utilized (g) by total chamber airflow (L).
-The animals were exposed to nickel powder for 66 minutes. Six minutes were added to the 60 minute exposure period in order to allow the test system to reach 99% of the desired concentration (point of equilibration).
-During exposure, the animals were individually housed in wire-mesh cages. Following exposure, the animals remained in the chamber for at least six minutes. The chamber was maintained during these six minutes at the designated airflow rate of 100 L/minute using clean ambient air only. After the exposure, animals were individually housed. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Measurements were taken at initiation, once during and at the conclusion of exposure, using a Taylor wet bulb/dry bulb hygrometer placed within the chamber.
- Duration of exposure:
- 1 h
- Concentrations:
- 10.2 mg/l
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- PURPOSE OF STUDY
To evaluate the potential toxicity of a dust aerosol generated from Nickel Powder that is administered via inhalation to five male and five female Sprague-Dawley albino rats (randomly chosen from acclimated animals).
EXPOSURE DETAILS
- Rationale for the selection of the exposure concentration: The nominal Nickel Powder exposure concentration was calculated by dividing the net weight of test article utilized (g) by total chamber airflow (L).
-The animals were exposed to nickel powder for 66 minutes. Six minutes were added to the 60 minute exposure period in order to allow the test system to reach 99% of the desired concentration (point of equilibration).
-During exposure, the animals were individually housed in wire-mesh cages. Following exposure, the animals remained in the chamber for at least six minutes. The chamber was maintained during these six minutes at the designated airflow rate of 100 L/minute using clean ambient air only. After the exposure, animals were individually housed.
OBSERVATION DETAILS
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were recorded periodically during exposure, subsequent to exposure on day one and twice daily for 14 additional days; body weights were recorded on days 1 (just prior to exposure), 8, and 15.
- Other examinations performed: observe for clinical signs of toxicity
-Necropsy of survivors performed: no - Statistics:
- Not provided
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: NOAEC
- Effect level:
- >= 10.2 mg/L air
- Exp. duration:
- 66 min
- Remarks on result:
- other: No effects observed over a 14-day period post-exposure
- Mortality:
- No mortality was observed in any of the animals.
- Clinical signs:
- other: No signs of toxicity were observed in any of the animals.
- Body weight:
- No adverse effect on body weight was observed.
- Gross pathology:
- Not examined
- Other findings:
- The mean particle size of nickel powder could not be accurately determined. No particles were present in the first and second stage of the particle size impactor, indicating that nickel powder did not remain suspended in the test atmosphere. However, it cannot be concluded that the majority of particles generated with the test article were not less than 12 micrometers in size.
Any other information on results incl. tables
Applicant's summary and conclusion
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
Summary of FDRL (1985)
Five male and five female rats were whole-body exposed for one hour to a dust aerosol, which was generated from nickel powder at the nominal concentration
of 10.2 mg/l. The animals were observed periodically during exposure and for 14 days following exposure. No mortality or signs of toxicity were observed.
The exposure duration in this study was too short compared with the Annex V method (4 h).
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