Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-215-7 | CAS number: 1313-99-1
- 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 with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of NiCl2 and NiO in Wistar rats after oral uptake and inhalation exposure respectively.
- Author:
- Weischer CH, Kordel W, Hochrainer D
- Year:
- 1 980
- Bibliographic source:
- Zentralbl Bakteriol Mikrobiol Hyg [B]. 17(4-5): 336-51.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Effects of a 21-day exposure to NiO-aerosols were evaluated in pregnant rats and their fetuses. Endpoint evaluated included changes in body weight, organ weight, hematological assessment, urinalysis, various clinical chemistry assays, and fetal survival.
- 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
- Molecular formula:
- NiO
- IUPAC Name:
- oxonickel
- Details on test material:
- - Name of test material (as cited in study report): NiO-aerosols
- Generation of NiO: NiO aerosols were generated via pyrolysis of Ni-acetate. The degree of pyrolosis was measured in a series of experiments where the tube furnace was operated at different temperatures. Aerosol particles were sampled each time; the sample was weighed and the amount of Ni in the sample determined by titration. The relative content of the Ni from the aerosol samples peaks between 500°C and 600°C with a Ni-content exactly as expected for NiO. Thus it was assumed that with a tube furnace temperature of 550°C, a complete pyrolysis of the Ni acetate to Ni oxide was obtained.
- Particle size distributions were measured with a spiral centrifuge.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: TNO W 74
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: TNO W 74, virgin females
- Housing: fully climatized room
- Diet (e.g. ad libitum): to minimize oral nickel uptake, new uncontaminated food was offered in the evening only and remaining food was taken away in the morning.
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Details characterizing the test atmosphere/chamber description were not described.
TEST ATMOSPHERE
- Brief description of analytical method used: filter samples were taken on 0.2µm pore size membrane filters; sample volume of about 1m3 was drawn through the filters
- Samples taken from breathing zone: samples were taken of the aerosol immediately before and after the inhalation chamber. The concentration in the chamber was calculated as the mean of the two values. The concentration before the chamber was usually 5% higher than after the chamber.
- Particle size distributions were measured with a spiral centrifuge:
Arithmetic mean diameter = 0.58µm
Standard deviation of the distribution = 0.82 µm
Geometric mean diameter = 0.43 µm
Geometric standard deviation = 1.6 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Aerosol samples were taken from breathing zone before and after the inhalation chamber. The concentration in the chamber was calculated as the mean of the two values. The concentration before the chamber was usually 5% higher than after the chamber.
- Details on mating procedure:
- Virgin Wistar rats were mated with males of the same strain overnight. The following morning, a vaginal smear was examined microscopically for sperm. The positive animals were then selected for the inhalation study.
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- 24 hours a day (except for daily 10-20 minute interruptions for cleaning of the inhalation chambers and feeding
- Duration of test:
- Clinical and clinico-chemical parameters were determined following exposure.
- No. of animals per sex per dose:
- 10-13 pregnant rats/group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Not Applicable
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: beginning and end of experiment
FOOD CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: kidney, liver, lung
OTHER:
HAEMATOLOGY:
- Time schedule for collection of blood: following the exposure period
- Anaesthetic used for blood collection: yes; blood was taken from the carotid artery via PVC tube
- Animals fasted: No data
- How many animals: all animals (10-13 per dose group and controls)
- Parameters checked: erythrocytes, leukocytes, hematocrit, hemoglobin, MCV (mean cell volume of erythrocytes) in blood
CLINICAL CHEMISTRY:
- Time schedule for collection of blood: following the exposure period
- Animals fasted: No data
- How many animals: all animals (10-13 per dose group and controls)
- Parameters checked: alkaline phosphatase, urea, bilirubin, glucose in serum
URINALYSIS: Yes
- Time schedule for collection of urine: 0.5 to 1.5 ml urine was collected in a PVC tube following the exposure period
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked: creatinine, alkaline phosphotase and urea in urine. - Ovaries and uterine content:
- Not Reported
- Fetal examinations:
- - External examinations: No data
- Soft tissue examinations: No data
- Skeletal examinations: No data
- Head examinations: No data
- Other: number of fetuses, number of placentas, body weight, wet weight of placentas, hemoglobin, hematocrit, erythrocytes, leukocytes, MCB in blood, and urea and alkaline phosphatase in serum. - Statistics:
- The mean and standard deviation were determined; results were proved using test of Kruskal and Wallis and the rank test of Wilcoxon, Whitney and Mann
- Indices:
- Not Reported
- Historical control data:
- Not Reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal Rats:
Significant reductions were observed in
- body weight (all exposure groups)
- wet weights of kidneys (1.6 and 3.2 mg/m3 exposure groups)
- erythrocytes (1.6 and 3.2 mg/m3 exposure groups)
- urea in serum (3.2 mg/m3 exposure group)
Significant increases were observed in:
- wet weight of lungs (all exposure groups)
- hematocrit (3.2 mg/m3 exposure group)
- MCV (1.6 and 3.2 mg/m3 exposure groups)
- leukocytes (0.8 mg/m3 exposure group)
No changes were observed in alkaline phosphatase in serum or urine, bilirubin, urea in urine, or liver weight.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- dose level:
- Effect level:
- > 1.6 - < 3.2 mg/m³ air
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- other:
- Basis for effect level:
- other: effect type not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Body weights were reduced in mid- and high dose groups (1.6 and 3.2 mg/m3). Leukocytes and urea in serum in mid-dose group were increased. No effects of exposure were observed for: number of fetuses or placentas, wet weight of placenta, hemoglobin, hematocrit, erythrocytes, MCV, or alkaline phosphatase in serum.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Not Applicable
Applicant's summary and conclusion
- Conclusions:
- The authors did not provide a conclusion to their study.
- Executive summary:
In a multi-part study, Weischer et al (1980) evaluated the effects of a continuous, 21-day gestational inhalation exposure to NiO (unspecified color) aerosols (0.8, 1.6 and 3.2 mg/m3) in rats (note: effects in males and non-pregnant animals reported in the repeated dose toxicity section). NiO aerosols were generated by the authors via pyrolysis of nickel acetate at 550°C. Virgin Wistar rats (TNO W 74) were mated with males of the same strain overnight. The following morning, a vaginal smear was examined microscopically for sperm and positive animals were then selected for the inhalation study (10-13 per exposure group, 13 controls). On GD 21, fetuses were removed by cesarean section and fetal blood collected. Maternal blood, serum and urine were also collected. Endpoints evaluated included changes in body weight, organ weight, hematological assessments, urinalysis, various clinical chemistry assays, and fetal survival (very limited traditional evaluations of teratogenic or developmental toxicities, such as soft tissue or skeletal examinations, were included). In maternal rats, significant reductions were observed in body weight (all exposure groups), wet weights of kidneys and erythrocyte count (1.6 and 3.2 mg/m3 exposure groups), and urea in serum (high exposure only). Significant increases were observed in wet weight of lungs (all exposure groups), hematocrit (3.2 mg/m3 exposure group), MCV (1.6 and 3.2 mg/m3 exposure groups), and leukocytes (low exposure group only). No changes were observed in alkaline phosphatase in serum or urine, bilirubin, urea in urine, or liver weight. In fetuses, body weights were reduced in mid- and high exposure groups. Leukocytes and urea in serum in mid-dose group were increased. No effects of exposure were observed for: number of fetuses or placentas, wet weight of placenta, hemoglobin, hematocrit, erythrocytes, MCV, or alkaline phosphatase in serum. Though the authors did not offer a general conclusion, data generally suggest that both maternal and developmental toxicities (as assessed by evaluation of hematological and clinical chemistry endpoints only) occurred in a dose-dependent fashion. STUDY RATED BY AN INDEPENDENT REVIEWER
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.