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EC number: 212-751-3 | CAS number: 866-81-9
- 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:
- sub-chronic toxicity: inhalation
- 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: Comparable to guideline study with acceptable restrictions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- - no urinalysis, no clinical chemistry; limited documentation of the results
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 10026-24-1
- EC Number:
- 600-050-9
- Cas Number:
- 10026-24-1
- IUPAC Name:
- 10026-24-1
- Reference substance name:
- cobalt(II)sulfate heptahydrate
- IUPAC Name:
- cobalt(II)sulfate heptahydrate
- Details on test material:
- - Name of test material (as cited in study report): cobalt(II)sulfate heptahydrate
- Molecular formula (if other than submission substance): CoSO4*7H2O
- Molecular weight (if other than submission substance): 281 g/mol
- Analytical purity: 99%
- Other: The pH of aqueous solutions of cobalt(II)sulfate heptahydrate was measured at three concentrations. Solutions of 0.01, 0.1, and 1 M were found to have pH values of 6.3, 6.2 and 5.2, respectively.
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Inc. (Germantown, NY, USA)
- Age at study initiation: 7 weeks
- Housing: individual housing
- Diet (e.g. ad libitum): NIH 07 rat and mouse ration (Zeigler Bros., Inc., Gardners, PA); ad libitium except during exposure periods
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7 - 25.2
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: The mass median aerodynamic diameter of the aerosol for all exposures ranged from 0.83 to 1.10 µm.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hazleton 2000, Lab Products, Inc.
- System of generating particulates/aerosols: Cobalt sulfate heptahydrate aerosol was generated from an aqueous solution by nebulisation using dried compressed air. The aerosol was diluted to the desired concentration with air from the chamber air-conditioning system.
- Method of particle size determination: Cascade impactor samples were taken to determine aerosol size distribution. The mass median aerodynamic diameter of the aerosol for all exposures ranged from 0.83 to 1.10 µm. Cobalt sulfate hydration in the aerosol distribution line was determined by ultraviolet/visible spectroscopy. Hydration ratios of 7.66 and 7.67 were determined for two samples taken during the studies.
TEST ATMOSPHERE
- Brief description of analytical method used: Three real-time aerosol monitors (Model RAM-1, GCA Environmental Instruments) were used to determine the concentration of the aerosol in the exposure chambers once every 20 minutes throughout the exposure period. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Three real-time aerosol monitors (Model RAM-1, GCA Environmental Instruments) were used to determine the concentration of the aerosol in the exposure chambers once every 20 minutes throughout the exposure period.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.3, 1, 3, 10, 30 mg/m3
Basis:
other: nominal conc.; calculated as the anhydrous salt of cobalt(II)sulfate heptahydrate
- Remarks:
- Doses / Concentrations:
0.300±0.029; 0.990±0.087; 2.93±0.275; 9.95±0.579; 30.0±1.64 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Animals distributed to weight classes and then assigned to cages and groups by a table of random numbers.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice per day
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weighed initially and once per week thereafter
HAEMATOLOGY: Yes
- Blood was obtained from the supraorbital sinus.
OTHER:
- estrous cyclicity
- sperm parameters (testis weight, sperm motility, sperm morphology)
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- The analysis of organ weight and male reproductive system data was carried out by using the non-parametric multiple comparison procedures of Dunn (1964) or Shirley (1977) to assess the significance of pairwise comparisons between dosed and chamber control groups. Jonckheere´s test (Jonckheere, 1954) was used to evaluate the significance of dose-response trends and to determine whether Dunn´s or Shirley´s test was more appropriate for pairwise comparisons.
The proportion of time spent in each stage of the estrous cycle was compared by using the Wilks criterion statistic (Wilks, 1932) of the multivariate analysis of variance procedure, which was performed after an arc sine transformation of the data.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two of ten males exposed to 30 mg/m3 died before termination of the study. No observed clinical signs appeared to be related to the exposure, with exception of rapid breathing and skin discoloration in the two males that died during week 11.
BODY WEIGHT AND WEIGHT GAIN
Mean body weights of males and females exposed to 30 mg/m3 and females exposed to 10 mg/m3 were lower than those of controls throughout the study. The final mean body weight of mice at 30 mg/m3 was 14% lower than that of the controls for males and 22% lower for females.
HAEMATOLOGY
No consistent or dose-related hematologic effects were observed.
ORGAN WEIGHTS
The absolute lung weights and the lung weight to body weight ratios were significantly increased in the 10 and 30 mg/m3 exposure groups. The absolute testis weight and the testis weight to body weight ratios were significantly decreased for males exposed to 30 mg/m3.
GROSS PATHOLOGY/HISTOPATHOLOGY:
Compound-related microscopic examinations were generally limited to the respiratory tract of mice of each sex. Lesions were concentration related and similar in incidence and severity in males and females. In the nose, degeneration of olfactory epithelium, squamous metaplasia of the respiratory epithelium, and an acute inflammatory cell exudate in the nasal cavity were seen primarily at the two highest exposure concentrations.
At the highest exposure concentration, necrosis, inflammation, and squamous metaplasia of the laryngeal epithelium were present in most mice. Some foci of necrosis in the laryngeal epithelium extended through the basement membrane into the underlying lamina propria. Squamous metaplasia of the respiratory epithelium in the trachea also occured in the higest exposure group in male and female mice. In all exposure groups below 30 mg/m3, inflammation and squamous metaplasia were observed.
In the lung of mice exposed to 10 or 30 mg/m3, there was regeneration of bronchiolar epithelium and hyperplasia of the alveolar epithelium. Infiltration of histiocytes (macrophages) into the alveolar spaces was also present. Chronic inflammation occurred primarily at the highest exposure concentration and consisted of fibrosis around bronchioles and in alveolar septae along with an inflammatory cell infiltrate. At the lower concentration, only a minimal increase in macrophages was seen in the alveoli.
Lymphoid hyperplasia was present in the mediastinal lymph nodes of mice at the 30 mg/m3 exposure concentration.
At the highest exposure concentration, atrophy of the testes was observed, which consisted of a loss of ferminal epithelium in the seminiferous tubules; more severely affected testes also contained foci of mineralisation.
OTHER:
REPRODUCTIVE FUNCTION: ESTROUS CYCLE
The estrous cycle was significantly longer in female mice exposed to 30 mg/m3.
REPRODUCTIVE FUNCTION: SPERM MEASURES
The number of abnormal sperm in mice exposed to 30 mg/m3 was significantly increased, and sperm motility was significantly reduced in mice exposed to 3, 10, or 30 mg/m3.
At the highest concentration, atrophy of the testis was observed, which consisted of a loss of germinal epithelium in the seminiferous tubules; more severly affected testes also contained foci of mineralisation.
Effect levels
open allclose all
- Dose descriptor:
- LOAEC
- Effect level:
- 0.3 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: calculated as the anhydrous salt of cobalt(II)sulfate heptahydrate; the LOAEC based on squamous metaplasia in the larynx
- Dose descriptor:
- LOAEC
- Effect level:
- 0.5 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: CoC6H6O7; recalculated value
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Lesions seen in the respiratory tract included degeneration of the olfactory epithelium, squamous metaplasia of the respiratory epithelium, and inflammation in the nose. The most sensitive tissue was the larynx, with squamous metaplasia observed also at the lowest exposure concentration. Thus, no NOAEC was identified.
Applicant's summary and conclusion
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.
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