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EC number: 295-032-7 | CAS number: 91782-60-4
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Version / remarks:
- 1997-07-21
- Deviations:
- yes
- Remarks:
- ; only 4 animals were tested (acc. to guideline: 5 test animals are required); samples for analysis were taken at only one time point (acc. to guideline. samples should be taken at two separate times).
- GLP compliance:
- no
- Remarks:
- As an investigative study, this study was conducted in accordance with applicable test facility SOPs and was fully documented but was not subjected to Quality Assurance audit or review.
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 1308-06-1
- Cas Number:
- 1308-06-1
- IUPAC Name:
- 1308-06-1
- Reference substance name:
- tricobalt tetraoxide
- IUPAC Name:
- tricobalt tetraoxide
- Details on test material:
- - Name of test material (as cited in study report): Tricobalt tetraoxide, black cobalt (II, III) oxide- Molecular formula (if other than submission substance): Co3O4- Molecular weight (if other than submission substance): 250.80 g/mol- Physical state: solid No further details are given.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Harlan, USA - Age at study initiation: At treatment, the animals were approximately 21 days old. - Assigned to test groups randomly: yes, under following basis: Randomisation was done by stratification using body weight as the parameter. Males and females were randomised separately. Animals in poor health or at the extremes of the body weight range were not assigned to groups.- Fasting period before study: no - Housing: Each dam and litter were housed on corn cob bedding in solid bottomed cages equipped with an automatic watering valve. After randomization and until euthanasia, animals were housed in groups of 13 pups in the single dose phase study and 9 to 11 pups (including spare animals) in the multi-dose phase study, alongside their respective mother rats (dams).- Diet: All animals had free access to a standard certified pelleted commercial laboratory diet except during designated procedures. - Water: Municipal tap water, suitable for human consumption, was freely available to the animals except during designated procedures.- Acclimation period: 7 days; Following arrival, each animal was given a general physical examination by a member of the veterinary staff to ensure normal health status. ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 3 - Humidity (%): 50 +/- 20 - Photoperiod: 12 hours dark/light cycle No further details are given.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: aqueous 1% v/v methylcellulose - Amount of vehicle (if gavage or dermal): 10 mL/kg body weight- Lot/batch no. (if required): 125K0196 (methylcellulose 400 cps)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: not applicableDIET PREPARATIONAll formulations were prepared once prior to each phase on the first day of use. The required amount of each compound was weighed into a pre weighed beaker and a small amount of vehicle was added to make a paste. The formulations were brought to final weight with the vehicle and homogenised until an apparently homogenous suspension was obtained.
- Duration of treatment / exposure:
- 16 hours
- Frequency of treatment:
- single administration on day one
- Post exposure period:
- 15 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 other: mg/kg bw (nominal conc.)
- Dose / conc.:
- 1 000 other: mg/kg bw (nominal conc.)
- Dose / conc.:
- 2 000 other: mg/kg bw (nominal conc.)
- No. of animals per sex per dose:
- groups of 2 male and 2 female rats were treated with the vehicle control or test substance
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide monohydrate (CAS: 6055-19-2) - Route of administration: oral, gavage (single dose) - Doses / concentrations: The control article was administered using a dose volume of 10 mL/kg bodyweight. 1,2-Dimethylhydrazine dihydrochloride (CAS: 306-37-6)- Route of administration: oral, gavage (single dose) - Doses / concentrations: The control article was administered using a dose volume of 10 mL/kg bodyweight. The positive control solution was freshly prepared on the day of use.
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A preliminary toxicity test was performed, partly to determine an estimated maximum tolerated dose (MTD) of the test article given the uncertainty and variability of published values. Dose levels for each phase of the preliminary test were determined at the time of the test and were based on the clinical signs/mortalities obtained in the previous phase.TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Colchicine was administered to all animals (except those in Group 1 (preliminary study) in the single dose phase) at 4 μg/kg 1 hour prior to euthanasia by intraperitoneal injection (10 mL/kg bodyweight) to arrest bone marrow cells in metaphase. The appropriate animals were euthanised 16 hours after the last or only treatment by exsanguination from the abdominal aorta under isofluorane anaesthesia.DETAILS OF SLIDE PREPARATION: Both femurs were dissected from each animal and the proximal heads removed. The proximal head was removed from each femur while keeping the distal head intact, and as much tissue as possible was removed from the bones. The bone marrow from both femurs of each animal was pooled/eluted in 5 mL Hanks’ Balance Salts Solution by aspiration through an appropriate size needle fitted to a plastic syringe. The resulting cell suspensions were centrifuged and the resulting pellets were resuspended in 10 mL aqueous 0.075M potassium chloride (hypotonic solution) and incubated for approximately 12 minutes at ca. 37°C, before addition of 2 mL of fixative (3 vol methanol:1 vol acetic acid) with mixing. Following centrifugation, the supernatant was discarded and the cells treated with 3 changes of neat fixative. After the third change of fixative, the cell pellet was collected by centrifugation and resuspended in fixative at an appropriate density for slide preparation.The fixed cells were dropped onto clean slides in a humid atmosphere and air-dried before staining. At least two slides were prepared from each animal. Slides were washed with 3 changes of purified water then stained with 10% (v/v) Giemsa for 15 minutes. METHOD OF ANALYSIS:Mitotic Index (MI): Slides were randomised and examined by light microscopy, and the mitotic index was determined by examination of at least 1000 cells per animal. The relative mitotic index (RMI) was calculated as a percentage ratio compared with the concurrent vehicle control group.Detailed Examination for Chromosome Aberrations: A total of 100 readable metaphases per animal were examined for the presence of chromosome aberrations using oil-immersion optics.Readable metaphases were identified by the following criteria:- chromosome number between 40 and 44 in a single stage of condensation, - well-spread with minimal overlap of chromosomes and chromosome arms, - chromatids separate with centromere intact and - structure of chromosomes clear and well-defined. The International System for Chromosome Aberration Nomenclature (ISCN 1985) was followed to designate the observed aberrations. Since the nature of chromosomal and chromatid gaps is uncertain (they may or may not represent true breaks in chromatid structure), these two types of aberration were recorded but not included in statistical analysis of aberrations. A gap is defined as an unstained region within the chromatid, where the width of this region is shorter than the width of a chromatid. The incidences of numerical types of aberration, such as polyploidy and endoreduplication, were recorded and reported here, as required by OECD guideline 475. The location (Vernier reading) of observed aberrant metaphases was recorded for potential peer review.OTHER: Unscheduled Euthanasia: Animals euthanized for humane reasons pre- or post-treatment underwent exsanguination from the abdominal aorta following isoflurane anaesthesia. No gross pathology examination was performed and animal carcasses were discarded without examination or tissue retention. No tissues were retained for any animal.
- Evaluation criteria:
- no data
- Statistics:
- Due to the limited group size, no formal statistical analysis was performed on results from the single dose experiment. Exact two-sided p-values were calculated for MI, and one-sided values for other parameters using permutation tests (Gibbons 1985, Agresti et al 1990) based on absolute values and rank dose level with the individual animal being considered as the unit of variance.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- No substantial increase in the bone marrow metaphases showing chromosome aberrations was obtained.
- Toxicity:
- no effects
- Remarks:
- No adverse clinical signs were observed and no mortalities were obtained.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY- Dose range: up to the standrad limit dose of 2000 mg/kg- Clinical signs of toxicity in test animals: No clinical signs and no mortalities were observed in any treatment group in the preliminary phase.RESULTS OF DEFINITIVE STUDYNo treatment had any apparent effect on mitotic index in the bone marrow. As expected, animals in the first group, which did not receive colchicine, had a relatively low mitotic rate in bone marrow.- Evidence of cytotoxicity in tissue analysed: In a multi-dose phase Cobalt sulphate, Cobalt monoxide and Tricobalt tetraoxide were additionally tested. Animals were dosed once daily for up to 5 days. High multiple doses of cobalt compounds depress erythropiesis, as indicated by a reduction in bone marrow mitotic index with Cobalt monoxide and an associated general reduction in reticulocyte counts with all three compounds.No further details.
Any other information on results incl. tables
Single dose of tricobalt tetraoxide – Summary Results for Bone Marrow
Treatment |
Dose (mg/kg) |
MI |
RMI |
No. cells examined(M+F) |
% Aberrant Male |
% Aberrant Female |
% Aberrant (M+F) |
Vehicle† |
- |
1.6 |
66 |
400 |
1.5 |
6.0 |
3.8 |
Vehicle |
- |
2.4 |
100 |
400 |
0.0 |
3.0 |
1.5 |
Tetraoxide |
500 |
2.9 |
121 |
400 |
1.5 |
0.5 |
1.0 |
Tetraoxide |
1000 |
3.0 |
125 |
400 |
2.5 |
0.0 |
1.3 |
Tetraoxide |
2000 |
2.6 |
107 |
400 |
0.0 |
1.0 |
0.5 |
CP |
10 |
3.6 |
150 |
400 |
19.5 |
7.5 |
13.5 |
DMH |
10 |
3.6 |
142 |
400 |
4.5 |
8.0 |
6.3 |
† Not treated with colchicines; All other animals were given colchicine at 4 mg/kg by I.P. injection 1 hour prior to euthanasia.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Tricobalt tetraoxide has no mutagenic effects in the chromosome aberration tests. Evident for the validity of the exposure route is the results from a multi-dose phase test conducted with three cobalt compounds. The results show that under given experimental conditions cobalt ions reaches the bone marrow .
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