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Diss Factsheets
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EC number: 200-755-8 | CAS number: 71-48-7
- 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
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Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
LD50= 708 mg cobalt diacetate tetrahydrate/kg bw (confidence interval: 569-880 mg/kg bw)
Acute dermal toxicity:
Conduct of an acute dermal toxicity study for cobalt di(acetate) is unjustified since dermal uptake is considered negligible.
Acute inhalation toxicity:
The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Methodology well-documented Minor deviations from the guideline: - The stability of the test item was not stated. - According to the guideline, necropsy of all animals should be carried out. There was no information,if necropsy of the animals was carried out. - According to the guideline, the observation period should be at least 14 days. In this study only an observation period of 10 days was used. - According to the guideline, the number of animals that died or were killed during the test and the time of death after dosing should be stated. This information was missing in this publication. -According to the guideline, the LD50 values for the sex dosed determined at 14 days should be stated. The LD50 for combined sexes determined at 10 days was stated. - According to the guideline, the animals should be fasted before test item administration. There is no statement in the study, if this was done. - According to the guideline the individual weights of animals should be determined shortly before the test substance is administered, weekly thereafter and at death; changes in weight should be calculated and recorded when survival exceeds one day. At the end of the test surviving animals are weighed and then sacrificed. This information is missing in the report.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- yes
- Remarks:
- , see "rational for reliability"
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The colony of the Animal Breeding Unit, National institute of Public Health, Bilthoven
- Weight at study initiation: approx. 100 g
- Housing: Caged singly or in pairs of the same sex and dose group, in wire cages.
- Diet (ad libitum): Semi-purified diet (Murneon-SSP Tox (Trouw Ltd. Putten)
- Water (ad libitum): Drinking water
ENVIRONMENTAL CONDITIONS
- Temperature: 22- 25 °C
- Relative humidity: 35 - 55 %
No further information on the test animals was stated. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
The compound was dissolved in in distilled water.
No further information about the oral exposure was stated.
- Doses:
- 250 mg/kg bw, 375 mg/kg bw, 560 mg/kg bw, 840 mg/kg bw, 1260 mg/kg bw
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 10 days
- Frequency of observations and weighing: Signs of reaction and deaths were recorded for 10 days, and the rectal temperature was mesured in all survivng rats 1.5, 24 and 48 hr after administration of the cobalt compound.
- Necropsy of survivors performed: No data
No further information on the study design was stated. - Statistics:
- The oral LD50 values for male and female combined, were calculated according to the method of maximum likelihood of Finney (1971).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 708 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 569 - <= 880
- Remarks on result:
- other: This is the LD50 for the cobalt compound tested.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 503 mg/kg bw
- Remarks on result:
- other: This is the LD50 for the anhydrous form of the test item. The LD50 of the anhydrous form of the cobalt compound was derived from the LD50 data of the cobalt compound tested.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 168 mg/kg bw
- Based on:
- element
- Remarks on result:
- other: This is the LD50 for the cobalt (II) ion. The LD50 of the cobalt (II) ion was derived from the LD50 data of the cobalt compound tested.
- Mortality:
- No data
- Clinical signs:
- other: The highest dose caused sedation and diarrhoea. Respiratory disturbances were apparent in rats given the test item. A decrease in body temperature was recorded. The temperature reductions were time- and dose-related.
- Gross pathology:
- No data
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The following LD50 value was determined for cobalt (II) acetate tetrahydrate:
LD50 (combined male and female rats): 708 mg/kg bw (95 % confidence interval: 569-880 mg/kg bw)
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 708 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Key study
Justification for selection of acute toxicity – dermal endpoint
Weight of evidence information
Justification for classification or non-classification
- Speijers (1982): LD50 (combined male and female rats): 708 mgcobalt diacetate tetrahydrate/kg bw /kg bw (95 % confidence interval: 569-880 mg/kg bw)
- Llobet, Domingo (1983): LD50: 819 mgcobalt diacetate tetrahydrate/kg bw (Confidence interval: 751 - 891)
Acute oral toxicity
The references Speijers (1982) and Llobet, Domingo (1983) are considered as the key studies for acute oral toxicity and will be used for classification. Female/male rats were dosed cobalt diacetate tetrahydrate at 250, 375, 560, 840, 1260 mg/kg orally via gavage and at 600, 645, 693, 745, 801, 861, 926 and 995 mg/kg orally via gavage respectively. During the conduct of the study mortalities occurred, thus the following LD50 values were derived:
The classification criteria according to regulation (EC) 1272/2008 as acutely toxic category 4 are met since the ATE is above 300 mg/kg body-weight and below 2,000 mg/kg body-weight.Cobalt diacetate will be classified as acutely toxic category 4 (H302).
Specific target organ toxicant (STOT) – single exposure: oral
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since the toxic effects observed in the acute oral toxicity test already leads to an acute oral toxicity classification. No additional effects in animals or humans are known that would justify a specific target organ toxicant (STOT) – single exposure: oral classification.
Acute dermal toxicity
Conduct of an acute dermal toxicity study for cobalt di(acetate) is unjustified since dermal uptake is considered negligible.
Specific target organ toxicant (STOT) – single exposure: dermal
Conduct of an acute dermal toxicity study for cobalt di (acetate) is unjustified since dermal uptake is considered negligible.
Acute inhalation toxicity and Specific target organ toxicant (STOT) – single exposure: inhalation
Cobalt compounds are not generally associated with local effects following acute inhalation exposure; only after long-term exposure, some inflammatory responses are seen. Thus, any acute inhalation toxicity may reasonably be assumed to be predominantly determined by systemic availability.
Based on the outcome of dustiness testing (Heubach rotating drum method; for details, please refer to the IUCLID endpoint study record under IUCLID section 7.1.1 basic toxicokinetics) coupled with particle size analysis of the airborne fraction, all cobalt compounds have moderate to low values for total dustiness, indicating similar propensities to become airborne. Based on the concurrent particle size analysis, inhalation deposition modelling via MPPD clearly indicates that only minor substance amounts can be expected to be deposited in the pulmonary fraction of the respiratory tract of humans; in contrast, the majority of inhaled material will deposit in the extrathoracic and tracheo-bronchiolar regions, and therefore can safely be assumed to undergo translocation to the gastrointestinal tract via mucociliary escalation and subsequent swallowing.
Thus, any systemic effects may be read across from acute oral toxicity. Based on the LD50 for cobalt di(acetate) of 708 mg/kg observed in an acute oral toxicity test, it is therefore proposed to adopt the classification as acutely inhalation toxic category 4 also for cobalt di(acetate), and to waive the testing requirement for acute inhalation toxicity in accordance with section 1.1, annex XI of regulation (EC) 1907/2006.
Furthermore a testing programme is currently being executed, investigation the acute toxicity of eleven cobalt compounds via inhalation. The aim was to cover a wide spectrum of substances to allow read-across to non-testes substances, to reduce the number of animals. The test items were selected according to the following criteria:
- high dustiness, as determined in the Heubach rotating drum method
- small MMAD to ensure highest possible exposure of the respiratory tract of the test animals
- coverage of high, medium and low bioaccessible substances, determined in artificial alveolar lining fluid (ALF)
According to the above criteria, the following substances were selected for testing: cobalt metal powder (fine and coarse sample), cobalt carbonate, cobalt resinate, cobalt stearate, cobalt acetyl acetonate, cobalt sulfate, cobalt monoxide, tricobalt tetraoxide, cobalt sulfide.
The registrant ensures that the results will be included in the respective dossiers upon availability.
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.
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