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EC number: 295-033-2 | CAS number: 91782-61-5
Acute oral toxicity:LD50=310 mg/kgAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation: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.
Acute oral toxicity
The reference McKenzie (2013) is considered as the key study for acute oral toxicity and will be used for classification. The test was conducted according to OECD 425. The LD50 for female rats was calculated to be 310.2 mg/kg bw
The classification criteria according to regulation (EC) 1272/2008 as acutely toxic category 4 (CLP) are met since the ATE is between 300 and 2000 mg/kg body-weight. Cobalt borate propionate will be classified in accordance with regulation (EC) 1272/2008 as acutely toxic category 4 (H302) and in accordance with 67/548/EEC as harmful if swallowed (R22).
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 is unjustified since dermal uptake is considered negligible.
Specific target organ toxicant (STOT) – single exposure: dermal
Acute inhalation toxicity andSpecific 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 extra thoracic 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 borate propionate of 310 mg/kg observed in an acute oral toxicity test, it is therefore proposed to adopt the classification as acutely oral toxic category 4 also for acute inhalation toxicity, 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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