Registration Dossier
Registration Dossier
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EC number: 235-387-7 | CAS number: 12208-13-8
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The REACH Regulation (EC) 1907/2006) states that a PBT and vPvB (very persistent very bioaccumulative) assessment shall be conducted as foreseen in Article 14 (3) (d) in conjunction with Annex I Section 4 according to the criteria as laid down in Annex XIII (as updated in Commission Regulation (EU) No 253/2011 of 15 March 2011). The PBT and vPvB criteria of Annex XIII however only apply to organic substances, including organometals.
The draft Guidance to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures for metals and metal compounds qualitatively distinguishes metals from organometals based on their dissociation behaviour upon dissolution in water:“Organometals do not dissociate or dissolve in water as the metal ion, as metals and inorganic metal compounds do. … Metal compounds that contain an organic component but that dissociate easily in water or dissolve as the metal ion should be treated in the same way as (inorganic) metal compounds".
Potassium hexahydroxoantimonate is an inorganic substance. Therefore, strictly spoken, there is no legal obligation for a PBT and vPvB assessment for these inorganic Sb substances.However, the available data has nevertheless been compared to the criteria and is discussed below.All inorganic Sb substances are covered by the PBT assessment of the Sb-ion released upon dissolution.
Persistence: whereas antimony formally meets the criterion for persistence based on the absence of any degradation, this criterion is considered not to be applicable to inorganic elements. In addition, under conditions of a standard EUSES lake and the median partition coefficient for suspended matter, Sb meets the criteria for rapid removal from the water column.
Bioaccumulation:Antimony does not meet the criteria for bioaccumulation because the BCF values reported for aquatic organisms are all much lower than the threshold of 2,000 l/kg, and there is evidence to support that antimony does not biomagnify in the food chain.Therefore, antimony is not considered bioaccumulative (B) or very bioaccumulative (vB) based on the definitive criteria.
Toxicity: Chronic NOEC values are available for fish, invertebrates and algae. The lowest NOEC is 1.13 mg Sb/l for fish (Kimball, 1978b). Antimony and antimony compounds do not meet any of the PBT criteria based on carcinogenicity, mutagenicity or reprotoxicity and there is no evidence of other chronic concerns. Therefore, antimony is not considered toxic (T) based on the definitive criteria.
It is therefore concluded that antimony and inorganic antimony compounds are neither a PBT substance, nor a vPvB substance.
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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