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EC number: 234-853-7
CAS number: 12036-76-9
This substance is included in Annex VI, Table 3.1 of Commission Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, under the entry “lead compounds with the exception of those specified elsewhere in this Annex” (Index No 082-001-00-6). As such this entry is legally binding and must there be cited on both the label and SDS. However, for hazard classes not covered by Annex VI, the manufacturer or importer is required to self-classify the substance in accordance with the criteria described in the guidance on CLP. Endpoints marked by an asterisk (*) in Annex VI denote a minimum classification; manufacturers and importers must classify in a more severe hazard category in cases where they have further information which shows this is more appropriate.
Classification - Health
The basis of the original human health classifications is unknown. However, the CSR includes self-classification that, based on industry’s analysis of current data, proposes CHANGES TO THE EU CLASSIFICATION.
Based upon supporting data referenced in the REACH Registration dossier, the minimum classification of STOT-RE 2 is changed to STOT-RE 1, as human evidence exists for repeat dose effects on CNS, kidney and haematological (blood) systems. It is proposed that the existing SCL of ≥0.5% is maintained for STOT-RE1.
Multiple studies have now demonstrated that a number of soluble lead compounds can induce cancer in different species of test animals. Given the large doses of soluble lead compounds required to induce tumours in animals, only compounds with significant bioavailability will likely elicit a carcinogenic response. The bioavailability of most high-production-volume lead compounds is not known, but the sparingly soluble nature of some of the compounds under consideration does not equate with limited bioavailability under the acidic conditions of the stomach. For example, both lead oxide and lead carbonate exhibit high bioavailability in animal feeding studies and when tested in in vitro gastric simulation systems. While not all lead compounds may exhibit high bioavailability, extension of Carc. 2 (CLP) classification to most inorganic lead compounds can be considered unless there is evidence that limited bioavailability of a specific substance obviates cancer risk. Thus Carc. 2; H351: Suspected of causing cancer is added.
In addition, as lead may be transferred from mother to child in breast milk it is proposed that an additional hazard statement “H362: May cause harm to breast-fed children” be assigned.
It should be noted that Industry believes that data are available that support removal of classification Acute Tox. 4 (oral); H302: Harmful if swallowed and Acute Tox. 4 (inhalation); H332: Harmful if inhaled. These existing classifications for lead compounds are not supported by the read-across data. Acute toxicity is not observed in animals after oral exposures up to the limit values of acute toxicity testing for seven different inorganic lead compounds. Lead oxide, predicted to yield similar deposition patterns in the lung and comparable systemic uptake, is also not acutely toxic. Three similar compounds are lacking in dermal toxicity and in irritancy properties for the skin or eyes. Although toxic under chronic exposure situations, the acute toxicity of lead oxide sulfate is predicted to be quite low and does not require classification.
It is noted, however, that removal of the harmonised classification for acute toxicity can only be undertaken by making a proposal to ECHA to be discussed at RAC and the classification officially changed via an Adaption to Technical Progress.
This situation is also the case for the harmonised classification Repro. 1A; H360Df, evidence of impact upon human male fertility indicates consideration of Repr. Cat. 2 being changed to Repr. Cat. 1A under CLP.
Classification - Environment
This substance is included in Regulation (EC) No 1272/2008 Annex VI Table 3.1 under the entry “lead compounds with the exception of those specified elsewhere in this Annex (Index No 082-001-00-6). As such, the harmonised classification of Acute 1, Chronic 1 is legally binding. The basis of the original environmental classifications is unknown. However, no change to the existing EU environmental classifications is proposed. M factors have been assigned for both acute and chronic effects to the aquatic environment:
NB Pb compound M factors may be reviewed in light of the Pb metal ENV CLH debate which is still ongoing at the time of writing.
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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