Source: http://healthdocbox.com/Allergies/78183913-Justification-for-the-selection-of-a-candidate-corap-substance.html
Timestamp: 2019-02-24 06:09:23
Document Index: 10102758

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Justification for the selection of a candidate CoRAP substance - PDF
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Alexandrina Skinner
1 Justification for the selection of a candidate CoRAP substance Substance Name (Public Name): Chemical Group: Aluminium sulphate Inorganic mono-constituent EC Number: CAS Number: Submitted by: France Published: 20/03/2013 NOTE This document has been prepared by the evaluating Member State given in the CoRAP update.
2 Contents 1 IDENTITY OF THE SUBSTANCE Name and other identifiers of the substance CLASSIFICATION AND LABELLING Harmonised Classification in Annex VI of the CLP Proposal for Harmonised Classification in Annex VI of the CLP Self classification JUSTIFICATION FOR THE SELECTION OF THE CANDIDATE CORAP SUBSTANCE Legal basis for the proposal Grounds for concern Information on aggregated tonnage and uses Other completed/ongoing regulatory processes that may affect suitability for substance evaluation Information to be requested to clarify the suspected risk Potential follow-up and link to risk management... 6 EC no MSCA France Page 2 of 6
3 1 IDENTITY OF THE SUBSTANCE 1.1 Name and other identifiers of the substance Table 1: Substance identity Public Name: Aluminium sulfate EC number: EC name: Aluminium sulphate CAS number (in the EC inventory): CAS number: CAS name: Sulfuric acid, aluminium salt (3:2) IUPAC name: Aluminium sulphate Index number in Annex VI of the CLP Regulation Molecular formula: Molecular weight or molecular weight range: Al.3/2H2O4S; General formula Al2(OH)x(SO4)(3- x/2), with x=0 and x=3and x ranging from 0 to 3. >= <= g/mol Synonyms: Sulfuric acid, aluminum salt (3:2); Aluminum sulfate (2:3); Aluminum trisulfate; Aluminum(III) sulfate; Dialminum trisulfate; Aluminiumsulfat; sulfato de aluminio; sulfate d'aluminium; Aluminium sulfate Polyaluminium sulphate Sulfuric acid, aluminium salt, basic Type of substance: Mono-constituent Multi-constituent UVCB Structural formula: EC no MSCA France Page 3 of 6
4 2 CLASSIFICATION AND LABELLING 2.1 Harmonised Classification in Annex VI of the CLP None 2.2 Proposal for Harmonised Classification in Annex VI of the CLP None 2.3 Self classification The registration data includes the following self classification: According to CLP criteria: Met. Corr. 1, H290: May be corrosive to metals Eye Damage 1, H318: Causes serious eye damage According to DSD criteria: Xi; R41 Irritant; Risk of serious damage to eyes In addition are the following classification(s) included in the Classification and Labelling Inventory: Acute Tox. 4, H302: Harmful if swallowed Skin Irrit. 2, H315: Causes skin irritation STOT SE 3, H335: May cause respiratory irritation Aquatic Acute 1, H400: Very toxic to aquatic life Aquatic Chronic 1, H410: Very toxic to aquatic life with long lasting effects Eye Irrit. 2, H319: Causes serious eye irritation Aquatic Chronic 2, H411: Toxic to aquatic life with long lasting effects Aquatic Chronic 3, H412: Harmful to aquatic life with long lasting effects EC no MSCA France Page 4 of 6
5 3 JUSTIFICATION FOR THE SELECTION OF THE CANDIDATE CORAP SUBSTANCE 3.1 Legal basis for the proposal Article 44(1) (refined prioritisation criteria for substance evaluation) Article 45(5) (Member State priority) 3.2 Grounds for concern (Suspected) CMR Wide dispersive use Cumulative exposure (Suspected) Sensitiser Consumer use High RCR (Suspected) PBT Exposure of sensitive populations Aggregated tonnage Suspected endocrine disruptor This substance is a very high tonnage substance with high exposure (some RCR in the registration data are >0.5). There are several uncertainties regarding this substance that should be clarified: uncertainty regarding carcinogenicity and mutagenicity, uncertainty regarding skin sensitisation (with spraying uses), uncertainty regarding the granulometry of the tested material. 3.3 Information on aggregated tonnage and uses 1-10 t t t ,000 t 10, ,000 t 100, ,000 t > 1000,000 t Confidential Industrial Use Professional Use Consumer Use Closed System EC no MSCA France Page 5 of 6
6 3.4 Other completed/ongoing regulatory processes that may affect suitability for substance evaluation Compliance Check Testing Proposal(s) Substance Identification Issues ESR Programme Annex VI (CLP) Annex XIV (Authorisation) Annex XVII (Restriction) There is a proposal for classification by The Netherlands in the framework of PPP regulation (expected for September 2012). 3.5 Information to be requested to clarify the suspected risk Information on toxicological properties Information on fate and behaviour Information on ecotoxicological properties Information on exposure Information on uses Information on physico-chemical properties There are several uncertainties regarding this substance that should be clarified: uncertainty regarding carcinogenicity and mutagenicity, uncertainty regarding skin sensitisation (with spraying uses), uncertainty regarding the granulometry of the tested material. 3.6 Potential follow-up and link to risk management Restriction Authorisation Harmonised C&L Follow-up will depend on the outcomes of the substance evaluation process. EC no MSCA France Page 6 of 6
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