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Annex XV dossier PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR 1A OR 1B, PBT, vPvB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN Substance Name: 1-bromopropane; n-propyl bromide EC Number: 203-445-0 CAS Number: 106-94-5 Submitted by: European Chemicals Agency at the request of the European Commission ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC 2 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC CONTENTS CONTENTS .................................................................................................................. 3 TABLES ....................................................................................................................... 3 PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR 1A OR 1B, PBT, VPVB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN ........................................ 4 PART I ........................................................................................................................ 5 JUSTIFICATION .......................................................................................................... 5 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES .......................... 5 1.1 Name and other identifiers of the substance .......................................... 5 1.2 Composition of the substance................................................................. 6 2 HARMONISED CLASSIFICATION AND LABELLING............................................................ 7 3 ENVIRONMENTAL FATE PROPERTIES........................................................................... 9 4 HUMAN HEALTH HAZARD ASSESSMENT........................................................................ 9 5 ENVIRONMENTAL HAZARD ASSESSMENT ...................................................................... 9 6 CONCLUSIONS ON THE SVHC PROPERTIES.................................................................. 9 6.1 CMR assessment..................................................................................... 9 PART II..................................................................................................................... 10 INFORMATION ON USE, EXPOSURE, ALTERNATIVES AND RISKS .............................. 10 TABLES Tables Table 1: Substance identity ...............................................................................................................................5 Table 2: Constituents ...........................................................................................................................................6 Table 3: Classification according to part 3 of Annex VI, Table 3.1 ((list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008 .........7 Table 4: Classification according to part 3 of Annex VI, Table 3.2 (list of harmonized classification and labelling of hazardous substances from Annex I of Council Directive 67/548/EEC) of Regulation (EC) No 1272/2008 ........................................................................................8 3 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC PROPOSAL FOR IDENTIFICATION OF A SUBSTANCE AS A CMR 1A OR 1B, PBT, VPVB OR A SUBSTANCE OF AN EQUIVALENT LEVEL OF CONCERN Substance Name: 1-bromopropane; n-propyl bromide EC Number: 203-445-0 CAS number: 106-94-5 The substance is proposed to be identified as substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to its classification as toxic for reproduction category 1B1 which corresponds to classification as toxic for reproduction category 22. Summary of how the substance meets the criteria set out in Article 57 (c) of REACH (Repr. 1B). 1-bromopropane; n-propyl bromide is covered by Index number 602-019-00-5 in Regulation (EC) No 1272/2008 and classified in Annex VI, part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as toxic for reproduction, Repr. 1B (H360FD: "May damage fertility. May damage the unborn child."). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of harmonised and classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008 is toxic for reproduction, Repr. Cat. 2; R60 ("May impair fertility"). Therefore, this classification of the substance in Regulation (EC) No 1272/2008 shows that it meets the criteria for classification as toxic for reproduction in accordance with Article 57 (c) of REACH. Registration dossier(s) submitted for the substance? Yes 1 Classification in accordance with Regulation (EC) No 1272/2008 Annex VI, part 3, Table 3.1 List of harmonised classification and labelling of hazardous substances. 2 Classification in accordance with Regulation (EC) No 1272/2008, Annex VI, part 3, Table 3.2 List of harmonised classification and labelling of hazardous substances (from Annex I to Council Directive 67/548/EEC). 4 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC PART I JUSTIFICATION 1 Identity of the substance and physical and chemical properties 1.1 Name and other identifiers of the substance Table 1: Substance identity EC number: EC name: CAS number (in the EC inventory): CAS number: Deleted CAS numbers: CAS name: IUPAC name: 203-445-0 1-bromopropane; n-propyl bromide 106-94-5 106-94-5 Propane, 1-bromo1-bromopropane; n-propyl bromide Index number in Annex VI of the CLP 602-019-00-5 Regulation Molecular formula: C3H7Br Molecular weight range: 123.0 g/mol Synonyms: 1-Propyl bromide; Propyl bromide n-Propyl bromide Structural formula: Br CH3 5 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC 1.2 Composition of the substance Name: 1-bromopropane; n-propyl bromide Description: --Degree of purity: 98 - 100 % Table 2: Constituents Constituents 1-Bromopropane 203-445-0 Typical concentration Concentration range 98 - 100 % Remarks Information according to the available registration dossiers. 6 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC 2 Harmonised classification and labelling 1-bromopropane; n-propyl bromide is covered by Index number 602-019-00-5 in Annex VI, part 3 of Regulation (EC) No 1272/2008 as follows: Table 3: Classification according to part 3 of Annex VI, Table 3.1 ((list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008 Index No International Chemical Identification 602-019-00-5 1-bromopropane; n-propyl bromide EC No 203-445-0 CAS No Classification Labelling Hazard Class and Category Code(s) 106-94-5 Flam. Liq. 2 Repr. 1B STOT RE 2 * Eye Irrit. 2 STOT SE 3 Skin Irrit. 2 STOT SE 3 Hazard statement code(s) Pictogra m, Signal Word Code(s Hazard statement code(s) H225 H360-FD H373 ** H319 H335 H315 H336 GHS02 GHS08 GHS07 Dgr H225 H360FD H373 ** H319 H335 H315 H336 Suppl. Hazard statement code(s) Spec. Conc. Limits, M-factors Notes 7 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC Table 4: Classification according to part 3 of Annex VI, Table 3.2 (list of harmonized classification and labelling of hazardous substances from Annex I of Council Directive 67/548/EEC) of Regulation (EC) No 1272/2008 Index No 602-019-00-5 International Chemical Identification 1-bromopropane; n-propyl bromide EC No 203-445-0 CAS No Classification Labelling 106-94-5 F; R11 Repr. Cat. 2; R60 Repr. Cat. 3; R63 Xn; R48/20 Xi; R36/37/38 R67 F; T R: 60-1136/37/3848/20-63-67 S: 53-45 Concentration Limits Notes E 8 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC 3 Environmental fate properties Not relevant for the identification of the substance as SVHC in accordance with Article 57c. 4 Human health hazard assessment See section 2 on harmonised classification and labelling. 5 Environmental hazard assessment Not relevant for the identification of the substance as SVHC in accordance with Article 57c. 6 Conclusions on the SVHC Properties 6.1 CMR assessment 1-bromopropane; n-propyl bromide is covered by Index number 602-019-00-5 in Regulation (EC) No 1272/2008 and classified in Annex VI, part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as toxic for reproduction, Repr. 1B (H360FD: "May damage fertility. May damage the unborn child"). The corresponding classification in Annex VI, part 3, Table 3.2 (the list of harmonised and classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008 is toxic for reproduction, Repr. Cat. 2; R60 ("May impair fertility"). Therefore, this classification of the substance in Regulation (EC) No 1272/2008 shows that it meets the criteria for classification as toxic for reproduction in accordance with Article 57 (c) of REACH. 9 ANNEX XV - IDENTIFICATION OF 1-BROMOPROPANE AS SVHC PART II INFORMATION ON USE, EXPOSURE, ALTERNATIVES AND RISKS The available use and exposure information is provided in the registration dossiers (authorities with access rights only) or on ECHA's dissemination website3: http://echa.europa.eu/information-on-chemicals ECHA has not carried out further analysis of this information. 3 Information published by ECHA on the substance can be searched at this site (field "Search for Chemicals" at upper right) by EC number, CAS number or substance name. 10