SVHC-51 N-甲基吡咯烷酮 1-methyl-2-pyrrolidone_ec_212-828-1(R 生殖毒性)

SVHC SUPPORT DOCUMENT Substance name: 1-methyl-2-pyrrolidone EC number: 212-828-1 CAS number: 872-50-4 MEMBER STATE COMMITTEE SUPPORT DOCUMENT FOR IDENTIFICATION OF 1-METHYL-2-PYRROLIDONE AS A SUBSTANCE OF VERY HIGH CONCERN BECAUSE OF ITS CMR PROPERTIES Adopted on 20 May 2011 SVHC SUPPORT DOCUMENT 1 CONTENTS 1 IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES............................ 4 1.1 NAME AND OTHER IDENTIFIERS OF THE SUBSTANCE ......................................................................................... 4 1.2 COMPOSITION OF THE SUBSTANCE.................................................................................................................... 5 1.3 PHYSICOCHEMICAL PROPERTIES ....................................................................................................................... 6 2 HARMONISED CLASSIFICATION AND LABELLING ................................................................................. 7 3 CONCLUSIONS ON THE SVHC PROPERTIES............................................................................................... 8 3.1 PBT, VPVB ASSESSMENT ................................................................................................................................. 8 3.2 CMR ASSESSMENT ........................................................................................................................................... 8 3.3 SUBSTANCES OF EQUIVALENT LEVEL OF CONCERN ASSESSMENT...................................................................... 8 4 REFERENCES........................................................................................................................................................ 8 TABLES Table 1: Substance identity...........................................................................................................................................4 Table 2: Constituents ....................................................................................................................................................5 Table 3: Impurities........................................................................................................................................................5 Table 4: Additives.........................................................................................................................................................5 Table 5: Overview of physicochemical properties .......................................................................................................6 Table 6: 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 7: 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...............7 SVHC SUPPORT DOCUMENT 2 LIST OF ABBREVIATIONS CAS Chemical Abstracts Service CLH Harmonised Classification and Labelling CSR Chemical Safety Report CMR Carcinogenic, mutagenic or toxic for reproduction ECHA European Chemicals Agency EU European Union MSCA Member State Competent Authority NMP N-Methyl Pyrrolidone OECD Organisation for Economic Co-operation and Development PBT Persistent, Bioaccumulative and Toxic REACH Registration, Evaluation and Authorisation of Chemicals vPvB Very Persistent and very Bioaccumulative SVHC SUPPORT DOCUMENT 3 Substance Name: 1-methyl-2-pyrrolidone EC Number: 212-828-1 CAS number: 872-50-4 • The substance is 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 1 B1 which corresponds to classifications as toxic for reproduction category 22. Summary of how the substance meets the criteria as category 1B reproductive toxicant. N-methyl-2-pyrrolidone is listed as entry 606-021-00-7 of Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009, as of 1 December 2010 and classified in Annex VI, part 3, Table 3.1 (the list of harmonised classification and labelling of hazardous substances) as toxic for reproduction category 1B (H360D: “May damage the unborn child”). The corresponding classification .in Annex VI, part 3, Table 3.2 (the list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC) of Regulation (EC) No 1272/2008 is toxic for reproduction category 2 R61 (“May cause harm to the unborn child”). Therefore, this classification of the substance in Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009 shows that the substance meets the criteria for classification as toxic for reproduction, in accordance with Article 57 (c) of REACH. Registration dossiers 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 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009. 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) as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009. SVHC SUPPORT DOCUMENT 4 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: 212-828-1 EC name: 1-methyl-2-pyrrolidone CAS number (in the EC inventory): 872-50-4 CAS number: Deleted CAS numbers: 872-50-4 53774-35-9, 57762-46-6, 26138-58-9 CAS name: 2-Pyrrolidinone, 1-methyl- IUPAC name: 1-Methylpyrrolidin-2-one Index number in Annex VI of the CLP Regulation 606-021-00-7 Molecular formula: C5H9NO Molecular weight range: 99 g/mol Synonyms: 1-Methyl-2-pyrrolidinone 1-Methyl-5-pyrrolidinone 1-Methylazacyclopentan-2-one 1-Methylpyrrolidone AgsolEx 1 M-Pyrol Microposit 2001 N 0131 N-Methyl-α-pyrrolidinone N-Methyl-α-pyrrolidone N-Methyl-γ-butyrolactam N-Methyl-2-ketopyrrolidine N-Methyl-2-pyrrolidinone N-Methyl-2-pyrrolidone N-Methylbutyrolactam N-Methylpyrrolidone NMP NSC 4594 Pharmasolve Pyrol M SL 1332 SVHC SUPPORT DOCUMENT 5 Structural formula: N O CH3 1.2 Composition of the substance Name: 1-methyl-2-pyrrolidone Description: --- Degree of purity: ≥80 - ≤100 % Table 2: Constituents Constituents Typical concentration Concentration range Remarks 1-Methylpyrrolidin-2- one ≥80 - ≤100 % Table 3: Impurities Impurities Typical concentration Concentration range Remarks Information not relevant Table 4: Additives Additives Typical concentration Concentration range Remarks None SVHC SUPPORT DOCUMENT 6 1.3 Physicochemical properties Table 5: Overview of physicochemical properties3 Property Value Remarks Physical state at 20°C and 101.3 kPa Liquid, colourless with ammonia-like odour Harreus (2005) Melting/freezing point -24.4 °C Harreus (2005) Boiling point 204.3 °C at 101.3 kPa Harreus (2005) Vapour pressure 0.04 kPa at 25 °C Lide (1994) Density 1.028 g/cm3 at 25 °C Harreus (2005) Water solubility completely miscible with water Harreus (2005) Partition coefficient n- octanol/water (log value) -0.54 at 25 °C ECHA (2011) Domanska and Lachwa (2002) Surface tension 52.9 mN/m at 25 °C and 0.1 vol. % 50.1 mN/m at 50 °C and 0.1 vol. % 50.8 mN/m at 25 °C and 1 vol. % 48.0 mN/m at 50 °C and 1 vol. % 48.3 mN/m at 25 °C and 10 vol. % 44.6 mN/m at 50 °C and 10 vol. % García-Abuín et al. (2008) pH value 7.7 – 8 Concentration: 10 % aqueous solution Harreus (2005) Viscosity 1.796 mPa s at 20 °C Harreus (2005) Refractive index 1.469 at 25 °C Harreus (2005) Flash point 91 °C (DIN 51758) Harreus (2005) Auto-Ignition Temperature 245 °C (DIN 51794) Harreus (2005) 3 The references of the values reported in Table 5 are available in the technical dossier. SVHC SUPPORT DOCUMENT 7 2 HARMONISED CLASSIFICATION AND LABELLING Pursuant to the first ATP to Regulation (EC) No 1272/2008 (Commission Regulation (EC) No 790/2009) as of 1 December 2010, 1-methyl-2-pyrrolidone is listed with index number 606-021-00- 7 in Annex VI, part 3 of Regulation (EC) No 1272/2008 (list of harmonised classification and labelling of hazardous substances) with the following classification: Table 6: 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 Classification Labelling Index No International Chemical Identification EC No CAS No Hazard Class and Category Code(s) Hazard state- ment code(s) Pictogram , Signal Word Code(s Hazard statement code(s) Suppl. Hazard statement code(s) Spec. Conc. Limits, M- factors Notes 606-021-00-7 N-methyl-2- pyrrolidone; 1-methyl-2- pyrrolidone 212-828-1 872-50-4 Repr. 1B Eye Irrit. 2 STOT SE 3 Skin Irrit. 2 H360D*** H319 H335 H315 GHS08 GHS07 Dgr H360D*** H319 H335 H315 Repr. 1B; H360D: C ≥ 5 % STOT SE 3; H335: C ≥ 10 % Repr. 1B, H360D***4 May damage the unborn child. Eye Irrit. 2 H319 Causes serious eye irritation. Skin Irrit. 2 H315 Causes skin irritation. STOT Single Exp. 3 H335 May cause respiratory irritation. Table 7: 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 International Chemical Identification EC No CAS No Classification Labelling Concentration Limits Notes 606-021-00-7 N-methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone 212-828-1 872-50-4 Repr. Cat. 2; R61 Xi; R36/37/38 T R: 61-36/37/38 S: 53-45 Repr. Cat. 2; R61: C ≥ 5 % Xi; R36/37/38: C ≥ 10 % Repr. Cat. 2; R61 May cause harm to the unborn child. Xi - R36/37/38 Irritating to eyes, respiratory system and skin. 4 According to Annex VI (Part 1, entry 1.2.3): H360 and H361 indicate a general concern for effects on both fertility and development: ‘May damage/Suspected fertility or the unborn child’. According to the criteria, the general hazard statement can be replaced by the hazard statement indicating only the property of concern, where either fertility or developmental effects are proven to be not relevant. In order not to lose information from the harmonised classifications for fertility and developmental effects under Directive 67/548/EEC, the classifications have been translated only for those effects classified under that Directive. These hazards statements are indicated by reference *** in Table 3.1. SVHC SUPPORT DOCUMENT 8 3 CONCLUSIONS ON THE SVHC PROPERTIES 3.1 PBT, vPvB assessment Not relevant for the identification of the substance as SVHC in accordance with Article 57(c). 3.2 CMR assessment Pursuant to Regulation (EC) No 1272/2008 as amended and adapted to technical and scientific progress by Regulation (EC) No 790/2009, as of 1 December 2010, N-methyl-2-pyrrolidone is listed as entry 606-021-00-7 in Annex VI, part 3, Table 3.1 (the list of harmonised classification and labelling of hazardous substances) of Regulation (EC) No 1272/2008 as toxic for reproduction category 1B1. Its 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 category 22. Therefore, this classification of the substance in Regulation (EC) No 1272/2008 shows that the substance meets the criteria for classification as toxic for reproduction, in accordance with Article 57 (c) of REACH. 3.3 Substances of equivalent level of concern assessment Not relevant for the identification of the substance as SVHC in accordance with Article 57(c). 4 REFERENCES Domanska U. and Lachwa J. (2002). (Solid + liquid) phase equilibria of binary mixtures containing N-methyl-2-pyrrolidinone and long-chain n-alkanols at atmospheric pressure. Fluid Phase Equilibria 198, 1-14. ECHA (2011). Calculation according to EPISUITE performed with the module WSKOWWIN, 2011 García-Abuín, A.; Gómez-Díaz, D.; Navaza, J.M. and Vidal-Tato, I. (2008). Surface Tension of Aqueous Solutions of Short N-Alkyl-2-pyrrolidinones. J. Chem. Eng. Data 2008, 53, 2671–2674. Harreus, A. L. (2000): Ullmann's Encyclopedia of Industrial Chemistry Copyright © 2008 by John Wiley & Sons, Inc. All Rights Reserved. Last updated: 30 Oct 2008 Harreus, A. L. (2005): 2-Pyrrolidone. Wiley-VCH Verlag GmbH & Co.KGaA, Weinheim, 2005 Lide, D. R. (1994). Handbook of Chemistry and Physics, 75th Edition, CRC Press, Boca Raton, Ann Arbor, London, Tokyo, 1994