SYNIMED SAFETY DATA SHEET ISSUE DATE AUGUST 6, 2019 REVIEW: ----- THIS SAFETY DATA SHEET HAS BEEN PREPARED IN ACCORDANCE WITH DIRECTIVES 91/155 / CEE, 93/112 / CE, 2001/5 / CE AND SGA / GHS AND RES.SRT Nº 801/15 PAGE 1 OF 7 DATE: 06/08/2019 SURGICAL CEMENT Section 1 PRODUCT IDENTIFICATION Product: Surgical Cement (Acrylic resin with a powder component and a liquid component) Product use: The mixture of both components is used for the repair of cranial and facial bone defects of traumatic, surgical or tumor origin. Their reaction gives rise to a solid and rigid piece (cured cement). Maker: Laboratorios SL SA, Estados Unidos 4503 (B1667JHA), Area Promoción el Triangulo, Malvinas Argentinas, Buenos Aires, Argentina. (+54 11) 5272 4060 e-mail: [email protected] Authorized representative to the EU: Synimed Synergie Ingénierie Médicale SARLZA de l´Angle, 19370 Chamberet, France Emergency telephone number: Tel. +5411 52724060 Section 2 HAZARDS IDENTIFICATION 2.1 Classification of the mixture Component Description Classes and categories of danger Warnings Solid Methyl polymethacrylate Non-hazardous - Barium sulfate Non-hazardous - Liquid Methyl methacrylate Flammable liquid (Category 2) Skin irritation (Category 2) Skin sensitization (Category 1) Specific toxicity for target organs - single exposure (Category 3) H225 H315 H317 H335 N, N-dimethyl p- toluidine Specific toxicity for target organs - repeated exposure (Category 2) Toxicity for the aquatic environment (Category 3) Acute toxicity, inhalation (Category 3) Acute toxicity, Dermal (Category 3) Acute toxicity, oral (Category 3) H373 H412 H311 H331 H301 2.1.2 Classification according to Directives 67/548 / CEE or CEE or 1999/45 / CE Component Description R and S phrases Solid Methyl polymethacrylate Non-hazardous - Barium sulfate Non-hazardous - Liquid Methyl methacrylate Flammable, irritant R11 / R37 / R38 / R43 N, N-dimethyl-p-toluidine Toxic by inhalation, skin contact and ingestion. Danger of cumulative effects. Harmful to aquatic organisms. R23/24/25 R33 R52/53 Notes: Carcinogenicity, teratogenicity, mutagenicity, chronic toxicity on the reproductive system and synergistic properties are not known SDSJ0912A 1 of 7
