SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 WORKING COPY Dental Use

Transcription

1 Page 1 of 6 SECTION 1 : Identification of the substance/preparation and of the company/undertaking 1.1. Product identifier Product code Product name Product description : VS/64500 : : Hemostatic gel 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses : Professional Dental Hemostatic Agent 1.3. Details of the supplier of the safety data sheet Distributor Henry Schein Inc.(manufacturer) 135 Duryea Road Melville, NY USA EC/REP HENRY SCHEIN U.K. HOLDINGS LTD. MEDCARE HOUSE, CENTURION CLOSE GILLINGHAM BUSINESS PARK GILLINGHAM, ME8 0SB U.K. Emergency Phone : cbdeurope@henryschein.de 1.4. Emergency telephone number CHEMTREC (NORTH AMERICA) :(800) (INTERNATIONAL) :+1(703) SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification according to Directive 1999/45/EC Danger symbols 2.2. Label elements : Xn Classification according to Directive 1999/45/EC Hazard pictogram(s) : Xn Harmful Classification according to Regulation (EC) No 1272/2008 [CLP] Hazard pictogram(s) :

2 Page 2 of 6 Hazard pictogram(s) : Signal Word Hazard statement(s) Precautionary statement(s) General 2.3. Other hazards Immediate concerns Exclamation mark : WARNING : H302: Harmful if swallowed. : P301: IF SWALLOWED: P331: Do NOT induce vomiting. P310: Immediately call a POISON CENTER or doctor/physician. P305: IF IN EYES: P315: Get immediate medical advice/attention. P333+P313: If skin irritation or rash occurs: Get medical advice/attention. : R36/38: Irritating to eyes and skin. SECTION 3: Composition / information on ingredients 3.1. Substances Not Applicable 3.2. Mixtures Chemical Name CAS EINECS No. Wt.% Iron Anion-Sulfate and Subsulfate < 25 For full text of H-statements and R-phrases: see SECTION 16. SECTION 4: First aid measures Classification according to Directive 67/548/EEC Xn; R22; R36/38 Classification according to Regulation (EC) No 1272/2008 [CLP] H302; H290; H317; H314; H335; H332; H Description of first aid measures Following eyes Following skin Following ingestion : Immediately flush eyes with plenty of water for at least 15 minutes. Get immediate medical attention. : Wash with soap and water. : If swallowed, rinse mouth with water, Do NOT Induce Vomiting. Give victim a glass of water or milk. Call a physician or poison control

3 Page 3 of 6 Following inhalation center immediately. Never give anything by mouth to an unconscious person. : No specific treatment is necessary since this material is not likely to be hazardous by inhalation. If exposed to excessive levels of dusts or fumes, remove to fresh air and get medical attention if cough or other symptoms develop Most important symptoms and effects, both acute and delayed Eyes Skin Ingestion Inhalation : Irritating to eyes. : Prolonged or exposure may cause skin irritation : Harmful if swallowed. : None expected for this product Indication of any immediate medical attention and special treatment needed Notes to physician SECTION 5: Fire fighting measures 5.1. Extinguishing media : Not Applicable Extinguishing media : Please see Fire Fighting Equipment under Section Special hazards arising from the substance or mixture Explosion hazards Fire explosion Sensitive to static discharge Sensitivity to impact 5.3. Advice for firefighters Fire fighting procedures Fire fighting equipment SECTION 6: Accidental release measures : As in any fire, wear self-contained breathing apparatus pressure demand, (MSHA/NIOSH) approved or equivalent) and full protective gear. : Water spray, alcohol - resistant foam,dry chemical or carbon dioxide 6.1. Personal precautions, protective equipment and emergency procedures General procedures 6.2. Environmental precautions Water spill : Refer to Section 8 for Personal Protective Equipment Methods and material for containment and cleaning up Small spill Large spill 6.4. Reference to other sections Reference to other sections SECTION 7: Handling and storage : Do not allow to enter sewers or drains that may lead to waterways. : Wipe up with cloth, soap and water. : Collect in tightly closed containers. : Not Applicable

4 Page 4 of Precautions for safe handling Handling : Use suitable protective equipment. Storage : See product labeling Conditions for safe storage, including any incompatibilities Shelf life : See product labeling 7.3. Specific end use(s) Specific end use(s) : Professional Dental Hemostatic Agent SECTION 8: Exposure controls / personal protection 8.1. Control parameters Control parameters 8.2. Exposure controls Eye/face protection : Wear eye protection Skin protection : S36/37: Wear suitable protective clothing and gloves. Respiratory protection : Good general ventilation should be sufficient to control airborne levels. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Gel Colour : Yellowish-brown Odour : Slight iron odor Solubility in water : Partially Soluble 9.2. Other information Percent volatile SECTION 10: Stability and reactivity Reactivity Reactivity : Yes Chemical stability Chemical stability : Sensitive to light Possibility of hazardous reactions Hazardous polymerization : No Conditions to avoid Conditions to avoid : None known Incompatible materials Incompatible materials : Strong acids, strong bases, and oxidizing agents Hazardous decomposition products

5 Page 5 of 6 Hazardous decomposition products : None known. SECTION 11: Toxicological information Information on toxicological effects Acute Notes SECTION 12: Ecological information Toxicity Toxicity Aquatic toxicity (acute) 96-hour LC hour EC hour EC Persistence and degradability : Device is biocompatible when used as directed by dental professionals per ISO : Do not allow to enter sewers or drains that may lead to waterways. Persistence and degradability Bioaccumulative potential Bioaccumulative potential Mobility in soil Mobility in soil Results of PBT and vpvb assessment Results of PBT and vpvb assessment Other adverse effects Environmental data SECTION 13: Disposal considerations : Not Available Waste treatment methods Disposal method : Dispose of in compliance with governmental regulation.(ec 1975L /11/2003) SECTION 14: Transport information UN number UN number : UN proper shipping name UN proper shipping name : Corrosive Liquid, Acidic, Inorganic, N.O.S. (Ferric sulfate mixture) Transport hazard class(es)

6 Page 6 of 6 Hazard classification : Packing group Packing group Environmental hazards Marine pollutant # Special precautions for user ADR - road RID - rail IMDG - sea IATA - air : II Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Transport in bulk SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture RoHS Chemical safety assessment Chemical safety assessment SECTION 16: Other information Relevant R-phrases and/or H- statements (number and full text) Prepared by General statements : Please refer to Medical Devices Directive 93/42/EEC : R22: Harmful if swallowed. R36/38: Irritating to eyes and skin. H290: May be corrosive to metals. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H317: May cause an allergic skin reaction. H318: Causes serious eye damage. H332: Harmful if inhaled. H335: May cause respiratory irritation. : Anu Kattoju : NA = Not Applicable Additional SDS information : Revision #:1 Manufacturer disclaimer : FOR DENTAL USE ONLY: Use as directed. The information and recommendations are taken from sources (raw material MSDS(s) and manufacturer's knowledge) believed to be accurate; however, the manufacturer makes no warranty with respect to the accuracy of the information or the suitability of the recommendation and assumes no liability to any user thereof. Each user should review these recommendations in the specific context of the intended use and determine whether they are appropriate.