SAFETY DATA SHEET according to Regulation (EC) No. 453/2010 Orthodontic Use

Transcription

1 Page 1 of 7 SECTION 1 : Identification of the substance/preparation and of the company/undertaking 1.1. Product identifier Product code Product name Product description : Metal Type (Style II) : 300 Series Stainless Steel: Avex MX, Avex BX, Molar Bands, Esprit, Via Wires, Arch Wires, Ligature Wires (incl. Kobayshi), Ball Hooks, Split Stops, Micro Stops : Stainless Steel Wires and Attachments Brackets, Buccal Tubes, Molar Bands, Class II Corrector 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses : Orthodontic archwire 1.3. Details of the supplier of the safety data sheet Manufacturer Distributor Opal Orthodontics MPG Service GmbH 505 W S Gereonstrasse South Jordan, UT D Cologne, Germany mpgservicekoeln@googl .com Emergency Phone : +49(0) 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 2.2. Label elements : Not Applicable Classification according to Regulation (EC) No 1272/2008 [CLP] Hazard statement(s) 2.3. Other hazards Immediate concerns Additional information : 9502HLMN: This Material is not considered to be hazardous for the health. : No adverse human effects : Nickel may cause an allergic skin reaction. SECTION 3: Composition / information on ingredients 3.1. Substances Not Applicable

2 Page 2 of Mixtures Chemical Name CAS EINECS No. Wt.% Classification according to Directive 67/548/EEC Iron* Xi; R36/38 Chromium Nickel Metal Manganese Molybdenum Aluminum Copper Cobalt Metal Powder Additional information For full text of H-statements and R-phrases: see SECTION 16. SECTION 4: First aid measures 4.1. Description of first aid measures Following eyes Following skin Following ingestion : *THESE SUBTANCES ARE REGULATED IN THEIR OXIDE FORM* : Immediately flush eyes with plenty of water for at least 15 minutes. Get immediate medical attention. : Wash with soap and water. Get medical attention if irritation develops or persists. : While ingestion of large enough quantities to cause health effects is unlikely. Consult a physician if it occurs. Xn; R22; R40 T; Xn; R40; R43; R48/23; R52/53 F, Xi; R11; R22 Xi; R22 F; R11; R15; R17; R38 Xi; R22 Xn; R22; R42/43; R53

3 Page 3 of 7 Following inhalation : 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 : May cause mild irritation. : None expected for this product. : Not likely to be ingested. : 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 SECTION 6: Accidental release measures : General: Evacuate all personnel; use protective equipment for firefighting. Use self-contained breathing apparatus when the product is involved in fire Personal precautions, protective equipment and emergency procedures General procedures : Ventilation: If your process causes a release of dust or fume, use local and general exaust ventilation to keep airborne concentrations of dust or fumes below the TLV. Respiratory Protection: If your process causes a release of dust or fume in excess of the permissible exposure limit, use approved respirators for protection against airborne dust or fumes should be worn. Respirators should be used in accordance with 29CFR Protective Equipment: Gloves and barrier creams may be necessary to prevent skin sensitization and dermititis. If your process involves grinding or any other action that causes the release of dust or fumes, approved safety glasses or goggles should be worn.

4 Page 4 of Environmental precautions 6.3. Methods and material for containment and cleaning up Small spill 6.4. Reference to other sections Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling Storage : Vacuum or sweep up material and place in a disposal container. : Not Applicable : See product labeling Conditions for safe storage, including any incompatibilities Shelf life 7.3. Specific end use(s) Specific end use(s) : See product labeling : Orthodontic Archwire SECTION 8: Exposure controls / personal protection 8.1. Control parameters Control parameters 8.2. Exposure controls Eye/face protection : Wear eye protection Skin protection : No special measures required. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Colour : Metallic Luster Odour : No characteristic odor 9.2. Other information Percent volatile SECTION 10: Stability and reactivity Reactivity Stable : Yes Chemical stability Chemical stability : Stable when stored and handled under recommended conditions Possibility of hazardous reactions Hazardous polymerization : No

5 Page 5 of Conditions to avoid Conditions to avoid Incompatible materials Incompatible materials : None Hazardous decomposition products Hazardous decomposition products SECTION 11: Toxicological information : None known Information on toxicological effects Acute Dermal LD 50 Oral LD 50 Inhalation LC 50 Carcinogenicity SECTION 12: Ecological information Toxicity Aquatic toxicity (acute) 96-hour LC Persistence and degradability Persistence and degradability Bioaccumulative potential Bioaccumulative potential Mobility in soil Mobility in soil : This product may contain the following chemicals which are subject to the reporting requirements of Section 313 of the Emergency Planning and Community Right to Know Act of 1986 and of 40 CFR 372: Aluminum, Manganese, Chromium, Nickel, Cobalt, Vanadium, Copper : Do not allow to enter sewers or drains that may lead to waterways Results of PBT and vpvb assessment Results of PBT and vpvb assessment Other adverse effects Environmental data SECTION 13: Disposal considerations : Not Available

6 Page 6 of 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 Transport hazard class(es) Primary hazard class/division Packing group Packing group Environmental hazards Marine pollutant # Special precautions for user ADR - road RID - rail IMDG - sea IATA - air : Not classified Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code Transport in bulk Additional information SECTION 15: Regulatory information : Not dangerous according to current transportation regulations Safety, health and environmental regulations/legislation specific for the substance or mixture RoHS General comments Chemical safety assessment Chemical safety assessment SECTION 16: Other information : Please refer to Medical Devices Directive 93/42/EEC : Warning: The following are on the Prop.65 list of chemicals know to the State of California to cause cancer, Nickel (Metallic), Cobalt Metal Powder. Relevant R-phrases and/or H- statements (number and full : R11: Highly flammable. R15: Contact with water liberates extremely flammable gases.

7 Page 7 of 7 text) Prepared by Revision summary General statements Manufacturer disclaimer R17: Spontaneously flammable in air. R22: Harmful if swallowed. R36/37/38: Irritating to eyes, respiratory system and skin. R36/38: Irritating to eyes and skin. R38: Irritating to skin. R40: Limited evidence of a carcinogenic effect. R42/43: May cause sensitization by inhalation and skin contact. R43: May cause sensitization by skin contact. R48/23: Toxic : danger of serious damage to health by prolonged exposure through inhalation. R52/53: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R53: May cause long-term adverse effects in the aquatic environment. : Anu Kattoju : This SDS replaces the 2/24/2014 SDS. =Not Applicable : FOR ORTHO 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.