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 : Catalog Part# 361 Product name Product description : : Surgical grade latex, holds the arch wire in the bracket slot 1.2. Relevant identified uses of the substance or mixture and uses advised against Relevant identified uses : Orthodontic Elastics 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 Classification according to Regulation (EC) No 1272/2008 [CLP] Health 2.2. Label elements : The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. This material is not considered hazardous to health. : Not Classified Classification according to Directive 1999/45/EC : This material is not considered to be hazardous for the health. Classification according to Regulation (EC) No 1272/2008 [CLP] Hazard statement(s) Precautionary statement(s) Prevention Response : 4068JGBC: This Material Is Not Considered Hazardous For The Health. : P333+P313: If skin irritation or rash occurs: Get medical advice/attention. : P305: IF IN EYES: P351: Rinse cautiously with water for several minutes. P337+P313: If eye irritation persists: Get medical advice/attention.

2 Page 2 of 7 Storage Disposal 2.3. Other hazards Immediate concerns P302+P352: IF ON SKIN: Wash with plenty of soap and water. P332+P313: If skin irritation occurs: Get medical advice/attention. : P410: Protect from sunlight. : P501: Dispose of in compliance with governmental regulation. (EC 1975L /11/2003) : May cause sensitization. SECTION 3: Composition / information on ingredients 3.1. Substances Not Applicable 3.2. Mixtures Chemical Name CAS EINECS No. Wt.% Classification according to Regulation (EC) No 1272/2008 [CLP] Polyisoprene rubber N/A < 100 Not classified SECTION 4: First aid measures 4.1. Description of first aid measures Following eyes Following skin Following ingestion Following inhalation : Immediately flush eyes with plenty of water. Get medical attention, if irritation persists. : Wash with soap and water. Get medical attention if irritation develops or persists. : If swallowed in small quantity the product is harmless, otherwise consult a doctor. : None Expected Most important symptoms and effects, both acute and delayed Eyes Skin Ingestion Inhalation : May cause eye irritation. : May cause sensitization to skin. : May be harmful if swallowed in large quantities. : None expected for this product Indication of any immediate medical attention and special treatment needed SECTION 5: Fire fighting measures : May irritate persons with latex allergies

3 Page 3 of Extinguishing media Extinguishing media : Please see Fire Fighting Equipment under Section Special hazards arising from the substance or mixture Hazardous combustion products: None known. Explosion hazards Fire explosion Sensitive to static discharge Sensitivity to impact 5.3. Advice for firefighters Fire fighting procedures Fire fighting equipment : Not Applicable 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. : Water, fog or foam, dry chemical : When exposed to flame, emits oxides of carbon and other acrid fumes such as sulfur dioxide and carbon monoxide 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. : Not Applicable 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 Handling Storage : Vacuum or sweep up material and place in a disposal container. : Not Applicable : Use suitable protective equipment. : 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 Elastics SECTION 8: Exposure controls / personal protection

4 Page 4 of Control parameters Control parameters 8.2. Exposure controls Engineering controls Eye/face protection Skin protection Work hygienic practices SECTION 9: Physical and chemical properties : No special ventilation requirements. : Not needed for normal use. : Not needed for normal use Information on basic physical and chemical properties Physical state Colour Odour : Workers exposed to latex gloves and other medical products containing natural rubber latex may develop allergic reactions such as skin rashes, hives, eye or sinus symptoms, asthma and (rarely) shock. : Persons allergic to fruits or persons with spina bifida may be allergic to natural rubber. : Solid : Color dependent : Rubber Density : 0.95 at 20 C Solubility in water 9.2. Other information Percent volatile SECTION 10: Stability and reactivity Reactivity Reactivity Chemical stability Chemical stability : Stable Possibility of hazardous reactions Hazardous polymerization Conditions to avoid Conditions to avoid Incompatible materials Incompatible materials : Stable when stored and handled under recommended conditions. : None : High Temperatures Hazardous decomposition products Hazardous decomposition products

5 Page 5 of 7 SECTION 11: Toxicological information Information on toxicological effects Acute Dermal LD 50 Oral LD 50 Inhalation LC 50 SECTION 12: Ecological information Toxicity Aquatic toxicity (acute) 96-hour LC hour EC hour EC Persistence and degradability 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 : No data 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 Transport hazard class(es)

6 Page 6 of 7 Hazard classification Packing group Packing group Environmental hazards Marine pollutant # Special precautions for user ADR - road RID - rail IMDG - sea IATA - air 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 Prepared by : Please refer to Medical Devices Directive 93/42/EEC : Caution: This product contains natural rubber latex which may cause an allergic reaction. : Anu Kattoju Revision summary : This SDS replaces the 12/04/2012 SDS. Revised: Section 1: GENERAL USE, PREPARED BY. Section 2: EMERGENCY OVERVIEW - IMMEDIATE CONCERNS. Section 3: Wt.%. Section 4: COMMENTS, SIGNS AND SYMPTOMS OF OVEREXPOSURE ( INGESTION, INHALATION, SKIN ). Section 5: COMMENTS, EXPLOSION HAZARDS, EXTINGUISHING MEDIA, FIRE EXPLOSION, FIRE FIGHTING EQUIPMENT, HAZARDOUS COMBUSTION PRODUCTS, SENSITIVE TO STATIC DISCHARGE, SENSITIVITY TO IMPACT. Section 6: GENERAL PROCEDURES, WATER SPILL,. Section 7: SHELF LIFE, STORAGE,. Section 8: COMMENTS, PERSONAL PROTECTIVE EQUIPMENT ( EYES AND FACE ), WORK HYGIENIC PRACTICES,. Section 9: DENSITY, ODOR, PERCENT VOLATILE, SOLUBILITY IN WATER. Section 10: HAZARDOUS POLYMERIZATION, STABILITY, STABLE. Section 11: ACUTE ( ORAL LD 50 (rat), INHALATION LC 50 (rat) ). Section 12: CHEMICAL FATE INFORMATION, DISTRIBUTION, BIOACCUMULATION/ACCUMULATION, AQUATIC TOXICITY (ACUTE) ( 48-HOUR EC 50, 96-HOUR EC 50 ), SECTION 12: Ecological

7 Page 7 of 7 General statements information. Section 14: AIR (ICAO/IATA) - SPECIAL PROVISIONS ROAD AND RAIL (ADR/RID), ROAD AND RAIL (ADR/RID) ( PROPER SHIPPING NAME, UN NUMBER, PACKING GROUP ), VESSEL (IMO/IMDG) ( SPECIAL PROVISIONS ), ROAD AND RAIL (UK only) (CDG) - SPECIAL PROVISIONS SECTION 14: Transport information. Section 15: COMMENTS, RoHS, SECTION 15: Regulatory information. Section 16: Revision Summary, GENERAL STATEMENTS. = Not Applicable Additional SDS information : Revision #:1 Manufacturer disclaimer : FOR ORTHO USE ONLY: Use as directed. The information and recommendations are taken from sources (raw material SDS(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.