1 of 10 sorbion eet BERET Sen char MATERIAL SAFETY DATA SHEET 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Product Identifier: ‘sorbion sachet border Product Description: Absorbent wound dressing combined with an adhesive backsheet that is indicated for moderate to heavy exuding ‘wounds. ‘Synonyms: N/A Chemical Family: Wound pad: mixture of wood cellulose and polyacrylate enclosed in polypropylene nonwoven - Backsheet: single coated polyurethane foam tape. - Liner: siliconized paper. Chemical Formula: na Manufacturer: sorbion GmbH & Co. KG Im Suedfeld 11 48308 Senden Germany ‘www.sorbion.com Distributor USA: Alliqua Biomedical Inc. 2150 Cabot Blvd West Langhorne, PA 19047 USA For further product information, please contact info@alliqua.com or (215) 702-8550. Emergency Telephone Number (215) 702-8550. Proprietary information. No disclosure without sorbion’s written approvalsorbion Betnepat mera sorbion sachet border 2. COMPOSITION / INFORMATION ON INGREDIENTS - WOUND PAD (sorbion sachet S): ‘Component CAS No. Risk Phrases Safety Phrases % (w/w) ‘Sodium polyacrylate 9033-79-8 —- - 48 - 53 Wood pulp 65996-61-4 - : 37-40 Polypropylene 9003-07-0 - - 5-12 Cellulose Tissue__n/a : : 2-3 - BACKSHEET: Single coated polyurethane foam tape. The adhesive is a solventless medical acrylic adhesive. The carrier is a polyurethane foam/polyurethane film. + LINER: siliconized paper. 3. POTENTIAL HEALTH EFFECTS: This product is not considered to be dangerous to man and the environment. There is no evidence to suggest that this product constitutes adverse physicochemical, human health and environmental effects and symptoms during use and handling under intended product use conditions. INHALATION: Not considered a likely route of entry under intended product use conditions. However, if inhaled can give respiratory irritation, cough. SKIN CONTACT: The product is designed for skin contact EYE CONTACT: Not considered a likely route of entry under intended product use conditions. However, the material can give irritation to eyes; turing red. INGESTION Not considered a likely route of entry under intended product use conditions. However, the material may cause gastrointestinal irritation if swallowed. DANGEROUS DECOMPOSITION OF THE PRODUCT: ‘The product is stable at room temperature. Proprietary information. No disclosure without sorbion’s written approval.sorbion Date Prepared: 2014-01-21 Revision: US1 Product: sorbion sachet border 4. FIRST AID MEASURES INHALATION: EYE CONTACT: ‘SKIN CONTACT: INGESTION: Unlikely as product is solid. If involved in a fire, toxic materials are likely to be formed from the breakdown of the polyurethane film/foam. Avoid breathing dust, use dusk mask if necessary. Remove to fresh air. If persistent iritation, coughing or breathing difficulties occur, get medical attention. Flush with water. Remove contact lenses for better cleaning. If irritation persists or flushing is inadequate, get medical attention Product is designed for skin contact. If a rash, persistent irritation or dermatitis occurs, get medical attention. Get medical attention if any related symptoms occur after accidental ingestion. 5. FIRE & EXPLOSION HAZARD DATA FLASHPOINT: FLAMMABLE / EXPLOSIVE LIMITS IN AIR: FIRE FIGHTHING INSTRUCTIONS: na LEL = see explosion hazards UEL = na Burning is accompanied by melting and dripping which may cause the fire to spread. Combustion will evolve irritant, possibly toxic vapours. In addition to the normal breakdown products from buming paper and cellulose (CO, CO>, etc.) thermal degradation of the foam will generate breakdown products which might include NHs, hydrocarbons, nitrogen oxides, isocyanate vapours and hydrogen cyanate vapours. The film component may form some nitrogenous organic compounds. The ratio depends on the burning temperature and the presence of oxygen. Extinguish with foam, sand, dry powder or carbondioxide. Do not use water jet. Dust explosion Proprietary information. No disclosure without sorbion’s written approvalsorbion Page: 4 Date Prepared: 2014.01.21 Revision: US1 Product: __sorbion sachet border PROTECTIVE EQUIPMENT FOR FIRE FIGHTING: EXPLOSION HAZARDS: hazard may result from forceful application of fire extinguishing agents. Wear self contained positive pressure breathing apparatus with full face mask and full protective clothing, Depending on moisture content, particle diameter and rate of heating cellulose dust may explode in the presence of an ignition source. 6. ACCIDENTAL RELEASE MEASURES SPILL OR LEAK PROCEDURES: WASTE DISPOSAL METHODS: 7. SPECIAL PRECAUTIONS HANDLING & STORAGE: OTHER PRECAUTIONS: The product is a solid and insoluble product. Therefore uncontrolled release (into air or water) is highly unlikely. Recycle or dispose of as a non-hazardous, solid waste in accordance with local regulations and requirements. For proper handling and usage of the dressing please refer to the instructions for use. Store at normal room temperature (below 30 °C), out of direct sunlight and in a dry location. Handle and store away from ignition sources. Minimize compressed air blowdown or other practices that may generate high dust levels. Edges of the release paper / film can be sharp, causing possible lacerations. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION EYE PROTECTION: Not applicable for the product in the purchased form. Safety glasses or goggles may be needed if product is used in a way that generates dust Proprietary information. No disclosure without sorbion’s written approval.sorbion SKIN PROTECTION: RESPIRATORY PROTECTION: OTHER PERSONAL PROTECTION: VENTILATION: WORK / HYGIENE PRACTICLES: EXPOSURE GUIDELINES: Date Prepared: 2014-01-21 Revision: USI Product: _sorbion sachet border Not applicable for the product in the purchased form. The product is designed for skin contact. Not applicable for the product in the purchased form. NIOSH approved for particulate as needed when allowable dust exposure limits may be exceeded. If required only wear appropriate approved respiratory protections. None Local exhaust as needed to control below PEL. Avoid creation of dust. The European Disposables and Nonwoven Association EDANA recommended Industrial Hygiene Guideline is 0.05 mg/m? respirable superabsorbent polymer dust (particle size < 10 um) based on NOEL (see section 10). 9. PHYSICAL AND CHEMICAL PROPERTIES WOUND PAD: COLOR: VAPOR PRESSURE: VAPOR DENSITY: SPECIFIC GRAVITY: (water = 1) BOILING POINT: MELTING POINT: AUTO IGNITION POINT: pH White NIA NIA <1 NIA 170 °C / 388 °F 232°C / 450 °F NIA Proprietary information. No disclosure without sorbion’s written approval.- : 2 pasetawae sorbion a POLYMERIZATION: Does not occur. STABILITY: Product is stable. INCOMPATIBILITY: Avoid acids, bases, strong oxidizing agents and ignition sources. - BACKSHEET: PHYSICAL STATE: Solid ODOUR: Slight smell. COLOUR: Adhesive: clear; Carrier: beige. pH: NIA BOILING POINT: NIA FLASHPOINT: NA DECOMPOSITION TEMP.: NIA AUTO-IGNITION TEMP. N/A RELATIVE DENSITY (ADHESIVE): 1.0201 gicm* SOLUBILITY IN WATER: VAPOUR DENSITY: STABILITY: + LINER: PHYSICAL STATE: COLOUR: VAPOR DENSITY: RELATIVE DENSITY: Not soluble in water. NIA The product is stable under normal operating conditions. Solid White N/A (solid product) na Proprietary information. No disclosure without sorbion’s written approvalsorbion BOILING POINT: FLASHPOINT: AUTO IGNITION POINT: pH: DECOMPOSITION TEMP.: STABILITY: Pag 7 Date Prepared: 2014-01-21 Revision: US1 Product: _sorbion sachet border N/A (solid product) na Wa N/A na Product is stable under normal operating conditions. 10. TOXICOLOGICAL INFORMATION FINISHED PRODUCT ASSESMENT: The biological safety of the finished product has been evaluated according to the requirements of DIN EN ISO 10999. The adhesive dressing is intended to be used on chronic wounds within the indication given in the instructions for use ACUTE TOXICITY FROM SUPERABSORBENT POLYMERS TARGET ORGANS: INGESTION: SKIN CONTACT: Lungs from dust. Single dose oral toxicity is considered to be low. The oral LD50 for rats is >2500 mg/kg. No hazards anticipated from swallowing small amounts incidental to normal handling operations. A single prolonged exposure is not likely to result in, the material being absorbed through the skin in harmful amounts. The LD50 for skin contact in rats is > 2000 mg/kg. IRRITATION OF THE SUPERABSORBENT POLYMER, SKIN: EYES: Prolonged or repeated exposure is not likely to cause significant skin irritation. May cause eye irritation. May cause very slight transient (i.e. temporary) comeal injury. ry Information. No disclosure without sorbion's written approval.sorbion INHALATION: CARCINOGENICITY: MUTAGENICITY: TERATOGENICITY: SENSITIZER: Page: 8 Date Prepared: 2014-01-21 Revision: USt Product: _sorbion sachet border Dust may cause irritation to upper respiratory tract (throat and nose). Not an OSHA, IARC or NTP carcinogen. A chronic (2 years) lifetime inhalation study with micronized superabsorbent polymer dust (to get completely respirable particles) performed on rats resulted in a non-specific inflammatory respond in the lung of the rats, followed in the highest chronic exposure level by tumor development in some animals. in the absence of chronic inflammation tumors are not expected. The study found a definite NOEL of 0.05 mg/m: of micronized superabsorbent polymer dust. In vitro mutagenicity studies were negative. Animal mutagenicity studies were negative. NIA NIA 11. ECOLOGICAL INFORMATION MOBILITY AND BIO- ACCUMULATION POTENTIAL: DEGRADATION: AQUATIC TOXICITY: Partitioning from water to n-octanol is not applicable. Bioaccumulation is not expected because of the relatively high molecular weight (MW > 1000 Da). Potential for mobility in soil is slight (Poc between 2000 and 5000). Biodegradation is not expected in a wastewater plant. Chemical degradation (hydrolysis) is expected in the environment within month or years. Parts of the product will slowly degrade under exposure of Uv-light. Acute LC50 for fathead minnow (Pimephales promelas) is 610 mg/L. Acute LC50 for water flea (Daphnia magna) is > 1000 mg/L. Material is not harmful to aquatic organisms (LCSO/ECSO/IC5O > 100 mg/L). Proprietary information. No disclosure without sorbion’s written approval.sorbion Page: 8 Date Prepared: 2014-01-21 Revision: US1 Product: _sorbion sachet border 12, DISPOSABLE CONSIDERATION WASTE DEPOSIT METHOD: 13. TRANSPORT INFORMATION Deposit in a landfill or incinerate in accordance with federal state and local regulations. ‘The product is not a hazardous good by any means of transportation. Special labels are not required. 14. REGULATORY INFORMATION CERCLA: SARA TITLE Ill: TSCA: OTHER: CALIFORNIA PROPOSITION 65: This product is not listed as a hazardous substance under 40 CFR 302.4. 311 / 312 Hazardous Categories: None. 313 Reportable Ingredients: None. This product or components of this product are listed on the TSCA Inventory. We recommend that you contact local authorities to determine if there may be other local reporting requirements. Some chemical compounds listed by the State of California under Proposition 65 may naturally be present in this product. The manufacturer is unaware of any universal analytical scheme that enables us to analyze this product for the presence or absence of all chemical compounds listed by the State of California. No testing has been done for Proposition 65 listed chemical compounds. Proprietary information. No disclosure without sorbion’s written approvalb i Page: 10 sorbion SE iepe eons a ere 15. OTHER INFORMATION For more non-emergency information about this product, please call the distributor or the manufacturer. THE INFORMATION IN THIS SAFTY DATA SHEET IS GIVEN IN GOOD FAITH AND RELATES TO THIS SPECIFIC MATERIAL. IT IS ACCURATE TO THE BEST OF OUR KNOWLEDGE BUT IT MAY NOT BE VALID FOR THIS MATERIAL IF USED IN COMBINATION WITH ANY OTHER MATERIALS OR IN ANY PROCESS. IT IS THE USERS’ RESPONSIBILITY TO SATISFY THEMSELVES AS TO THE SUITABILITY AND COMPLETENESS OF THIS INFORMATION FOR THEIR OWN PARTICULAR USE AND UNDER LOCAL HEALTH AND SAFETY LEGISLATIONS Effective date: 2014-01-21 Supersedes: : Va = not available N/A = Not Applicable Proprietary information. No disclosure without sorbion's written approval.