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1 1. IDENTIFICATION Product Name: Product Number: IS50 (33730), IS100 (33736), IS200 (33737) Date Prepared: 3/25/15 Manufacturer: Telephone: MEDICAL EMERGENCY: TRANSPORTATION EMERGENCY: INFORMATION: Halyard Health Inc Windward Parkway Alpharetta, Georgia Call 911 or your local Emergency Room or Poison Control Services Chemtrec or (collect calls accepted) HALYARD Product Use: InteguSeal* is intended for use after typical preoperative skin preparations and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure. 2. HAZARDS IDENTIFICATION GHS Classification: Not Hazardous GHS Labeling: No GHS labeling required. 3. COMPOSITION/INFORMATION ON INGREDIENTS Chemical Name n-butyl Cyanoacrylate (enbucrylate; enbucrilate) Tributyl o-acetylcitrate (2- Acetyltributylcitrate; 1,2,3- Propanetricarboxylic acid, 2- (acetoxy)-, tributyl ester) CAS-No./ EINECS-No / / % GHS Classification: 80% Not Hazardous 20% Not Hazardous 4. FIRST AID MEASURES Inhalation: Move to fresh air. If symptoms persist, call a physician. Skin contact: Do not force separation. Peel or roll skin apart in warm, soapy water using a blunt instrument such as a spoon. Pre-soaking in a solution of 5% sodium bicarbonate will assist separation. Discontinue use and obtain medical attention if irritation develops and persists. Eye contact: Do not force eye open. If eyelids are bonded closed, release eyelashes with warm water by covering with a wet pad. Cyanoacrylate that has bonded to eye protein will 1/6

2 produce tears, which will assist in the debonding process. Keep eye covered with a wet pad until debonding is complete, usually within 1-3 days. Seek medical advice if solid cyanoacrylate particles are trapped behind the eyelid. Particles may cause abrasive damage. Obtain medical attention if irritation persists. Ingestion: If contents are swallowed - Do not induce vomiting. If victim is conscious, rinse mouth with a small amount of water. Never give anything by mouth to a person who is unconscious or drowsy. Obtain immediate medical attention. Saliva should lift adhesive in 12 to 48 hours. Avoid swallowing adhesive after detachment. Lips may become bonded together. Apply large amounts of warm water and encourage wetting from saliva inside the mouth. Peel or roll lips apart gently. Most Important symptoms and effects, both acute and delayed: May cause bond eye and skin tissues. Prolonged skin contact may defat the skin and produce dermatitis. Bonds in seconds. May cause irritation of respiratory tract. May cause sensitization by inhalation in sensitive ndividuals. Indication of any immediate medical attention and special treatment needed: None required. 5. FIRE-FIGHTING MEASURES Suitable (and unsuitable) Extinguishing Media: Use media suitable for surrounding materials. Foam, carbon dioxide, dry chemical or water spray or fog. Do not use straight stream of water. Burning product may float on the top of water and may spread fire. Specific Hazards Arising from the Chemical: None. Hazardous Combustion Products: Combustion produces toxic gases. Special Protective Equipment and Precautions for Fire-fighters: Wear selfcontained breathing apparatus and protective suit. 6. ACCIDENTAL RELEASE MEASURES Personal Precautions, Protective Equipment, and Emergency Procedures: Ventilate the area. Remove all sources of ignition. Wear appropriate protective clothing and equipment. Environmental Precautions: Report releases as required by local and federal regulations. Methods and Materials for Containment and Cleaning Up: Use water spray to polymerize product, then scrape off floors and other surfaces. Place in a suitable container for disposal. 7. HANDLING AND STORAGE Precautions for Safe Handling: Avoid contact with skin, eyes and clothing. Avoid breathing vapors or mists. For external use only. Do not use on patients with known sensitivity to cyanoacrylate. Potential adverse risks may include an allergic reaction to the 2/6

3 cyanoacrylate or skin irritation. Do not use in surgical procedure involving mucous membranes or on the eyes. Conditions for Safe Storage, including any Incompatibilities: Store to room temperature (41ºF to 77ºF) (5ºC to 25ºC). 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Exposure limit(s) Chemical Name n-butyl Cyanoacrylate (enbucrylate; enbucrilate) Tributyl o-acetylcitrate (2- Acetyltributylcitrate; 1,2,3- Propanetricarboxylic acid, 2-(acetoxy)-, tributyl ester) Exposure limit(s) None established None established Appropriate Engineering Controls: Use process enclosure, local exhaust ventilation or other engineering controls as needed to minimize exposure. Individual Protection Measures, such as Personal Protective Equipment: Respiratory Protection: No personal respiratory protective equipment normally required. If engineering controls are not adequate to minimize exposure or while controls are being installed, wear an appropriate NIOSH certified dust respirator. Protective Gloves: Wear chemical resistant gloves such as polyethylene to avoid skin contact. Eye Protection: Safety glasses or goggles recommended. 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance and Odor Odor Threshold: Boiling point/range Melting point/range Relative Density (water=1) 1.03 Vapor pressure Vapor density (air=1) Solubility ph Partition coefficient (n-octanol/water): Liquid, slightly pigmented violet color, slightly pungent odor. >150ºC (302ºF) Insoluble in water 3/6

4 Evaporation Rate (Butyl acetate=1) Viscosity: Volatile Organic Carbon Compounds (VOC) (g/l) Flashpoint: Flammable Limits in Air % by Volume: Autoignition temperature: Decomposition temperature: Flammability (solid, gas): 108ºC (227ºF)closed cup LEL (Lower):Not applicable UEL (Upper): Not applicable None. Not applicable 10. STABILITY AND REACTIVITY Reactivity: Not reactive. Chemical Stability: Keep away from heat. Possibility of Hazardous Reactions: None currently known. Conditions to Avoid: None currently known. Incompatible Materials: Avoid contact with amines, alcohols, water, cotton, wool and alkalies prior to product polymerization. Hazardous Decomposition Products: Carbon and nitrogen oxides. 11. TOXICOLOGICAL INFORMATION Symptoms/Effects of Overexposure: In vitro and non-clinical biocompatibility testing of this product does not indicate a potential for dermal irritation, dermal sensitization, cytotoxicity or systemic toxicity. Inhalation: Inhalation of vapors or mists may cause mucous membrane and respiratory irritation. Prolonged or repeated overexposure may result in allergic reaction with asthmalike symptoms in certain individuals. Skin contact: Bonds skin in seconds. Eye contact: May cause severe irritation. Bonds in seconds. Will cause weeping, tearing and double vision until polymerization has occurred. Cured cyanoacrylate will not bond to the eye, however, there is a chance of corneal damage due to abrasion. Ingestion: Bonds to oral tissue in seconds. Saliva will lift adhesive in 1-2 days. Chronic toxicity: None currently known. Carcinogenicity Data: None of the components of this product is listed as a carcinogen by IARC, NTP, US OSHA or the EU CLP Annex VI. 4/6

5 Reproductive Toxicity: No adverse effects on reproduction are known. Numerical Measures of Toxicity: n-butyl Cyanoacrylate: Oral rat LD50 >5000 mg/kg Tributyl o-acetylcitrate: LD50 oral rat > mg/kg, Dermal rabbit LD50 >1000 mg/kg 12. ECOLOGICAL INFORMATION Ecotoxicity: No data is currently available. Persistence and Degradability: No data is currently available. Bioaccumulative Potential: No data available Mobility in Soil: No data available Other Adverse Effects: No adverse effects on the environment are expected. 13. DISPOSAL CONSIDERATIONS Dispose in accordance with all state, local and federal regulations. 14. TRANSPORT INFORMATION US DOT Shipping Description: Not regulated IATA Shipping Description (Air): Not regulated IMDG Shipping Description (Vessel): Not regulated 15. REGULATORY INFORMATION US Regulations EPA Toxic Substances Control Act (TSCA): All of the components of this product are listed on the TSCA Inventory or exempted from TSCA. SARA 302 Listed Chemicals: None. SARA 311/312 Hazard Categories: Not Hazardous SARA 313 This Product Contains the Following Chemicals Subject to Annual Release Reporting Requirements Under the SARA Section 313 (40 CFR 372): None. California Proposition 65: This product does not contain chemicals listed per the Safe Drinking Water and Toxic Enforcement Act of International Regulations EU EINECS Status: All of the components of this product are listed on the EINECS Inventory or exempted from notification. 5/6

6 16. OTHER INFORMATION Date Prepared: 3/2/15 HMIS Rating: Health 1 Fire 1 Physical Hazard 0 The information contained herein is true and correct to the best of Halyars s knowledge. However, no warranty, expressed or implied, is made. Nothing herein should be interpreted as a recommendation to infringe existing patents or violate any laws or regulations. Final determination of the suitability of the material is the sole responsibility of the user. 6/6