1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

Transcription

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Product Name: Product Number: 33731, 33732, 33734, Date Prepared: 3/8/2006 Manufacturer: Telephone: MEDICAL EMERGENCY TRANSPORTATION EMERGENCY INFORMATION Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA United States of America Chemtrec KC-HELPS ( ) 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. COMPOSITION/INFORMATION ON INGREDIENTS Chemical Name CAS-No./ EINECS- No % EU Classification (67/548/EEC): n-butyl Cyanoacrylate (enbucrylate; enbucrilate) Tributyl o- Acetylcitrate (2- Acetyltributylcitrate; 1,2,3- Propanetricarboxylic acid, 2-(acetoxy)-, tributyl ester) / % Xi R36/ / % Not applicable See Section 16 for further information on EU Classification. 3. HAZARDS IDENTIFICATION Liquid, slightly pigmented violet color, slightly pungent odor. Emergency Overview: Irritating to eyes. Bonds skin in seconds. May cause irritation of respiratory tract. May cause sensitization by inhalation. EU Classification (1999/45/EC): Xi, R36/37 See Section 16 for further information on EU Classification. 1

2 Medicinal and cosmetic products in the finished form, intended for the final user are not subject the Directive relating to the classification, packaging and labelling of dangerous preparations (1999/45/EC). US OSHA Classification (29CFR ): Eye Irritant. Skin Irritant. Skin Sensitizer Canadian WHMIS Classification: Medical devices are not subject to the Hazardous Products Act (WHMIS). 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 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. Drink 1 or 2 glasses of water. 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. 5. FIRE-FIGHTING MEASURES Suitable Extinguishing Media: 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. Special Fire Fighting Procedures: Wear self-contained breathing apparatus and protective suit. Unusual Fire and Explosion Hazards: Combustion produces toxic gases. Hazardous Combustion Products: Carbon monoxide, carbon dioxide. Oxides of nitrogen. 6. ACCIDENTAL RELEASE MEASURES Ventilate the area. Remove all sources of ignition. Wear appropriate protective clothing and equipment. Use water spray to polymerize product, then scrape off floors and other surfaces. 2

3 Place in a suitable container for disposal. Comply with all federal, state and local regulations. 7. HANDLING AND STORAGE 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 cyanoacrylate or skin irritation. Do not use in surgical procedure involving mucous membranes or on the eyes. Store to room temperature (41ºF to 77ºF) (5ºC to 25ºC). 8. EXPOSURE CONTROLS / PERSONAL PROTECTION 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 Ventilation: Use process enclosure, local exhaust ventilation or other engineering controls as needed to minimize exposure. Respiratory Protection: No personal respiratory protective equipment normally required. If engineering controls are not adequate to minimize exposure or while controls are bring installed, wear an appropriate NIOSH certified dust respirator. Protective Gloves: Wear chemical resistant gloves. Polyethylene gloves recommended. Eye Protection: Safety glasses or goggles recommended. 9. PHYSICAL AND CHEMICAL PROPERTIES Appearance and Odor Boiling point/range Melting point/range Specific Gravity (water=1) 1.03 Vapor pressure Liquid, slightly pigmented violet color, slightly pungent odor. >150ºC (302ºF) Not applicable Vapor density (air=1) Solubility ph Partition coefficient (n-octanol/water): Insoluble Not applicable 3

4 Evaporation Rate (Butyl acetate=1) Percent Volatile by Volume (%) Volatile Organic Carbon Compounds (VOC) (g/l) Flashpoint: Flammable Limits in Air % by Volume: LEL (Lower): UEL (Upper): 21ºC (70ºF) 108ºC (227ºF)closed cup 10. STABILITY AND REACTIVITY Stability: Stable Conditions to Avoid: Keep away from heat. Materials to avoid: Avoid contact with amines, alcohols, water, cotton, wool and alkalies prior to product polymerization. Hazardous Decomposition Products: Carbon monoxide, carbon dioxide. Oxides of nitrogen. Hazardous Polymerization: Does not occur. 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 asthma like 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. Medical Conditions Aggravated by Exposure: Pre-existing skin and lung diseases. Carcinogenicity Data: None of the components of this product is listed as a carcinogen by IARC, NTP, US OSHA or the European Directive (67/48/EEC). Reproductive Toxicity: No adverse effects on reproduction are known. Acute Toxicity Values: Tributyl o-acetylcitrate: LD50 oral rat 4000 mg/kg. 4

5 12. ECOLOGICAL INFORMATION 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: Acute Health Chronic Health SARA 313 This Product Contains the Following Chemicals Subject to Annual Release Reporting Requirements Under the SARA Section 313 (40 CFR 372): None. International Regulations Canadian CEPA: All of the components are either listed on or exempted from the Domestic Substances List (DSL). Canadian WHMIS Classification: Medical devices are not subject to the Hazardous Products Act (WHMIS). EU EINECS Status: All of the components of this product are listed on the EINECS Inventory or exempted from notification. EU Labeling: Medicinal and cosmetic products in the finished form, intended for the final user are not subject the Directive relating to the classification, packaging and labelling of dangerous preparations (1999/45/EC). 16. OTHER INFORMATION HMIS Rating: Health 2 Fire 1 Reactivity 0 EU Classes and Risk Phrases for Reference (See Sections 2 and 3): Xi - Irritant R36/37 - Irritating to eyes and respiratory system. 5

6 The information contained herein is true and correct to the best of Kimberly-Clark's knowledge. However, no warranty, express 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