2. SL - 119 - C - 0.00. © 2 0 1 5 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 P hone 412.787.0202 • fax 412.788.2526 Ethylene Oxide ( EtO ) Fact Sheet Continued Detection Methods  ChemDAQ Steri - Trac ® continuous monitor for ethylene oxide . 20  E xposure badge s, e.g. 3M 21  OSHA method 1010, absorption on HBr Charcoal tube followed by extraction and GC analysis 22 Storage in Healthcare  Since use cartridges, no more than one day supply and < 12 cartridges near sterilizer. 23 Cartridges should be stored in approved flammable cabinet that must be actively vented to prevent a build up of EtO gas.  EtO use often requires permitting , dedicated ventilation, emissions control and special training. Consult appropriate regulations and standards for guidance. Spill Control Since EtO is a gas under normal conditions, any spills or leaks will rapidly vaporize and will be removed by ventilation. EtO should only be used in well ventilated areas, typically 10 air exchanges per hour (see local regulations) . In the event of a leak , 20 http://www.chemdaq.com/products/steri - trac - area - monitors/steri - trac - hydrogen - peroxide - area - monitor/ http://www.chemdaq.com/products/steri - trac - area - monitors/ethylene - oxide/ 21 http://solutions.3m.com/wps/portal/3M/en_EU/PPE_SafetySolutions_EU/Safety/Product_ Catalogue/~/3M - Ethylene - Oxide - Monitor - Badge - 3551?N=5002444+329485 7473+4294890672&rt=rud 22 www.osha.gov/dts/sltc/methods/mdt/mdt1010/1010.pdf 23 Ethylene oxide sterilization in health care facilities: Safety and effectiveness. ANSI/AAMI ST:41:1999/®2005, section 4.8.1.1 it is important to take measure s to prevent worker exposure. Emissions regulations may also apply. Regulatory Environment United States OSHA  Duties: Employers have a duty to provide a safe work e nvironment and employees have a duty to work safely. 24  Hazard Communication Regulation 25 , suppliers (labels, safety data sheets), Employers (facilities, work practices, training and personal protective equipment ) to enable the safe use of the chemicals.  Ethy lene Oxide Standard 29 CFR 1910.1047 26 has additional EtO specific requirements. EPA Hospitals Emissions from hospitals: Requirement to only run full loads for non - emergency. 27 No separate aeration, i.e. aeration must be in the sterilization chamber. 28 Indus try : Maximum emissions depend on volume of EtO used. 29 DOT UN 1040 24 Occupational Safety and Health Act 1970, §5 25 29 CFR 1910.1200 26 https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_i d=10070 27 http://www.epa.gov/ttn/atw/eo/fr28de07b.pdf 28 http://www.epa.gov/pesticides/reregistration/ethylene_oxide/ethylene_oxide_fs.html 29 40 CFR 63.360 htt p://www.ecfr.gov/cgi - bin/text - idx?SID=33630738b852e4c2ecc3c3fe5a5df1d8&mc=true&node=se40.10.63_1360&rgn= div8 Standards : N FPA 560: Standard For The Storage, Handling, And Use Of Ethylene Oxide For Sterilization And Fumigation 30 Canada WHMIS 1988 classification: A - Compressed Gas; B1 - Flammable G as; D1A - Very Toxic; D2A - Very Toxic (Carcinogenicity; Mutagenicity; Reproductive toxicity); E - Corrosive; F - Dangerously Reactive 31 Occupational exposure limits and other requirements vary with province, most follow ACGIH (1 ppm 8 hr TWA). 32 United Ki ngdom COSHH Regulations. (Employers have a duty to assess the workplace, identify chemical health hazards, take necessary measures to protect health, provide information & training to employees, and plan for emergencies). 33 CHIP regulations concern hazardo us informati on and packaging (implementing the Dangerous Substances Directive (No. 67/548/EEC), and the Dangerous Preparations Directive (No. 99/45/EC). 34 CHIP is being replaced by the European Regulation (EC) No 1272/2008 on classification, labelling and p ackaging of substances and mixtures (CLP Regs.) 35 Professional Societies Ethylene oxide sterilization association 36 30 http://www.nfpa.org/codes - and - standards/document - information - pages?mode=code&code=560 31 http://www.ccohs.ca/oshanswers/chemicals/chem_profiles/ ethylene_oxide.html 32 For summary of occupational exposure limits by province see ‘Guide to Gas Detection in Healthcare Canada March 2014.doc’ available from ChemDAQ Inc. 33 http://www.hse.gov.uk/coshh/basics.htm 34 http://www.hse.gov.uk/chemical - classif ication/legal/chip - regulations.htm 35 http://www.hse.gov.uk/chemical - classification/legal/clp - regulation.htm 36 http://www.eosa.org/

1. SL - 119 - C - 0.00. © 2 0 1 5 ChemDAQ Inc. • 300 Business Center Drive • Pittsburgh, PA • 15205 P hone 412.787.0202 • fax 412.788.2526 Ethylene Oxide ( EtO ) Fact Sheet Ethylene Oxide ( C 2 H 2 O ) is a sterilant chemical often used in healthcare sterile processing and medical device manufacture . E thylene oxide is flammable, toxic , and a known carcinogen . Know the facts for process management a nd safety. Synonyms Dimethylene oxide, 1,2 - epoxyethane, EtO, EO, ethene oxide, and oxirane . Uses of Ethylene Oxide 1 , 2 Sterilant : Healthcare, medical device s , fumigant 3 , 4 Synthesis of ethylene glycol, polyethylene gly cols, nonionic surfactants, acrylonitr ile , polyester and polyethylene terephthalate . The world production of ethylene oxide was 20 million tonnes in 2009 making EtO the 14th most produced organic chemica l. Chemical Properties ( C 2 H 2 O ) 2 , 5  Colorless, extremely flammable gas at room temperature and pressure, explosive limits 3 – 100% vol  Mol. Wt 44.05 g/mol, MP - 111 o C, BP 10.7 o C ; Conversion: 1 mg/m 3 = 1.80 ppm at 25 o C, 1 atm. ,  CAS No.: 75 - 21 - 8  Vapor pressure 152 kPa at 22.1 o C  Soluble in water, alcoh ol and ether , rapidly hydrolyzed in acids to ethylene glycol  100% EtO may polymerize on prolonged storage, refrigeration will prolong shelf life. Microbiocidal Activity Ethylene oxide has been shown to be effective as a sterilant against all forms of micr oorganisms, including bacterial spores and protozoal cysts . 1 https://en.wikipedia.org/wiki/Ethylene_oxide 2 Merck Index, 12 Ed. 3 http://www.fao.org/docrep/x5042e/x5042e0d.htm 4 http://www3.epa.go v/airtoxics/eo/eoguide.pdf 5 Gas Data Book, 6 th Ed, Matheson, W. Braker, A.L. Mossman (1980). Mode of sterilization action: E t O is a direct alkylating agent that does not require metabolic activation, and its microbiologic inactivation properties are the result of alkylation cellular cons tituents of organisms, such as nucleic acid and functional proteins, including enzymes, which leads to consequent denaturation. 6 Hazard Summary 7 , 8 , 9 I rritant: irritates mucous membranes of the nose and throat at > 200 parts per million, higher contents ca use damage to the trachea and bronchi, progressing into the partial collapse of the lungs. High concentrations can cause pulmonary edema and damage the cardiovascular system; the damaging effect of ethylene oxide may occur only after 72 hours after exposur e . Ethylene oxide is a CNS depressant. High - dose exposures can result in diverse neurologic manifestations including seizures, loss of consciousness, and coma. Onset of neurologic signs and symptoms may be delayed 6 hours or more after exposure. Respirator y paralysis and delayed peripheral nerve damage have been reported after massive exposure. Sensitization occurs with some people Carcinogenicity: The IARC and NTP classify EtO as a class 1, known human carcinogen . 10 , 11 Skin: Ethylene oxide is rapidly absorbe d after inhalation, and solutions of ethylene oxide can penetrate human skin . Skin contact with concentrated solutions of ethylene oxide, liquid ethylene oxide, or 6 http://www.ajicjournal.org/article/S0196 - 6553(07)00052 - 1/pdf 7 https://en.wikipedia.org/wiki/Ethylene_oxide 8 http://www.atsdr.cdc.gov/mmg/mmg.asp?id=730&ti d=133 9 http://www.who.int/ipcs/publications/cicad/en/cicad54.pdf 10 http://monographs.iarc.fr/ENG/Monographs/vol100F/mono100F - 28.pdf 11 https://ntp.niehs.nih.gov/ntp/roc/content/profiles/ethyleneoxide.pdf high vapor concentrations may cause chemical burns. Contact with liquefied ethylene oxide ma y result in frostbite. Exposure to high levels of the gas to eyes may cause corneal burns and cataracts. Odor threshold ~ 430 ppm; with a misleadingly pleasant aroma, o dor is not a reliable indicator of ethylene oxide's presence and does not provide adequa te warning of hazardous concentrations. NIOSH RTECS #: RTECS #: KX2450000 12 RTECS Compound Description: Agricultural Chemical , Tumorigen , Drug , Mutagen , Reproductive Effector , Human Data , Primary Irritant . NFPA Limits : 13 Health 3, flammability 4, react ivity 3 (Hazard rating key 0 = minimal, 1 = slight, 2 - = moderate, 3 = serious, 4 = severe) Exposure Limits  US OSHA PEL 1 ppm ( 8 Hr TWA) ; 15 min. STEL (Excursion Limit) 5 ppm 14  UK HSE WEL 5 ppm ( 8 hr TWA ) 15  Mexico 1 ppm (8 hr TWA) 16  ACGIH STEL TLV 1 ppm, ( 8 H r TWA) 17  NIOSH REL <0. 1 ppm (hr TWA) , 5 ppm ceiling 18 , IDLH 800 ppm. 19 12 http://www.cdc.gov/niosh - rtecs/KX256250.html 13 http://nj.gov/health/eoh/rtkweb/documents/fs/0882.pdf 14 29 CFR 1910.1047 15 EH40/2005 Workplace exposure limits (publ. 2011) 16 http://asinom.stps.gob.mx:8145/upload/nom/10.pdf 17 2014 Guide to Occupational Exposure Values, ACGIH 18 http://www.cdc.gov/n iosh/npg/npgd0335.html 19 http://www.cdc.gov/niosh/idlh/intridl4.html