Significant excesses of chromosomal abnormalities in bone marrow cells have been reported in rats exposed to EtO by oral doses of 9 mg/kg of body weight (in aqueous solution),39 or by inhalation of EtO at 250 ppm for 7 hours per day for 3 days.19 Chromosomal aberrations have been reported in humans accidentally exposed to high concentrations of EtO.40 More detailed reviews of the mutagenicity of EtO are available.1,41,42. This study examined the kinetics of EO metabolism The first tumor appeared in the 50th week of treatment. EE values can be used to support risk assessment and risk management decisions for chemicals such as EO … NIOSH RTECS Number: KX2450000 Shell Chemical Ethylene oxide may also be referred to as oxirane and EtO. Peritoneal mesothelioma was reported to be treatment-related in the male rats exposed at 33 and 100 ppm. Depending on manufacturing processes, PEGs may be contaminated with measurable amounts of ethylene oxide and 1,4-dioxane. None of the animals (0/822) in the control group had HT. This can be accomplished with a well-designed local exhaust ventilation system that physically encloses the process as much as possible, with sufficient capture velocity to keep the contaminant from entering the workplace atmosphere. Normally, there should be no DNA synthesis in the testes during sperm maturation. Such findings may indicate a chemical’s carcinogenic potential, although the relevance of subcutaneous tumors at injection sites to carcinogenicity is often questioned. Before mating, animals were exposed 5 days per week; during and after mating they were exposed 7 days per week. Safe levels of carcinogens have not been demonstrated, but the probability of developing cancer should be reduced by decreasing exposure. Ethylene oxide (EtO), a known human carcinogen, is a colorless, flammable gas that is used to sterilize medical equipment and to make chemicals used in household and personal care products.During this process, traces of EtO are sometimes left behind. Ethylene Oxide Is a Carcinogen You Need to Know About. Two investigators reported dominant lethal mutations: in mice following intraperitoneal administration of a single dose of EtO at 150 mg/kg of body weight,33 and in rats following a single inhalation exosure of 1,000 ppm for 4 hours.34 An unpublished study by Cumming et al.35 reports a dose-response relationship for unscheduled DNA synthesis (UDS) in the testes of mice exposed to EtO by inhalation. Dow Chemical U.S.A. Government publications referenced in this appendix are available from the Government Printing Office (GPO). 1,3-Butadiene is a colourless gas with a mild aromatic or gasoline-like odour. A dose-response relationship was observed; 9.36% (38/406) of the animals had HT in the high dose group, while 1.32% (6/456) had HT in the low dose group. The primary routes of human exposure to ethylene oxide are inhalation and ingestion, which may occur through occupational, consumer, or environmental exposure. However, they should be given consideration for all settings and be adapted to specific work situations as required. The National Institute for Occupational Safety and Health (NIOSH) recommends that ethylene oxide be regarded in the workplace as a potential occupational carcinogen, and that appropriate controls be used to reduce worker exposure. Two control groups were used: one received the vehicle (tricaprylin) only, and the other group received no treatment. reported the results of a historical prospective mortality study of workers employed in a Swedish EtO production facility.5 Individuals in this investigation were employed as of 1961 and exposed or employed for more than 1 year. Therefore, some of the above synonyms and identifiers may be trademarked but are not so indicated above. At both 600 and 800 ppm a maximum response indicating DNA damage was observed after 4 hours of exposure. However, since ethylene oxide is both genotoxic and carcinogenic, intakes from food sources should be as Three separate cohorts were studied: 89 persons who worked full time in the EtO production area, with 1,234 person-years of observation; 86 maintenance workers who intermittently worked in the EtO area, with 1,211 person-years of observation; and 66 workers who had never worked in EtO production, with 955 person-years of observation. Northern Petrochemical Company More recent work in this area was presented at a seminar sponsored by the Health Industry Manufacturers Association (HIMA). It is also used as a sterilizing agent for medical equipment and a fumigating agent for spices. However, the International Agency for Research on Cancer (IARC) has classified ethylene oxide as a human carcinogen and mutagen. CHARACTERIZATION OF THE CARCINOGENIC HAZARD The DNA-damaging properties of EtO have been studied since the 1940s. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. However, exposure to EtO can be controlled with the use of this equipment: Proper maintenance procedures, good housekeeping in the work area, and worker education are all vital aspects of a good control program. Epidemiologic investigations of cancer mortality among Swedish workers exposed to EtO suggest an increased risk of leukemia and other cancers.5,6 Recent information also suggests that EtO is associated with chromosomal abnormalities in peripheral lymphocytes of exposed workers.7 The environmental measurements reported indicate that these workers were exposed to 8-hour TWA concentrations below the current OSHA standard. This work, performed by the MITRE Corporation under EPA Contract No. You will be subject to the destination website's privacy policy when you follow the link. be about 15-20 µg ethylene oxide per day (Törnqvist, 1996). EPA classified ethylene oxide as a human carcinogen in December 2016. Current production capacity in the United States is about 6.1 billion pounds (2.8 Tg) per year. If you would like to reproduce some or all of this content, see Reuse of NCI Information for guidance about copyright and permissions. A significant reduction in mean fetal body weight compared with controls was reported for all four treatment periods at the 150-mg/kg level. Substitutes of lesser hazards should be used where practicable. The dangerous side effects and human carcinogen health risks involved in the use of Ethylene Oxide have mostly been hidden from public view. ETHYLENE OXIDE Ethylene oxide was considered by previous IARC Working Groups in 1976, 1984, 1987, 1994, and 2007 ( IARC, 1976, 1985, 1987, 1994, 2008). Ethylene oxide is a direct-acting alkylating agent that has been used as an industrial intermediate and as a The EPA found that some residents are at an increased risk of cancer. During this process, traces of EtO are sometimes left behind. Most of us are aware of the potential cancer-causing substances (aka carcinogens) that we should steer clear of. (APF = 50) Any air-purifying, full-facepiece respirator (gas mask) with a chin-style, front- or back-mounted canister providing protection against ethylene oxide*; or Any self-contained breathing apparatus with a full facepiece; or Any supplied-air respirator with a full facepiece. Lymphoma and leukemia are the cancers most frequently reported to be associated with occupational exposure to ethylene oxide. Studies also showed an increased risk of breast cancer in females. Since that time new data have become avail - able, which have been incorporated in this Monograph, and taken into consideration in the present evaluation. Washington, D.C. 20402, BASF – Wyandotte Corporation Potential carcinogen: comes from a harmonised C&L classifying the substance as a suspected carcinogen Carc.2. The values recommended by NIOSH in 1977 were the same as the Threshold Limit Values (TLVS) then recommended by the American Conference of Governmental Industrial Hygienists (ACGIH) for Time Weighted Average (TWA) and Short Term Exposure Level (STEL) concentrations, respectively.44 In 1979, ACGIH published its intent to change its TLV to 10 ppm (20 mg/cu m3) as a TWA concentration.45,46, Reflecting increased concern over the mutagenic and carcinogenic potential of EtO, some manufacturers and commercial users of the chemical are adopting occupational exposure guidelines lower than the OSHA standard. These individuals were followed through 1977. However, quadriradial chromosomes are rare, and while their significance is not well understood, their occurrence should be viewed with concern. Studies also showed an increased risk of breast cancer in females. The literature reporting these effects was reviewed in the 1977 NIOSH document.1 More recently, cases of peripheral neuropathy among exposed workers have been reported.8. However, one leukemia death was observed among the maintenance workers, compared with 0.13 expected deaths. The incidence of this disease in the exposed females increased linearly with dose. Considerable attention has been directed toward developing control methods for sterilizing and fumigating operations. On the basis of this information, NIOSH requests that producers, distributors, and users of ethylene oxide, and of substances and materials containing ethylene oxide, give this information to their workers and customers, and that professional and trade associations and unions inform their members. In 1979, Hogstedt et al. Effects such as upper respiratory irritation, dermatitis, or other forms of sensitization and irritation should alert management that unacceptable acute exposure to EtO may be occurring. Results of a one-generation reproductive study in rats also have been reported.3 This study involved exposing male and female rats to EtO vapor for 12 weeks prior to mating. Ethylene oxide is a flammable gas with a somewhat sweet odor. Lyon, France: World Health Organization, 2012. Depending on manufacturing processes, PEG s may be contaminated with measurable amounts of ethylene oxide and 1,4-dioxane. Ethylene Oxide EXECUTIVE SUMMARY (CASRN 75-21-8) In Support of Summary Information on the Integrated Risk Information System (IRIS) December 2016 National Center for Environmental Assessment Office of Research and Development U.S. Environmental Protection Agency Washington, DC Ethylene Oxide (or EtO) is a human carcinogen that has been shown to cause cancers of the white blood cells, including non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia. 1993-1994 ACGIH TLV: 1 ppm (1.8 mg/m 3) TWA, A2. Between 1972 and 1977, 3 cases of leukemia (2 women, 1 man) occurred among the workforce of 230 persons. Also, epidemiologic investigators reported excess cancer mortality at two worksites where workers were exposed to EtO. EPA classified ethylene oxide as a human carcinogen in December 2016. The largest consumption of EtO is in the production of ethylene glycol for automotive antifreeze and as an intermediate for polyester fibers, films, and bottles. EWG’s Skin Deep rates thousands of personal care product ingredients, culled from ingredient labels on products, based on hazard information pulled from the scientific literature and industry, academic and regulatory databases. Ethylene oxide is an important raw material used in the manufacture of chemical derivatives that are the basis for major consumer goods in virtually all industrialized countries. Celanese Corporation Careful planning and thought should be used prior to implementation. In December 2016, the U.S. Environmental Protection Agency (EPA) classified ethylene oxide gas as a human carcinogen. Also in 1979, Hogstedt et al. During the 1980s, it is estimated that more than 270,000 U.S. workers were exposed to the chemical every year. Although humans and animals may differ in their susceptibility to specific chemical compounds, any substance that produces cancer in experimental animals should also be considered to have carcinogenic potential in humans. Reference 49: From GPO as #017-033-00136-7 for $3.90, GPO publications can be ordered from: People may be exposed to the toxic chemical in or near chemical plants or factories. Appelgren et al. Ethylene oxide is known to be a human carcinogen based on evidence from studies in humans and experimental animals and from supporting mechanistic data. In its 1977 review of EtO, NIOSH recommended that occupational exposure be limited to a ceiling concentration of 75 ppm (135 mg/m3), determined during a 15-minute sampling period. Among the full-time production workers, 23 deaths were observed, compared with 13.5 expected (p<0.05). Studies of workers show that their exposures to ethylene oxide are associated with an increased risk of cancers of the white blood cells (the infection-fighting cells of the immune system). The Environmental Protection Agency (EPA) and the International Agency for Research on Cancer (IARC) have designated ethylene oxide as a carcinogen. Triangle Park, NC: National Institute of Environmental Health and Safety, 2016. Ethylene Oxide is a CARCINOGEN, MUTAGEN and TERATOGEN. Appelgren et al., in 1978, reported significantly increased numbers of polychromatic erythrocytes containing micronuclei in mice and rats following intravenous injection of EtO.36 Fomenko and Strekalova37 and Strekalova et al.38 reported increased numbers of chromosomal aberrations in bone marrow cells of rats exposed to EtO by inhalation at concentrations ranging from 1 to 112 mg/m3 (0.6 to 63 ppm). The excess cancer risks to workers exposed to EtO at or below the present OSHA standard of 50 ppm as a TWA concentration have not yet been estimated. The widespread recognition of EtO as an effective alkylating agent and mutagen reinforces concern over the carcinogenic potential of EtO. The above information was obtained from the NIOSH’s computerized Registry of Toxic Effects of Chemical Substances (RTECS), and from the National Library of Medicine’s computerized chemical dictionary file CHEMLINE. In 1978, the industrial consumption of EtO was about 4.9 billion pounds (2.2 Tg), and the projected consumption for 1983 is about 6.2 billion pounds (2.8 Tg). Sun-Olin Corporation U.S. Government Printing Office Ethylene Oxide, Report on Carcinogens, Fourteenth Edition. Although this bulletin focuses on new evidence of carcinogenic, mutagenic, and reproductive hazards, EtO has other adverse effects on health. These epidemiologic findings are not by themselves proof of an excess risk of cancer resulting from EtO exposure. It is used primarily to produce other chemicals, including antifreeze. Despite these precautions, workers and people who live near industrial facilities that produce or use ethylene oxide may be exposed to ethylene oxide through uncontrolled industrial emissions. The number of subcutaneous tumors at the injection site appeared to increase with the size of the dose; the number of tumors at sites distant from the injection sites was not significantly greater in the treatment groups than in control groups. Back to School . Because ethylene oxide is emitted in Texas and has been determined to be a carcinogen, TCEQ undertook an inhalation carcinogenic dose-response assessment to derive a unit risk factor and an effect screening level for this chemical. They also say the companies knew or should have known that ethylene oxide is a dangerous carcinogen that has been linked to various illnesses. Ethylene oxide is known to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in humans, including epi-demiological studies and studies on mechanisms of carcinogenesis. 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