Ethylene oxide toxicity

Inhalation. Workers who develop symptoms or signs of ethylene oxide toxicity should be removed immediately from the contaminated area. Oxygen can be administered to workers with persistent dyspnea. 

Poly(ethylene oxide) resins are safely used in numerous pharmaceutical and personal-care appHcations. Poly(ethylene oxide) resins show a low order toxicity in animal studies by all routes of exposure. Because of their high molecular weight, they are poorly adsorbed from the gastrointestinal tract and completely... 

Significant use properties of poly(ethylene oxide) are complete water solubiHty, low toxicity, unique solution rheology, complexation with organic acids, low ash content, and thermoplasticity. 

Pharmaceutical and Biomedical Applications. On account of its low toxicity and unique properties, poly(ethylene oxide) is utilized in a variety of pharmaceutical and biomedical appHcations. 

It is necessary to determine the bioburden and make cycle verification studies when ethylene oxide sterilization is used, as it is for other sterilization methods. The manufacturer of hospital sterilization equipment provides cycle recommendations based on the expected bioburden and the consideration of an appropriate safety factor. In ethylene oxide sterilization, it is necessary to determine if residues of the stefilant are absorbed by the sterilized article, and to examine the possible formation of other potentially toxic materials as a result of reaction with ethylene oxide. 

Butyl glycol ethers, the largest volume derivatives of -butyl alcohol used ia solvent appHcations (10), are obtained from the reaction of 1-butanol with ethylene oxide. The most important of these derivatives, 2-butoxyethanol, is used principally ia vinyl and acryHc paints as well as ia lacquers and varnishes. It is also employed ia aqueous cleaners to solubilize organic surfactants. 2-Butoxyethanol [111-76-2] has achieved some growth at the expense of the lower alkoxyethanols (ie, methoxy and ethoxyethanol) because of 2-butoxyethanol s lower toxicity. 

Polymers. Studies to determine possible exposure of workers to residual epichl orohydrin and ethylene oxide monomers in the polymers have been done. Tests of warehouse air where Hydrin H and Hydrin C are stored showed epichl orohydrin levels below 0.5 ppm. Air samples taken above laboratory mixing equipment (Banbury mixer and 6" x 12" mill) when compounds of Hydrin H or C were mixed gave epichl orohydrin levels below detectable limits, and ethylene oxide levels less than 0.2 ppm, well below permissible exposure limits (46). A subacute vapor inhalation toxicity study in which animals were exposed to emission products from compounded Parel 58 suggests that no significant health effects would be expected in workers periodically exposed to these vapors (47). 

Toxicology. An excellent review of the toxicity and health assessment of ethylene oxide has been compiled (233). Ethylene oxide (EO) can be relatively toxic as both a Hquid and gas. Inhalation of ethylene oxide ia high concentrations may be fatal. Estimates of lethal ethylene oxide inhalation levels in animals depend on the duration of exposure. The reported 4-h LC q values for rats, mice, and dogs are 1460, 835, and 960 ppm, respectively (234). More recent information (235) indicates that the 1-h LC q in rats is approximately 5000 ppm. 

Fumigation with ethylene oxide does indeed lead to a considerable reduction in the germ count (and at the same time destruction of insects), but the process, because of the formation of toxic reaction products (ethylene chlorhydrin, ethylene glycol) has been banned throughout the European Community since 01.01.1990 Ionizing irradiation a declaration of the treatment is obligatory, but such drugs find little acceptance by the public who expect nature s products as such. 

Although poloxamers show poor biodegradability, they exhibit very low acute toxicity [92] and are reported as having low potential for causing irritation and skin sensitization [26]. Toxicity decreases as ethylene oxide content increases, and the least toxic poloxamers are approved as food additives [80]. 

Alcohol ether sulfates are still less toxic than alcohol sulfates and their LD values are commonly above 4000 mg/kg and sometimes above 10,000 mg/kg [335]. Toxicity decreases as the number of moles of ethylene oxide added to the base alcohol increases. 

Formaldehyde gas for use in sterilization is produced by heating formalin (37% wA aqueous solution of formaldehyde) to a temperature of 70-75°C with steam, leading to the proeess known as LTSF. Formaldehyde has a similar toxicity to ethylene oxide and although absorption to materials appears to be lower similar desorption routines are leeommended. A major disadvantage of formaldehyde is low penetrating power and this limits the packaging materials that eanbe employed to principally paper and eotton fabrie. 

Where toxic gases or solvents have been used in the manufacturing process, validation data on their removal and relevant release and shelf life specifications and acceptance limits should be included in the dossier (taking into account the ICH guidelines on residual solvents and the CPMP guideline on ethylene oxide usage). These can be discussed in the development pharmaceutics section or elsewhere. 

Sterilization by irradiation was introduced by mid-fifties. In about 20 years, it was fully operational. When compared with the traditional methods of sterilization such as using formaldehyde, ethylene oxide (a toxic gas), or heating in an autoclave, several advantages of irradiation may be noted (Artandi, 1977) ... 

Irradiation avoids the use of toxic chemicals (e.g., ethylene oxide) or high temperatures (as in the autoclave). Throughout the world, there are -100 plants for sterilization of medical products by irradiation. 

Determine whether the following chemicals (a) are covered under the RMP (40 CFR 68.130) and (b) are listed as toxic or flammable. If they are listed, (c) what are their threshold quantities The chemicals are acrolein, hydrogen chloride, phosgene, propane, ethylene oxide, and methanol. 

PCR based, 22 472 studies of, 27 309 by synthetic DNA, 22 518 as a toxic effect, 25 206 Mutagenic effects, of ethylene oxide,... 

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