Chemical name: Ethanol, 2-methoxy- Final regulatory action has been taken for the category: Industrial Final regulatory action: The chemical is Severely Restricted Use or uses prohibited by the final regulatory action: 2-ME was added to the Prohibited Toxic Substances List of the Prohibition Regulations, 2005, in Schedule 2, Parts 1 and 2. In Part 1, the Regulations prohibit the manufacture, use, sale, offer for sale or import of 2-ME if it is present, incidentally or not, in diethylene glycol methyl ether, which has the molecular formula C5Hq203,and if the concentration exceeds the limit of 0.5% (w/w). In Part 2, the Regulations prohibit the manufacture, use, sale, offer for sale or import of 2-ME, with the exceptions listed below. Use or uses that remain allowed: Part 1 allows any use of 2-ME in diethylene glycol methyl ether, where the concentration does not exceed the limit of 0.5% (w/w). Part 2 allows the use of 2-ME in coatings for aircraft refinishing and semiconductor manufacturing processes. The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: The Prohibition of Certain Toxic Substances Regulations, 2005 prohibit the manufacture, use, sale, offer for sale and import of toxic substances listed in Schedules 1 and 2 to the Regulations. 2-ME is found in Schedule 2, which includes toxic substances that are subject to prohibitions related to concentration or use. Schedule 1 lists prohibited toxic substances subject to total prohibition, with the exception of incidental presence. Schedule 2 lists substances that are subject to prohibitions related to concentration or use. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: The Canadian Environmental Protection Act, 1999 (CEPA, 1999) requires the federal Ministers of the Environment and of Health to prepare and publish a Priority Substances List (PSL) that identifies substances, including chemicals. groups of chemicals, effluents and wastes, that may be harmful to the environment or constitute a danger to human health. The Act also requires both Ministers to assess these substances and determine whether they are "toxic" or capable of becoming "toxic" as defined in Section 64 of the Act, which states: ... a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that: (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity; (b) constitute or may constitute a danger to the environment on which life depends; or (c) constitute or may constitute a danger in Canada to human life or health. Descriptions of the approaches to assessment of the effects of Priority Substances on the environment and human health are available in published documents ("Environmental Assessments of Priority Substances under the Canadian Environmental Protection Act. Guidance Manual Version 1.0 - March 1997" (http://w~w.ec.qc.ca/substancesleselena/psap/quidman2.cfm)). It should be noted that the approach outlined in this document has evolved to incorporate recent developments in risk assessment methodology, which will be addressed in future releases. The approach to assessment of 2-ME was necessarily restricted because of the extremely limited data upon which to base estimates of population exposure. Moreover, use of this substance declined substantially worldwide in the years leading up to the publication of the Assessment Report, as it had been replaced with less hazardous substances. Indeed, available information indicated that 2-ME had not been produced in Canada in the previous several years. Therefore, in view of the fact that measures had been introduced to reduce population exposure, a screening approach was adopted for assessment of whether or not the substance would be considered "toxic" under Paragraph 64(c) of CEPA 1999 primarily as a basis for determining whether the current measures were sufficiently protective of human health. In view of the limited objectives of the screening assessment, therefore, lowest effect levels identified primarily from secondary sources were compared with worst-case or bounding estimates of exposure. The adequacy of these rather crude margins of exposure was considered in relation to intake from various sources estimated on the basis of primary review of the limited available Canadian data on exposure from various sources, including environmental media and consumer products. On this basis, areas where additional information may be required to ensure that current measures for reduction of population exposure are sufficiently protective were identified. Data on the health effects of 2-ME were identified primarily from a review prepared in 1996 by BlBRA International, which was updated and modified in 1998. Relevant data identified subsequent to this update are summarized in Health Canada document (1999. Datasheets for recent studies on 2-methosyethanol. Priority Substances Section, Ottawa, Ontario). Although relevant data were limited, exposure of the general population through environmental media was expected to be low, due to reported declining use of the compound as it was replaced with less hazardous compounds. Margins between worst-case estimates of exposure from environmental media and lowest effect levels for developmental toxicity obtained in toxicological investigations in experimental animals were large. However, available data are insufficient to conclude that margins between worst-case estimates of exposure in consumer products and lowest effect levels were adequate. There was considerable evidence that 2-ME causes a range of adverse effects in experimental animals (including those considered to be severe and irreversible, such as teratogenicity), some for which it could not be precluded that there was some probability of occurrence at any level of exposure. In addition, the margins between worst-case estimates of exposure to 2-ME via some consumer products (although data were extremely limited) and effect levels for adverse health effects in experimental animals were considered inadequate to address requisite elements of uncertainty. Thus, on the basis principally of its high health hazard I potential, 2-ME is considered to constitute a danger in Canada to human life or health and is, therefore, deemed "toxic" under Paragraph 64(c) of CEPA 1999. According to monitoring data on concentrations in occupational air collected between 1983 and 1994 by the Ontario Ministry of Labour, the majority of industries with concentrations of 2-ME above the limit of detection were commercial printing and small electrical appliances, machinery and equipment manufacturing. Expected effect of the final regulatory action in relation to human health: The Canadian federal government has proposed that 2-ME be subjected to virtual elimination provisions of CEPA 1999. The prohibition on manufacture, use, sale, offer for sale, or import of 2-ME, will work towards the objective of virtual elimination. Date of entry into force of the final regulatory action: 09/02/2007 |