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Protection of Environmental and Human Health

The United States Environmental Protection Agency (EPA) (2013) has developed an inhalation reference concentration (equivalent to a tolerable concentration) of 20 mg/m3 for methanol. Its approach involved the calculation of four candidate inhalation reference concentration values from combinations of different studies, endpoints and benchmark response levels. The lowest value was selected as the inhalation reference concentration. The Canadian Council of Ministers of the Environment (CCME) has adopted this value as the tolerable concentration in the calculation of soil quality guidelines for methanol. The EPA noted significant limitations in the oral database for methanol, and opted to derive an oral reference dose by using relevant inhalation data and route-to-route extrapolation with the aid of the EPA’s physiologically based pharmacokinetic model. This approach was felt to be appropriate because methanol absorption has been shown to be rapid and essentially complete by both the oral and inhalation routes of exposure, and, once absorbed, it distributes rapidly to all organs and tissues according to water content, regardless of route of exposure. The EPA calculated an oral reference dose for methanol using the same four combinations of critical effects and response levels as used for the inhalation reference concentration. The lowest of the four candidate oral reference dose values (rounded to one significant figure) was 2 mg/kg per day. CCME has adopted this value as the tolerable daily intake in the calculation of soil quality guidelines for methanol.