Article ID Journal Published Year Pages File Type
2592701 Regulatory Toxicology and Pharmacology 2009 10 Pages PDF
Abstract
The forestomach mucosal hyperplastic and even dysplastic changes, observed chronically, were reversible, provided the HD exposure was not longer than 6 months. This again supports a non-genotoxic MOA. In addition, the route and rate of EA exposure in rodents for forestomach neoplasia are irrelevant to potential human exposure, since humans do not have forestomach and are not exposed to EA by oral bolus. Thus, the weight of evidence indicates that the tumors produced in the rodent carcinogenicity studies arise from conditions that are irrelevant for human risk assessment.
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