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Abstract This article discusses the methodological limitations of epidemiological and experimental studies when these studies are utilized to establish the causality between environmental and occupational exposures and diseases. The high probability of non-causal explanations for weak associations revealed by observational studies is emphasized; additionally, the consequences are revealed when weak associations are taken to guide public health interventions, to support diagnosis in occupational medicine and expert reports addressed to the court, and to communicate risks. Shortcomings of risk estimations based only on the evidence from experimental toxicology studies are discussed. Uncertainties involved in extrapolating toxicological findings between species and the relevance of taking into account the dose–response relationships and exposure levels experimented on human populations are also commented upon. Author Biography Francisco José Roma Paumgartten, Laboratório de Toxicologia Ambiental, Departamento de Ciências Biológicas, Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ Laboratório de Toxicologia Ambiental, Departamento de Ciências Biológicas, ENSP-FIOCRUZ

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