Epidemiological effects

The Toxicological and Epidemiological Effects of Pesticide Contamination in California Ground Water... 

Kreutzer RA, Hewitt DJ, Draper WM An epidemiological assessment of the Cantara metam sodium spill acute health effects and methyl isothiocyanate exposure, in Environmental Epidemiology Effects of Environmental Chemicals on Human Health. Edited by Draper WM. Washington, DC, American Chemical Society, 1994, pp 209-230... 

Biochemistry and biocatalysis (green chemistry) genetic engineering genomics and proteomics epidemiology effects of contaminants on humans biomimetic processes... 

The French mostly drink red wine, so the epidemiological effect was associated specifically with red wine rather than white wine. Other benefits of red wine have been discovered since then, some of them even proven, so a search for the active ingredients was started. Ethanol was a logical choice as it is the second most abundant component in wine after water. 

Epidemiological studies of nickel-producing and nickel-using workers seldom indicate excess mortaUty from nonmalignant respiratory disease. Evidence for such effects exists mainly as a few reports of isolated incidents of asthma, pulmonary fibrosis, chronic bronchitis, and emphysema in nickel workers. Nickel may or may not play a causal role in these incidents (131). 

A comprehensive study of the tolerance of laboratory animals to vapors of 2-nitropropane was reported in 1952 (100). In a study pubHshed in 1979, rabbits and rats survived exposure to nitromethane for six months at 750 and 100 ppm, respectively, with no unexpected findings (101). Similarly, no compound-related effects were found for rabbits exposed to 2-nitropropane at 200 ppm or for rabbits or rats exposed at 27 ppm. Liver damage was extensive in male rats exposed at 207 ppm for six months, and hepatocellular carcinomas were observed. Subsequendy, the International Agency for Research on Cancer (lARC) found that there is "sufficient evidence" to conclude that 2-nitropropane causes cancer in rats but that epidemiologic data are inadequate to reinforce the conclusion in humans (102). The National Toxicology Program also concluded that it "may reasonably be anticipated to be a carcinogen" (103). 

There appear also to be toxic effects. In animals, nitrous oxide has been shown to inactivate methionine synthetase which prevents the conversion of deoxyuridine to thymidine and thus has the potential for inducing megaloblastic anemia, leukopenia, and teratogenicity (44—46). A variety of epidemiologic surveys suggest positive correlations between exposure to nitrous oxide and spontaneous abortion in dental assistants (47). 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Effects in Humans. In chlorophenol production, irritation symptoms of the nose, eyes, respiratory tract, and skin resulting ia chloroacne have been observed. The results of epidemiology studies on the long-term effects of chlorophenols are quite contradictory and have not allowed the experts to reach any firm conclusions (54). 

In the 1970s questions were raised about certain immunological complications as a consequence of male sterilisation or vasectomy. Clinical epidemiological data do not appear to indicate that this actually occurs in clinical practice. No significant long-term side effects of male sterilisation have been demonstrated. 

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