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4 Reproductive and Developmental Effects
Pages 42-49

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From page 42...
... The criteria included consideration of identification of adverse effects that were not confounded by excessive maternal toxicity, use of multiple experimental exposures, identification of a no-observed-adverse-effect level (NOAEL) , and conformity with current regulatory testing guidelines.
From page 43...
... For example, only two studies of the reproductive toxicity of tetrachloroethylene are described, and many of the developmental-toxicity studies described have limitations. The limitations include use of a single exposure level, insufficient study details, excessive maternal toxicity, and lack of conformity with current EPA and Organisation for Economic Co-operation and Development (OECD)
From page 44...
... (1975) study, tetrachloroethylene produced a statistically significant increase in resorptions and mild, statistically significant maternal toxicity (4-5% reductions in mean maternal body weight compared with controls)
From page 45...
... 40) , which state: "The minimum evidence necessary to judge that a potential hazard exists generally would be data demonstrating an adverse developmental effect in a single, appropriate, well-conducted study in a single experimental animal species." There is insufficient evidence to indicate that tetrachloroethylene does not cause reproductive toxicity in experimental animals on the basis of the negative findings on reproductive performance and fertility in Tinston.
From page 46...
... EPA did not comment on the relatively high concentrations of TCA required to cause developmental toxicity compared with the concentration expected to result from metabolism of tetrachloroethylene in vivo or on whether this could account for the difference in the type of developmental effects that result from tetrachloroethylene exposure. The lack of information on the availability of metabolized TCA to the developing fetus and the potential differences related to oral vs inhalation exposure in the TCA and tetrachloroethylene studies, respectively, also were not addressed.
From page 47...
... , EPA cites "some evidence for growth retardation in infants born to mothers residing in housing with drinking water contaminated with tetrachloroethylene" as the main evidence of a reproductive outcome of concern. That conflicts with the conclusions in Chapter 4, where EPA indicates that the strongest evidence is on spontaneous abortion on the basis of the occupational studies.
From page 48...
... . Finally, the discrepancy in emphasizing spontaneous abortion as the outcome with the strongest evidence of an association with tetrachloroethylene exposure in Chapter 4 and intrauterine growth retardation in Chapter 6 suggests that the evidence on reproductive outcomes was not carefully evaluated.
From page 49...
... Stating explicitly whether the animal evidence is sufficient or insufficient for these important end points will help risk managers and others to more readily identify and protect against potential adverse health effects. It will also help to identify data gaps in the tetrachloroethylene database.


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