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3 Health Effects: Toxicity Studies
Pages 18-27

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From page 18...
... . No deaths or clinical signs of toxicity were observed immediately after exposure or during the 3- or 14'As used by the subcommittee, acute means continuous exposure for up to 24 h, subacute means repeated exposures for at least I month; and subchronic means repeated exposures for at least I month but no longer than 3 months.
From page 19...
... All male and female rats exposed to 10.0% or 12.8% CF31 survived the 2-wk observation period, and no other clinical signs oftoxicity were noted. At necropsy, the rats exposed to 32.0% test material had dark red and puffy lungs that were consistent with hydrogen fluoride exposure.
From page 20...
... The body weight of male rats exposed to 12.0% TABLE 3-1 Summary of Acute Rat Inhal ation Exposure Studies Animal CF31 Exposure Results Reference 30 male Single 4-h, No deaths during the 3- or 14- Kinkead et Fischer344 nose orlly; day observation period;slight al. 1994; rats 0.0%, 0.5%, or decreases in thyroxine and Dodd et al.
From page 21...
... and female rats (400/o) ; 8.0%, mild increase in thyroid follicnlar colloid in male and female rats at 13 wk CF31 was statistically decreased on study days 7 and 14, and the body weight of male rats exposed to 6.0%, on study day 14.
From page 22...
... On necropsy, a mild mcrease m thyroid follicular colloid was found in all CF31 groups, although no biologically significant effects were found in the absolute or relative organ weights after 4 or 13 wk of treatment. Treatment-related microscopic effects, such as rhinitis, were found after 4 wk of treatment in male and female rats exposed to CF31 at greater than 4.0% but not after 13 wk of exposure.
From page 23...
... tested with and without S-9 metabolic activation were weakly positive for inducing frame-shift and base-pair mutations, two (TA 1535 and TA 100) were strongly positive, and m the micronucleus test the two highest concentrations were positive for structural chromosomal aberrations in both sexes.
From page 24...
... Given the varied genotoxicity resWts, the subcommittee suggests that it would be prudent to verify the micronucleus results in a mouse or rat bone marrow chromosomal-aberra60n study. We offer this
From page 25...
... Therefore, the subcommittee recommends short-term testing for carcinogenicity. Studies of in vitro cellular transformation, such as the Syrian hamster embryo cell culture (LeBoeuf et al.
From page 26...
... A search of the published literature by the subcommittee failed to identify any other reproductive or developmental toxicity studies for CF31. Therefore, given the lack of reproductive or development toxicity from exposure to CF31 and the availability of developmental toxicity studies conducted for several other halocarbons that failed to demonstrate any adverse effects, no additional testing of CF31 for reproductive or developmental effects is recommended by the subcommittee.
From page 27...
... There is rninirnal human experience with CF31 (see Chapters 4 and 6) , but no human health studies were identified.


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