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' . • PEAK Antifreeze Page Page 7 of l 1 <br />itro mutagenicit studies were negatie. Animal mutagenicit studies were <br />negatie. <br />A AA PE EEAE A <br />Ethlene glool has een shown to produce dose relatesd teratogenic <br />effects in rats and mice when given by gavage or in drinking water at <br />high concentrations or doses. he no effect doses for developmental <br />toxicity for ethylene glycol given by gavage over tite period of <br />organogenesis has been shown to be 1 SO mg/kg/day for the mouse and <br />500 mg/kg/da for the rat. Also, in a preliminary study to asses the <br />. effects of exposure of pregnant rats and made to aerosis at concentrations <br />of 150, 1000 and 25000 mglm3 far 6 hours a day throughout the period <br />of organogenesis, teratogenic effects were produced at the highest <br />concentra#ion ut onl in mice. The conditions of these latter <br />experiments did not allow a conclusion as to whether the developmental <br />toxicity was mediated by inhalation of aerosol percutaneous absorption of <br />ethylene glycol from contaminated skin, or swallowing ethylene glycol as <br />a result of grooming the wetted coat. In a further study, comparing <br />effects horn high aerosol concenUration whole od or nose only <br />epasure it was shown that nose only exposure resulted in maternal <br />toxicity {1000 and 25000 mg/m3) and developmental toxicity with <br />minimal eidence of teratogenictit 2500 mg/m3. he no effects <br />concentration aced on maternal toicit was SOO mg/m3. In a further <br />study in mice, no teratogenic effects could be produced when ethylene <br />glycol was applied r~ elrin ofdregnant mice over the--pot'iod of <br />organogenesis. The above observations suggest that ethylene glycol is to <br />. e regarded as an animal teratogen. There is currently no available <br />information to suggest that ethylene glycol has caused birth defects in <br />humans. Cutaneous application of ethylene glycol is ineffective in <br />producing deelopmental toicit. Exposure to high aerosol <br />concentrations is only minimally effective in producing developmental <br />taicit. `The major route for producing developmental toxicity is <br />perorall. Two chronic feeding studies, using rats and mice, have not <br />produced an eidence that ethlene glwl causes dose related increases <br />in tumor incidence or a different pattern of tumors ccm-pared with <br />untreated controls. The absence of carcinogenic potential for ethylene <br />glycol has been supported by numerous in vitro genotoxicity studies <br />showing that it does not produce mutagenic aR clastogenic effects. <br />A chronic dietary feeding study of diethylene glycol with rats showed <br />mild kidney injury at 1%, while concentrations of 2"/° and 4% caused <br />more. marked kidne incr. In addition, at 2% and 4% of diethylene <br />glycol in the diet, some rats developed benign papillary rumors in the <br />urinar ladder. These have been attributed to the presence of urinary <br />ladder ~ calcium palate stones. No evidence for carcin~~genicity was <br />found with a chronic skin painting stud with diethlene glcol in mice. <br />The absence of a direct chemical carcinogenic effect addords with the <br />results in vitro genotoxieity studies that show that it does not produce <br />mutagenic or ctastogenic effects. A feeding study employing up to S.t)% <br />diethlene glcol in the diet failed to produce an teratogenic effects. In <br />a mouse continuous breeding study with large doses of diethylene glycol <br />in drinking water, there was evidence for reproductive toxicity at 3.5% <br />http:l/www.peakantifreeze.com/msds/fullforce_msds.html 9/24/01 <br />