90-Day Oral Gavage Toxicity Study of 8-2 Fluorotelomer Alcohol in Rats

Authors:
  • GKGerald L. Kennedy
    Gerald L. Kennedy
  • JOJohn O'Connor
    John O'Connor
  • NENancy Everds
    Nancy Everds
  • LMLinda A. Malley
    Linda A. Malley
  • SFSteven R. Frame
    Steven R. Frame
  • SGShawn Gannon
    Shawn Gannon
  • RJReinhard Jung
    Reinhard Jung
  • TRThomas Roth
    Thomas Roth
  • HIHiroyuki Iwai
    Hiroyuki Iwai
  • SSSeiji Shin-Ya
    Seiji Shin-Ya
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Abstract
8-2 fluorotelomer alcohol is a fluorinated chemical intermediate used to manufacture specialty polymers and surfactants. The potential subchronic toxicity and the reversibility of the effects of this chemical were evaluated following approximately 90 days of oral gavage dosing to Crl:CD(SD)IGS BR rats. A complete toxicological profile, including neurobehavioral assessments and hepatic beta-oxidation, were conducted at selected intervals and a group of rats was included for a 90-day postdosing recovery period. Dose levels tested were 0 (control), 1, 5, 25, and 125 mg/kg. No test-substance-related mortality occurred at any dose level. Rats at 125 mg/kg developed striated teeth, such that these animals were switched to ground chow at 77 days. No treatment-related alterations in body weight, food consumption, neurobehavioral parameters, or hematology/clinical chemistry were found. Hepatic beta-oxidation was increased in males at 125 mg/kg and in females at 25 and 125 mg/kg. In both males and females, plasma fluorine levels were increased at 125 mg/kg and urinary fluorine was elevated at > or =5 mg/kg. Degeneration/disorganization of enamel organ ameloblast cells was observed at 125 mg/kg in males, but not females. Liver weight increases accompanied by focal hepatic necrosis were observed at both 25 and 125 mg/kg, and chronic progressive nephrotoxicity occurred in female rats at 125 mg/kg. With the exception of hepatocellular necrosis in males at 125 mg/kg and the increased incidence and severity of chronic progressive nephropathy in females at 125 mg/kg, all other changes showed evidence of reversibility. The no-observed-adverse-effect level was 5 mg/kg.

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