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Triprolidine: 104-week feeding study in rats

D L Greenman1, W Sheldon, G Schieferstein

  • 1Office of Associate Director for Scientific Coordination, National Center for Toxicological Research, Jefferson, Arkansas 72079-9502, USA.

Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology
|September 1, 1995
PubMed
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The antihistamine triprolidine hydrochloride was not found to be carcinogenic in Fischer 344 rats over a two-year study. While survival was extended, particularly at high doses, no evidence of cancer was detected.

Area of Science:

  • Toxicology
  • Carcinogenicity Studies
  • Pharmacology

Background:

  • Antihistamines are widely used medications.
  • Understanding the long-term safety profile of antihistamines is crucial.
  • Triprolidine hydrochloride is a commonly used antihistamine.

Purpose of the Study:

  • To evaluate the potential carcinogenicity of triprolidine hydrochloride.
  • To assess the long-term effects of dietary triprolidine hydrochloride in rats.

Main Methods:

  • Fischer 344 rats (60 per sex) were fed triprolidine hydrochloride at dietary concentrations of 0, 250, 1000, or 2000 ppm for up to 2 years.
  • Hematology, clinical chemistry, and histopathology were evaluated at 65 weeks and 2 years.
  • Survival, body weight, and lesion incidences were analyzed.

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Main Results:

  • Survival was significantly extended in triprolidine-treated rats, especially at the high dose.
  • Negative dose trends were observed for numerous neoplastic and hyperplastic lesions in both sexes.
  • Increased incidences of cytoplasmic alterations in the parotid gland and certain liver lesions were noted in treated animals.

Conclusions:

  • Triprolidine hydrochloride was not carcinogenic in Fischer 344 rats under the conditions of this study.
  • The study suggests a lack of carcinogenic potential for triprolidine hydrochloride.
  • Further investigation into specific non-neoplastic lesions may be warranted.