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A lifetime oncogenicity study in rats with acrylamide

M A Friedman1, L H Dulak, M A Stedham

  • 1Cytec Industries Incorporated, West Paterson, New Jersey 07424, USA.

Fundamental and Applied Toxicology : Official Journal of the Society of Toxicology
|August 1, 1995
PubMed
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This study characterized acrylamide's carcinogenic potency in rats, confirming its role in thyroid, mammary, and testicular tumors. Acrylamide did not induce glial tumors, and the no-observable-effect level for scrotal mesotheliomas was 0.5 mg/kg.

Area of Science:

  • Toxicology
  • Carcinogenesis
  • Oncology

Background:

  • Acrylamide is a widely used industrial chemical with known carcinogenic potential.
  • Previous studies have indicated acrylamide's ability to induce tumors in various tissues.
  • A comprehensive understanding of acrylamide's dose-response relationship in oncogenesis is crucial for risk assessment.

Purpose of the Study:

  • To accurately characterize the carcinogenic potency of acrylamide through a lifetime oncogenicity study in Fischer 344 rats.
  • To identify specific tumor types induced by acrylamide exposure and establish dose-response relationships.
  • To evaluate the no-observable-effect level (NOEL) for specific acrylamide-induced tumors.

Main Methods:

  • A 106-week study administering acrylamide in drinking water to male and female Fischer 344 rats at varying doses (0-3.0 mg/kg/day).

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  • Comprehensive necropsy, gross pathology, and histopathology examinations of all study animals.
  • Statistical analysis to determine significant increases in tumor incidence compared to control groups.

    • Main Results:

    • Significant increases in mesotheliomas of the testicular tunic in high-dose males.
    • Significant increases in mammary gland adenocarcinomas and fibroadenomas in both acrylamide-dosed female groups.
    • Significantly increased thyroid follicular cell adenomas and adenocarcinomas in high-dose males and females, and low-dose females.
    • Sciatic nerve degeneration observed in high-dose groups; no visual neurotoxicity.
    • Acrylamide did not induce glial tumors, and the NOEL for scrotal mesotheliomas was 0.5 mg/kg.

    Conclusions:

    • This study confirms acrylamide's carcinogenicity, specifically its induction of benign tumors of the thyroid and mammary glands, and mesotheliomas of the testis.
    • Acrylamide exposure did not lead to an increased incidence of glial tumors in this study.
    • The findings establish a NOEL for scrotal mesotheliomas and indicate that mammary tumor increases were within historical control ranges, providing valuable data for risk assessment.