Drug Investigation

, Volume 5, Supplement 1, pp 50–67 | Cite as


Toxicological Profile of a Chemical Derivative of 2-Pyrrolidinone
  • Bernhard Schläppi
  • H. Bürgin
  • E. Gocke


Complete toxicological screening with aniracetam, a nootropic agent, showed the drug to be very well tolerated by mice, rats, rabbits and dogs, after both single and repeated dose administration. No adverse effects on the reproductive system were seen and the compound was negative in a battery of mutagenicity tests. Lifelong treatment in mice and rats did not reveal any carcinogenic potential of the drug. The effects found in the various animal studies occurred only at extremely high doses and were in general of minor toxicological relevance. The therapeutic index of the compound is therefore considered to be very large.


Drug Invest High Dose Group Bodyweight Gain Aniracetam Toxicological Profile 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Ames BN, McCann J, Yamasaki E. Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test. Mutation Research 31: 345–364, 1975CrossRefGoogle Scholar
  2. Anonymous. Aniracetam. Drugs of the Future 6: 127–128, 1981Google Scholar
  3. Anonymous. Aniracetam. Drugs of the Future 8: 251–252, 1983aGoogle Scholar
  4. Anonymouse. Pramiracetam hydrochloride. Drugs of the Future 8: 795–796, 1983bGoogle Scholar
  5. Anonymous. Aniracetam. Drugs of the Future 9: 211–212, 1984Google Scholar
  6. Barrow WV, Taylor WJ. A rapid method for detecting malformations in rat fetuses. Journal of Morphology 127: 291–305, 1969PubMedCrossRefGoogle Scholar
  7. Cumin R, Bandle EF, Gamzu E, Haefely WE. Effects of the novel compound aniracetam (Ro 13-5057) upon impaired learning and memory in rodents. Psychopharmacology 78: 104–111, 1982PubMedCrossRefGoogle Scholar
  8. Dawson AA. A note on the staining of the skeleton of cleared specimens with alizarin Red S. Stain Technology 1: 123–124, 1926Google Scholar
  9. De Angelis L. Oxiracetam. Drugs of the Future 5: 405–407, 1980Google Scholar
  10. De Angelis L. Etiracetam. Drugs of the Future 6: 552–553, 1981Google Scholar
  11. Frantz CN, Mailing HV. The quantitative microsomal mutagenesis assay method. Mutation Research 31: 365–380, 1975PubMedCrossRefGoogle Scholar
  12. Green MHL, Bridges BA, Rogers AM, Horspool G, Muriel WJ, et al. Mutagen screening by a simplified bacterial fluctuation test: use of microsomal preparations and whole liver cells for metabolic activation. Mutation Research 48: 287–294, 1977PubMedCrossRefGoogle Scholar
  13. Ishidate M, Sofuni T, Yoshikawa K. Chromosomal aberration test in vitro as a primary screening test for environmental mutagens and/or carcinogens. GANN Monograph Cancer Research 27: 95–108, 1981Google Scholar
  14. Moos WH, Davis RE, Schwarz RD, Gamzu ER. Cognition activators. Medical Research Reviews 8: 353–359, 1988CrossRefGoogle Scholar
  15. Poschel BPH, Marriott JG, Gluckman MI. Pharmacology of the cognition activator pramiracetam (CI-879). Drugs Under Experimental and Clinical Research 9: 853–871, 1983Google Scholar
  16. Salewski E. Färbemethode zum makroskopischen Nachweis von Implantationsstellen am Uterus der Ratte. Archiv für experimentelle Pathologie und Pharmakologie 247: 367, 1964Google Scholar
  17. Schildler U, Rush DK, Fielding S. Nootropic drugs: animal models for studying effects on cognition. Drug Development Research 4: 567–576, 1984CrossRefGoogle Scholar
  18. van Julsingha EB, Bennett CG. A dissecting procedure for the detection of anomalies in the rabbit foetal head. In Neubert D, et al. (Eds) Methods in prenatal toxicology, pp. 126–144, Thieme, Stuttgart, 1977Google Scholar
  19. Zimmermann FK, Kern R, Rasenberger H. A yeast strain for simultaneous detection of induced mitotic crossing over, mitotic gene conversion and reverse mutation. Mutation Research 28: 381–388, 1975CrossRefGoogle Scholar

Copyright information

© Adis International Limited 1993

Authors and Affiliations

  • Bernhard Schläppi
    • 1
  • H. Bürgin
    • 1
  • E. Gocke
    • 1
  1. 1.Pharma Division, Preclinical ResearchF. Hoffmann-La Roche LtdBaselSwitzerland

Personalised recommendations