Types of Studies

    • 6 to 24 months – GLP compliant

     

    General recommendations and objectives

    • The three main routes of administration used are oral, dermal and inhalation
    • The study will provide information on the possible health hazards likely to arise from repeated exposure over a considerable part of the lifespan of the species used
    • Identification of a NOAEL or BMD, as well as a prediction of chronic toxicity effects at human exposure levels

Readouts

  • Clinical Signs (morbidity and mortality)
  • Food consumption; body weight
  • Clinical Examination – tumors, distended abdomen, kyphosis, etc
  • Ophthalmologic examination – cataracts, eye discharge, corneal opacity, etc
  • Functional Observational Battery (FOB) – tail stiffening, forelimb grip strength, body temperature, etc
  • Neuronal Observational Battery (NOB) – gait disorders, tremor, menace reflex
  • Necropsy
  • Organ Weight
  • Hematology and Clinical Biochemistry
  • Histopathology

Guidelines

  • CPMP/SWP/1042/99 Rev. 1 Corr
  • OECD 452

© 2024 digital connection | All rights reserved | Privacy policy| Data Privacy Contact Form