Types of Studies

    • 90 days with recovery period – GLP compliant

     

    General recommendations and objectives

    • The same recommendations relevant to sub-acute dose toxicology
    • 90-days studies provides information on the possible health hazards likely to arise from repeated exposure over a prolonged period of time
    • The study will provide information on the major toxic effects, indicate target organs and the possibility of accumulation of test chemical, and can provide an estimate of NOAEL
    • This study provides dose response related data that may be used to estimate point of departure for hazard assessment using appropriate modelling methods

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 408, 411

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