Companion Animal Safety

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Animal health companies seeking to bring a product formulation to market in the United States for the treatment of external pests on animals must provide safety data to the US EPA. If the product is for use in dogs and cats, then a Companion Animal Safety (CAS) Study must be conducted in compliance with the EPA’s Health Effects Test Guideline number OPPTS 870.7200: Companion Animal Safety. CAS studies are not full toxicology studies such as those conducted as part of a pesticide registration. The CAS studies do not include animal sacrifice nor histopathology, nor do they establish no-observed-effect-levels (NOEL). Rather, their intent is to provide assurance of an adequate safety margin and guidance for product labeling. They are most similar in scope to an acute dermal local tolerance study. Additionally the guidance is only applicable to products intended for use in dogs and cats. The guidance is harmonized to some extent to be consistent with the CVM’s Target Animal Safety Guidance.

*EPA 712–C–98–349, August 1998

The scope of a CAS study typically includes these requirements and components:

  • GLP study conduct.
  • The formulation evaluated should be the product intended to be marketed.
  • The study design should reflect the use instructions on the product label, including method of administration and frequency of application.
  • Study conduct in the intended species in an age range of animals intended for the product. Thus, if the drug label will include juvenile animals, for example, then a CAS evaluation in pediatric animals at the same age will be required, as well as studies in adult animals.
  • The study should be randomized, controlled (placebo or negative control), and masked (blinded to treatment).
  • The study will typically include 4 treatment groups (control, 1X, 3X, and 5X the intended treatment dose level), with 4 male and 4 female animals per group.
  • Study durations are recommended to be 14 days post treatment. Repeated treatment will require the study to continue until 14 days have elapsed following the final treatment.
  • Total study durations (e.g., number of repeated treatments, or duration of flea/tick collar studies) will be determined in consultation with the EPA prior to the initiation of the study.
  • It is standard practice to provide the EPA with the draft study design, to receive any comments and obtain their concurrence.
  • Major study variables will include physical examinations, body weight, food intake and full clinical observations, and multiple time points of clinical pathology tests.
  • Necropsy and histopathology examinations are not included in CAS studies, except for animals dying or sacrificed moribund. Gross necropsies should be conducted to determine the cause of death and abnormal organs/tissues should be examined histologically in such instances.

Laboratories conducting the study must have significant experience with CAS study conduct, and evaluating CAS study variables in animals. Clinical pathology data must be interpreted by a board certified veterinary clinical pathologist, and all endpoint data are subject to statistical analysis by a qualified biostatistician.

* International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products

Sinclair has industry leading experience in conducting CAS studies! In fact, Sinclair has reported more CAS studies to the EPA than any other CRO, or registrant laboratory, and the industries most experienced CAS study directors reside at Sinclair!

When a client brings a CAS study to Sinclair, the study will be done right, regardless of the type of product, or age of the animal at administration! The CAS studies conducted at Sinclair include many pediatric studies in cats and dogs supporting labeling for treatment as young as 6 weeks. Such studies happen at an extremely vulnerable time in the life of a cat or dog. Sinclair takes extreme care, using proprietary facility SOPs to insure that all pediatric animals are healthy and vigorous at the start of the study, insuring our clients that they have the best opportunity possible for a successful study outcome.

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