These tests assess the local irritation potential of a test material, using sites such as skin or mucous membranes, in rabbits

Catalog number EA672

Required from Customer

  • Device or device material
  • MSDS or handling and storage information, e.g., light sensitive, store at -20°C, biological activity, etc.

Deliverables

  • In-life observations on each animal
  • Local site reactions
  • Toxicology report

Substrate

  • Device material or an extract thereof in a vehicle suitable for dosing by the specified route of administration

Study System

  • Rabbits

Study Conditions

  • Intracutaneous Irritation Test:
    • Recommended for externally communication devices or internal contact devices
    • Inject device material, or an extract thereof, intradermally in triplicate animals (N=3)
    • After a 72-hour exposure, score the injection sites for erythema and edema
  • Primary Skin Irritation Test:
    • Recommended for topical devices that have external contact with intact or breached skin
    • Apply device material, or an extract thereof, in triplicate animals (N=3) directly to intact and abraded sites on the skin
    • After a 24-hour exposure, remove the test material and score the sites for erythema and edema
  • Mucous Membrane Irritation Test:
    • Recommended for devices that will have externally communicating contact with intact natural channels for tissues
    • Apply device material, or an extract thereof, in triplicate animal (N=3) directly to the site of the test (see below)
    • Common sites of administration include vaginal mucosa, cheek pouch mucosa, and eye
    • At the end of the study, score the test site for erythema and edema

Study QA

  • ISO 10993
  • GLP

Notes

  1. Route (skin, eye, mucosa) and duration of exposure should be consistent with the clinical use of the test material.
  2. Absorption Systems will supply and test an extract of a USP negative control material.
  3. Materials Biocompatibility Matrix (ISO Standard 10993, Biological Evaluation of Medical Devices) recommends this test for all blood contact devices. It may also be appropriate for any other device that contacts internal tissues.
  4. Biocompatibility testing of device materials may be conducted prior to manufacturing, but eventually the finished device must be tested as well. Testing of materials alone is not sufficient for market approval in most cases.
  5. This study will be conducted per appropriate ISO standards and FDA guidelines.

Options

  1. The customer must specify:
    • either the standard or custom report format
    • which irritation test(s) to perform
    • the route(s) of administration of test material
    • the dose(s) of test material
  2. The customer can request:
    • additional doses of test material
    • additional routes of administration
    • additional replicates