Module 2 - Existing in vivo data - OECD 404
With well-defined IATA model, conferring the primary importance to existing data, in vivo animal test data (Module 2) occupies the top level preference, next to existing Human data (Module 1).
PART 1: Existing Information, Physico-Chemical Properties and Non-Testing Methods
Module 2: Existing In Vivo Data – OECD 404
A modified version of Draize test with dual amendment conferred to this test guideline.
Year 1992 :
- Approach to waive in vivo testing based on a positive in vitro skin corrosion test result
- Use one animal in a first step of the in vivo procedure allowing certain chemicals to be exempted from further testing
- Full spectrum Classification capability: No Cat., Cat. 3 Cat. 2, Sub-cat 1C, 1B or 1A.
Year 2002 :
- Sequential testing and evaluation strategy
PROS:
o Effect Reversibility check
o Reflects Mode of Action of substance on
CONS:
o Species difference to reactivity of test substance.
o Although same CAS, methodology and Impurity composition may vary test result in reality.
o Results Prediction variability across scientific staff
o Constrains with uniform application of test item for certain physical forms of chemicals.
Although existing data on OECD 404 is a very relevant information; as a manufacturer with undefined impurities or with a different combination impurities coming out of a varied manufacturing process, may not mimic to the exact details as available in QSAR and other parallel existing data.
With OECD 404 in-vitro test alternatives well established and validated; laboratory activity in this domain is always an added advantage for the manufacturer to be regulatory ready at any given point of time.
Come explore your product’s in vitro test results with us at Bioneeds. With expertise advanced to latest regulatory demands; we meet your commitments to compliance with utmost pride of being associated with you.
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