Dermal Penetration

Validated Non-animal Alternatives

Ex vivo human and/or animal skin preparations and various test protocols are acceptable for dermal penetration testing according to the Organisation for Economic Co-operation and Development (OECD) Test Guideline 428, Skin Absorption: In Vitro Method, and the OECD Guidance Document for the Conduct of Skin Absorption Studies (GD No. 28). European Union agencies consider the in vitro methods superior to the animal methods for dermal penetration testing, and have therefore accepted the in vitro skin methods without formal validation studies (industry internally validated the methods). US agencies still require animal dermal penetration test data.