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EU accepts in vitro alternative for the Draize-test
Recently, the EU has accepted the in vitro skin irritation test using reconstituted human skin as stand alone test to determine the skin irritancy potential of a substance within a testing and evaluation strategy.
The assessment of skin damage previously required the use of laboratory animals, in which the test substance was applied to the skin of healthy albino rabbits. In the last decade alternative in vitro methods have been developed. Many of these alternatives are currently accepted by federal regulatory agencies. NOTOX implemented in vitro tissue culture models of human epidermis, in which the corrosive and irritation potential of chemical and physical stress can be assessed.
Substances will be applied to, and interact with three-dimensional multilayered in vitro tissues that closely approximate the biochemical and physiological properties of the upper parts of the human skin. Substances that are able to penetrate the stratum corneum by diffusion are possible cytotoxic to the cells in the underlying layers, which can be measured. Skin irritation is defined as the production of reversible damage to the skin, whereas skin corrosion is defined as the production of irreversible damage of the skin, namely visible necrosis through the epidermis and into the dermis.
The in vitro skin corrosion test, using human skin, has already been accepted in 2000 by the EU (Method B.40 bis) and has been adopted in 2004 as OECD test guideline (OECD TG 431).The REACH test methods regulation (Commission Regulation (EC) No 440/2008) has been amended by Commision Regulation (EC) No 761/2009, to include the in vitro skin irritation test (Method B.46).
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In accordance with Council Directive 86/609/EEC, the number of animals to be used for experimental purposes has to be reduced wherever possible. Consequently the in vitro skin irritation test should be used to cover the skin irritation endpoint in REACH Annex VII and VIII under provisions laid down in REACH Annex XI 1.4 to avoid in vivo testing for skin irritation under the standard testing regime and in compliance with Article 25 of REACH (Regulation (EC) No 1907/2006).
Validated methods for the in vitro skin irritation test, like EpiSkinTM are therefore now recommended as stand-alone replacement test method for the rabbit in vivo test for classifying GHS category 2 irritant substances.
Within the EU the acceptance of the in vitro skin irritation test is of high importance for REACH but also for the 7th Amendment of the European Cosmetics Directive in which alternative, non-animal tests must be used as soon as they have been validated. Since March 2009 there is a ban on animal testing of cosmetic ingredients or formulations and on the sale of cosmetic products and ingredients tested on animals for most toxicological endpoints. From March 2013 on, there will be a complete ban on the sale of cosmetic products or ingredients that have been tested on animals
A draft in vitro test method for skin irritation is still under discussion within the OECD, and therefore method B.46 will be updated as soon as this guideline has been adopted within the OECD or if other justified information becomes available.
The in vitro skin irritation test can be used to test (semi) solids, aqueous or non-aqueous liquids, and waxes. Solids may be soluble or insoluble in water. It has to be taken into account that this test cannot be used for gases and aerosols. Mixtures have not yet been determined in a validation study.
NOTOX has implemented the in vitro skin corrosion and skin irritation test in respectively 2002 and 2008, even before its recommendation in international guidelines. The acceptance of in vitro alternatives by the EU is considered as a major step forward in toxicology in the replacement of animal testing.
References:
ECHA guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance. May 2008
European Community (EC). Council Directive 86/609/EEC: Approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Official Journal L 358, 18 December 1986.
European Community. Council Directive 2003/15/EC. Amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (7th Amendment to the Cosmetics Directive). Official Journal L66, 11 March 2003.
European Community. Regulation (EC) No. 1907/2006, Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC. Official Journal L 396, 30 December 2006.
European Community (EC). Commission regulation (EC) No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test". Official Journal of the European Union No. L142, 31 May 2008.
European Community (EC). Commission regulation (EC) No. 761/2009, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.46 "In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test ". Official Journal of the European Union No. L220, 24 August 2009.
Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Guideline no. 431: In Vitro Skin Corrosion: Human Skin Model Test (adopted 13 April 2004). Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method.
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