title: Local tolerance testing under REACH: Accepted non-animal methods are not on equal footing with animal tests.
abstract: In general, no single non-animal method can cover the complexity of any given animal test. Therefore, fixed sets of in vitro (and in chemico) methods have been combined into testing strategies for skin and eye irritation and skin sensitisation testing, with pre-defined prediction models for substance classification. Many of these methods have been adopted as OECD test guidelines. Various testing strategies have been successfully validated in extensive in-house and inter-laboratory studies, but they have not yet received formal acceptance for substance classification. Therefore, under the European REACH Regulation, data from testing strategies can, in general, only be used in so-called weight-of-evidence approaches. While animal testing data generated under the specific REACH information requirements are per se sufficient, the sufficiency of weight-of-evidence approaches can be questioned under the REACH system, and further animal testing can be required. This constitutes an imbalance between the regulatory acceptance of data from approved non-animal methods and animal tests that is not justified on scientific grounds. To ensure that testing strategies for local tolerance testing truly serve to replace animal testing for the REACH registration 2018 deadline (when the majority of existing chemicals have to be registered), clarity on their regulatory acceptance as complete replacements is urgently required.
authors: Scientific Consultancy - Animal Welfare, Neubiberg, Germany.
authors: Ursula G
authors: UG
authors: Sauer
authors: Institute for In Vitro Sciences (IIVS), Gaithersburg, MD, USA.
authors: Erin H
authors: EH
authors: Hill
authors: Institute for In Vitro Sciences (IIVS), Gaithersburg, MD, USA.
authors: Rodger D
authors: RD
authors: Curren
authors: Institute for In Vitro Sciences (IIVS), Gaithersburg, MD, USA.
authors: Hans A
authors: HA
authors: Raabe
authors: BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
authors: Susanne N
authors: SN
authors: Kolle
authors: BASF Schweiz AG, Basel, Switzerland.
authors: Wera
authors: W
authors: Teubner
authors: BASF Personal Care and Nutrition GmbH, Düsseldorf, Germany.
authors: Annette
authors: A
authors: Mehling
authors: BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany.
authors: Robert
authors: R
authors: Landsiedel
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D003877:Dermatitis, Contact; D005062:European Union; D005128:Eye Diseases / Q000139:chemically induced; D005131:Eye Injuries / Q000139:chemically induced; D015386:Hazardous Substances / Q000633:toxicity*; D007880:Legislation, Drug; D012871:Skin Diseases / Q000139:chemically induced; D018675:Toxicity Tests / Q000592:standards*
chemical_list: D015386:Hazardous Substances