Introduction of in vitro data into local irritation/corrosion testing strategies by means of SAR considerations: assessment of chemicals.
The European legislation on control and evaluation of chemicals requires hazard and risk assessment of chemicals for human health and the environment. Technical guidance on carrying out this assessment includes the use of information based on results of testing with animals and on results of alternatives to animal testing. Within regulatory risk assessment the use of in vitro data for hazard and risk classification purposes is in the very beginning, because in vitro results do not mirror the total of effects observed in standardised animal tests, and hence cannot be easily related to current regulatory classification criteria. In vitro tests aim at the detection of only a few aspects considered crucial for the formation of a very complex health hazard observed in vivo. Therefore, they need a clear definition of the toxicological questions they can answer and of the limits of their evidence with respect to meeting regulatory classification criteria. In order to enhance the use of in vitro results within the regulatory classification procedure, the Organisation for Economic Co-operation and Development (OECD) developed tiered testing and assessment strategies that combine in vitro results and structure-activity relationship (SAR) considerations.
Gerner
Ingrid
I
Department Assessment of Chemicals, German Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV), Thielallee 88-92, D-14195 Berlin, Germany. i.gerner@bgvv.de
Schlede
Eva
E
D000826:Animal Testing Alternatives / Q000379:methods; D000818:Animals; D005123:Eye / Q000187:drug effects / Q000473:pathology; D006801:Humans; D066298:In Vitro Techniques; D007509:Irritants / Q000009:adverse effects / Q000737:chemistry / Q000633:toxicity*; D012867:Skin / Q000187:drug effects / Q000473:pathology; D013329:Structure-Activity Relationship; D018675:Toxicity Tests / Q000379:methods; D014116:Toxicology / Q000379:methods*; D015262:Xenobiotics / Q000009:adverse effects / Q000737:chemistry / Q000633:toxicity*
D007509:Irritants; D015262:Xenobiotics