PROTEIN BIOMARKERS FOR IN VITRO TESTING OF DEVELOPMENTAL TOXICITY AND ENBRYOTOXICITY OF CHEMICAL SUBSTANCES

摘要

Presently, the toxicological assessment of chemicals is mainly performed in vivo using a variety of animal species and in addition taking into account human clinical, biochemical, pathological and morphological data. Over the past years it became increasingly clear that some substances are particularly harmful for children and thus there is a focus on the special vulnerability of the developing human brain. Meanwhile there is a recommendation to test substances with a known neurotoxic or teratogenic (in particular a neuroteratogenic) risk additionally for embryotoxicity. Moreover the US Environmental Protection Agency (EPA) requires embryotoxicity tests for pesticides. Further tests are required if substances shall be used as medicaments (S7A Safety Pharmacology Studies for Human Pharmaceuticals, Guidelines of the International Conference on Harmonization, ICH, 2001).