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 Background and state-of-the-art
This proposal addresses the need for efficient and validated methods to test the effects of chemicals on human health and the environment.

Genotoxicity testing: Standard methods based on in vivo testing of rodents are under scrutiny, and a battery of appropriate in vitro tests is seen by many as a more efficient and valid way of assessing potential effects of chemicals on human health. Extrapolation from animals to humans is far from reliable. Moreover in vitro human cell models are more suitable for studying specific mechanisms and pathways leading to genotoxic effects.

Environmental safety: Even in the best regulated countries, such as Norway, there is serious concern about the accidental or uncontrolled release of chemicals (both existing and novel) into the environment, particularly as a result of agricultural, industrial and domestic activities. Contamination affects air, soil and water; usually the aquatic environment is the ultimate recipient. Ecotoxicology is at present an underdeveloped discipline – largely because of the weakly enforced regulatory framework.

The overall health of an ecosystem can be assessed by applying standard toxicity testing methods to sentinel organisms exposed in their natural environment. In addition, laboratory studies involve exposing organisms (plants, invertebrates and vertebrates) to controlled doses of chemicals or radiation, the usual endpoint being the LD50 (dose killing 50% of organisms). This is a very crude measure, and more sensitive biomarkers are increasingly employed – among them, cytogenetic and genotoxicity assays.

Nanotechnology, nanomaterials: The unique properties of nanoparticles (small size, relatively high surfaceto‐volume ratio, and reactivity), while likely to benefit many aspects of our lives, are also a cause of concernas their possible impact on human health is not fully understood. There are ongoing discussions within EC committees and REACH‐competent authorities on hazard and risk assessment of nanomaterials, and special testing strategies might be needed. Current approaches used to test the safety of chemicals apply also to nanomaterials.

Human safety and biomonitoring: An increasingly important aspect of epidemiology is the use of biomarker assays to disclose unwanted exposure and indicate disease risk. Further development of improved and more efficient assays is currently addressed by the project leaders. Standardisation and validation of the comet assay as a biomonitoring tool is an important issue.

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