The quality and identity of the active substance and products that contain the active substance need physical chemical testing, development and validation of analytical methods, storage stability and other quality control and compatibility tests.

 

The toxicology package includes investigation of the genotoxicity, acute and subacute toxicity, ecotoxicity, and metabolism. The effects on the environment are tested in biodegradation, leaching and other environmental fate studies, often with radiolabelled test substances.

 

Efficacy testing is a special challenge, since it is difficult to find realistic test designs and specialised laboratories with appropriate technical equipment and safety standards. Further information can be found on the OECD website.