According to the EMEA (European Medicine Agency) guideline an environmental risk assessment shall accompany an application for a marketing authorization for a medical product for human use.
Long-term toxicity tests on fish, daphnia and algae are the base set of tests proposed to determine the predicted no effect concentration (PNECaquatic) of a substance, for which adverse effects are not expected to occur. Dependent on the outcome of a Phase I evaluation, it may also be required to examine the transformation in soil, the toxicity to soil invertebrates and the effects on terrestrial plants and microorganisms.
Our laboratory is authorized by the Danish Medicines Agency to carry out studies in compliance with the OECD principles of Good Laboratory Practice (GLP).
We perform all the ecotoxicological tests recommended by EMEA on physical-chemical, fate and effects studies in compliance with the OECD GLP.
| Aquatic studies |
Test description |
Guideline |
Adsorption/desorption using a batch equilibrium method |
OECD 106 |
Ready biodegradability test |
OECD 301 |
Aerobic and anaerobic transformation in aquatic sediment systems |
OECD 308 |
Alga, growth inhibition test |
OECD 201 |
Daphnia sp. reproduction test |
OECD 211 |
Fish Early Life Stage toxicity test (FELS) |
OECD 210 |
Activated sludge, respiration inhibition test |
OECD 209 |
Terrestrial studies |
Test description |
Guideline |
Aerobic and anaerobic transformation in soil |
OECD 307 |
Soil microorganisms: Nitrogen transformation test |
OECD 216 |
Terrestrial plants, growth test |
OECD 208
DHI agreement with sub contractor |
Earthworm, acute toxicity test |
OECD 207 |
Collembola, reproduction test |
ISO 11267 |