
Environmental impact assessment for veterinary medicinal products (VMP) according CVMP/VICH/790/03-FINAL
Phase II: Tier A
Physico-chemical Properties
- UV/VIS absorption spectra
- Melting point / Melting range
- Water solubility
- Partition Coefficient log Kow
- Dissociation constant in water
- Vapour pressure (calculation)
Terrestrial Ecotoxicology
- Nitrogen transformation
- Terrestrial plants growth
- Earthworm subacute / reproduction
Environmental Fate
- Biodegradation (soil or aquatic)
- Adsorption / Desorption in soil Kd / Koc
- Photolysis (optional)
- Hydrolysis (optional)
Aquatic Ecotoxicology
- Algae growth inhibition
- Daphnia immobilisation
- Fish acute toxicity
(Additional salt water test systems for products used for aquaculture)
Phase II: Tier B
Depending on the results of the studies from Tier A, additional studies are necessary:
- Environmental Fate
- Terrestrial Ecotoxicology
- Aquatic Ecotoxicology
Assessment of Environmental Safety for Veterinary Medicinal Products
