Introduction
Directive 2001/82/EC, as amended by Directive 2004/28/EC on the community code relating to veterinary medicinal products includes provision for an assessment of environmental risk. The latest guidance on the assessment of environmental risks of veterinary medicinal products was provided by the European Commission in June 2009 (DG ENTR/F2/JR(2009). That guidance refers, in turn, to the VICH guidelines GL6 and GL38, produced in 2000 and 2005 respectively. GL6 refers to the Phase I, desk based assessment, GL38 refers to Phase II and lays out the criteria for environmental fate and ecotoxicity testing.
Brixham Environmental Laboratory can provide the Phase I assessment and all of the Phase II testing.
Study Capability
| STUDY | GUIDELINE |
| Physical-chemical Properties Studies at Tier A | |
| Water Solubility | OECD 105 |
| Dissociation Constants in Water | OECD 112 |
| UV-Visible Absorption Spectrum | OECD 101 |
| Melting Point/Melting Range | OECD 102 |
| Vapour Pressure | OECD 104 |
| n-Octanol/Water Partition Coefficient | OECD 107 or 117 |
| Environmental fate studies at Tier A | |
| Soil Adsorption/Desorption | OECD 106 |
| Soil Biodegradation (route and rate) | OECD 307 |
| Degradation in aquatic systems | OECD 308 |
| Photolysis | Seek regulatory guidance |
| Hydrolysis | OECD 111 |
| Aquatic effects studies at Tier A | |
| Freshwater Algal growth inhibition | OECD 201 |
| Freshwater Daphnia immobilization | OECD 202 |
| Freshwater/Saltwater Fish acute toxicity | OECD 203 |
| Saltwater Algal growth inhibition | ISO 10253 |
| Saltwater Crustacean acute toxicity | ISO 14669 |
| Terrestrial effects studies at Tier A | |
| Nitrogen Transformation | OECD 216 |
| Terrestrial plants | OECD 208 |
| Earthworm Subacute/reproduction | OECD 220 /222 |
| Environmental fate study at Tier B | |
| Bioconcentration in fish | OECD 305 |
| Aquatic effects studies at Tier B | |
| Freshwater Algae growth inhibition | OECD 201 |
| Freshwater Daphnia magna reproduction | OECD 211 |
| Freshwater Fish, early-life stage | OECD 210 |
| Freshwater Sediment invertebrate species toxicity | OECD 218, 219 |
| Saltwater Algae growth inhibition | ISO 10253 |
| Saltwater Crustacean chronic toxicity or reproduction | Seek regulatory Guidance |
| Saltwater Fish chronic toxicity | Seek regulatory Guidance |
| Saltwater Sediment invertebrate species toxicity | Seek regulatory Guidance |
| Terrestrial effects studies at Tier B | |
| Nitrogen Transformation (100 days– extension of Tier A study) | OECD 216 |
| Terrestrial plants growth, more species | OECD 208 |
