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Brixham Environmental Laboratory

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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

STUDYGUIDELINE
Physical-chemical Properties Studies at Tier A
Water SolubilityOECD 105
Dissociation Constants in WaterOECD 112
UV-Visible Absorption SpectrumOECD 101
Melting Point/Melting RangeOECD 102
Vapour PressureOECD 104
n-Octanol/Water Partition CoefficientOECD 107 or 117
Environmental fate studies at Tier A
Soil Adsorption/DesorptionOECD 106
Soil Biodegradation (route and rate)OECD 307
Degradation in aquatic systemsOECD 308
Photolysis Seek regulatory guidance
Hydrolysis OECD 111
Aquatic effects studies at Tier A
Freshwater Algal growth inhibitionOECD 201
Freshwater Daphnia immobilizationOECD 202
Freshwater/Saltwater Fish acute toxicityOECD 203
Saltwater Algal growth inhibitionISO 10253
Saltwater Crustacean acute toxicityISO 14669
Terrestrial effects studies at Tier A
Nitrogen TransformationOECD 216
Terrestrial plantsOECD 208
Earthworm Subacute/reproductionOECD 220 /222
Environmental fate study at Tier B
Bioconcentration in fishOECD 305
Aquatic effects studies at Tier B
Freshwater Algae growth inhibitionOECD 201
Freshwater Daphnia magna reproductionOECD 211
Freshwater Fish, early-life stageOECD 210
Freshwater Sediment invertebrate species toxicityOECD 218, 219
Saltwater Algae growth inhibitionISO 10253
Saltwater Crustacean chronic toxicity or reproductionSeek regulatory Guidance
Saltwater Fish chronic toxicitySeek regulatory Guidance
Saltwater Sediment invertebrate species toxicitySeek regulatory Guidance
Terrestrial effects studies at Tier B
Nitrogen Transformation (100 days– extension of Tier A study)OECD 216
Terrestrial plants growth, more speciesOECD 208

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