Environmental risk
Rovaltain Research Staphyt
Environmental risk assessment (ERA)
As part of international regulation and norms to assess the environmental risk of substances and final products, RRS offers to realise the requested tests to complete an ERA file mainly for pharmaceutic, medicine and veterinary industry.
Environmental risk and Medicinal products for veterinary use
According to EMEA about CVMP
According to the guideline 2004/28/EC
According to the VICJ GL6 and GL38
RRS offers to realise physico-chemical, ecotoxicologic and environmental tests as part of environmental risk assessment veterinary pharmaceuticals.
Phase 2 Tier A :
Physico-chamical properties
- OECD 105 Water Solubilit
- OECD 101 UV-VIS Absorption Spectra
- OECD 102 Melting Point/ Melting Range
- OECD 107, 117 123 Partition Coefficient (n-octanol/water)
Environmental fate
- OECD 106 Adsorption — Desorption Using a Batch Equilibrium Method
- OECD 111 Hydrolysis as a Function of pH
- OECD 307 Aerobic and Anaerobic Transformation in Soil
- OECD 308 Aerobic and Anaerobic Transformation in Aquatic Sediment
Aquatic ecotoxicology
- OECD 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test
- OECD 202 Daphnia sp. Acute Immobilisation Test
- OECD 203 Fish, Acute Toxicity Test
- ISO 10253 Marine algal growth inhibition test with Skeletonema sp. and Phaeodactylum tricornutum
- ISO 14669 Determination of acute lethal toxicity to marine copepods (Copepoda, Crustacea)
Terrestrial ecotoxicology
- OECD 216 Soil Microorganisms: Nitrogen Transformation Test
- OECD 208 Terrestrial Plant Test: Seedling Emergence and Seedling Growth
- OECD 222 Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)
Phase 2 Tier B :
Physico-chemical properties
- OECD 305 Bioconcentration: Flow-through Fish Test
Aquatic ecotoxicology
- OECD 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test
- OECD 211 Daphnia magna Reproduction Test
- OECD 210 Fish, Early-life Stage Toxicity Test
- OECD 218 Sediment-Water Chironomid Toxicity Using Spiked Sediment
- OECD 219 Sediment-Water Chironomid Toxicity Using Spiked Water
- ISO 10253 Marine algal growth inhibition test with Skeletonema sp. and Phaeodactylum tricornutum
- Other tests in seawater…
Terrestrial ecotoxicology
- OECD 216 Soil Microorganisms: Nitrogen Transformation Test
- OECD 208 Terrestrial Plant Test: Seedling Emergence and Seedling Growth
- OECD 232 Collembolan Reproduction Test in Soil
Environmental risk and medicinal products for human use
According to CHMP
According to the guideline 2004/27/EC
According to the ERA of medicinal products for human Use, 2006
RRS offers to realise physico-chemical, ecotoxicologic and environmental tests as part of environmental risk assessment for medicinal products for human use.
Phase 1 :
- OECD 107 or 123 Partition Coefficient (1-Octanol/Water)
Phase 2 Tier A :
- OECD 106 Adsorption — Desorption Using a Batch Equilibrium Method
- OECD 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test
- OECD 209 Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation)
- OECD 210 Fish, Early-life Stage Toxicity Test
- OECD 211 Daphnia magna Reproduction Test
- OECD 301 Ready Biodegradability
- OECD 308 Aerobic and Anaerobic Transformation in Aquatic Sediment
Phase 2 Tier B :
- OECD 307 Aerobic and Anaerobic Transformation in Soil
- OECD 216 Soil Microorganisms: Nitrogen Transformation Test
- OECD 208 Terrestrial Plant Test: Seedling Emergence and Seedling Growth
- OECD 232 Collembolan Reproduction Test in Soil
- Earthworm, Acute Toxicity Tests
- ISO 11267 Inhibition of reproduction of Collembola (Folsomia candida) by soil contaminants