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- Aquatic Ecotoxicology
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- OECD 202: Daphnia sp., Acute Immobilisation Test
- OECD 211: Daphnia magna Reproduction Test
- OECD 235: Chironomus sp., Acute Immobilisation Test
- OECD 218/219: Sediment-Water Chironomid Toxicity Test Using Spiked Sediment/Spiked Water
- OECD 233: Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment
- OECD 225: Sediment-water Lumbriculus Toxicity Test Using Spiked Sediment
- OECD 242: Potamopyrgus antipodarum Reproduction Test
- OECD 243: Lymnaea stagnalis Reproduction Test
- Fish and other vertebrates
- OECD 203: Fish, Acute Toxicity Test
- OECD 215: Fish Juvenile Growth Study
- OECD 212: Fish, Short-term Toxicity Test on Embryo and Sac-fry Stages
- OECD 231: The Amphibian Metamorphosis Assay
- OECD 236: Fish Embryo Acute Toxicity Test
- OECD 210: Fish, Early-life Stage Toxicity Test
- OECD 229 Fish Short Term Reproduction Assay and OECD 230 21-day Fish Assay
- OECD 240 Medaka Extended One Generation Reproduction Test (MEOGRT)
- OECD 248: Xenopus Eleutheroembryonic Thyroid Assay
- OPPTS 850.1500: Fish Life Cycle Toxicity Test
- OÈCD 234 Fish sexual development test
- Aquatic plants
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- Storage Stability Studies
- OPPTS 830.6302, OPPTS 830.6303,and OPPTS 830.6304: Physical State, Colour and Odor at 20 °C and at 101.3 kPa
- EU A.1: Melting temperature/range
- EU A.2: Boiling temperature
- EU A.3: Relative density (liquids and solids)
- EU A.4: Vapour pressure
- EU A.5: Surface tension
- EU A.9: Flashpoint
- EU A.10: Flammability (solids)
- EU A.12: Flammability (contact with water)
- EU A.13: Pyrophoric properties of solids and liquids
- EU A.16: Relative self-ignition temperature for solids
- EU A.17: Oxidising properties
- OECD 114: Viscosity of Liquids
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- Transformation in Soil
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- Transformation in Manure
- Adsorption on Soil and Sewage Sludge
- Bioaccumulation and Bioconcentration
- Terrestrial Ecotoxicology
- Non-target Arthropods
- Non-target arthropod testing with the parasitic wasp (Aphidius rhopalosiphi)
- Non-target arthropod testing with the lacewing (Chrysoperla carnea)
- Non-target arthropod testing with the ladybird beetle (Coccinella septempunctata)
- Non-target arthropod testing with the predatory bug (Orius laevigatus)
- Non-target arthropod testing with the predatory mite (Typhlodromus pyri)
- Non-target arthropod testing with the rove beetle (Aleochara bilineata)
- Non-target arthropod testing with the carabid beetle (Poecilus cupreus)
- Non-target arthropod testing with the wolf spider (Pardosa spec.)
- Soil Organisms
- Honey Bees and other Pollinators
- OECD 213/214: Honey bees, Acute Oral and Acute Contact Toxicity Test
- OECD 245: Honey Bee (Apis Mellifera L.), Chronic Oral Toxicity Test (10-Day Feeding)
- OECD 237: Honey Bee Larval Toxicity Test, Single Exposure
- OECD 239: Honey Bee Larval Toxicity Test
- EPPO 170: Honey Bee Field Study – do plant protection products effect honey bee colonies?
- Oomen et al. 1992: Honey Bee Brood Feeding Study
- OECD 75: Honey Bee Brood Test under Semi-field Conditions in Tunnels
- OECD 246/247 Acute Oral and Contact Toxicity to the Bumblebee, Bombus terrestris L.
- Solitary Bee Acute Contact Toxicity Study in the Laboratory (Osmia sp.) Solitary Bee Acute Oral Toxicity Study in the Laboratory (Osmia sp.) (protocols for ringtests with solitary bees recommended by the non-Apis working group)
- SANTE/11956/2016 rev.9 Residue trials for MRL setting in honey
- Non-target plants
- OECD 208: Terrestrial Plant Test - Seedling Emergence and Seedling Growth Test
- OECD 227: Terrestrial Plant Test - Vegetative Vigour Test
- OCSPP 850.4100: Seedling Emergence and Seedling Growth
- OCSPP 850.4150: Vegetative Vigor
- EPPO PP 1/207(2): Efficacy evaluation of plant protection products, Effects on succeeding crops
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- Testing of Potential Endocrine Disruptors
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Manure Degradation Study to Refine the ERA of VMP
9th December 2020
Assessment of the environmental impact of veterinary medicinal products (VMP) is a legal obligation and must be performed to evaluate and limit potential adverse effects of these substances on the environment.
The environmental exposure (PECsoil) is estimated based on the intended use of the product and compared to the predicted no effect concentration (PNEC). If the trigger value for environmental exposure is exceeded (risk quotient), a specific investigation assessing the effects of the substance on particular ecosystems is required. However, no further investigations are needed if the exposure concentration can be refined to a level of no concern. One option for refinement is to carry out a degradation study in manure.
No OECD guideline for investigating the degradation of veterinary medicines in manure is yet available. In 2015/2016, a test procedure was developed during an inter-laboratory comparison test (ring test). ibacon took part in the ring test and was involved both in the development of this test procedure and in discussing its key elements.
We at ibacon offer the study assessing degradation in manure as a standard test in several manure types (cattle, pig or chicken) under GLP conditions. The experience we gained enables us to identify the essential parameters of the study and to design the investigation of your substances in the best possible way.
References:
- Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase I, CVMP/VICH Topic GL6 (Ecotoxicity Phase I), CVMP/VICH/592/98-FINAL, June 2000
- Guideline on Environmental Impact Assessment for Veterinary Medicinal Products - Phase II, CVMP/VICH Topic GL38, CVMP/VICH/790/03-FINAL, October 2005
- Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38, EMA/CVMP/ERA/418282/2005, June 2016
- Guideline on determining the fate of veterinary medicinal products in manure, EMA/CVMP/ERA/ 430327/2009, revised in 2011
- Junker T, Römbke J, Hennecke D, Herrchen M, Düring RA, Thiele-Bruhn S, Meinerling M, Fiebig S, Topp E, Völkel W (2016), Harmonization of environmental exposure assessment for veterinary pharmaceuticals and biocides: ring test for validation of a draft test protocol for studies on transformation in manure.UBA-Texte 80/2016, Umweltbundesamt, Dessau-Roßlau, Germany, p 231, November 2016, https://www.umweltbundesamt.de/publikationen/harmonization-of-environmen...