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Fapas - Proficiency Testing
Globally recognised provider of proficiency tests, running over 400 tests annually across an extensive range of matrices and analytes
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Our services
We can support with the design and delivery of studies at every step of the ERA process. Find out more about our specific services across Physico-chemical Properties, Ecotoxicology and Environmental Fate, below:
Physico-chemical Properties
Physico-chemical property testing characterises the inherent properties of a molecule, which is necessary to support the design of subsequent experimental studies and can contribute to environmental exposure modelling.
We are equipped to design and deliver a broad range physico-chemical property studies according to your needs:
| EMA requirement |
 OECD 101 - UV-visible absorption spectrum |
| OECD 105 - Water solubility |
| OECD 107 / 123 Octanol / water partitioning |
| OECD 112 - Dissociation in water |
| Potential additional requirements |
| OECD 102 – Melting point/melting range |
| OECD 104 – Vapour pressure |
| OECD 117 – Kow by HPLC |
Ecotoxicology
Ecotoxicology studies examine the effects of chemical compounds on non-target organisms. The goal of ecotoxicology testing as part of the pharmaceutical risk assessment process is to determine the concentrations at which pharmaceuticals pose an acceptable hazard to the environment, so that these levels can be compared to anticipated exposure concentrations following use.
There are different types of ecotoxicology testing, including:
Aquatic ecotoxicology studies
Examining the potential impact of a compound on aquatic species across the different trophic levels – fish, invertebrates (such as Daphnia) and primary producers (such as green algae and cyanobacteria). Studies can be performed on both pelagic and benthic taxa.
Terrestrial ecotoxicology studies
Examining the potential impact of a compound on terrestrial species across the different trophic levels – micro-organisms, invertebrates (such as earthworms) and higher plants.
Endocrine disruptor studies
Evaluating a compound’s potential to alter the endocrine systems of aquatic species, which can impact their reproduction and development. In recent years, there has been increasing concern around endocrine-disrupting effects, leading to the inclusion of data requirement for tailored assessments for the aquatic compartment.
| EMA requirement |
| OECD 201 - Algal growth inhibition test |
| OECD 209 – Activated sludge respiration inhibition test |
| OECD 210 – Fish, early life stage toxicity test |
| OECD 211 - Daphnia magna reproduction test |
| Potential additional requirements |
| OECD 218 / 219 – Chironomous sediment-water toxicity |
| OECD 233 – Chironomous, sediment-water life cycle |
| OECD 225 – Lumbriculus sp. spiked sediment |
| OECD 216 – Nitrate transformation (28 or 100 days) |
| OECD 208 – Terrestrial plants |
| OECD 222 / 220 – earthworm / enchytraeid reproduction |
| OECD 232 – Collembola reproduction |
| OECD 229 – Fish short-term reproduction assay |
| OECD 230 – 21-day fish assay |
| OECD 234 – Fish embryo acute toxicity |
| OECD 240 – Medaka extended one-generation reproduction toxicity test |
| OECD 241 - Larval amphibian growth and development assay |
Environmental Fate
Environmental fate studies examine the behaviour of pharmaceutical compounds in different environmental compartments and provide information used to estimate exposure of the compound and its potential degradation products in soil, sediment, surface water and groundwater. Degradation studies are performed in a range of environmental compartments to generate information on the rate of degradation as well as the pathway of degradation, often using radiolabelled test chemicals. Subsequent analysis can be performed to elucidate the structural identity of degradation products that may be formed.
Adsorption/desorption studies are used to generate information on the mobility of a compound which can be used to estimate the potential movement from the site of entry into the environment to other environmental compartments.
At Fera we are equipped to design and deliver a broad range environmental fate studies according to your needs:
| EMA requirement |
| OECD 301F – Ready biodegradability |
| OECD 106 – Adsorption - desorption using a batch equilibrium method |
| Potential additional requirements |
| OECD 308 – Degradation in aquatic sediment systems |
| OECD 307 – Degradation in soil |
| OECD 314B – Degradation in wastewater |
| OECD 305 – Bioaccumulation in fish |
Our People
Fera has the best people in the right place focused on delivering the right solution. We continuously invest in our people and support them in delivering the best science to our partners.
Copyright © 2023 Fera Science Limited (“Fera”). All rights reserved.
Registered Office: 65 Gresham St, London, EC2V 7NQ. Registered in England & Wales, No 9413107. Fera
is a joint venture company of Capita Plc, 65 Gresham St, London, EC2V 7NQ. Registered in England and
Wales No 02081330. VAT Registration ID: GB 618184140
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