Environmental Fate Testing

Charles River scientists perform the in-life phases of environmental fate studies in environmentally controlled incubation rooms or incubators. Self-contained flow-through incubation systems (aerobic and anaerobic), with the flexibility to accommodate different trapping systems for collection of volatile products, are available for radiolabeled degradation studies; a similar flow-through apparatus is used in photolysis studies. Sealed systems are available for investigations with volatile test items, as well as systems for collection and quantification of reduced radiolabeled volatile products.

Chart from scientific poster titled Modification of a laboratory water sediment study using sunlight to refine the estimated environmental concentration.

Modification of a laboratory water sediment study using sunlight to refine the estimated environmental concentration.
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Environmental Fate and Related Studies

We can obtain test systems such as sediment, surface waters and soils from a variety of local and international geographical sources. Prior to study conduct, we fully characterize all test systems and confirm their viability.

eFate Study design:

  • Aerobic and anaerobic degradation in soils and sediment waters
  • Aerobic mineralization in surface waters
  • Degradation in manure and slurry
  • Ready and inherent biodegradation
  • Soil or sludge adsorption, desorption and mobility investigations
  • Hydrolytic stability and accelerated hydrolysis studies
  • Photolytic degradation – moist and dry soil surfaces, aqueous systems
  • Radiolabeled or non-radiolabeled

A Comprehensive Overview of Environmental Risk Assessment for Human Pharmaceuticals

Compliance and regulation documents

This two-part webinar series introduces the tiered process of Environmental Risk Assessment (ERA) in Europe and compares it with the one used in the United States.

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Support Services

In radiolabeled studies, we achieve quantitative and qualitative determination of parent test items and metabolites primarily using HPLC, with either online or offline radiodetection, including TopCount low level counting. We routinely perform confirmatory analysis and structure elucidation using market leading high resolution LC-MS systems. These include hybrid quadrupole-orbitrap, quadrupole-ion trap-orbitrap and quadrupole-ion mobility-time of flight systems to support analysis of the most challenging samples.

Environmental Fate Frequently Asked Questions (FAQs)

  • What is environmental fate testing?

    A program of regulatory environmental fate (eFate) studies is required for globally acceptable submissions for agrochemicals, chemicals (REACH regulations) and pharmaceutical risk assessments (human and veterinary). These studies are used to determine the fate and behavior of both the actives and their degradation products within commonly occurring environmental systems.

  • What are the current guidelines?

    The guidelines you need to follow are dependent on the Regulatory Authority you wish to submit your registration to. For example, if you wish to submit within the EFSA jurisdiction, the data you require may differ from that required to register with the EPA. Our experts would be happy to advise you.