Environmental Safety Assessment

Drawing on decades of experience identifying and quantifying test substances in complex matrices, we bring world-leading, multidisciplinary expertise to every environmental safety testing program for your REACH registration. 

Environmental Safety studies are conducted by experts, at laboratories across the world.  We offer world-class avian safety studies as well as aquatic, terrestrial safety and environmental fate studies that meet ECHA’s regulatory submission requirements. All studies are performed under Good Laboratory Practice (GLP).

Our environmental safety capabilities include:

• Avian Safety Studies: Our avian laboratory in Easton, Maryland, US, has conducted more avian studies than any other laboratory in the world. The highly skilled team offers the full suite of acute and reproduction studies (radiolabeled and unlabeled) as well as custom-designed investigations in non-traditional species to or to meet client-specific needs.
• Aquatic Safety Studies: Our scientists bring decades of experience performing acute and chronic studies. They are performed in freshwater for algae, fish and invertebrates as well as amphibians. We offer the latest required tests for sediment dwellers, and endocrine tests with invertebrates, fish and frogs. Our laboratories are uniquely equipped with temperature controlled custom-designed static, semi static and flow-through test systems. The test systems are designed to secure high degree of precision and accuracy during the entire study.
• Terrestrial Safety Studies: Our laboratories offer a full spectrum of testing on non-target plants, earthworms, and other soil invertebrates. Our environmental testing scientists are on the forefront of science behind evolving REACH regulations and developing new methods.
• Environmental Fate Studies: Environmental fate covers a wide spectrum of complex studies, all of which are competently conducted by our dynamic and well-trained team with state of the art equipment. With access to more than 50 different soils from Europe (including UK), US and Japan, as well 10 different water and sediment sources we are able to find the suitable setup for your study.
  • We also offer custom-made C-14 label synthesis as well as the synthesis of unlabelled reference compounds required for E-Fate studies and analytical references.

We can help you fulfill global regulatory requirements for assessment of potential endocrine-disrupting substances

In recent years, an emerging area of concern with regard to its impact on human and environmental health has been the potential for chemical substances and mixtures to affect the endocrine systems of mammals and non-mammalian species. In recent years the potential impact of endocrine disruptors has been increasingly regulated on a global scale with a variety of legislative implementations, also impacting REACH (1907/2006).

The effects of endocrine-disrupting compounds – which interfere with the actions of naturally occurring hormones in humans and animals – have become a central point of focus for the scientific community and caused alarm among the public at large. Authorities around the world have begun to aggressively regulate these substances and implement screening programs to minimize their environmental impact, requiring manufacturers in all industries to start testing their products for potential endocrine-disrupting effects.

We have been at the forefront of developing specific tests to identify endocrine disruptors and determine their effects, and are proud to be the go-to CRO for such testing.  

This legislation is supported by guidance documents from non-regulatory bodies such as the OECD (Organization for Economic and Cooperation and Development) and WHO (World Health Organization). We operate in full compliance with the latest OECD guidelines, offering every type of endocrine disruption study from physical chemical data to in-vitro testing to complex multi-generational and long term studies with vertebrates and invertebrates.

To improve data quality and study conduct, we offer feasibility tests from the onset - this feature differentiates us from other CROs

These conversations on test substance and study design consideration are held in the proposal/quoting process.  A feasibility test assesses features such as which test design (static, semi-static or flow-through), test substance administration, sampling, stabilization, and/or sample preparation is most suitable, by gathering critical information on the test item behavior in small-scale upfront pilot tests. The feasibility testing does add to timescale of the laboratory phase and requires more work on the actual study, it is our experience that the definitive tests typically run much smoother without further surprises or challenges in the biological and analytical chemistry aspects.

Our biologists and chemists can develop tailor-made studies in accordance with the respective guidelines and substance specifics. We believe that repeating studies is not only expensive, but also time consuming. With tight deadlines given by ECHA and highly limited market capacities, the advantage of a perfectly planned study is absolutely vital for success.

Special Expertise

We have extensive experience in performing biological tests with analytical monitoring for substances, some of which are classified as difficult to test, including:

• Volatile substances
• Low soluble substances
• Hydrolytically instable substances
• Biologically instable substances
• Photolytic instable substances
• Adsorbing substances
• Oxidizing substances
• Multi-component substances