An endocrine disruptor (ED) is a substance that interferes with the body’s endocrine system producing adverse effects. These adverse effects may influence development, reproduction, neurological function or the immune system – impacting individual animals, populations and ecosystems. Regulators across the globe increasingly require assessment of endpoints that signal a substance’s potential to cause endocrine disruption.
Covance has been at the forefront of ED testing, leading the field in the adoption and validation of ED testing approaches relevant to regulatory authorities in Europe, the US and around the world. By building capabilities and capacity that stay ahead of the scientific and regulatory curve, your current and future needs are catered for. Partner with us and let us help navigate you through the scientific, technical and regulatory complexity of ED testing.
- A strategic scientific approach combined with regulatory insight optimizes ED testing and allows us build compelling regulatory arguments from a strong evidence base
- Extensive in vitro and in vivo testing capabilities deliver robust and credible data acceptable to regulators around the world including the EPA, EFSA and ECHA
- Cutting-edge techniques answer the most challenging questions related to thyroid hormone analysis
Endocrine disruptor (ED) programs can be technically challenging to plan, run and interpret
ED screening tests can be challenging to conduct and interpret. Regulatory endpoints vary between regulators and are constantly evolving. To optimize the value and efficiency of your testing program you need high levels of technical expertise and excellent scientific insight. Informed study design maximizes the value of your data and reduces redundancy in your ED testing program. However, finding appropriate expertise and capacity can be a challenge.
It can be difficult to craft coherent arguments that win over regulators
It’s not enough to catalogue your results, you need to interpret your in silico, in vitro and in vivo ED data in a way that’s relevant to regulators.
Reliable analytics, especially for thyroid hormone measurement, are not widely available
A major challenge in ED testing is the accurate measurement of thyroid hormones levels at very low concentrations. Many ED assays require the measurement of serum thyroid hormones T3 and T4 in fetuses or pups. In such young animals, thyroid hormone levels may be in the low pg/mL level. This is at the detection limits of standard analytical approaches, which undermines the reliability of your test results. You need a partner who has this capability to measure such low levels.
Historic control data relevant to endocrine disruptor endpoints
To interpret the results from ED tests effectively you need to compare them to control data. The optimum comparator is to historic data gathered over years. For some new endpoints, like thyroid hormone levels, such historic data may not be available or may be unreliable.
Designing the optimum ED testing strategy matched to your needs
Covance can partner with you in a flexible way to help clarify and address your needs. With ED testing insight gained from multiple EU and US submissions, our experts can leverage their knowledge to support you. Whether you need scientific guidance on an ED testing strategy or simply a set of ED tests run to high standards, we can help. Click the link below to explore our ED testing capabilities and how they can be utilized for all global regulators:
Supporting you through the complex regulatory minefield related to endocrine disruptors
Leverage the experience and insights of regulatory experts, scientists, analytical chemists and data modellers to build weight of evidence arguments supporting your substance’s ED profile. By taking an integrated approach, Covance can make scientific arguments that stand up to regulatory scrutiny. Find out more about the comprehensive support on offer here:
Cutting-edge techniques in thyroid hormone measurement
Covance has pioneered an in-house method that is sensitive and accurate for assessing thyroid hormones T3 and T4 down to low pg/mL concentrations. The technique involves the use of UHPLC-MS/MS and it has been widely applied to a range of OECD and EPA studies requiring thyroid function assessment. This overcomes a common barrier to ED screening by providing reliable and verifiable thyroid hormone results. Covance can offer this innovative and industry-leading technique to our partners.
Reliable historic data controls support verification of your results
Covance started working in endocrine disruptor testing in the 1990s. This has enabled us to build expertise, insight, techniques and historic data sets that you can benefit from. Our historic data sets are especially important for thyroid hormone assays and reflect our innovation in this area of ED testing.