Endocrine Disruptor

About Endocrine Disruptor Testing Services:

Concern about chemically mediated modulation of normal endocrine (hormonal) function in wildlife and humans has become a focal point of concern in the scientific community and the public as a whole. In 1996, the Food Quality Protection Act (section 408(p)) took action on this concern and directed the EPA to develop a screening program that would determine which chemicals may have hormone-altering effects. Based on this mandate, EPA’s Endocrine Disruptor Screening Program (EDSP) was established. The program has involved research and development aimed at establishment of testing guidelines for aquatic and terrestrial organisms. Some of the guideline development work is still underway.

In Europe, the EU has introduced specific legislative obligations aimed at phasing out endocrine disruptors in water, industrial chemicals, plant protection products and biocides. Furthermore, there is a requirement for all new pharmaceutical applications to consider the potential endocrine disrupting properties of drug substances.

Smithers Viscient’s Endocrine Disruptor Testing Expertise:

Smithers Viscient is active in the area of endocrine disruption in both the US and Europe.

In the US, Smithers Viscient has successfully conducted a significant number of FSTRA tests and AMA tests for Tier I studies and our leading toxicology experts are participating in development of the testing guidelines for both US EPA Tier 1 and Tier 2 phases. Our staff can assist clients with other EDSP questions regarding fish, amphibian and avian testing guidelines proposed for Tier 2 testing in the US. Smithers Viscient provides services that meet global regulatory endocrine testing requirements.

In Europe, our Harrogate laboratory is a recognised leading team in this field and conducts short-term reproduction assays (OECD 229, OECD 230), fish sexual development tests (OECD 234), the new medaka extended one generation reproduction test (OECD 240) and life cycle tests.

Smithers Viscient has seen a marked increase in the number of regulatory agency requests for partial and full fish life-cycle testing. The Harrogate and Wareham facilities have performed these studies either as standalone designs, or as combinations of the established OECD test guidelines to meet specific requests. Smithers Viscient appreciates that each compound is unique and testing may need to be tailored to generate the endpoints relevant for risk assessment.

In addition to laboratory testing of potential endocrine disruptor chemicals, Smithers Viscient has also developed field deployable techniques to monitor exposure of avian species to environmental estrogens. Both laboratory and field deployable techniques have been developed to measure hormonal status in various measurable parameters from excreted hormones to mate selection and nesting behavior. Though the application of our own techniques are very broad and can be customized to fit a multitude of data needs, we welcome the opportunity to explore new and unique techniques as needed.

 

Endocrine Disruptor Testing Guidelines:

Ring Testing Involvement

New guideline/method research projects

  • OECD 229 Short-term fish reproductive assay
  • OECD 230 21-day fish assay
  • OECD 240 Medaka extended one generation reproduction test (MEOGRT)
  • EPA EDSP Tier 1 FSTRA
  • EPA EDSP Tier 2 mysid two-generation study
  • EPA EDSP Tier 2 avian two-generation study

 

A complete list of guidelines and test species is available upon request. Contact Us

 

Endocrine Disruptor Equipment and Instrumentation includes:

In-house ELISA and PCR capabilities for VTG analysis and genetic sex determination