Endocrine Disruption Screening Program (EDSP)

In order to meet the requirements of the United States Environmental Protection Agency's Endocrine Disruption Screening Program (EDSP) for new and existing chemicals and pesticides, Harlan Laboratories is validating the list of prescribed assays that make up the Tier 1 testing battery at three of our test facilities.

In vitro assays

• Estrogen receptor binding assay (Rat uterine cytosol)
• Androgen receptor binding assay (Rat prostate cytosol)
• Estrogen receptor transcription activation assay (Human cell line HeLa 9903)
• Aromatase assay (Human recombinant)
• Steroidogenesis assay (Human cell line H259R)

Ecotoxicology assays

• Fish short-term reproduction assay
• Amphibian metamorphosis assay

Mammalian toxicology assays

• Rat uterotrophic assay
• Rat Hershberger assay
• Rat male pubertal assay
• Rat female pubertal assay

All assays are designed and validated to reflect the test methods that are outlined in the published USEPA OPPTS series of testing guidelines. These test methods are expected to fulfill the criteria of evaluation of endocrine disruption screening worldwide.

In addition to this EDSP Tier 1 testing battery, we offer other ED screening tests:

• Recombinant yeast screen assay for assessment of estrogenic and androgenic activity
• Fish short-term screening assay (OECD test guideline 230)
• Fish sexual development test (OECD draft test guideline)

Our company expertise in chemicals and agrochemicals allows us to incorporate this new screening methodology into our portfolio of safety evaluation services, which we can offer to the industry worldwide.