Pharmacelsus

Endocrine Disruption Screening Services

With a proven track record of 30+ years in steroid endocrinology, the Pharmacelsus scientists are excellently skilled to support your studies for agrochemical, chemical, pesticide and personal health care registration programs.

Out of the OECD Conceptional Framework Pharmacelsus offers in vitro and in vivo studies for levels 1 to 3.

Assays from Level 1 OECD framework

Physical and Chemical Properties

  • Solubility testing
  • Biodegradability testing

ADME Prediction

  • In vitro ADME testing
    • Intestinal absorption
    • Plasma protein binding
    • Hepatic metabolism

Assays from Level 2 OECD framework

Aromatase Assay
(human recombinant)

  • Screening assay to identify substances that affect the endocrine system by inhibiting the aromatase enzyme (CYP19), which catalyses the conversion of androgens to estrogens.
  • In vitro model:
    human recombinant aromatase
  • Readout:
    IC50 determination (dose response for test substance at 8 concentrations)

H295R Steroidogenesis Assay

  • Assay to detect substances that interfere with steroid biosynthesis
  • In vitro model:
    human adrenocortical cell line
  • Readout:
    YES/NO answer regarding the potential of the test substance for induction or inhibition of estradiol and / or testosterone production
  • Assay conducted on the basis of Guidance document:
    OECD TG 456 (2011)

MCF-7 Cell Proliferation Assay

  • Assay to detect substances with in vitro estrogen receptor agonistic or antagonistic activity.
  • In vitro model:
    human breast cancer cell line
  • Readout:
    EC50 or IC50 determination (dose response for test substance at 11 concentrations)
  • Assay conducted on the basis of protocol described in MCF-7 draft validation study report (NICEATM, 2012)

All studies are conducted according to international Guidelines.

Assays from Level 3 OECD framework

Hershberger Bioassay in vivo

  • Short-term in vivo screening test to detect agonistic or antagonistic androgenic activities or 5α-reductase inhibition
  • In vitro model:
    castrated peripubertal male rats
  • Readout:
    organ weights
  • Assay conducted on the basis of Guidance document OECD TG 441 (2009)

Uterotrophic Bioassay in vivo

  • Short-term in vivo screening test to detect agonistic or antagonistic estrogenic activities
  • In vitro model:
    immature female rats prior to puberty
  • Readout:
    organ weights
  • Assay conducted on the basis of Guidance document OECD TG 440 (2007)

Assays on Endocrine Disruption were implemented according to OECD Guidance Document 150 and are conducted under GLP.

Please contact us for your Endocrine Disruption screening demand!

Dr. Ursula Mueller-Vieira
Head of ADMET & in vitro Pharmacology
mueller@pharmacelsus.de

Dr. Bettina Husen
Head of in vivo Pharmacology & Pharmacokinetics
husen@pharmacelsus.de