JRF is the only CRO in the eastern part of the globe to validate and submit the EDSP studies in full compliance with the OPPTS guideline and submitted to the leading regulatory authority.
EDSP is a program implemented by the US EPA as well as rest of the regulators. The testing paradigm is used for screening of pesticides, chemicals and environmental contaminants for their potential to affect the estrogen, androgen and thyroid hormone systems. The testing is two-tiered; the tier I comprises a battery of 5 In-vitro and 6 In-vivo screening assays that shall identify substances that have the potential to act as the endocrine disruptor screening chemicals, while tier II, involves prenatal and developmental toxicology testing.
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Designing the customized programs for assessing possible endocrine disruptive effects as per EPA and OECD guidelines.
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JRF can offer large capacity with high quality state of the art equipment and accommodate multiple compounds simultaneously.
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JRF excels in delivering the reports within rapid turnaround times with professional project communication and support from our dedicated team of experts.
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Our Scientists are capable to help you to prioritize your testing schedule minimize animal use economically as well as customizing the report format.
Tier 1 Screening Battery
In Vitro Assays
|
Assay |
Guideline |
Endpoint |
Study Duration |
|
Androgen Receptor Binding |
OPPTS 890.1150 |
Saturation Binding- Estimation of Kd and Bmax, Competitive Binding with methyl trienolone, - IC50, RBA, |
Experiment:15 days
Report: 30 days |
|
Aromatase |
OPPTS 890.1200 |
Measurement of Generated Estrone by Liquid scintillation counting, IC50 |
Experiment: 15 days
Report: 30 days |
|
Estrogen Receptor Binding |
OPPTS 890.1250 |
Saturation Binding- Estimation of Kd and Bmax, Competitive Binding- 3 Consecutive runs, IC50, RBA, |
Experiment: 15 days
Report: 30 days |
|
Estrogen Receptor Transcriptional Activation |
OPPTS 890.1300 |
Quantitative measurement of bioluminescence product (Luminescence signal) by Luminometer |
Experiment: 15 days
Report: 30 days |
|
Steroidogenesis |
OPPTS 890.1550 |
Measurement of the levels of Testosterone and 17β-Estradiol produced by cell line with LC-MS/MS, 17β-Estradiol will be measured after Derivatization with Dansyl Chloride, Cell Viability at end of treatment using Invitrogen’s LIVE/DEAD Viability kit. |
Experiment: 30 days
Report: 30 days |
In Vivo Assay
|
Assay |
Guideline |
Endpoint |
Study Duration |
|
Uterotrophic Assay |
OPPTS 890.1600 |
Organ Weight:
Uterine Weight both “Wet” Weight and “Dry” Weight
Optional Histopathology:
Uterus |
18 Weeks |
|
Hershberger Bioassay |
OPPTS 890.1400 |
Organ Weight:
Ventral Prostate, Seminal Vesicles, Levator Bulbocavernosus Muscle, Cowpers Glands, Paired Epididy¬mides, Paired Testis Weight, Glans Penis
Optional Organ Weight:
Liver, Kidneys, Adrenals
Optional Hormone Analysis:
T3, T4, Testosterone, LH |
18 Weeks |
|
Pubertal Development And Thyroid Function In Intact Juvenile/Peripubertal Male Rats |
OPPTS 890.1500 |
Sexual Maturation:
Daily Assessment of Preputial Separation
Blood Chemistry
Organ Weights:
Seminal Vesicles/Coagulating Glands, Ventral Prostate, Dorsal Prostate Levator Ani Plus Bulbocaver¬nosus Muscle, Epididymis, Testis, Thyroid (Post Fixation), Liver, Kidney, Adrenals, Pituitary
Histopathology:
Epididymis, Testis, Thyroid, Kidney
Hormone Analysis: T3, T4, THS, Testosterone |
24 Weeks |
|
Pubertal Development And Thyroid Function In Intact Juvenile/Peripubertal Female Rats |
OPPTS 890.1450 |
Sexual Maturation:
Daily Assessment of Vaginal Separation
Blood Chemistry
Organ Weights:
Uterus (Blotted), Ovaries, Thyroid (Post Fixation), Liver, Kidney, Pituitary, Adrenals
Histopathology: Uterus, Ovary, Thyroid, Kidney
Hormone Analysis: T3, T4, THS |
24 Weeks |
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