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Evaluating H295R steroidogenesis assay data for robust interpretation.

H Tinwell1, A Karmaus2, V Gaskell3

  • 1Bayer SAS, 16 Rue Jean-Marie Leclair, 69009, Lyon, France.

Regulatory Toxicology and Pharmacology : RTP
|July 25, 2023
PubMed
Summary
This summary is machine-generated.

The H295R steroidogenesis assay can identify chemicals affecting hormone synthesis. Stricter interpretation criteria improve data reliability and reduce unnecessary follow-up testing for endocrine disruption.

Keywords:
Assay performanceEndocrine disruptionIn vitroOECD TG456Steroidogenesis

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Area of Science:

  • Endocrinology
  • Toxicology
  • Assay Development

Background:

  • The H295R steroidogenesis assay (OECD TG 456) assesses chemical interference with steroid hormone synthesis.
  • Positive results can necessitate extensive, higher-tier regulatory testing.
  • Stakeholder data compilation is crucial for assay outcome characterization.

Purpose of the Study:

  • To compile and analyze H295R assay data, including triggered higher-tier testing.
  • To evaluate the impact of statistical analysis and interpretation criteria on H295R outcomes.
  • To propose refined criteria for improved H295R data interpretation and regulatory use.

Main Methods:

  • Compilation of a stakeholder database of H295R reference and test item data.
  • Inclusion of information on triggered Level 5 reproductive toxicity studies.
  • Analysis of pairwise significance testing and application of complementary interpretation criteria (e.g., 1.5-fold change).

Main Results:

  • The H295R assay demonstrated challenges in meeting quality control acceptance criteria.
  • Pairwise significance testing led to overly sensitive positive outcomes, increasing the assay's positive hit rate.
  • Complementary interpretation criteria significantly reduced equivocal and positive outcomes, enhancing the identification of robust effects.

Conclusions:

  • Stricter data interpretation criteria, such as fold-change thresholds, can refine H295R assay results.
  • Improved interpretation can reduce unnecessary in vivo follow-up testing, as suggested by a case study.
  • The proposed criteria enhance H295R data interpretation for regulatory decision-making in endocrine disruption assessment.