Testing of chemicals

Endocrine Disrupter Testing and Assessment

 

Links to Peer Review Packages: 

Peer Review Package for the Fish Sexual Development Test

Androgenised Female Stickleback Screening Assay Fish Endocrine Screening Assay Updated TG407
Hershberger Assay Stably Transfected Transcriptional Activation Assay

Stably Transfected Human Androgen Receptor-α Transcriptional Activation Assay for Detection of Androgenic Agonist/Antagonist Activity of Chemicals


An important aspect of the OECD work on Environment, Health and Safety focuses on the regulatory management of chemicals, taking into account the possible effects of chemicals on human health and the environment.

 

In the context of the Chemicals Programme the work covers chemicals, including, e.g. industrial chemicals and pesticides.


In 1996, the OECD established a Special Activity on Endocrine Disrupter Testing and Assessment with the objectives of

  • Providing information and co-ordinating activities

  • Developing new and revised existing Test Guidelines to detect endocrine disrupters; and

  • Harmonising hazard and risk characterisation approaches

This activity was launched at the request of the Member countries and the Business and Industry Advisory Commitee to the OECD (BIAC) to ensure that testing and assessment approaches for endocrine disrupters would not substantially differ among countries.

 

Peer Review Package for the Fish Sexual Development Test

The Fish Sexual Development Test is intended for the detection and characterization of endocrine active substances. Validation studies of this test have been coordinated by Denmark, on behalf of the Nordic countries. The validation is now reviewed by an international panel of reviewers. The peer review package includes the draft validation reports of Phase 1 and Phase 2 and a preliminary draft Test Guideline.

 

Peer Review Package for the Androgenised Female Stickleback Screening Assay

The Androgenised Female Stickleback Endocrine Screening Assay is mainly intended to detect anti-androgen activity. Validation studies of this test have been coordinated by the United Kingdom. The validation is now reviewed by an international panel of reviewers. The peer review package, provided by the United Kingdom, includes the draft validation report, a number of relevant scientific articles and a preliminary draft Test Guideline.

  • Validation report of the 21-day androgenised female stickleback endocrine screening assay
  • Intercalibration exercise using a stickleback endocrine disrupterscreening assay (Allen et al, 2008)
  • Three-Spined Stickleback: an Emerging Model in Environmental Endocrine Disruption (Katsiadaki et al, 2007)
  • Detection of the anti-androgenic effect of endocrine disrupting environmental contaminants using in vivo and in vitro assays in the three-spined stickleback (Jolly et al, 2009)
  • Development of a stickleback kidney cell culture assay for the screening of androgenic and anti-androgenic endocrine disrupters (Jolly et al, 2006)
  • Detection of environmental androgens: a novel method based on enzyme-linked immunosorbent assay of spiggin, the stickleback (gasterosteus aculeatus) glue protein (Katsiadaki et al, 2002a)
  • The potential of the three-spined stickleback (Gasterosteus aculeatus L.) as a combined biomarker for oestrogens and androgens in European waters (Katsiadaki et al, 2002b)
  • The model anti-androgen flutamide suppresses the expression of typical male stickleback reproductive behavior (Sebire et al, 2008)

Peer Review Package for the Updated Test Guideline 407

The validation of the Test Guideline 407 Repeat Dose 28-day Oral Toxicity Study has been updated to possibly detect endocrine disruption effects. Validation studies of the updated Test Guideline have been performed under the OECD Test Guidelines Programme. The validation is now being reviewed by an international panel of reviewers. The peer review package, submitted to the panel, includes the validation report, the draft and the current Test Guidelines and a Secretariat document to support the peer review panel.

Peer Review Package for the Hershberger Assay

The Hershberger bioassay is intended to detect androgen agonists, antagonists and 5α-reductase inhibitors. Validation studies of this test have been performed under the OECD Test Guidelines Programme. The validation of the Hershberger assay is now being reviewed by an international panel of reviewers. The peer review package, submitted to the panel includes the 3 validation reports, the draft test guideline and a Secretariat document to support the peer review panel. A background review document will soon be available on this website.

  • Phase-1 report of the OCDE validation of the Rat Hershberger Bioassay
  • Draft Phase-2 report of the OCDE validation of the Rodent Hershberger Bioassay [Annexe 3]
  • Draft Phase-3 report of the OCDE validation of the Rat Hershberger Bioassay
  • Draft Test Guideline on Hershberger Bioassay in Rats
  • Background Review Document of the Hershberger Bioassay
  • Secretariat document supporting the peer review panel
  • Owens et al. (2006), Environmental Health Perspectives, Volume 14, No.8
    The OECD Programme to Validate the Rat Hershberger Bioassay to Screen Compounds for in vivo Androgen and Antiandrogen Responses.  Phase 1: Use of a Potent Agonist and a Potent Antagonist to Test the Standardized Protocol
  • Owens et al. (2007) Environmental Health Perspectives. The OECD Program to Validate the Rat Hershberger Bioassay to Screen Compounds for In Vivo Androgen and Antiandrogen Responses: Phase-2 Dose-Response Studies.
    Doi:10.1289/ehp.9666 (available at http://dx.doi.org/

 

Peer Review Package for the Stably Transfected Human Androgen Receptor-α Transcriptional Activation Assay for Detection of Androgenic Agonist/Antagonist Activity of Chemicals

The Stably Transfected Transcriptional Activation Assay is intended to detect transcriptional activation and inhibition of androgen receptor-mediated responses. Validation studies of this test have been performed by Japan. The validation is now reviewed by an international panel of reviewers. The peer review package, provided by Japan and submitted to the panel, includes the draft validation report and a draft Test Guideline.

 

Peer Review Package for the Stably Transfected Transcriptional Activation (TA) Assay

The Stably Transfected Transcriptional Activation Assay is intended to detect estrogenic activity. Validation studies of this test have been performed by Japan. The validation is now reviewed by an international panel of reviewers. The peer review package, provided by Japan and submitted to the panel, includes the draft validation report and a draft Test Guideline.

Peer Review Package for the 21-day Fish Endocrine Screening Assay

  • Report of Eight 21-day Fish Endocrine Screening Assays With Additional Test Substances for Phase-3 of the OECD Validation Program: Studies with Octylphenol in the Fathead Minnow (Pimephales promelas) and Zebrafish (Danio rerio) and with Sodium Pentachlorophenol and Androstenedione in the Fathead Minnow (Pimephales promelas)  PDF
  • Report of the Initial Work Towards the Validation of the 21-Day Fish Screening Assay for the Detection of Endocrine Active Substances (Phase 1A) PDF
  • Report of the Validation of the 21-Day Fish Screening Assay for the Detection of Endocrine Active Substances (Phase 1B) PDF
  • Report of Three 21-day Fish Endocrine Screening Assays to Complete CEFIC’s Contribution to Phase-2 of the OECD Validation Program PDF
  • Draft Report of the Validation of the 21-Day Fish Endocrine Screening Assay for the Detection of Endocrine Active Substances (Phase 2-Testing Negative Substances) PDF
  • Preliminary Draft Test Guideline: The Fish Screening Assay for Endocrine Active Substances PDF
  • Secretariat Paper: Application of Guidance Document 34 Criteria to the Validation of the 21-Day Fish Endocrine Screening Assay PDF

References for Series on Testing and Assessment No.38: Detailed Background Review of the Uterotrophic Bioassay

  • Ashby et al. (2003), Environmental Health Perspectives, Volume 111, No.12
    The Intact Immature Rodent Utertrophic Bioassay: Possible Effects on Assay Sensitivity of Vomeronasal Signals from Male Rodents and Strain Differences
  • Kanno et al. (2001) Environmental Health Perspectives, Volume 109, No.8
    The OECD Program to Validate the Rat Uterotrophic Bioassay to Screen Compounds for in vivo Estrogenic Responses: Phase 1
  • Kanno et al. (2003), Environmental Health Perspectives, Volume 111, No.12
    The OECD Program to Validate the Rat Uterotrophic Bioassay. Phase 2: Dose-Response Studies
  • Kanno et al. (2003), Environmental Health Perspectives, Volume 111, No.12
    The OECD Program to Validate the Rat Uterotrophic Bioassay. Phase 2: Coded Single-Dose Studies
  • OECD Principles and Criteria for Test Method Validation as Applied to the Fish Screening Assay
  • Owens et al. (2003), Environmental Health Perspectives, Volume 111, No.12
    The OECD Program to Validate the Rat Uterotrophic Bioassay. Phase 2: Dietary Phytoestrogen Analyses
  • Owens and Ashby, Critical Review and Evaluation of the Uterotrophic Bioassay for the Identification of Possible Estrogen Agonists and Antagonists: In Support of the Validation of the OECD Uterotrophic Protocols for the Laboratory Rodent
  • Owens and Koëter (2003), Environmental Health Perspectives, Volume 111, No.12
    The OECD Program to Validate the Rat Uterotrophic Bioassay: An Overview

 

Related Documents

 

What's new

Current Activities

How Work Is Carried Out

Conceptual Framework

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