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Sécurité des produits chimiques et biosécurité

Series on Testing and Assessment: Testing for Endocrine Disrupters

 

What's new

 ‌This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.


The OECD has released the Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide guidance for evaluating chemical using standardised test guidelines. Specific objectives include providing a description of the OECD conceptual framework for evaluating chemicals for endocrine disruption, background on the standardised test methods used, and guidance for interpreting the outcome of individual tests. The general approach taken by the document is primarily to provide guidance on how test results might be interpreted based on the outcome of standardised assays. Key questions addressed in the document concern likely mechanisms of endocrine action and any resulting apical effects that can be attributed to such action. The document is not proscriptive but provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios. The guidance document is focused primarily on endocrine modalities included in the conceptual framework; estrogen, androgen, and thyroid mediated endocrine disruption and chemicals that interfer with steroidogenesis.

 

PUBLICATIONS relevant to testing for endocrine disrupters

No. 353 Validation of the Rapid Androgen Disruption Activity (RADAR) assay for the detection of androgen axis active substances, described in OECD Test Guideline 251

No. 211: Guidance Document for Describing Non-Guideline In Vitro Test Methods

No 207: New scoping document on in vitro and ex vivo assays for the identification of modulators of thyroid hormone signalling

No 181:  Guidance document (GD) on standardised test guidelines for evaluating chemicals for endocrine disruption: Case studies using example chemicals

No 178: Detailed review paper on the state of the science on Novel in vitro and in vivo screening and testing methods and endpoints for evaluating endocrine disruptors

No 176: Report on the retrospective analysis of 2-generation reprotoxicity data

No 174:  Performance standards for the BG1Luc ER TA transactivation method to detect estrogen receptor antagonists for TG 457

No 173: Performance standards for stably transfected transactivation in vitro assays to detect estrogen agonists for TG 455

No 161: Peer review report for the validation of the stably transfected transcriptional activation assay for the detection androgenic and anti-androgenic activity of chemicals (2011)

No 158:  Report of progress on the interlaboratory validation of the OECD harpacticoid copepod development and reproduction test

No 151: Guidance document supporting OECD Test Guideline 443 on the extended one-generation reproductive toxicity test

No 150: Guidance document on standardised Test Guidelines for evaluating chemicals for endocrine disruption

No 148: Guidance document on the androgenised female stickleback screen

No 143: Peer Review report for the validation of the fish sexual development test and agreement of the Working Group of National Co-ordinators of the Test Guidelines Programme on the follow-up of the peer review

No 142: Report of the phase 2 of the validation of the fish sexual development test for the detection of endocrine substances

No 141: Report of the phase 1 of the validation of the fish sexual development test for the detection of endocrine substances

No 135: Detailed review paper on environmental endocrine disruptor screening: The use of estrogen and androgen receptor binding and transactivation assays in fish

No 133: Peer review report for the H295R cell-based assay for steroidogenesis

No 132: Report of the multi-laboratory validation of the H295R steroidogenesis assay to identify modulators

No 128: Validation report on the 21-day androgenised female stickleback screening assay

No 127:  Peer review report of the validation of the 21-day androgenised female stickleback screening assay

No 123: Guidance document on the diagnosis of endocrine-related histopathology in fish gonads

No 118: Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters part II (Appendicied including individual contributions from countries/region and stakeholders to the case study report prepared for the workshop, and workshop presentations are included in Part II)

No 118: Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters

No 115: Guidance document on the weanling hershberger bioassay in rats: A short-term screening assay for (anti) androgenic properties

No 111: Report of the expert consultation to evaluate an estrogen receptor binding affinity model for hazard identification

No 110: Report of the validation peer review for the weanling hershberger bioassay and agreement of the Working of National Coordinators of the Test Guidelines Programme on the follow-up of this report

No 109: Literature review on the 21-day fish assay and the fish short-term reproduction assay

No 108: Report of the validation of the hershberger bioassay (Weanling Model)

No 106: Guidance document for histologic evaluation of endocrine and reproductive tests in rodents 

Part 2

Part 3 (section 1)

Part 3 (section 2)

Part 3 (section 3)

Part 3 (section 4)

Part 3 (section 5)

Part 4

Part 5

Part 6

No 97: Detailed review paper on the use of metabolising systems for in vitro testing of endocrine disruptors

No 95: Detailed review paper on fish life-cycle tests

No 94: Report of the validation peer review for the 21-day fish endocrine screening assay and agreement of the Working Group of the National Coordinators of the Test Guidelines Programme on the follow-up of the report

No 93: Report of the validation of an enhancement of OECD TG 211: Daphnia magna reproduction test

No 92: Report of the validation peer review for the amphibian metamophosis assay and agreement of the Working Group of the National Coordinators of the Test Guidelines Programme on the follow-up of this report

No 91: Report of the validation of the amphibian metamorphosis assay (Phase 3)

No 90: Background review document on the rodent hershberger bioassay

No 86: Report of the OECD validation of the rodent hershberger bioassay - Phase 2: Testing of androgen agonists, androgen antagonists and a 5 α-reductase inhibitor in dose response studies by multiple laboratories

No 85: Report of the validation peer review for the hershberger bioassay, and the agreement of the Working Group of the National Coordinators of the Test Guidelines Programme on the follow-up of this report

No 83: Summary report of the peer review panel on the stably transfected transcriptional activation assay for detecting estrogenic activity of chemicals, and agreement of the Working Group of National Coordinators of Test Guidelines Programme on the follow-up of this report

No 82: Guidance document on amphibian histology

No 81: Summary report of the validation peer review for the updated Test Guideline 407, and agreement of the Working Group of the National Coordinators of the Test Guidelines Programme on the follow-up of this report

No 79: Validation report of the full life-cycle test with the harpacticoid copepods nitocra spinipes and amphiascus tenuiremis and the calanoid copepod acartia tonsa - Phase 1

No 78: Final report of the validation of the 21-day fish screening assay for the detection of endocrine active substances - Phase 2: Testing negative substances

No 77: Final report of the validation of the amphibian metamorphosis assay - Phase 2: Multi-chemical interlaboratory study

No 76: Final report of the validation of the amphibian metamorphosis assay for the detection of thyroid active susbstances - Phase 1: Optimisation of the test protocol

No 74: Detailed review paper for avian two-generation toxicity testing

No 73: Report of the validation of the rat hershberger assay - Phase 3: Coded testing of androgen agonists, androgen antagonists and negative reference chemicals by multiple laborotories. Surgical castrate model protocol.

No 71: Guidance document on the uterothrophic bioassay - Procedure to test for antioestrogenicity  (Korean version)

No 68: Summary report of the uterothropic bioassay peer review panel, including assessmenf of the Working Group of the National Coordinators of the Test Guidelines Programme on the follow-up of this report

No 67: Report of the uterotrophic bioassay: Additional data supporting the test guideline on the uterotrophic bioassay in rodents

No 66: OECD report of the validation of the rodent uterotrophic bioassay - Phase 2: Testing of potent and weak oestrogen agonists by multiple laboratories

No 65: OECD report of the initial work towards the validation of the rodent uterothophic assay - Phase 1

No 62: Final OECD report of the initial work towards the validation of the rat hershberger assay - Phase 1: Androgenic response to testosterone propionate, and anti-androgenic effects of flutamide

No 61: Report of the validation of the 21-day fish screening assay for the detection of endocrine active substances - Phase 1B

No 60: Report of the initial work towards the validation of the 21-day fish screening assay for the detection of endocrine active substances - Phase 1A

No 59: Report of the validation of the updated test guideline 407 - Repeat dose 28-day oral toxicity study in laboratory rats [Annexes]

No 57: Detailed review paper on thyroid hormone disruption assays

No 55: Detailed review paper on aquatic arthropods in life cycle toxicity tests with an emphasis on developmental, reproductive and endocrine disruptive effects

No 47: Detailed review paper on fish screening assays for the detection of endocrine active substances

No 46: Detailed review paper on amphibian metamorphosis assay for the detection of thyroid active substances

No 38: Detailed background review of the uterotrophic bioassay [References]

No 21: Detailed review paper: Appraisal of test methods for sex hormone disrupting chemicals

 

Documents connexes