GB/T 35519-2017Chemicals—Stably transfected human estrogen receptor transcriptional activation assay—Detection of estrogenic agonists activation (English PDF)
化学品 稳定转染人雌激素受体转录活性试验 雌激素激动活性法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
December 29, 2017
Implementation date
July 1, 2018
Scope
GB/T 35519-2017 is the English-translated version of 化学品 稳定转染人雌激素受体转录活性试验 雌激素激动活性法.
GB/T 35519-2017 specifies a transcriptional activation assay that uses stably transfected cell lines to detect estrogen receptor agonists, covering the terms and definitions, the test principle, the test method and procedure, and the data and reporting.
Clause 1 states that it applies to the use of stably transfected cell lines to test estrogen receptor agonists in the assessment of the estrogen-like biological activity of chemicals, and records no exclusions.
The introduction states that Appendix A and Appendix B have both been verified: Appendix A uses hERalpha-HeLa-9903 cells stably transfected with human ERalpha, and Appendix B uses BG1Luc-4E2 cells that express the human estrogen receptor.
It also places the standard in the second phase of the five-phase conceptual framework that the Organization for Economic Co-operation and Development revised in 2012 for assessing potential endocrine disruptors, the in vitro assay phase that provides information on endocrine mechanisms, and says the method can be used across countries, which is conducive to the mutual recognition of data.
Clause 2 sets out terms, definitions and abbreviations, and defines agonist, antagonist, anti-estrogenic activity, activated charcoal and dextran treatment, cytotoxicity, estrogenic activity and performance standard.
The foreword names OECD Chemical Test Method No. 455 of 2012, but prints that sentence incompletely, so the exact relationship between the two documents cannot be read here; the draft also breaks off inside the definition of performance standard, so the clauses on the test principle, the test method and procedure and the reporting are not shown. It was issued on 2017-12-29 and has applied since 2018-07-01.
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Document preview — GB/T 35519-2017
National Standard of the People's Republic of China
- ICS
- 13.300; 11.100
- Classification
- A 80
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Terms, definitions and abbreviations
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard and the Organization for Economic Co-operation and Development (OECD) Chemical Test Method No. 455 "Performance-BasedTest nists "(2012) technical content.
Introduction
This standard describes the use of stable transfected cell lines detect estrogen receptor agonist in vitro transcriptional activation test method, including the principle and Functionally similar estrogen receptor (ERs) agonists are designed to promote similar or improved detection methods to match Organization for Economic Co-operation and Development Guidance on Validation and Recognition of New Methods of Hazard Assessment.
This standard Appendix A and Appendix B have been verified. Appendix A utilizes hERalpha-HeLa-9903 cells stably transfected with human ERalpha Transcriptional Activation Assay to Test Estrogenic Activity of Chemicals, Appendix B to BG1Luc-4E2 Cells that Express Human ERa Estrogen receptor transcriptional activation test. This standard estrogen receptor transcriptional activation test method can be used across countries, is conducive to data Mutual recognition.
In 1998, the Organization for Economic Co-operation and Development initiated a priority project activity aimed at revising the current Guiding Principles, Potential new potential guidelines for endocrine disruptors. OECD measurements to assess potential endocrine disruptors The conceptual framework was revised in 2012. The conceptual framework consists of five phases, with different phases corresponding to different phases of biological complexity. This standard is The second phase of the "In Vitro Assay, Providing Endocrine Mechanisms/Access Information." This standard is to identify estrogen receptor agonist in vitro transcription Activate the test method.
1 Scope
This standard specifies the use of stable transfected cell lines test estrogen receptor agonist terms and definitions, test principle, test side Law and Procedure, Data and Reporting.
This standard applies to the use of stable transfected cell lines test estrogen receptor agonist assessment of chemical estrogen-like organisms active.
2 Terms, definitions and abbreviations
2.1 Terms and definitions
The following terms and definitions apply to this document.
2.1.1 Agonist
A substance that produces a response (eg, transcription) when bound to a particular receptor.
2.1.2 Antagonist
Ligands or ligands of a class of receptors that, upon binding to a receptor, do not themselves elicit a biological response, but block or inhibit agonist-mediated responses Learning products.
2.1.3 Anti-estrogenic activity
A chemical that inhibits 17beta-estradiol-mediated estrogen receptor activity.
2.1.4 Activated charcoal/dextran treatment
Plasma treatment in cell culture removes endogenous hormones and hormone-binding proteins.
2.1.5 Cytotoxicity
Toxic effects on cell structure or function and eventual cell death, compared to parallel solvent controls, are manifested as toxicity After exposure, the number of cells decreases or the cell function decreases.
2.1.6 Estrogenic activity
Chemicals mimic 17beta-estradiol's ability to bind and activate estrogen receptors.
2.1.7 Performance standard
Evaluate whether a test method is consistent with the verification method in terms of mechanism and function. include.
--- Basic test methods;
--- In the verification method used to prove that the test method is feasible list of the minimum control chemicals;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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