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GB/T 34713-2017: Chemicals -- Validation process and principles of alternative methods for in vitro toxicological testing
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GB/T 34713-2017: Chemicals -- Validation process and principles of alternative methods for in vitro toxicological testing

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Chemicals-Validation process and principles of alternative methods for in vitro toxicological testing ICS 13.300; 13.020.40 A80 National Standards of People's Republic of China Chemical in vitro toxicity test alternative method Verification procedures and principles Posted.2017-11-01 2018-05-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard part adopts the OECD guideline OECDENV/JM/MONO (2005) 14 "Guidance Document Verification of New or Updated Test Method Validation and Internationally Accepted Guidance Documents for Hazard Assessment" and internationalaceptanceofneworupdatedtestmethodsforhazardassessment (in English), the relevant technology Technical content reference to the above documents organized. This standard by the National Standardization Technical Committee of hazardous chemicals management (SAC/TC251) and focal point. This standard was drafted by the Chinese Academy of Inspection and Quarantine. The main drafters of this standard. Cui Yuan, Li burning, Zhang Jing, Chen Huiming. Chemical in vitro toxicity test alternative method Verification procedures and principles

1 Scope

This standard specifies the verification procedures and principles for alternative methods of chemical in vitro toxicity testing. This standard applies to chemicals in vitro toxicity test alternative method.

2 Terms and definitions

The following terms and definitions apply to this document. 2.1 Alternative alternative Improve test design and test efficiency to reduce the number of animals required for a given test (reduce substitution) and reduce stress in animals Replacement), and the use of animals that completely stopped a trial (absolute substitution). 2.2 Alternative test alternativetesting Using free organs, cultured cells or organelles, biological simulation systems to reduce, optimize or replace traditional animal experiments for toxic Neutrinos, Neutropenia, Neutropenia, Neutropenia, Neutropenia 2.3 Validation validation The process of assessing the reliability and relevance of a method or procedure for a given purpose.

3 verification procedures

Appendix A provides a skin corrosive in vitro test verification program application examples. 3.1 Alternative methods of development and reporting Alternative methods from the laboratory were developed and built, including. a) Description of the purpose of the method; b) Description of method requirements; c) Origin of the method; d) Application Description e) what needs to be clarified in the validation study; f) Test Method Draft. 3.2 Pre-verification and optimization of alternative methods The pre-verification process is a small-scale, inter-laboratory study in order to optimize the test methodologies and predictive models for methodological relevance ...