T/SHSOT 004.2-2022 Active Group standards

T/SHSOT 004.2-2022 Guidelines for optimizing in vitro toxicological testing methods Part 2: In vitro human epidermal model testing for skin irritancy testing

Publish Date: 2022-09-28 Implement Date: 2022-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHSOT 004.2-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Integrated Environmental Protection

ICS Name: Integrated Environment and Environmental Protection

Publish Date: 2022-09-28

Implement Date: 2022-10-15

Scope

Scope: This document specifies the development, experimental process, and validation evaluation requirements for optimizing the standard method of in vitro reconstructed human epidermal models used in skin irritation tests; basic principles, development and validation guidelines, and technical highlights; This document applies to the development, validation, and implementation of similar or optimized methods based on the standard method of in vitro reconstructed human epidermal models for skin irritation tests of chemicals and related products; Main technical content: 3.1 Applicable scope Part I: Standard applicability This document specifies the development, experimental process, and validation evaluation requirements for optimizing the standard method of in vitro reconstructed human epidermal models used in skin irritation tests; basic principles, development and validation guidelines; and this document applies to the development, validation, and implementation of similar or optimized methods based on the standard method of in vitro reconstructed human epidermal models for skin irritation tests of chemicals and related products; 3.2 Normative references 3.3 Terms and definitions Part 2 lists 10 terms related to this standard, including: cell viability, complete test sequence, consistency, half-inhibition time ET50, half-inhibition concentration IC50, qualified operation, qualified test, reproducibility, operation, and test. 4.4 Abbreviations Lists 10 abbreviations related to this standard, including GHS, HPLC, MTT, NSCkilled, NSC, NSMTT, and OD. 4.5 Basic principles 1. Consistency principle The validated reference method consists of three elements: structure, function, and procedures. Compared with the validated method, similar or improved methods should be consistent in both structure and function. By verifying the three elements of the in vitro method, the unique properties of the in vitro method, key details of the procedure, and quali