GB/T 35520-2017 in English

GB/T 35520—2017 Standard Overview

This standard specifies the terminology, principles, methods and quality control requirements for the embryotoxicity test of chemicals using embryonic stem cells, aiming to evaluate the effects of chemicals on embryonic development.

Test Principle

Based on the difference in sensitivity between mouse embryonic stem cells (ES cells) and 3T3 fibroblasts, the potential embryotoxicity of chemicals is judged by two endpoints: cytotoxicity and differentiation inhibition. ES cells are maintained in an undifferentiated state under specific culture conditions. After the removal of leukemia inhibitory factor, they will form embryoid bodies and differentiate into major embryonic tissues.

Test methods

Quality control

Result evaluation and classification

Based on the cell activity data obtained by MTT detection, calculate the IC50 value and make a comprehensive judgment based on multiple endpoint indicators. According to the classification criteria in Table 3, the tested chemicals are divided into three categories: non-embryotoxic, weak embryotoxic and strong embryotoxic.

Implementation suggestions

• Strictly follow the standard operating procedures to ensure the quality of materials and reagents.
• Establish a standardized quality control system and verify the test conditions regularly.
• Use data analysis software to assist in the calculation of endpoint indicators and classification models.