GB/T 44482-2024 化学品 嗜热四膜虫多代繁殖毒性试验

ICS

13.300

CCS

R04

中华人民共和国国家标准

GB/T44482—2024

化学品嗜热四膜虫多代繁殖毒性试验

Chemicals—Tetrahymenathermophilamulti-generationalreproductivetest

2024-09-29发布2025-04-01实施

国家市场监督管理总局发布

国家标准化管理委员会

GB/T44482—2024

目次

前言

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范围

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规范性引用文件

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3

术语和定义

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试验原理

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受试物信息

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参比物质

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试验系统

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7.1

仪器设备

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7.2

材料和试剂

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7.3

受试生物的选取

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7.4

试验溶液

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7.5

试验前的准备

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7.6

预试验

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正式试验程序

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限度试验

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质量控制

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数据与报告

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10.1

抑制率的计算

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10.2

ECx的计算

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10.3

LOEC和NOEC的计算

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10.4

试验报告

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附录A（资料性）嗜热四膜虫的实验室维护及培养方法实施指南

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A.1

概述

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A.2

常用培养基

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A.3

嗜热四膜虫的保种

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A.4

嗜热四膜虫的培养

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附录B（资料性）嗜热四膜虫不同时长﹘繁殖代际参考表

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附录C（资料性）嗜热四膜虫暴露试验24孔板设置推荐方案

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附录D（资料性）嗜热四膜虫相对细胞活力检测96孔板设置推荐方案

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参考文献

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GB/T44482—2024

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由全国危险化学品管理标准化技术委员会（SAC/TC251）提出并归口。

本文件起草单位：中国地质大学（武汉）、广东省科学院微生物研究所（广东省微生物分析检测中

心）、中国矿业大学、中检科健（天津）检验检测有限责任公司、中国科学院生态环境研究中心、生态

环境部华南环境科学研究所（生态环境部生态环境应急研究所）、湖北省生态环境科学研究院（省生态

环境工程评估中心）、临沂市检验检测中心。

本文件主要起草人：刘春生、张永康、梅承芳、程诗洋、高亮、徐胜男、孔任、李海山、周丽丽、

秦占芬、党垚、向明灯、易川、刘超武、霍健、张玉玲、冯连娜。

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GB/T44482—2024

化学品嗜热四膜虫多代繁殖毒性试验

1范围

本文件描述了化学品嗜热四膜虫多代繁殖毒性试验的试验原理、受试物信息、参比物质、试验系

统、限度试验、质量控制、数据与报告。

本文件适用于化学品对嗜热四膜虫的多代繁殖毒性测试试验。

2规范性引用文件

本文件没有规范性引用文件。

3术语和定义

下列术语和定义适用于本文件。

3.1

嗜热四膜虫密度tetrahymenathermophiladensity；TD

单位体积[一般为毫升（mL）]培养基所含的嗜热四膜虫个体数量。

3.2

效应浓度effectconcentration；EC

在给定测定周期内，与对照组相比，导致嗜热四膜虫密度降低x%的受试物浓度。

注1：效应浓度的英文缩写为EC，ECx表示抑制率为x%时的受试物浓度，如EC50表示半数效应浓度。

注2：效应浓度以每单位体积培养基所含的受试物量表示。

3.3

最低可观察效应浓度lowestobservedeffectconcentration；LOEC

在给定测定周期内，与对照组相比，在统计学意义上对嗜热四膜虫密度产生显著效应（p＜0.05）的

最低受试物浓度。

注：p值是一个用于衡量观察到的结果在统计学上的显著性的指标。在进行假设检验时，通常将显著性水平设置为

0.05，p＜0.05被认为观察到的差异在统计学上是显著的。

3.4

无可观察效应浓度noobservedeffectconcentration；NOEC

在给定测定周期内，与对照组相比，在统计学意义上对嗜热四膜虫密度未产生显著效应（p≥0.05）

的最高受试物浓度。

注：p≥0.05被认为观察到的差异在统计学上是不显著的。

4试验原理

嗜热四膜虫能在较短试验周期内完成多代繁殖，外源性化学物质的加入会对其生长状态和繁殖情况

产生影响，因此短时间内可以完成化学品的危害评价工作。将嗜热四膜虫暴露于含有不同浓度受试物的

培养基中，测定嗜热四膜虫的密度，进而评价受试化学品暴露对嗜热四膜虫多代繁殖的影响，计算得出

受试物的效应浓度（ECx）、最低可观察效应浓度（LOEC）和无可观察效应浓度（NOEC）。

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