标准解读
《GB/T 44482-2024 化学品 嗜热四膜虫多代繁殖毒性试验》是一项国家标准，旨在通过嗜热四膜虫（Tetrahymena thermophila）这一生物模型来评估化学品的长期毒性影响。该标准详细规定了实验设计、操作步骤及结果分析方法，适用于环境化学物质的安全性评价。
在试验过程中，首先需要准备健康的嗜热四膜虫作为测试对象，并确保其处于适宜生长条件下。接着，将待测化学品按照预设浓度加入到含有嗜热四膜虫的培养基中。根据化学品性质的不同，可能还需要设置多个不同浓度梯度以全面了解其对生物体的影响范围。整个暴露周期通常持续几代时间，期间需定期观察并记录嗜热四膜虫的数量变化、生长状态以及任何异常表现。
除了直接观测外，还应该采用显微镜检查等手段深入分析嗜热四膜虫细胞结构上的改变情况，以此判断化学品是否对其产生了遗传层面的损伤。此外，通过对后代数量统计与比较，可以进一步量化化学品对于嗜热四膜虫繁殖能力的具体影响程度。
该标准强调，在进行此类毒性测试时必须严格遵守实验室安全规范，合理处理废弃物，防止对环境造成二次污染。同时，所有数据收集过程均应保持客观公正，确保最终结论准确可靠。
如需获取更多详尽信息，请直接参考下方经官方授权发布的权威标准文档。
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文档简介
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
·····································································································
Ⅲ
1
范围
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1
2
规范性引用文件
······················································································
1
3
术语和定义
···························································································
1
4
试验原理
······························································································
1
5
受试物信息
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2
6
参比物质
······························································································
2
7
试验系统
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2
7.1
仪器设备
·························································································
2
7.2
材料和试剂
······················································································
2
7.3
受试生物的选取
·················································································
3
7.4
试验溶液
·························································································
3
7.5
试验前的准备
····················································································
3
7.6
预试验
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3
7.7
正式试验程序
····················································································
3
8
限度试验
······························································································
4
9
质量控制
······························································································
5
10
数据与报告
··························································································
5
10.1
抑制率的计算
···················································································
5
10.2
ECx的计算
······················································································
5
10.3
LOEC和NOEC的计算
·········································································
5
10.4
试验报告
························································································
5
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
···································
7
A.1
概述
·····························································································
7
A.2
常用培养基
······················································································
7
A.3
嗜热四膜虫的保种
··············································································
7
A.4
嗜热四膜虫的培养
··············································································
8
附录B（资料性）嗜热四膜虫不同时长﹘繁殖代际参考表
············································
9
附录C（资料性）嗜热四膜虫暴露试验24孔板设置推荐方案
······································
10
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
·····························
11
参考文献
································································································
12
Ⅰ
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。
Ⅲ
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
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