GBZ39262-2020 English PDF

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GBZ39262-2020: Nanotechnologies. Guidance on toxicological screening methods for nanomaterials
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Basic data

Standard ID: GB/Z 39262-2020 (GB/Z39262-2020)
Description (Translated English): Nanotechnologies. Guidance on toxicological screening methods for nanomaterials
Sector / Industry: National Standard
Classification of Chinese Standard: C04
Classification of International Standard: 07.030
Word Count Estimation: 31,355
Date of Issue: 2020-11-19
Date of Implementation: 2021-06-01
Quoted Standard: GB/T 32269-2015; ISO/TS 80004-1
Adopted Standard: ISO/TR 16197-2014, IDT
Regulation (derived from): National Standard Announcement No. 26 of 2020
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration
Summary: This standard specifies in vitro and in vivo toxicology and ecotoxicological screening test methods suitable for nanomaterials. These methods contribute to the screening of nanomaterials toxicology including ecotoxicology. The toxicology screening test in this guidance technical document can be used for early determination of research and product development, rapid feedback on its potential toxicology/safety risks, or preliminary evaluation. This guidance technical document can be divided into toxicological screening methods related to human health and environment related. Screening tests are relatively simple and inexpensive methods that are easy to perform and provide corresponding indications of whether nanomaterials have potential negative effects on humans and the environment. This guiding technical document focuses on describing the preliminary screening methods applicable to toxicological evaluation. It is a supplement to other foreign standards and is compatible with other international organizations.

GBZ39262-2020: Nanotechnologies. Guidance on toxicological screening methods for nanomaterials

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
GB /Z 39262-2020 (Nanotechnology Guide to toxicological screening methods for nanomaterials) ICS 07.030 C04 National Standardization Guiding Technical Documents of the People's Republic of China nanotechnology Guide to toxicological screening methods for nanomaterials 2020-11-19 released 2021-06-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee

Table of contents

Foreword Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Abbreviations 3 5 General 3 5.1 The role and relevance of toxicological screening in the safety evaluation of man-made nanomaterials 3 5.2 Toxicological screening is part of the toxicological assessment method of man-made nanomaterials 4 5.3 Dosage discussion related to toxicological screening 4 5.4 Relationship with ISO /T R16196 5 5.5 Relationship with ISO /T R13014 5 5.6 Review of other relevant international activities and publications 5 6 Toxicology screening methods related to human health 6 6.1 Overview 6 6.2 Positive and negative controls 6 6.3 In vitro toxicological screening methods 7 6.4 In vivo toxicological screening methods for nanomaterials 15 7 Environmental Toxicology Screening 16 7.1 Overview 16 7.2 Environmental fate and distribution 17 7.3 Environmental degradation and transformation 17 7.4 Environmental biological residues and accumulation 17 Reference 18

Foreword

This guiding technical document was drafted in accordance with the rules given in GB/T 1.1-2009. The translation method used in this guidance technical document is equivalent to the adoption of ISO /T R16197.2014 "Nanotechnology Manufacturing Nanomaterial Toxicology Screen Preparation and description of selection methods. The Chinese documents that have consistent correspondence with the normatively cited international documents in this guiding technical document are as follows. ---GB/T 30544.1-2014 Nanotechnology terminology Part 1.Core terminology (ISO /T S80004-1.2010, IDT) This guiding technical document has made the following editorial changes. --- Amend the standard name to "Nanotechnology and Nanomaterials Toxicology Screening Method Guide"; ---Reorder the references. This guiding technical document was proposed by the Chinese Academy of Sciences. This guiding technical document is under the jurisdiction of the National Nanotechnology Standardization Technical Committee (SAC/TC279). Drafting units of this guiding technical document. Institute of Basic Medicine, Chinese Academy of Medical Sciences, Peking University. The main drafters of this guiding technical document. Xu Haiyan, Meng Jie, Jia Guang, Chen Zhangjian, Wen Tao, Zhao Lin.

Introduction

This technical guidance document gives general rules for the toxicological screening of nanomaterials. These methods are suitable for the development of nanomaterials. Before application of comprehensive toxicology testing, analysis and risk assessment. Toxicological screening methods focus on providing information and tool. For example, this guidance technical document gives information on screening methods that can be used to screen nanomaterials to determine whether to continue Continue to develop the nanomaterials or products containing the nanomaterials, whether to invest a lot of money to carry out comprehensive toxicology testing, or decide to continue Have you set up appropriate controls before conducting nanomaterials research? This guiding technical document and a series of effective test methods provided are compatible with the current testing, utilization and disposal of nanomaterials. There is no conflict or/and competition between the regulatory requirements of management. The information provided in this technical guidance document conforms to other international standards. For example, ISO /T R16196.2016 discussed in different media The method of preparing toxicological test samples in quality; ISO 10993-18 specifically emphasizes the evaluation of the chemical characteristics of materials in medical devices; ISO 14971 points out that toxicological risk analysis should consider the chemical properties of the material; ISO /T R13014 discusses the properties of the material itself; ISO /T R13121 describes the process of distinguishing, evaluating and reporting the potential risks of nanomaterials, and provides layered nanomaterial toxicity testing guide. nanotechnology Guide to toxicological screening methods for nanomaterials

1 Scope

This technical guidance document provides methods suitable for in vitro and in vivo toxicology and ecotoxicology screening tests for nanomaterials. These parties The method is helpful for the screening of nanomaterials toxicology including ecotoxicology. The toxicology screening test in this guidance technical document can be used for research and Early determination of product development, quick feedback on its potential toxicology/safety risks, or preliminary evaluation. This guiding technique Technical documents can be divided into toxicological screening methods related to human health and environment-related. Screening tests are relatively simple and inexpensive methods The method is easy to carry out and can provide corresponding indications of whether nanomaterials have potential negative effects on humans and the environment. This guiding technical document focuses on describing the preliminary screening methods applicable to toxicological evaluation. It is a supplement to other foreign standards and is compatible with other countries. The relevant documents of international organizations such as OECD are not repeated. If the screening results suggest early indications of hazards, this guidance technical document will quote Instruct the tester to refer to the documents of other organizations for a comprehensive toxicological evaluation or further comprehensive research.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB/T 32269-2015 Terms and definitions of nanotechnology and nanoobjects Nanoparticles, nanofibers and nanosheets ISO /T S80004-1 Nanotechnology terminology Part 1.Core terminology

3 Terms and definitions

The following terms and definitions defined in GB/T 32269-2015 and ISO /T S80004-1 apply to this document. 3.1 Aggregates The aggregates, aggregates, or mixtures of weakly bound particles have an external surface area similar to the sum of the surface area of individual particles. Note 1.The forces supporting the agglomerates are weak forces, such as van der Waals forces or simple physical entanglements. Note 2.Agglomerates are also called secondary particles, while source particles are called primary particles. [GB/T 32269-2015, definition 3.2] 3.2 Aggregates The external surface area of new particles composed of strongly bound or fused particles may be significantly smaller than the sum of the surface areas of individual particles. Note 1.The forces supporting the aggregates are strong forces, such as covalent bonds or derived from sintering or complex physical entanglement. Note 2.Aggregates are also called secondary particles, while source particles are called primary particles. [GB/T 32269-2015, definition 3.3] ......

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