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GB/Z 43193-2023Nanotechnologies - Considerations for performing toxicokinetic studies with nanomaterials (English PDF)

纳米技术纳米材料毒物代谢动力学研究要素

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Issued by

State Administration for Market Regulation, China National Standardization Administration

Level / Type

National · Recommended

Issue date

September 7, 2023

Implementation date

April 1, 2024

Scope

GB/Z 43193-2023 is the English-translated version of 纳米技术纳米材料毒物代谢动力学研究要素.

GB/Z 43193-2023 is the Chinese standard "Nanotechnologies - Considerations for performing toxicokinetic studies with nanomaterials". Its scope clause reads: This document describes the background and principles for toxicokinetic studies relevant to nanomaterials.

Appendix A contains terms and definitions related to toxicokinetics used in OECD TG 417.2010. Its clauses include normative reference documents; terms and definitions.

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Document preview — GB/Z 43193-2023

National Standard of the People's Republic of China

ICS: 07.030
Classification: C 04

Issued by: State Administration for Market Regulation, China National Standardization Administration

Preface
Introduction
1 Scope
2 Normative reference documents
3 Terms and Definitions
4 Abbreviations
5 The importance of toxicokinetics for risk assessment of nanomaterials
5.1 Overview
5.2 Possible uses of toxicokinetic information
5.3 Metabolic kinetic issues of key toxicants in nanomaterials
6 Factors affecting toxicant metabolism kinetics of nanomaterials
6.1 Dissolution rate
6.2 Physicochemical properties of nanomaterials that determine toxicant metabolic kinetic behavior
7 Challenges of Analytical Methods
7.1 Overview
7.2 Elemental analysis
7.3 Analysis of radioactive or fluorescent labels of elements
7.4 Determination of particles
7.5 Detection limit
8 Questions related to drug administration
8.1 Overview
8.2 Dosage
9 Absorption of nanomaterials
9.1 Overview
9.2 Skin
9.3 Gastrointestinal tract
9.4 Respiratory tract
10 distribution
10.1 Overview
10.2 Organ distribution
10.3 Transport across the placenta, blood-brain barrier and reproductive organs
11 Metabolism/degradation
12 Excretion
13 Conclusion
Appendix A (informative) Definitions used in OECDTG417.201
Appendix B (Informative) Advantages and Challenges of Quantitative Methods for Nanomaterials

1 Scope

This document describes the background and principles for toxicokinetic studies relevant to nanomaterials.

Appendix A contains terms and definitions related to toxicokinetics used in OECD TG 417.2010.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations

For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

ISO /T S80004-1.2015 Nanotechnology terminology Part 1.Core terms (Nanotechnologies-Vocabulary-

Part 1.Coreterms)

Note. GB/T 30544.1-2014 Nanotechnology terminology Part 1.Core terms (ISO /T S80004-1.2010)

ISO /T S80004-2.2015 Nanotechnology terminology Part 2.Nanotechnologies-Vocabulary-

Part 2.Nano-objects)

3 Terms and definitions

The following terms and definitions as defined in ISO /T S80004-1.2015 and ISO /T S80004-2.2015 apply to this document.

The following URLs are database URLs used in standards that ISO and IEC are responsible for.

3.1 agglomerate

The surface area of an accumulation, aggregate or mixture of weakly bound particles is similar to the sum of the surface areas of its individual particles.

Note 1.The forces supporting 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.

[Source. ISO 26824.2013,1.2]

3.2 aggregate

New particles formed from particles that are strongly bound or fused together may have an external surface area that is significantly smaller than the sum of the surface areas of the individual particles.

Note 1.The forces supporting aggregates are strong forces, such as covalent bonds or originating from sintering or complex physical entanglements.

Note 2.Aggregates are also called secondary particles, while source particles are called primary particles.

[Source. ISO 26824.2013,1.3, modified]

3.3 nanoscale

In the size range between 1nm and 100nm.

NOTE 1.This size range generally, but not exclusively, exhibits characteristics that cannot be extrapolated from larger sizes. For these properties, the upper and lower scale values are similar.

Note 2.The purpose of introducing a lower limit (approximately 1 nm) in this definition is to avoid considering individual atoms or clusters of atoms as nano-objects or nano-structural units.

GB/T 36388 | YBB 2027 | YBB 6006 | GB/T 46333 | GB/T 45633 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 98 pages — is available in the English PDF.

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