GB/T 43450-2023Chemicals—In vitro cellular assay for acute eye irritation—TRPV1 activity detection method (English PDF)
化学品 急性眼刺激体外细胞试验 TRPV1活性检测法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
November 27, 2023
Implementation date
June 1, 2024
Scope
GB/T 43450-2023 is the English-translated version of 化学品 急性眼刺激体外细胞试验 TRPV1活性检测法.
GB/T 43450-2023 is an in vitro cell test for the acute eye irritation of chemicals, read from TRPV1 activity. Clause 1 states that it specifies the principle of the method, the instruments, the reagents and consumables, the testing itself and the determination of the result.
It defines eye irritation, taken from GB/T 21609, as well as agonist and antagonist, and its abbreviations include the area under the curve and bovine serum albumin.
Clause 1 also limits what the method may be used on: the chemicals are soluble in water and the pH of the test solution should be within the range 6.5 to 7.8. Among the standards it quotes are GB/T 6682, GB/T 21609, SN/T 2285 and SN/T 3899. Issued on 27 November 2023, it has applied since 1 June 2024.
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Document preview — GB/T 43450-2023
National Standard of the People's Republic of China
- ICS
- 13.300; 11.100
- Classification
- A 80
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms, definitions and abbreviations
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.
1 Scope
This document stipulates the method principles, instruments and reagents and consumables, testing and result determination of chemicals for acute eye irritation testing.
This document is suitable for in vitro testing of acute eye irritation of chemicals. The chemicals are soluble in water and the pH of the test solution should be in the range of 6.5~7.8. within the perimeter.
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.
GB/T 6682 Specifications and test methods for water used in analytical laboratories
GB/T 21609 Test methods for acute eye irritation/corrosion of chemicals
SN/T 2285 Laboratory specifications for in vitro substitution testing of cosmetics
SN/T 3899 Good cell culture and sample preparation practices for in vitro surrogate testing of cosmetics
3 Terms, definitions and abbreviations
3.1 Terms and definitions
The following terms and definitions apply to this document.
3.1.1 Eye irritation
Reversible inflammatory changes in the eye that occur after contact with the test substance on the surface of the eyeball. [Source: GB/T 21609,3.1]
3.1.2 Agonist
Compounds that have both affinity and intrinsic activity and can bind to receptors and stimulate the receptors to produce effects.
3.1.3 Antagonistantagonist
Compounds that do not cause biological effects after binding to the receptor, but can block the agonistic effect of the receptor.
3.2 Abbreviations
The following abbreviations apply to this document. AUC. Area under the curve (AreaUnderCurve)
BSA. Bovine Serum Albumin (BovineSerumAlbumin)
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 6682Water for analytical laboratory use - Specification and test methods
- GB/T 21609Chemicals — Test method of acute eye irritation/corrosion
- SN/T 2285Good laboratory practice for cosmetics alternative testing in vitro
- SN/T 3899Guidance on good cell culture practice and sample preparation for cosmetics alternative testing in vitro
Similar standards
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Related Standards
GB/T 21609-2025 — Chemicals — Test method of acute eye irritation/corrosion
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
SN/T 2285-2009 — Good laboratory practice for cosmetics alternative testing in vitro
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GB/T 43450-2023
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