GB/T 38496-2020 English PDF

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GB/T 38496-2020: Toxicological procedures and methods of safety evaluation for disinfectant
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 38496-2020	779	Add to Cart	6 days	Toxicological procedures and methods of safety evaluation for disinfectant	Valid

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Basic data

Standard ID: GB/T 38496-2020 (GB/T38496-2020)
Description (Translated English): Toxicological procedures and methods of safety evaluation for disinfectant
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C50
Classification of International Standard: 11.080
Word Count Estimation: 42,452
Date of Issue: 2020-03-06
Date of Implementation: 2020-10-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration
Summary: This standard specifies the procedures for the safety toxicological evaluation of disinfectants, the principles for determining the toxicological test items, the requirements for the test substances (tested disinfectant samples) for toxicological tests, the toxicological test methods and the results of the toxicological tests. safety evaluation. This standard applies to the toxicological safety evaluation of disinfectants produced in my country or produced abroad and sold and used in my country, as well as disinfectants produced by instruments or devices.

GB/T 38496-2020: Toxicological procedures and methods of safety evaluation for disinfectant

---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.
Toxicological procedures and methods of safety evaluation for disinfectant ICS 11.080 C50 National Standards of People's Republic of China Procedures and methods for toxicological evaluation of disinfectant safety 2020-03-06 release 2020-10-01 implementation State Administration of Market Supervision Published by the National Standardization Administration

Contents

Foreword III 1 Scope 1 2 Terms and definitions 1 3 Disinfectant Safety Toxicology Evaluation Procedure 1 4 Principles for determining disinfection toxicology test items 2 5 Requirements for test substances for toxicological tests 3 6 Toxicological test methods for safety evaluation of disinfectants 3 6.1 Acute oral toxicity test 3 6.2 Acute inhalation toxicity test 11 (Test disinfectant samples) requirements, toxicological test methods and safety evaluation of toxicological test results. This standard applies to disinfectants produced and sold in China and produced in China, as well as disinfectants produced by instruments or devices. Toxicological safety evaluation.

2 terms and definitions

The following terms and definitions apply to this document. 2.1 New disinfectants Disinfectants produced using new materials, new process technologies and new sterilization principles.

3 Toxicological evaluation procedure for disinfectant safety

3.1 Evaluation procedure requirements The toxicological evaluation procedure for the safety of disinfectants uses a phased system method to conduct toxicological tests step by step, and the toxicological tests are divided into four stages in turn. If the results of the toxicological test in the previous stage do not meet the safety requirements, additional toxicological tests in the subsequent stage should be added. 3.2 Toxicological test of disinfectant safety evaluation 3.2.1 Phase I tests, including. a) Acute oral toxicity test. b) Acute inhalation toxicity test. c) Skin irritation test. 1) A complete skin irritation test; 2) A broken skin irritation test; 3) Multiple complete skin irritation tests. d) Acute eye irritation test. e) Vaginal mucosal irritation test. f) Skin allergy test. 3.2.2 Phase II tests, including. a) Subacute toxicity test. b) Mutagenicity test. 1) In vitro mammalian L5178Y cell gene mutation test (somatic gene level, in vitro test); 2) In vitro mammalian V79 cell gene mutation test (somatic gene level, in vitro test); 3) In vitro mammalian cell chromosome aberration test (somatic chromosome level, in vitro test); 4) Micronucleus test of polychromatic erythrocytes in mouse bone marrow (somatic chromosome level, in vivo test); ......

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