GB/T 38496-2020_English: PDF (GB/T38496-2020)
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Toxicological procedures and methods of safety evaluation for disinfectant
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GB/T 38496-2020
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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 | 42,477 | Date of Issue | 2020-03-06 | Date of Implementation | 2020-10-01 | Drafting Organization | Environmental and Health-Related Product Safety Institute, Chinese Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Shanghai Center for Disease Control and Prevention | Administrative Organization | National Health Commission of the People's Republic of China | Proposing organization | National Health Commission of the People's Republic of China | Issuing agency(ies) | State Administration for Market Regulation, 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
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 range 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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