GB/T 38496-2020 in English

VALID

Toxicological procedures and methods of safety evaluation for disinfectant

Issued on:2020-03-06
Implemented on:2020-10-01
File Format:PDF
Delivery:Via email within 5 business days

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Standard No:	GB/T 38496-2020
Document status:	VALID
Title in English:	Toxicological procedures and methods of safety evaluation for disinfectant
Title in Chinese:	消毒剂安全性毒理学评价程序和方法
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2020-03-06
Implemented on:	2020-10-01
ICS Classification:	11.080-Sterilization and disinfection
Chinese Classification:	C50-Sanitation in general
Professional Classification:	GB-National Standard
Related Keywords:	skin disinfectant safety evaluation disinfectant introduction overview air disinfectant new disinfectant
Related Topics:	toxicology toxicity disinfectant Cosmetics Safety Evaluation Procedures and Methods Disinfectant en standard Cosmetic safety evaluation procedures and methods. Box disinfection method Disinfectant en Toxicology+ Joint Toxicity Evaluation Evaluation Center Toxicology Toxicology Long-term toxicity safety Virus passage method Evaluation of Toxicity Effectiveness Process Safety Evaluation Process Safety Evaluation Imaging agent safety evaluation Toxicological evaluation Toxicological analysis virus security Ocular Toxicology Toxicity standard poison Toxicological evaluation Toxicological evaluation Disinfectant Performance Evaluation Method Disinfectant Performance Evaluation Method Toxicological analysis What are the two methods of disinfection Disinfectant use What are the disinfection methods Agent toxicity There are several methods of disinfection Toxicity Risk Assessment Classification of disinfection methods There are several methods of disinfection Agent toxicity Sample Toxicology GBT38496 GB/T 38496-2020 Pharmacological and toxicological significance of ld50 and ed50 Chemical biological toxicity evaluation Toxicology Experimental Methods and Techniques Toxicological evaluation procedures and test methods for chemicals Part 2 How to disinfect applicator rods New techniques and methods in toxicology Methodological evaluation of colloidal gold method The correct way to draw blood and disinfect it Evaluate luminescence reagents Total nitrogen digestion method

《GB/T 38496-2020消毒剂安全性毒理学评价程序和方法》由628（国家疾病预防控制局）归口，主管部门为国家疾病预防控制局。

Introduction

Overview of the core content of the standard

This standard specifies the four-stage system approach for the toxicological evaluation of the safety of disinfectants:

Stage	Test items	Key indicators
Stage I	Acute oral/inhalation toxicity, skin irritation, etc.	LD50/LC50, irritation index
Stage II	Subacute toxicity, mutagenicity test	Maximum no observed adverse effect level
Stage III	Subchronic toxicity, teratogenicity test	Developmental toxicity assessment
Phase IV	Chronic toxicity and carcinogenicity tests	Tumor incidence

Key technical points

1. Experimental design principles

Determine the required and additional items according to the use scenario of the disinfectant:

Air disinfectant: It is necessary to add acute inhalation toxicity (6.2) and eye irritation tests (6.4)
Skin disinfectant: Select intact/broken skin irritation test according to the contact frequency (6.3)
New disinfectant: It is necessary to complete three types of mutagenicity tests (6.8)

2. Key test methods

Acute oral toxicity test (6.1)

LD50 is calculated by the probability unit-logarithmic graphical method. The classification standard is:

LD50(mg/kg)	Toxicity classification
≥5000	Practically non-toxic
500-5000	Low toxicity
50-500	Moderate toxicity
1-50	High toxicity
<1	Highly toxic

Implementation recommendations

Company compliance path

Material preparation: Provide complete disinfectant formula and physicochemical properties (5.2)
Project planning: Determine the test combination according to product use in accordance with clause 4.3
Risk control: When LC50<1000mg/m³, a warning needs to be added to the product instructions (7.1.2)

Handling of special situations

For two-component packaged disinfectants, they should be mixed according to the instructions for use and tested as prototype samples (5.3). The test concentration of mucous membrane disinfectants should be 5 times the use concentration (5.4).

More samples: DL/T 5154-2012 JJG 21-2008 NB/T 47013.2-2015

Sample only — not a preview of GB/T 38496-2020

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