GB/T 38496-2020Toxicological procedures and methods of safety evaluation for disinfectant (English PDF)

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.

3.1 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);