This standard is formulated for the first time. This standard specifies the terms and definitions, test methods and test results of acute skin irritation/corrosion tests on chemicals by animals. This standard is applicable to the determination of acute skin irritation and corrosion of chemicals. This standard is modified to adopt the United Nations Organization for Economic Cooperation and Development (OECD) Chemical Test Method No. 404 "Acute Skin Irritation/Corrosion Test" (1992.7) (English version). Compared with OECD Chemical Test Method No. 404, this standard has the following differences: - Editorial changes have been made to OECD Chemical Test Method No. 404; - Foreword has been added. GB/T 21604-2008 Chemical Acute Skin Irritation/Corrosion Test Method GB/T21604-2008 Standard Download Decompression Password: www.bzxz.net
This standard is formulated for the first time. This standard specifies the terms and definitions, test methods and test results of acute skin irritation/corrosion tests on chemicals by animals. This standard is applicable to the determination of acute skin irritation and corrosion of chemicals. This standard is modified to adopt the United Nations Organization for Economic Cooperation and Development (OECD) Chemical Test Method No. 404 "Acute Skin Irritation/Corrosion Test" (1992.7) (English version). Compared with OECD Chemical Test Method No. 404, this standard has the following differences: ———Editorial modification of OECD Chemical Test Method No. 404; ———Added the preface.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> This standard is modified to adopt the United Nations Organization for Economic Cooperation and Development (OECD) Chemical Test Method No. 404 "Acute Skin Irritation/Corrosion Test" (1992.7) (English version).
Compared with OECD Chemical Test Method No. 404, this standard has the following differences:
---Editorial revisions have been made to OECD Chemical Test Method No. 404;
---The foreword has been added.
This standard is proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). The
responsible drafting unit of this standard: Tianjin Institute of Inspection and Quarantine Science and Technology.
Participating drafting units of this standard: Tianjin Institute of Inspection and Quarantine Science and Technology, Jiangnan University, Sinochem Chemical Standardization Institute, Tianjin Entry-Exit Inspection and Quarantine Bureau, Institute of Occupational Health and Poisoning Control, Chinese Center for Disease Control and Prevention.
Main drafters of this standard: Zhang Yuan, Wang Libing, Zhao Zhuo, Xu Chuanlai, Wang Xiaobing, Yu Zhirui, Li Chaoyang. This standard is formulated for
the first time.
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this standard.
GB14924.4 Rabbit compound feed for experimental animals
GB14925 Environment and facilities for experimental animals

313.300：31.300
National Standard of the People's Republic of China
GB/T21604-2008
Chemicals
Test method for acute skin irritation/corrosionChemicalg--Test method of aeute ernal irritatinn/corrosit2008~04~01Published
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
2008-09-01Implementation
G8/T 21604---2008
This standard adopts the Chemical Test Method N10 Acute Skin Microbiology Test 1998. English)
This standard has the following differences with the ED Chemical Test Method N. E Chemical Test Method N. Logical changes: Added some parts
This standard retains the National Standardization Technical Committee (5AC C25). Tianjin Institute of Technology, Tianjin Institute of Inspection and Quarantine, ... 21606-2008
Test method for acute skin irritation/corrosion of chemicals This standard specifies the technical definition, method and safety of new chemicals for acute skin irritation and corrosion test. This standard is used to test the skin quality of chemicals. The following normative documents are the referenced documents of this standard. All of them (excluding revisions) are applicable to this standard. However, the latest documents in the field of this standard are based on the research and consultation of the parties involved in the standard.
GE 14924.4
1 1-323
3 Terms and Definitions
The following terms and definitions are used in this standard: Skin moisturizing agent
Skin irritation
Skin irritation
Skin irritation
4 Test methods
4.1 Test animals
4.1.2 Type and number of test animals
4.1.3 Animal strains and characteristics
4.1.4 Animal species and characteristics
4.1.5 Animal species and characteristicsbzxz.net
4.1.6 Animal species and characteristics
4.1.7 Animal species and characteristics
4.1.8 Animal species and characteristics
4.1.9 Animal species and characteristics
5.10 Animal species and characteristics
6.11 Animal species and characteristics
7.12 Animal species and characteristics
8.13 Animal species and characteristics
9.10 Animal species and characteristics
10.11 Animal species and characteristics
11.12 Animal species and characteristics
12.13 Animal species and characteristics
13.14 Animal species and characteristics
14.15 Animal species and characteristics
15.16 Animal species and characteristics
15.17 Animal species and characteristics
16.18 Animal species and characteristics
17.19 Animal species and characteristics
4.1.3 Rearing conditions
The animal should be kept in a simple manner in accordance with the requirements of GB11924 and GB344925. The room temperature of the experimental animal room should be 20°C ± 3°C, and the relative humidity should be 30-70°C. The animal should be kept in a room with sufficient light for 12 hours and shade for 12 hours. The animal should be fed with standard experimental food, and drinking water should be sufficient and unrestricted. 4.1.4 Preparation of the experiment
The animal skin should be kept in a suitable environment for 6 days. When the animal skin is released, carefully cut off the hair of the animal skin, without damaging the skin. The area of ​​the animal skin should be about 3×3m, and a healthy and sunny area should be selected for the experiment.
4.2 Test substance
4 If the test substance is a solid, "generally no release. According to the source liquid section 4.2.2 If the test substance is a solid, use water to make a suitable medium to moisten it to ensure that the test substance has good contact with the skin. Please consider using other media other than water before using the test substance on the skin. 21604--2008
4.2. If the irritant is a rubber or strong city with a pH value of 2 or H value of ., it is not necessary to conduct a skin irritation test. If the product has a skin irritation test result, and no skin irritation or skin moisturizing occurs in the acute phase test, or the product is used for skin irritation test, it is not necessary to conduct a skin irritation test. 4. 3 Steps || tt || 4.3.1 Inhale the test amount n1 (or 558) mouse in contact with the skin at 25°C. 3m size carbon fiber slowly, do not lose the drug tank, except for the training layer, use no micro-texture and grade loan period. The test substance is a relatively active substance, first place it on the gauze, then leave it in contact with the skin. 43.2 If the test substance may be corrosive, use a maximum of three test patches to cause continuous action on the skin. If there is a serious skin reaction, the second test patch can be used for 1h. If the result shows that the test substance is active, the time can be shortened. h, you can use the three-day test patch, 1h at most, remove the degree of resistance by the observer, immediately give the experiment, if the whole test substance shows no irritation, the test patch is sold for 4 to 5 days, 4.3.3 If the animal test shows that the patch is effective, no serious irritation is observed, and the number of animals used for this test is 3. The animal patch is spread on a piece of gauze coated with the test substance, and the number of patches is 1.5 micro-structure || tt || 5.1 Cat bed observation and scoring || tt || 5.1 .1 In order to ensure the feasibility of the response, the animal should be observed on the 14th day after the patch is removed. If a feasibility response occurs on the 14th day, or spontaneous irritation or failure occurs, the main test should be continued. 5.1.2 Observe the skin reaction of the test site at 34h, 18h and 721h after the removal of the test substance, and perform the response scoring according to Table 1. In addition to the irritation test, any skin lesions and other skin reactions observed should be sampled and recorded as much as possible. Any suspected skin reactions need to be tested in the study.
Skin irritation response scoring
Skin irritation response scoring
Skin irritation response scoring
Skin irritation response scoring
|tt||The meaning of micro-surgery (limited use)
The pain is gradually reduced
The amount of water is soluble
The water is washed by the money
The skin is swollen!
Severe edema can cause 1mm of edema beyond the infected area
5.2 Result evaluation
5.2.1 For the test animals, the score of skin erythema formation is recorded according to the prescribed observation points to obtain the total score of the skin reaction of the animals, and the theoretical maximum value is 8 points. Then, calculate the average of the total score of the reaction obtained by the total number of animals at each observation time point. 52.2 The total score of the irritant at each observation time point should be determined according to the name of the test substance and its skin irritant effect. In addition, the skin irritant of the test substance should be observed and measured, and the skin irritant properties should be comprehensively evaluated. 5.3 The maximum commercial total score value, s-2. 0
2. 0.~6 9
CB/Y 21604--2008
The reliability of the experimental results of the skin irritation test on animals is limited. The test animals and the system, the test conditions, the comfort of the test environment and the best factors of the test animals can all affect the accuracy and reliability of the experimental results. The closed test method is a common test method under rich experimental conditions. The experimental conditions are limited to the number of experimental animals. In most cases, there are no irritants or substances that are sensitive to human inflammation. The use of other types of animals and the use of test products on animals to obtain similar results will increase the reliability of the experimental results.4. Test report should include: name, chemical structure, chemical properties, H value, preparation method and quantity of test substance and suspected substance; type, sex, age, source and number of test animals; start and end time of the test!
"·Experimental data: The breeding environment of the experimental animals, the temperature of the animals, the humidity of the animals, the single cage housing, the accounting of the experimental animal room:
Experimental services, including the preparation of the experimental skin sites, the preparation of the test animals, the pre-infection methods and the materials used, the method of cleaning the test skin area of ​​the test animals, etc.:
Experimental results, including the scores of skin redness and erythema formation on each animal at the specified observation points, the total score of the skin reaction added up during the period, the mean total score of the skin reaction monitoring, the intensity of the skin stimulation, the skin resistance, the number of tissue changes, the reproducibility of skin development and the effects other than the stimulation or feedback measured by other methods: Evaluation of the results
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GR.T 21609-2008
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