Some standard content:
ICS 13, 300; 11. 100
National Standard of the People's Republic of China
GB/T27829—2011
Chemicals--In vitro test of skin corrosion-Membrane barrier method2011-12-30Promulgated
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaAdministration of Standardization of the People's Republic of China
Implementation on August 1, 2012
This standard was drafted in accordance with the rules given in GB/T1.1--2009. GB/T27829—2D11
This standard is consistent with the technical content of the Organization for Economic Cooperation and Development (OECD) Chemical Testing Guide No. 435 (2006) Skin Corrosion In Vitro Membrane Barrier Test Method (English version). This standard makes the following structural and editorial changes: Added a chapter on scope; The "Introduction" section in the original text of OECD DI35 is incorporated into the introduction of this standard; Part of the content in the "Annex: Definitions" in the original text of OECD 435 is used as the "Terms, Definitions and Abbreviations" of this standard; The unit of measurement is changed to the statutory unit of my country. This standard is proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). Drafting units of this standard: Institute of Occupational Health and Poisoning Control, Chinese Center for Disease Control and Prevention, Shanghai Exit-Entry Inspection and Quarantine Bureau, China Chemical Economic and Technological Development Center. The main drafters of this standard are Liu Qingjun, Qiu Lu, Wang Wanbing, Li Xiaolin, Yang Ting, and Jiang Jing. TTTKANTKACA
GB/T 27829—2011
Skin corrosion refers to the irreversible damage to the skin after the test substance is applied, which is manifested as obvious necrosis from the epidermis to the dermis [United Nations (UN) Globally Harmonized System of Classification and Labelling of Chemicals (GHS) I]. This test method is an in vitro method that does not use live animals. The original test method is an in vivo test method using the skin of selected rabbits (C) ECD TG404)]. OECD has proposed many in vitro test methods for the detection of corrosive substances as an alternative to the original in vivo test. The reaction of the artificial membrane used in the in vitro membrane barrier method to corrosive substances is similar to the reaction of the skin of the exposed part of the animal to corrosive substances. The traditional skin corrosion test method is to apply the test substance to the skin of a living animal, and after a certain period of time, the skin corrosion of the test substance is evaluated by evaluating the difference in tissue damage [-]. The United Nations GHS system's mitigation test and evaluation strategy for skin corrosion allows the use of validated and accepted in vitro test methods [11. In this graded testing and evaluation strategy, test substances with positive in vitro test results can be judged as corrosive substances and do not need to undergo animal testing, thus reducing and optimizing the use of animals in the test. According to this strategy, for test substances with negative in vitro test results, other tests are required [11. Therefore, the use of in vitro test methods to detect the corrosiveness of test substances avoids the pain and harm caused by animal testing. Corrositex is a validated and commercialized in vitro membrane barrier test method141. Given its recognized reasonable validity, this test method has been recommended as part of the graded testing strategy for evaluating the skin corrosion hazards of chemicals []. The newly established in vitro membrane barrier test method is used for skin corrosion. The reliability, relevance (accuracy) and comparability of the method should be determined before testing to ensure that the method is comparable with other validated reference methods [7-0. The limitations of this method are S1: Based on the initial compatibility test results, many non-corrosive chemicals or mixtures, as well as some corrosive chemicals or mixtures, cannot be tested using this method. Although 85% of the chemical aqueous solutions with a pH value of 4.5 to 8.5 are non-corrosive in animal tests, the chemical aqueous solutions within the above pH range are generally not suitable for in vitro membrane barrier testing. The in vitro membrane barrier test method can be used to test solids (including water-soluble and water-insoluble), liquids (including water-soluble and non-aqueous liquids) and emulsions. However, in compatibility tests, many test chemicals or quasi-compounds do not show detectable changes [i.e., the chemical detection system (CDS) shows a color change in the reference method], so they are not suitable for the membrane barrier method, and other test methods should be selected. The test substance can be a pure product, a dilute solution, a preparation or a waste. No sample pretreatment is required. OECD provides three in vitro test methods for detecting skin corrosion. In addition to this standard, the other two are based on the human reconstituted skin model (OECDTG431) [111] and the isolated rat skin model (OECDTG430) LI2I. The in vitro membrane barrier test method for skin corrosion of chemicals can be used for further classification (sub-classification) of corrosive substances in the GHS system and the classification of corrosive hazards in the United Nations dangerous goods transport packaging classification (Transport Packing Groups). This method is suitable for the identification of corrosive chemicals or mixtures, and for further refinement of the classification of corrosive substances in the GHS system (see Table 1 in the text). In addition, this method can also be used to determine whether some specific types of chemicals are transported as corrosive substances or non-corrosive chain substances, such as certain organic and inorganic acids, acid derivatives, and bases. This test procedure is similar to the verified reference experimental method. TTTKAONYKAcA
1 Scope
In vitro skin corrosion of chemicals
Membrane barrier test method
GB/T 27829—2011
This standard specifies the terminology, definitions and abbreviations, test principles, test methods, test data and reports for the membrane barrier test method for in vitro skin corrosion of chemicals.
This standard is applicable to the detection of skin corrosion of chemicals. 2 Terms, definitions and abbreviations
2.1 Terms and definitions
The following terms and definitions apply to this document. 2.1.1
Skin corrosion
The test substance acts on the skin patch to produce damage, which is manifested as obvious necrosis from the epidermis to the dermis. 2, 1.2
Accuracy
The degree of agreement between the results of a test method and the accepted reference value is a measure of the test method and an aspect of relevance. "Accuracy" is often interchangeable with "consistency", both referring to the proportion of the results obtained by a test method that agree with the true results\7-8,1a7.
False negative rate
The proportion of all results that are actually positive (active) but are judged to be negative according to the test. The false negative rate is an indicator of test performance. 2. 1. 4
False positive rate
The proportion of all results that are actually negative (inactive) but are judged to be positive according to the test. The false positive rate is an indicator of test performance.
Inter-laboratory reproducibility evaluates the degree to which different laboratories use the same method to perform the same test on the same test substance and obtain similar results in terms of quality and quantity. The repeatability between laboratories is determined before and during the validation phase. This repeatability indicates the degree to which the test can be successfully recognized between the two laboratories, that is, the repeatability of the experiment between the two laboratories. 2. 1.6
Reference standards performance standards are standards based on validated reference methods. For proposed methods that are similar in function and mechanism, this standard can provide a basis for evaluating their "comparability".
Note, the content includes: (1) the elements of the necessary test method; (2) a small number of reference materials selected from the list of chemical quaternary crystals used to demonstrate that the reference method is acceptable for operation; and (3) the corresponding levels of accuracy and reliability should be based on comparison with those validated reference methods. The establishment of the proposed method should be evaluated by using a minimum number of reference materials for testing
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GB/T 27829—2011
Reference material reference Chemicals
Materials used for verification.
Note! The reactions of reference materials in in vivo and in vitro test systems and target germplasm species are known. The multiple substances used in the process of validating the test method should be representative in the chemical classification. The selected reference materials should be able to represent all levels of isotropic reactions from strong to weak to negative. Different stages of the validation process, different test methods, different test results, and different series of reference materials need to be selected. 2. 1.8
Relevance
The self-standard data tested by the test should be an indicator of whether the test is regular and effective, that is, the degree to which the test correctly measures or detects the target biological effect. Relevance is expressed as the accuracy (consistency) of the test method [7-]. 2. 1. 9
Reliability
Describes the degree of reproducibility of test results when two or more laboratories use the same test method at different times. Reliability is evaluated by calculating the repeatability of results within and between laboratories! 2.1.10
Sensitivity
The ratio of positive (active) substances determined by the test to true positive (active) substances. It is an indicator for evaluating the accuracy of the test method used for classification. Sensitivity is an important factor in evaluating the relevance of the test method. 2.1.11
Specificity
The ratio of negative substances determined by the test to correctly classified negative substances. It is a standard for evaluating the accuracy of the test method that produces corrosive classification results. Specificity is also an important factor to consider when evaluating the relevance of the test method. 2.2 Abbreviations
CDS: Chemical Detection System (chem[cal detection system system) Note: a system equipped with an indicator that reacts when the test substance is present, and the reaction can be detected by visual or electrochemical equipment. These reactions include changes in the color of one or more pH indicators caused by the presence of the test substance or a certain chemical or electrochemical reaction. GHS: Globally Harmonized System of Classification and Labelling of Chemicals? Note: a system that classifies chemicals (single chemicals and mixtures) according to standard classification methods and the level of harm to individuals, the public and the environment, and takes into account the methods of information communication (pictograms, signal words, hazard statements, precautionary statements and safety data sheets) so as to convey all the hazard information of chemicals and protect relevant groups (including owners, workers, transport personnel, consumers and emergency responders) and the environment. 3 Test Principle
The test system consists of two parts: artificial macromolecular biofilm and CD5. This test assumes that the mechanism of corrosion on biological membranes is similar to that on living skin. The test substance is applied to the surface of an artificial membrane barrier. The damage to the membrane barrier caused by the corrosive test substance can be detected by a variety of methods, including changes in the color of the pH indicator and changes in other characteristics of the indicator bath. Before the test, it should be determined that the membrane barrier is effective, that is, relevant and reliable for the test purpose. This includes ensuring the consistency of the properties of the membrane barrier used, such as the ability to maintain barrier function for non-corrosive substances and the ability to classify various types of corrosive substances. Classification is based on the time when the test subject passes through the membrane barrier into the indicator. 4 Test method
4.1 Test procedure
The following test composition and steps-15, the membrane barrier and its compatibility reagents/indicators, and the corrosive classification reagents can be prepared by yourself or purchased as commercial products, such as Corrositex. The validated test method can be found at http://iccvam.niehs.nih.gov. The test operation is carried out at an ambient temperature of 17C ~ 25". 2
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4. 1. 1 Compatibility test of test substance
GB/T 27829--2011
Before conducting the membrane barrier test, a compatibility test is carried out to determine whether the CDS can detect the test substance. If the CDS cannot detect the test substance, the membrane barrier test method is not suitable for evaluating the corrosiveness of the test substance, and other different test methods are required. The CDS and the exposure conditions used in the compatibility test should be able to reflect the exposure conditions of the subsequent membrane barrier test. 4.1.2 Time scale classification test of test substance
If the test method is appropriate and passes the compatibility test, The time scale for the classification of the test substance should be determined, that is, the screening test for the strength of acidity and alkalinity. For example, in the validated reference test method, the time scale required for classification is determined by whether significant acid-base retention is detected. When identifying the brain corrosiveness of chemicals and classifying them for GHS skin corrosion, two different time scales should be selected based on the acid-base retention of the chemical. 4.1.3 Membrane barrier test
The test components of the membrane barrier test include the membrane barrier and the chemical detection system (CDS). 4.1.3.1 Membrane barrier
The membrane barrier consists of two parts: protein hydrogel and permeable support membrane. Liquids and solids cannot pass through the protein hydrogel, but can pass through after action. The constructed membrane barrier should be stored under appropriate conditions to prevent its denaturation, such as drying, microbial infection, displacement, cracking, etc., and should not be used again. Determine the shelf life of the membrane barrier. If it exceeds the shelf life, the membrane barrier cannot be used. During the preparation of the protein hydrogel and the test of the test substance, the permeable support membrane should play a supporting role on the protein hydrogel. The permeable support membrane should be able to prevent the gel from sinking and shifting, and be resistant to all changes in the test substances. It has good permeability. The protein gel matrix is composed of keratin, collagen or a mixture of proteins and is the target of the test substance. Light pins the protein gel to the surface of the support membrane to form a colloidal surface, and then the membrane barrier is placed on the indicator solution. The thickness and density of the protein hydrogel should be uniform, and there should be no airflow or other defects that affect the overall function.
4.1.3.2 Chemical detection system
The indicator solution should be the same as that used in the compatibility test and should react in the presence of the test substance. When the test substance is present or certain types of chemical or electrochemical reactions occur, a pH Indicators or combinations of indicators, such as red and methyl orange, that change color may be used in the test. This change can be detected by visual observation or electronic equipment. In addition to being able to detect whether the test substance has passed through the membrane barrier, the developed detection system should also be able to evaluate its accuracy and reliability, and explain its scope of application and detection limit. 4.2 Test operation
4.2.1 Assembly of test components
The membrane barrier is placed in a vial containing indicator solution, ensuring that the support membrane is in full contact with the indicator solution and that there are no bubbles between the membrane and the surface. Care should be taken to ensure the integrity of the membrane. 4.2.2 Test substance
Use an appropriate amount of test substance, such as 500 μL of liquid or 500 mg of fine powder [15], and carefully spread it evenly on the surface of the membrane barrier. Each test substance and corresponding control requires a certain number of parallel samples, such as four parallel samples. Record the time when the test substance acts on the membrane barrier. The action time of the parallel samples should be staggered to ensure that a shorter corrosion time can be accurately recorded. 3
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GB/T 27829—2011
4. 2. 3 Determination of membrane barrier permeability
Reasonably monitor each parallel test and record the time when the indicator color changes, that is, the time when the membrane permeability changes. Calculate the difference between the time when the test substance begins to act on the membrane barrier and the time when the membrane barrier permeability changes. 4.2.4. Controls If excipients or solvents are required to dissolve or decompose the test substance in the test, the excipients and solvents must be compatible with the membrane barrier system, that is, they must not change the integrity of the membrane barrier system or the corrosiveness of the test substance. To demonstrate compatibility of the solvent (or excipient) with the membrane barrier system, a control test with an excipient or solvent should be conducted simultaneously with the test substance test. A chemical with moderate corrosiveness, such as sodium hydroxide (GHS corrosiveness classification 1B), should be used as a positive (corrosive) control substance. This positive control substance should be tested simultaneously with the test substance to test whether the system is working properly. A second positive control substance should have the same classification as the test substance and can be used to assess the relative corrosive activity of the corrosive substance. In order to be able to detect whether the test system is working properly when the permeability change time is too long or too short relative to the reference value, a positive control substance with moderate corrosiveness (such as a substance with corrosiveness classification 1B) should be selected. Therefore, strongly corrosive substances (substances classified as 1A in GHS corrosivity) and non-corrosive substances should be used less. Substances classified as 1B in GHS corrosivity can be used to detect test substances with too fast or too slow penetration times. Weakly corrosive substances (substances classified as 1C in GHS corrosivity) can be selected as control substances to test the ability of the test method to distinguish between weakly corrosive and non-corrosive substances. In addition, the range of positive control values (expressed as ± 2-3 standard deviations of the mean value) should be determined by referring to the changes in the historical data of penetration time. In each test, the penetration time should be accurately determined based on the results of the negative control to eliminate values that are beyond the acceptable range. Negative (non-corrosive) controls, such as 10% citric acid and 6% propionic acid, should be tested simultaneously with the test substance as another quality control indicator to demonstrate the integrity of the membrane barrier function. 4.2.5 Acceptable criteria
The test method in this standard is applicable to the identification of corrosive chemicals or compounds, and the classification of corrosive substances into subcategories in the GHS system (see Table 1). In addition, this method can also be used to determine whether some specific types of chemicals are transported as corrosive substances or non-corrosive substances, such as some organic and inorganic acid derivatives, alkali "5,13- I]. The test procedures described in this standard are similar to the validated reference test methods.
Table 1 United Nations GHS skin corrosivity types and classifications Corrosivity type
(Type 1)
(Applicable to authorities that do not use subclassification) Corrosivity
Corrosivity classification
(Applicable only to certain authorities)
Corrosivity 1A
Corrosivity 1B
Corrosivity 1C
At least 1 of the 3 animals showed skin abrasion
3 min/≤1h
>1h→≤4 h
According to the time scale specified in the GHS corrosivity classification, calculate the time from the beginning of the test substance acting on the membrane barrier to the change in membrane barrier permeability (in mni For an acceptable test, the positive control run simultaneously with the test substance should show the expected permeation reaction time, the negative control run simultaneously should not show corrosiveness, and if there is a solvent control run simultaneously, the solvent control should not show corrosiveness and should not change the corrosiveness of the test substance. According to this guideline, before a laboratory uses a test method for routine testing, it can test with the 12 chemicals recommended in Table 2 to demonstrate its technical level. If a new test method is used in a laboratory that is not in accordance with the reference method, it can be tested with the 12 chemicals recommended in Table 2 to demonstrate its technical level. If a new test method with similar structure and function is used [141, before the new method is applied to the detection of substances, the reliability and precision should be verified according to the implementation criteria described in Appendix A of this standard. 4
Chemicals
Phosphorus pentaamine
Sodium hydroxide
1-{2-hydrogenethyl) oxazineWww.bzxZ.net
Benzenesulfonyl chloride
Hydroxyamine
Tetraethylenepithamine
Eugenol
Enoyl ester
Sodium bicarbonate|| tt||Table 2 Chemicals with known corrosion classification
American Chemical Abstracts Service Identification Number:
7697·37-2
10026-13-8
7783-08·6
638-29-9
1310-73-2
140-31-8
98-09-9
10039-54-0
112-57-2||tt| |97-53-0
2664-55-3
144-55-8
Chemical Classification
Inorganic Allergens
Inorganic Acid Precursors
Inorganic Acids
Acid Chlorides
Inorganic Bases
Aliphatic Amines
Acid Chlorides
Organic Ammonium Salts
Aliphatic Amines
Acrylates/Methacrylates
Inorganic Salts
GB/T 27829—2011
UN GHS Subclasses
Note: The 12 substances listed in the table cover each of the three GHS subclasses for corrosive substances and include three non-corrosive substances. In order to prove the accuracy and derivability of the test method with similar structure and function to the reference method, it is necessary to select reference substances for testing. The 12 substances in the table are selected from the 40 substances in the table of small reference substances (Appendix A). These chemicals are easy to obtain, and their UN GHS classification is based on the results of high-quality in vivo tests. The corresponding packaging categories I and IIII correspond to UN GHS classifications 1A, IB.1C, and non-corrosive substances, respectively.
4.2.6 Interpretation of results and classification of corrosiveness of test substances The time (in min) between the start of the test substance acting on the membrane barrier and the change in membrane barrier permeability =The time scale used for the corrosivity classification of the test substance is as follows: (1) The time scale used for the corrosivity classification of the test substance is as follows: (1) The time scale used for the corrosivity classification of the test substance is as follows: (2) The time scale used for the corrosivity classification of the test substance is as follows: (3) The time scale used for the corrosivity classification of the test substance is as follows: (4) The time scale used for the corrosivity classification of the test substance is as follows: (5) The time scale used for the corrosivity classification of the test substance is as follows: (6) The time scale used for the corrosivity classification of the test substance is as follows: (7) The time scale used for the corrosivity classification of the test substance is as follows: (8) The time scale used for the corrosivity classification of the test substance is as follows: (9) The time scale used for the corrosivity classification of the test substance is as follows: (10) The time scale used for the corrosivity classification of the test substance is as follows: (11) The time scale used for the corrosivity classification of the test substance is as follows: (12) The time scale used for the corrosivity classification of the test substance is as follows: (13) The time scale used for the corrosivity classification of the test substance is as follows: (14) The time scale used for the corrosivity classification of the test substance is as follows: (15) The time scale used for the corrosivity classification of the test substance is as follows: (16) The time scale used for the corrosivity classification of the test substance is as follows: (17) The time scale used for the corrosivity classification of the test substance is as follows: (11) The time scale used for the corrosivity classification of the test substance is as follows: (12) The time scale used for the corrosivity classification of the test substance is as follows: (13) The time scale used for the corrosivity classification of the test substance is as follows: (14) The time scale used for the corrosivity classification of the test substance is as follows: (15) The time scale used for the corrosivity classification of the test substance tt||5.2 The test report should include the following information
5.2.1 Test substance and control substance:
-Identification and identification information, Chemical Abstract Service (CAS) registration number (if known) physical properties and purity (major impurities);-Physical and chemical properties related to the test#
-Pre-test treatment of test substance/control substance (if applicable), such as heating, grinding, etc.:-Stability (if known).
GB /T27829—2011
Describe the rationality of the in vitro membrane barrier model and the method of use, and give the accuracy and reliability of the method. Test conditions:
Description of the test components and preparation methods;
The source and composition of the in vitro membrane barrier used, the components and properties of the indicator solution;
-Test method,
-The amount of test and control substances used!
-The number of parallel samples;
Description and judgment of the time scale classification test of the test substance;
-The amount of test and control substances used! Method of using the test substance;
Time of observation.
5.2.4 Results:
A table containing the raw data of each test of the test substance and the control; other effects observed
-Evaluation and classification criteria.
5.2.5 Discussion of results.
5.2.6 Conclusion.
A.1 Introduction
Appendix A
(Informative Appendix)
Implementation evaluation of the characteristics of the skin corrosion in vitro membrane barrier test GB/T 27829—2011
The reliability and accuracy of the newly established test method should be evaluated by measuring known corrosive and non-corrosive substances before formal use. When using Table A.When evaluating the reference chemicals recommended in 1, the newly developed test method should have the same reliability and accuracy as reference method 1 (see Table A, 2) to meet the requirements. When testing, both corrosive and non-corrosive substances are selected. The corrosive substances should include representative substances with a range of corrosiveness from mild to weak, so as to compare the reliability and accuracy of the newly developed test method with the verified reference method, including sensitivity, specificity, false negative rate and false positive rate [18-19]. In order to facilitate the classification of chemical transport hazards, the list of corrosive substances also covers the substances in the subclasses of the UN packing classification/GHS skin corrosive substances. The penetration time of the test substance obtained from the test results is also applicable to the UN packing classification/HS skin corrosive classification-20·211. The penetration time of each test substance and the associated packaging classification/GHS skin corrosive substance classification depend on the composition of the test barrier, the indicator, the classification system and the specific test method used. Before testing a new substance, the reliability of the test method should be tested first to understand whether the test results are higher or lower than the actual corrosiveness of the substance. If possible, substances should be identified for which test results are always higher or lower than the actual corrosivity. A.2 Implementation Standards
Reference substances are used to test the reliability and predictability of the new in vitro membrane barrier test method and whether it is comparable with the validated reference method [1]. The 40 reference substances listed in Table A.1 represent different corrosivity levels and can produce different degrees of corrosive reactions, namely non-corrosive, UN packing classification Corrosive I (GHS1A), Corrosive II (GHS1B) and Corrosive II (GHS1C). These corrosivity classifications are obtained from in vivo reference tests. The reference chemicals listed according to corrosivity and UN packing classification/GHS combined corrosive classification include 12 non-corrosive properties and 8 corrosive properties. Among the 28 corrosive chemicals, there are 9 substances belonging to the standard classification Corrosive I (GHS 1A) and Corrosive II (GHS 1B), and 10 substances belong to Corrosive II (GHS 1C). These 28 The reference substances constitute the minimum list of reference substances for evaluating the accuracy and reliability of in vitro membrane barrier skin corrosion tests. If the chemicals in the list are not available, other readily available substances with sufficient in vivo reference data can also be selected. Substances of other grades that are easily available, if there are sufficient in vivo reference data, can also be added to the minimum list of reference substances for in vitro tests to evaluate the accuracy and reliability of the new test method.
The reliability of the new test method should be equivalent to that of the validated reference method. However, if the new test method is only used in one laboratory, it is not necessary to conduct inter-laboratory repeatability evaluation. For the identification of corrosive and non-corrosive substances, the UN packaging classification/GHS skin corrosion classification test, the inter-laboratory repeatability should be at least Should reach 93%C1]. The coefficient of variation (CV) of the median membrane permeation time obtained in tests conducted in different laboratories should not exceed 30%, and the deviation of the results between parallel samples should not exceed 5%:19] Table A.1 Reference substances for accuracy and reliability test of in vitro membrane barrier bottom test Chemicals"
Chlorosulfonic acid
Phosphorus pentachloride
7789-21-1
7697-37-2
10026-13-8
Chemical classification
Inorganic acid
Inorganic glue
Inorganic acid precursor
Concentration/%
UN in vivo PG
Validated method
GB/T27829--201 1
Chemicals"
Borate trihydrate
Phosphorus tribromide
Sulfuric acid, 10%
Benzene oxide
1,2-Nitropropane
Acid: Octanoic acid (45:55)
Ammonium bifluoride
1-(2-nitrogen-based piperazine)
Ethanolamine
Hydrogen Sodium oxide
oxyuridine
benzenesulfonyl
crotonic acid
butyric anhydride
ammonium sulfate
2-methylbutyric acid
dicyclohexylamine
N,N-dimethylbenzylamine
tetraethylenepentamine
2-ethylhexylamine
cis-butylene
eugenol
Chromium fluoride ()
Ethyl propylene triglyceride
Main base acrylate
Benzalkonium
7783-08-6
13319-75-0
7789-60-5
7664-93-9
501-53-1
78- 90-0
7664-38-2
638-29-9
61-19-7
124-07-2
68937-75-7
1341-49-7
140-318
141-43-5||tt ||1310·73 2
108-77-0
98-09-0
107-93-7
106-31-0
10039-51-0
600-07-7
101-83-7
103833
112- 57-2
104 75-6 | |tt | 3
Table A.1 (continued)
Chemicals "Grading"
Inorganic acid
Inorganic acid
Inorganic acid precursor
Inorganic acid
Inorganic acid
Fluorinated amine
Inorganic acid
Acyl group
Organic acid
Organic acid
Organic ammonium salt
Aliphatic amine
Aliphatic amine
Inorganic storage
Substituted triazine
Alkenylamine
Organic lysine
Organic ammonium pad
Organic acid
Aliphatic amine
Aliphatic amine
Aliphatic embedded amine
Organic acid
Inorganic thermal
Non-peach salt
Acrylate/methacrylate
Acrylate/methacrylate
Organic chain salt
Liquidity/ %6
UN in vivo PGS
Validated Methods
Chemicals·
Sodium hydrogen sulfonate
Sodium undecenoate
50% sodium carbonate water
Calcium carbonate
144-55-8
3398-33-2
497-19·8
471-34-1
Table A 1 (Continued)
Chemical classification
Inorganic salts
Anionic surfactants
Inorganic salts
Inorganic salts
Concentration/%h
LN PG in vivo
GB/T27829--2011
Validated force method
Note: CASRN = Chemical Abstracts Registration Number; NA = Not Applicable, NC- Non-Reducible PG = Packaging Classification; LN = United Nations. : This list of 40 representative reference substances was selected from the 163 reference substances (Corrositex) originally used to validate the new test method. b The classification, concentration test, and pH value of the chemical are from Corrositex. pH is carefully rounded to one decimal place, pH
. In the GHS system, the classification corresponds to the PG classification as follows: PG I = 1A, PG positive = 1B, PG = 1C. These classifications are derived from in vivo test results of high-quality disks,
A,3 Accuracy of new and difficult test methods
The accuracy of the newly developed method (sensitivity, specificity, false negative rate, false positive rate. UN packaging group/GHS skin corrosion classification capability) should be at least equivalent to the reference method results [L8-1] (see Table A.2).2 Accuracy of the validated reference method for skin erosion test Source
Reference material 5
Number of chemicals
Sensitivity
(25/28)
Specificity
(9/12)
False negative rate
(3/28)
False positive rate·
(3/12)
Note: The data in the table are the results of skin erosion tests on 40 reference materials (Table A 1) using the validated reference method. Accuracy of packaging classification
<24/25)
In the test, a test substance is first determined to be erosive based on the results of the main test of one laboratory (if repeated tests are conducted) (with parallel samples). Subsequently, it is determined to be erosive based on the results of the main test of two laboratories (if multiple laboratories conduct the test). . The packing classification accuracy reflects the consistency of the classification results obtained by the external test method with the UN packing classification (or FHS skin and brain corrosive classification) results obtained by the in vivo domestic dermal abrasion test method for a certain compound. The test substance is the UN packing classification (or GHS skin and brain corrosive classification) substance based on the results of the domestic dermal abrasion in vivo test. The calculation is limited to the substances that Corrositex correctly classifies as corrosive, see Table A1.
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