Rules for classification and labelling of chemicals—Part 19:Skin corrosion/irritation
Some standard content:
ICS13.300
National Standard of the People's Republic of China
GB30000.19—2013
Replaces GB20593—2006
Rules for classification and labelling of chemicals
Part 19: Skin corrosion/irritation
chemicals-Part19:Skincorrosion/irritationPublished on October 10, 2013
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
Implementation on November 1, 2014
Chapter 4 and Chapter 6 of this part are mandatory, and the rest are recommended. The expected structure of GB30000 "Chemical Classification and Labeling Specification" and the national standards to be replaced are: Part 1: General (replaces GB13690-2009); Part 2: Explosives (replaces GB20576-2006); Part 3: Flammable gases (replaces GB20577-2006); Part 4: Aerosols (replaces GB 205782006); Part 5: Oxidizing gases (replacing GB205792006); Part 6: Gases under pressure (replacing GB20580-2006); Part 7: Flammable liquids (replacing GB20581-2006); Part 8: Flammable solids (replacing GB20582-2006); Part 9: Self-reactive substances and mixtures (replacing GB20583-2006); Part 10: White flammable liquids (replacing GB205852006); Part 11: Pyrophoric solids (replacing GB20586-2006); Part 12: Self-heating substances and mixtures (replacing GB20584-2006); Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replacing GB20587 -2006); Part 14: Oxidizing Liquids (replaces GB20589-2006); Part 15: Oxidizing Solids (replaces GB20590-2006); Part 16: Organic Peroxides (replaces GB20591-2006); Part 17: Metal Corrosives (replaces GB20588-2006); Part 18: Acute Toxicity (replaces GB20592-2006); Part 19: Skin Corrosion/Irritation (replaces GB20593-2006); Part 20: Serious Eye Damage/Eye Irritation (replaces GB20594-2006); Part 21: Respiratory or Skin Sensitization (replaces GB20595-2006); Part 22: Germ Cell Mutagenicity (replaces GB20596-2006); Part 23: 2006): Part 23: Carcinogenicity (replaces GB20597-2006); Part 24: Reproductive toxicity (replaces GB205982006): Part 25: Specific target organ toxicity - single exposure (replaces GB205992006); Part 26: Specific target organ toxicity - repeated exposure (replaces GB206012006): Part 27: Aspiration hazard;
Part 28: Hazards to the aquatic environment (replaces GB20602-2006); Part 29: Hazards to the aerobic layer;
Part 30: Warning signs in chemical workplaces; This part is Part 19 of GB30000
This part was drafted in accordance with the rules given in GB/T1.1-2009. GB30000.19—2013
This part replaces GB20593-2006 "Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals - Skin Corrosion/Irritation". This part is consistent with the relevant technical content of the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Globally Harmonized System of Classification and Labelling of Chemicals, GHS) (Fourth Revised Edition). Compared with GB20593-2006, the main technical content changes of this part are as follows: 1
GB30000.19—2013
The standard name has been modified. The Chinese name has been changed to "Chemical Classification and Labelling Rules Part 19: Skin Corrosion/Irritation", and the English name is \Rules for classification and labelling of chemicals Part 19: Skin corrosion/irritation", and the English name is \Rules for classification and labelling of chemicals Part 19: Skin corrosion/irritation. Labelling of chemicals - Part 19: Skin corrosion/irritation; Modified the scope of Chapter 1, changed "warning label" to "label", deleted "warning statement"; Modified the introductory words of Chapter 2 "Normative references"; Modified some sentences of Chapter 4 "Classification criteria of substances", and added Figure 1 as Appendix A; Modified some sentences of Chapter 5 "Determination process" and added Figures 2 and 3 as Appendix B: Deleted the original Chapter 7, and modified Table 6 of the original Chapter 7 as Normative Appendix C according to the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition);
According to the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth revised edition) The original Chapter 6, Chapter 7, and Chapter 8 were modified and integrated into Chapter 6; the original Table 5 was modified as normative Appendix D; the original Chapter 8 was deleted, and the relevant "Hazard Statements" and "Precautionary Statements" were included as informative Appendix E: Informative Appendix F\Label Examples" was added. This part was proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). Drafting units of this part: Anhui Entry-Exit Inspection and Quarantine Bureau, China Chemical Information Center, China Chemical Economic and Technological Development Center, Huafeng Group Co., Ltd.
The main drafters of this part: Wen Jinsong, Xia Xuedong, Yao Jian, Zhang Pu, Hu Yanyun, Zhang Junxi, Cao Mengran. The previous versions of the standards replaced by this part are: GB205932 006.
1 Scope
Chemical Classification and Labelling Specifications
Part 19: Skin Corrosion/Irritation
GB30000.19-—2013
This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and labeling of chemicals with skin corrosion/irritation.
This part applies to the classification and labeling of chemicals with skin corrosion/irritation in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (hereinafter referred to as GHS).
Normative references
The following documents are indispensable for the application of this document. For any referenced document with a date, only the version with the date applies to this document. For any undated referenced document, The latest version of the referenced documents (including all amendments) shall apply to this document. GB6944-2012 Classification and name numbering of dangerous goods GB13690 General rules for classification and hazard communication of chemicals GB30000.17 Specification for classification and labeling of chemicals Part 17: Metal corrosives GB/T27828 Chemicals: Test method for in vitro skin corrosion through skin resistance GB/T27830
Test method for in vitro skin corrosion of chemicals on human skin model United Nations "Globally Harmonized System of Classification and Labeling of Chemicals" (4th revised edition) United Nations Recommendations on the Transport of Dangerous Goods Model Regulations (17th revised edition) Terms and definitions
The terms and definitions defined in GB13690 and the following terms and definitions shall apply to this document. 3.1
Skin corrosionskincorrosion
The result of irreversible damage to the skin, that is, within 4 hours of application of the test substance, epidermal and dermal necrosis can be observed. Typical corrosion reactions are characterized by ulcers, hemorrhages, blood induration, and at the end of the 14-day observation period, the skin, areas of complete hair loss and induration fade due to bleaching. Suspicious lesions should be evaluated by histopathological examination. 3.2
Skin irritation
The result of reversible damage to the skin after application of the test substance for up to 4 hours. 4 Classification criteria
4.1 General principles
The general principles for classification and labeling of skin corrosion/irritation can be found in GB13690.1
GB30000.19—2013
4.2 Material classification criteria
4.2.1 This classification criteria includes guidance on the evaluation of data elements prior to conducting animal tests on skin corrosion and skin irritation, as well as the hazard classification of skin corrosion and skin irritation. Testing on humans solely to determine hazards is generally unacceptable. 4.2.2. A variety of factors should be evaluated before testing to determine the skin corrosion and irritation potential of chemicals. Solid substances (powders) may become corrosive or irritating when they become wet or come into contact with moist skin and mucous membranes. Existing human experience and data, including single or repeated exposure, and animal observations and data should be analyzed first, as they provide information directly related to skin effects. In some cases, information from structurally similar compounds is sufficient to make a classification. Similarly, although this correlation is not entirely correct, extreme pH values such as pH 2 and pH 11.5 may indicate that chemicals have skin effects, especially when the buffering capacity is known. Generally, such reagents will produce significant skin effects. Of course, if a chemical shows high toxicity through skin contact, skin irritation/corrosion studies may not be feasible because the doses of the test substances applied would greatly exceed the toxic dose and thus cause animal death. If the dilutions used are long-lasting for the species tested, when skin irritation/corrosion is observed in acute toxicity studies and is observed at extreme doses, then no additional testing is required. Validated and recognized in vitro alternative tests can also be used to assist in classification.
All of the above information on a chemical should be used when deciding whether in vivo skin irritation testing is necessary. Of course, relevant information may be available from the single parameter assessment within a single layer (see 4.2.3). For example, alkaline bases with extreme pH should be considered skin irritants, but it is still valuable to evaluate all the available information. This is especially true when only some parameters are available and determine that the overall weight of evidence is still valuable (not all parameters). In general, the primary emphasis should be placed on existing human experience and data, followed by animal experiments and test data, and then information from other sources, but a case-by-case analysis is necessary to make a determination. 4.2.3 In view of the fact that in some cases it is not possible to make a decision (see Appendix 4.2.4 Corrosion: All factors are relevant. A tiered approach should be used to evaluate the original information based on the situation. Classification method 1 provides skin corrosion classification criteria using animal test results. It is necessary to make multiple distinctions between corrosion and corrosion. The table provides the following in the corrosion category: Category 1A records reactions after contact for up to 3 minutes and observation for up to 1 month: Category 1B records spontaneous reactions after contact for 15 minutes and observation period: Category 1C records spontaneous reactions after contact for 15 minutes and observation period: - Record exposure between 1h and 41 and observation time Patch
For classification, reliable epidemiological data and experience (e.g. occupational data, data from accident databases) relevant to the effects of the chemical on humans should be reflected in the evaluation of the health hazard of a chemical to humans. 4.2.5 Irritation
4.2.5.1 Classification criteria for skin irritation are provided in Table 2: a
Medium sensitivity in existing classifications: b)
Some test substances are known to cause effects that may persist throughout the test: It is known that animal responses may vary greatly in a single test, and an additional mild irritation category is provided for use by competent authorities that wish to have more than one skin irritation category. GB 30000.19—2013
4.2.5.2 Reversibility of skin lesions is another consideration in evaluating irritation responses. When inflammatory phenomena persist at the end of the observation period in two or more test animals, such as alopecia (limited area), hyperkeratosis, hyperproliferation, and desquamation, the substance should be classified as irritant 4.2.5.3 As in erosion tests, animal irritation responses may vary greatly in a single test. When a significant irritation response occurs but is less than the average score criterion for a positive test result, another irritation criterion may be introduced. For example, if at least one of the three test animals shows a positive reaction throughout the study, including when the lesions remain normal for the 14-day observation period, the test substance can be classified as an irritant. Other reactions can also meet this criterion, but it should be ensured that the reaction is the result of exposure to the chemical. Adding this irritation criterion will increase the sensitivity of the classification system.
4.2.5.4 A single irritation category (category 2) using animal test results is given in Table 2. A less severe mild irritation category (category 3) can also be used, such as for the classification of pesticides. Several criteria distinguish these two categories, see Table 2. They mainly differ in the severity of the skin reaction. The main criterion for the irritation category is that at least two test animals have an average score of not less than 2.3 and not more than 4.0. For the mild irritation category, the average score of at least two test animals is between 1.5 and 2.3. Test substances in irritation category 2 cannot be classified in the mild irritation category. Table 2 Skin irritation categories
Irritation (Category 2)
(Applicable to all competent authorities)
Mild irritation (Category 3)
(Applicable to some competent authorities)
In graded tests 24h, 48h and 72h after patch removal, or if the reaction is delayed, in graded tests for 3 consecutive days after the onset of the skin reaction, the average value of erythema or edema in at least 2 of the 3 tested animals is not less than 2.3 and not more than 4.0; or inflammation persists in at least 2 animals until the end of the normal 14-day observation period. Particular attention is paid to alopecia (limited areas, hyperkeratosis, hyperproliferation and desquamation); or in some cases, there is a significant variability in the response between different animals. Only one animal has a very clear3)
positive reaction related to the contact with the chemical, but below the above criteria. In 24h, 48h and 72h graded tests, or if the reaction is delayed, in 3 consecutive days of graded tests after the onset of the skin reaction (when not included in the above irritation category), the average value of erythema/indulgence or edema in at least 2 of the 3 test animals is 1.5~2.3. For classification, when evaluating the health hazard of a chemical to humans, reliable epidemiological data and experience related to the effects of the chemical on humans (such as occupational data, data from accident databases) should be reflected. From skin irritation tests.
4.3 Classification of mixtures
4.3.1 Classification of mixtures when data on the entire mixture are available4.3 .1.1 Mixtures will be classified using the classification criteria for substances, with attention also paid to the testing and evaluation strategies used to develop the data for these hazard categories.
4.3.1.2 Unlike other hazard categories, some chemicals may have alternative tests used to determine their skin corrosion that provide accurate results for classification and are simple to implement and relatively inexpensive. When testing mixtures, classifiers are encouraged to use the tiered weight of evidence strategy in the classification principles for skin corrosion and skin irritation to help ensure the accuracy of the classification and avoid unnecessary animal testing. If a mixture has a pH of 2 or a pH ≥ 11.5, it is considered to be corrosive (Skin Corrosion Category 1). If a base/acid reserve is present, even if the substance or mixture has a low or very high pH, but may not be corrosive, then further testing is required to confirm this, preferably using an appropriate validated in vitro test. 3
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4.3.2 Classification of mixtures when no data are available for the mixture as a whole: bridging principles4.3.2.1 Where the mixture itself has not been tested to determine its skin irritation/corrosion, but there are sufficient data on the individual ingredients and similar tested mixtures to characterize the hazards of the mixture, then these data may be used in accordance with the bridging principles set out below. This ensures that the classification process uses the available data to the greatest extent possible to characterize the hazards of the mixture without the need for additional animal testing.
4.3.2.2 Dilution
If a mixture is diluted with a diluent that has an equal or lower skin corrosion/irritation classification than the least skin corrosive/irritating ingredient in the mixture, and this dilution does not affect the corrosion/irritation of the other ingredients, then the new mixture may be classified in the same category as the original mixture. You may also use the method explained in 43.2.3 Product batches The skin corrosion/irritation classification of a tested mixture of the same batch produced under the control of the manufacturer may be assumed to be identical to the skin corrosion/irritation classification of another untested batch produced by the same manufacturer or in commercial product, unless there is reason to believe that the skin corrosion/irritation classification of the untested batch is the same as that of another untested batch produced by the same manufacturer or in commercial product, unless there is reason to believe that the skin corrosion/irritation classification of the untested batch is different from that of another untested batch produced by the same manufacturer or in commercial product, unless there is reason to believe that the skin corrosion/irritation classification of the mixture in the highest skin corrosion/irritation category is different, a new classification should be made. If the tested mixture classified in the highest skin corrosion subcategory is a concentrate, then the more concentrated untested mixture should be classified in the highest corrosion subcategory without additional testing. If the tested mixture classified in the highest skin irritation subcategory is a concentrate and does not contain a corrosive ingredient, then the more concentrated untested mixture should be classified in the highest irritation category without additional testing. 4.3.2.5 Interpolation within the same corrosion/irritation category For three mixtures with the same ingredients, if mixtures A and B and have been tested as equivalent skin corrosion/irritation categories and each has the same skin corrosion/irritation activity as mixture A and mixture B, and mixture C has no active ingredient and its concentration is between that of mixtures A and B, then the mixture is considered to have the same skin corrosion/irritation category as A and B. 4.3.2.6 Substantially similar mixtures Given the following situation: Two mixtures: I: AB, II: C Components The concentration of component B is essentially the same in the two mixtures; b)
the concentration of component A in mixture I is equal to the concentration of component C in mixture II; skin corrosion/irritation classification data are available for A and C and are substantially equivalent, i.e. they belong to the same hazard category d)
and are not expected to affect the skin corrosion/irritation hazard characteristics of B. If mixture I or II has been classified based on the test data, then the other mixture may be classified into the same hazard category. 4.3.2.7 Aerosols
If the added aerosol propellant does not affect the skin corrosion/irritation hazard characteristics of the mixture when it is sprayed, then the aerosol mixture is classified as the same hazard category as the non-aerosol mixture that has been tested. 4.3.3 Classification of mixtures when data are available for all or only some of the components of the mixture 4.3.3.1 In order to classify the skin corrosion/irritation hazard characteristics of the mixture using all existing data, the following assumptions are made and applied as appropriate to the GB30000.19--2013
tiered approach: The "relevant components" of the mixture are components with a concentration of not less than 1 (mass fraction for solids, liquids/dusts, mists and vapors. Volume fraction for gases), unless it is inferred that a component may still be relevant to the skin corrosion/irritation classification of the mixture when present at a concentration of less than 1% (for example, the case of a corrosive component). 4.3.3.2 In general, when data are available for the components of the mixture, but data are not available for the entire mixture itself: The classification method for skin corrosion/irritation of the mixture is based on the theory of additivity, that is, each corrosive or irritating component contributes to the overall skin corrosion/irritation hazard characteristics of the mixture, and the degree of contribution is proportional to its potency and concentration. When the concentration of the corrosive component is below the concentration limit for classification in Category 1, but reaches the concentration limit for the mixture to be classified as a skin irritant, the corrosive component uses a weighting factor of 10. When the sum of the concentrations of such ingredients exceeds the cut-off concentration limit, the mixture is classified as skin corrosion or skin irritation. 4.3.3.3 Table 3 provides the cut-off values/concentration limits for whether a mixture is classified as skin corrosion/irritation. Table 3 Concentration of ingredients that determine a mixture as hazardous to the skin, Skin Category 1, 2 or 3 (Mixture Skin Category 1, 2 or 3) Concentration of ingredients for which the mixture is classified
(classified by total ingredients)Skin Category
Skin Category
Skin Category 2
Skin Category 3
(10×Skin Category 1)+Skin Category
(10XSkin Category
Skin Category 2
Skin Category
Skin Corrosion
Category 1
Category 2
1% to 5%
Skin Irritation
Category 3
% and 10%
and ≤10%
When using a sub-category of Skin Category 1 In the case of a mixture classified as skin 1A, the sum of all ingredients in the mixture shall be not less than 5% of the sum of ingredients in the skin 1A subcategory, but the sum of ingredients in the skin 1A subcategory shall be less than 5% to classify the mixture as skin 1A. In the case of a mixture classified as skin 1A, the sum of ingredients in the mixture shall be not less than 5% of the sum of ingredients in the skin 1E or 1C subcategory. If the sum of ingredients in the skin 1A+1B subcategory is not less than 5%, the mixture shall be classified as skin 1A. 4.3.3.4 Particular care should be taken when classifying certain types of chemicals, such as acids and greases, inorganic salts, aldehydes, phenols and surfactants. Given that many of these substances have skin erosion/irritation hazard characteristics when added at less than 1%, they should be classified in 4.3.3.1 and 4.3. The method described in 3.2 may not be applicable to the determination of such substances. For mixtures containing strong acids or strong bases, pH should be used as the classification principle (see 4.3.1.2). Because pH is a better indicator of corrosivity than the concentration limits in Table 3, mixtures containing corrosive or irritating components
cannot be classified according to the additivity method in Table 3 due to their chemical properties. They are classified as skin category 1 when the corrosive component they contain is not less than 1%, and as skin category 2/3 when the irritation group they contain is not less than 3%. When containing components for which the method in Table 3 is not applicable for classification (classification of mixtures), the classification method in Table 4 can be referred to. Table 4 Classification of mixtures as skin corrosives/irritants when the additivity method is not applicable. Concentration of components in the mixture
pH ≤ 2 Acids of
Bases of pH 11.5
Other corrosion (Category 1) components not applicable to the additivity methodOther irritation (Category 2/3) components not applicable to the additivity method, including acid and base concentrations
Skin category of the mixture
(Skin) Category 1
(Skin) Category 1
(Skin) Category 1
(Skin) Category 2
4.3.3.5 Sometimes, reliable data may show that the skin corrosion/irritation hazard characteristics of a component are not obvious at its concentration above the general concentration cut-off values described in Tables 3 and 4. In this case, the mixture can be classified based on these data. Sometimes, when the concentration of a 5
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GB 30000.19—2013
component exceeds the concentration limit value specified in Tables 3 and 4 for the category, but the skin corrosion/irritation hazard characteristics of the expected components are not obvious, the mixture can be tested. In such cases, a tiered weight of evidence strategy should be applied, as shown in 4.3.2.4 and Annex A. 4.3.3.6 If data indicate that one or more ingredients may have skin corrosion/irritation hazardous properties at concentrations less than 1% (corrosion) or less than 3% (irritation), the mixture should be classified accordingly. 5 Decision Logic
The decision logic is for reference only. The decision logic is provided in Annex B. It is highly recommended that the person responsible for classification study Chapter 1 before and during the use of the decision logic.
6 Labelling
6.1 General
6.1.11 For skin corrosion/irritation labels, the hazard categories are listed in the order of the designated pictogram, signal word and hazard statement. The hazard classes or categories covered by the United Nations Recommendations on the Transport of Dangerous Goods Model Regulations (hereinafter referred to as the "Model Regulations") should be listed on the label for each designated corresponding pictogram. For the allocation of skin corrosion/irritation label elements, see Appendix C6.1.2 For the classification criteria and label elements for skin corrosion/irritation, see Appendix D6.1.3 The information required on the label includes hazard pictograms, signal words, hazard statements, precautionary statements, product identifiers and supplier logos, etc. Note: For other label elements that have not yet been standardized, such as precautionary statements, they need to be included on the label. The competent authorities may also require additional information, and the supplier may also add supplementary information.
6.2 Hazard pictograms
Hazard pictograms should use black symbols with a white background and a red frame that is wide enough to be eye-catching: the hazard pictograms, graphic symbols, colors, numbers and minimum sizes specified in the Model Regulations are shown in Appendix C. 6.3 Signal words
Signal words are words used on the label to indicate the relative severity of the hazard and to alert the reader to potential hazards. For skin corrosion, use the signal word "Danger". For skin irritation, use the signal word "Warning". 6.4 Hazard Statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Hazard statements for skin corrosion/irritation are given in Table D.1 in Appendix D and refer to Appendix E6.5 Precautionary Statements
A precautionary statement is a word (and/or pictogram) describing recommended measures to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. For the purposes of this document, there are five categories of precautionary statements: general, precautionary, emergency, storage and disposal. Skin corrosion/irritation precautionary statements are given in Appendix E6.6 Product Identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the MSDS. If a substance or mixture is listed in the Model Regulations, the correct UN shipping name should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization or specific target organ toxicity appear on the label, the label shall include the chemical names of all ingredients or alloying elements that may cause these hazards. The competent authority may require that the chemical names of all ingredients or alloying elements that may cause mixtures or alloys be listed on the label. 6.7 Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture shall be provided on the label. 6.8 Label sample
See Appendix F for examples of skin corrosion/irritation labels. rkAoNrKAca-
GB30000.19—2013
Appendix A
(Normative Appendix)
Stratified test and evaluation strategy for skin corrosion/irritation Figure A.1 shows the steps of the tiered test and evaluation strategy for skin corrosion/irritation
Existing human or animal experience
Non-corrosive or no data
Existing human or animal experience
Non-irritating or no data
Existing human or animal experience
No data
Structure-activity relationship
Non-corrosive or no data
Structure-activity relationship
Non-corrosive or no sensitizer
Buffering PH
No limit H or no data
Available animal skin data
Indicates that no animal testing is required
No indication or no data
Negative reaction in a valid, recognized in vitro skin corrosion test or no data
Negative reaction in a valid, recognized in vitro skin corrosion test or no data
Corrosive
Non-corrosive
Change microscope
pH 2 or
pH ≥11.5
Positive reaction
Negative reaction
Tiered testing and evaluation strategy for skin corrosion/irritation Figure A.1
Classified as "corrosive"
Classified as irritant
For further testing Test,
Not of this type
Classified as corrosion"
Classified as irritation
Classified as corrosion
May be considered corrosion/irritation without further testing
Classified as corrosion"
Classified as irritation
In vivo skin corrosion test (1 animal)
Negative reaction
In vivo skin irritation test (3 animals in total) +
Negative reaction
When ethical, human patch test
No above situation
As shown in the figure, divided into appropriate categories,
Positive reaction
Positive reaction
No further testing
Positive Reaction
Negative reaction
GB30000.19—2013
Classified as corrosion
Classified as irritation
No further test,
Not of this type
Classified as scratch irritation
No further test:
Not of this type
It may be sufficient to measure pH alone, but it is also best to evaluate acid and base preparations, and various methods are needed to evaluate buffer capacity. Existing animal data should be carefully reviewed to determine whether in vivo skin corrosion/irritation testing is required. For example, when the test material shows no skin irritation at the limit dose in the acute skin toxicity test
, or produces significant toxic effects in the acute skin toxicity test, no further product insurance is required. In the latter case, the skin toxicity is classified as very harmful, and it has no practical significance whether the substance is irritating or irritating to the skin. When assessing the acute dermal properties of this substance, it should be borne in mind that the reported skin lesions may not be complete, that the subjects of the tests and observations are domestic animal species, and that the sensitivity of the reactions may vary between animal species. G/T 27830 (CD1) is an internationally recognized, validated in vitro skin irritation test method, for example G/T 2828 (OECD 430 and GB 127830). An in vitro skin irritation or skin irritation test method that is valid and recognized by the country of origin should be used. This can be done by conducting a double negative test on only one animal. Repeated or repeated contact can be used to obtain acceptable human skin irritation test methods, but there are no internationally recognized recommendations (EC guidance). Results from only one animal.1bzxz.net
Classified as corrosion"
Classified as irritation
Further testing is required,
Not such
Classified as corrosion"
Classified as irritation
Classified as corrosion
May be considered corrosion/irritation without further testing
Classified as corrosion"
Classified as irritation
In vivo skin corrosion test (1 animal)
Negative reaction
In vivo skin irritation test (3 animals in total) +
Negative reaction
When ethical, human patch test||tt| |None of the above
As shown in the figure, classified into appropriate categories,
Positive reaction
Positive reaction
No further test
Positive reaction
Negative reaction
GB30000.19—2013
Classified as erosion
Classified as irritation
No further test,
Not of this type
Classified as scratching
No further test:
Not of this type
It may be sufficient to measure pH alone, but it is best to also evaluate the acid-base preparation. Various methods are needed to evaluate the buffer capacity The available animal data should be carefully reviewed to determine whether in vivo skin corrosion/irritation testing is required. For example, when the test material shows no skin irritation at the limit dose in the acute skin toxicity test, or produces significant toxic effects in the casual skin toxicity test, no further product insurance is required. In the latter case, the substance is classified as very hazardous to the skin and it is of no practical significance whether the substance is irritating or irritating to the skin. When evaluating the acute skin toxicity information of the substance, it should be borne in mind that the reported skin lesions may not be complete, the test and observation subjects are domestic animal species, and the sensitivity of the reactions between animal species is important. Different from the internationally recognized, valid in vitro skin corrosion test method G/T 27830 (CD1) is an example of an OECD G/T 2828 (OECD 430 and GB 1994). The in vitro skin irritation or test method is valid and recognized by the country. The double negative irritation test can be conducted on only one animal. It can be used for repeated or repeated contact. There is no internationally recognized human skin irritation test method, but there is no (EC guidance recommendation). The results of only one animal.1
Classified as corrosion"
Classified as irritation
Further testing is required,
Not such
Classified as corrosion"
Classified as irritation
Classified as corrosion
May be considered corrosion/irritation without further testing
Classified as corrosion"
Classified as irritation
In vivo skin corrosion test (1 animal)
Negative reaction
In vivo skin irritation test (3 animals in total) +
Negative reaction
When ethical, human patch test||tt| |None of the above
As shown in the figure, classified into appropriate categories,
Positive reaction
Positive reaction
No further test
Positive reaction
Negative reaction
GB30000.19—2013
Classified as erosion
Classified as irritation
No further test,
Not of this type
Classified as scratching
No further test:
Not of this type
It may be sufficient to measure pH alone, but it is best to also evaluate the acid-base preparation. Various methods are needed to evaluate the buffer capacity The available animal data should be carefully reviewed to determine whether in vivo skin corrosion/irritation testing is required. For example, when the test material shows no skin irritation at the limit dose in the acute skin toxicity test, or produces significant toxic effects in the casual skin toxicity test, no further product insurance is required. In the latter case, the substance is classified as very hazardous to the skin and it is of no practical significance whether the substance is irritating or irritating to the skin. When evaluating the acute skin toxicity information of the substance, it should be borne in mind that the reported skin lesions may not be complete, the test and observation subjects are domestic animal species, and the sensitivity of the reactions between animal species is important. Different from the internationally recognized, valid in vitro skin corrosion test method G/T 27830 (CD1) is an example of an OECD G/T 2828 (OECD 430 and GB 1994). The in vitro skin irritation or test method is valid and recognized by the country. The double negative irritation test can be conducted on only one animal. It can be used for repeated or repeated contact. There is no internationally recognized human skin irritation test method, but there is no (EC guidance recommendation). The results of only one animal.
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