Rules for classification and labelling of chemicals — Part 19: Skin corrosion/irritation
1 Scope
This part of GB 30000 stipulates the terms and definitions, classification standard, judgment logic and labelling of chemicals with skin corrosion/irritation.
This part is applicable to the classification and labelling of chemicals with skin corrosion/irritation according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (hereinafter referred to as GHS).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 6944 Classification and code of dangerous goods
GB 13690 General rule for classification and hazard communication of chemicals
GB 30000.17 Rules for classification and labelling of chemicals — Part 17: Corrosive to metals
GB/T 27828 Chemicals — Test method of in vitro skin corrosion — Transcutaneous electrical resistance test (TER)
GB/T 27830 Chemicals — Test method of in vitro skin corrosion — Human skin model test
The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (Rev.4)
The United Nations Recommendations on the Transport of Dangerous Goods: Model Regulations (Rev.17)
3 Terms and definitions
For the purposes of this document, the term and definition given in GB 13690 and the following apply.
3.1
skin corrosion
result of irreversible damage to skin, that is, epidermal and dermal necrosis can be observed within 4 hours after using the test substance. Typical corrosion reactions are characterized by ulcer, bleeding and scab, and at the end of the 14d observation period, the skin, completely alopecia area and scab are faded due to bleaching. Suspicious lesions shall be evaluated by histopathological examination.
3.2
skin irritation
result of reversible damage to skin after using the test substance for 4h
4 Classification standards
4.1 General principles
4.1 See GB 13690 for general principles of classification and labelling of skin corrosion/irritation.
4.2 Substance classification standards
4.2.1 This classification standard includes guidance on the evaluation of data elements before the animal testing of skin corrosion and skin irritation, and also includes the hazard classification of skin corrosion and skin irritation. It is generally unacceptable to test on human beings just to determine the danger.
4.2.2 A variety of factors shall be comprehensively evaluated when determining the skin corrosion and stimulation potential of chemicals before the test. Solid substance (powder) may become corrosive or irritant when it gets wet or comes into contact with wet skin and mucous membrane. First of all, the available human experience and data including one or repeated contact and animal observation and data shall be analyzed, because they provide direct information related to skin effect. In some cases, it is enough to classify from information of compounds with similar structures. Similarly, although this correlation is not entirely correct, pH limit 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 reagent has a significant skin effect. Of course, if a chemical shows high toxicity through skin contact, skin irritation/corrosion researches may not be feasible, because the dose of the testing substance applied will greatly exceed the toxic dose, and thus result to animal death. If the used dilutions are equivalent to the tested species, when skin irritation/corrosion is observed in acute toxicity study, and the observation is carried out at limit dose, no additional test is required. It is also possible to use proven and recognized alternative tests in vitro to assist classification.
All the above information of chemicals shall be used when determining whether in vivo skin irritation test is needed. Although information may be obtained from the evaluation of a single parameter in the first layer (See 4.2.3), for example, caustic alkali with pH limit value shall be regarded as skin corrosion, it is still valuable to evaluate all available information and determine the overall weight of evidence. This is especially true when only some but not all parameters can be obtained. Generally, the primary focus shall be on the existing human experience and data, followed by animal experiment and testing data, and then information from other sources, but it is necessary to make a determination after specific analysis.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification standards
5 Judgment logic
6 Labeling
Annex A (Normative) Tiered test and evaluation strategy of skin corrosion/irritation
Annex B (Informative) Judgment logic of skin corrosion/irritation
Annex C (Normative) Allocation of labelling elements of skin corrosion/irritation
Annex D (Normative) Classification and labelling elements of skin corrosion/irritation
Annex E (Informative) Hazard statement and precautionary statement of skin corrosion/irritation
Annex F (Informative) Label example of skin corrosion/irritation
Rules for classification and labelling of chemicals — Part 19: Skin corrosion/irritation
1 Scope
This part of GB 30000 stipulates the terms and definitions, classification standard, judgment logic and labelling of chemicals with skin corrosion/irritation.
This part is applicable to the classification and labelling of chemicals with skin corrosion/irritation according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (hereinafter referred to as GHS).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 6944 Classification and code of dangerous goods
GB 13690 General rule for classification and hazard communication of chemicals
GB 30000.17 Rules for classification and labelling of chemicals — Part 17: Corrosive to metals
GB/T 27828 Chemicals — Test method of in vitro skin corrosion — Transcutaneous electrical resistance test (TER)
GB/T 27830 Chemicals — Test method of in vitro skin corrosion — Human skin model test
The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (Rev.4)
The United Nations Recommendations on the Transport of Dangerous Goods: Model Regulations (Rev.17)
3 Terms and definitions
For the purposes of this document, the term and definition given in GB 13690 and the following apply.
3.1
skin corrosion
result of irreversible damage to skin, that is, epidermal and dermal necrosis can be observed within 4 hours after using the test substance. Typical corrosion reactions are characterized by ulcer, bleeding and scab, and at the end of the 14d observation period, the skin, completely alopecia area and scab are faded due to bleaching. Suspicious lesions shall be evaluated by histopathological examination.
3.2
skin irritation
result of reversible damage to skin after using the test substance for 4h
4 Classification standards
4.1 General principles
4.1 See GB 13690 for general principles of classification and labelling of skin corrosion/irritation.
4.2 Substance classification standards
4.2.1 This classification standard includes guidance on the evaluation of data elements before the animal testing of skin corrosion and skin irritation, and also includes the hazard classification of skin corrosion and skin irritation. It is generally unacceptable to test on human beings just to determine the danger.
4.2.2 A variety of factors shall be comprehensively evaluated when determining the skin corrosion and stimulation potential of chemicals before the test. Solid substance (powder) may become corrosive or irritant when it gets wet or comes into contact with wet skin and mucous membrane. First of all, the available human experience and data including one or repeated contact and animal observation and data shall be analyzed, because they provide direct information related to skin effect. In some cases, it is enough to classify from information of compounds with similar structures. Similarly, although this correlation is not entirely correct, pH limit 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 reagent has a significant skin effect. Of course, if a chemical shows high toxicity through skin contact, skin irritation/corrosion researches may not be feasible, because the dose of the testing substance applied will greatly exceed the toxic dose, and thus result to animal death. If the used dilutions are equivalent to the tested species, when skin irritation/corrosion is observed in acute toxicity study, and the observation is carried out at limit dose, no additional test is required. It is also possible to use proven and recognized alternative tests in vitro to assist classification.
All the above information of chemicals shall be used when determining whether in vivo skin irritation test is needed. Although information may be obtained from the evaluation of a single parameter in the first layer (See 4.2.3), for example, caustic alkali with pH limit value shall be regarded as skin corrosion, it is still valuable to evaluate all available information and determine the overall weight of evidence. This is especially true when only some but not all parameters can be obtained. Generally, the primary focus shall be on the existing human experience and data, followed by animal experiment and testing data, and then information from other sources, but it is necessary to make a determination after specific analysis.
Contents of GB 30000.19-2013
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification standards
5 Judgment logic
6 Labeling
Annex A (Normative) Tiered test and evaluation strategy of skin corrosion/irritation
Annex B (Informative) Judgment logic of skin corrosion/irritation
Annex C (Normative) Allocation of labelling elements of skin corrosion/irritation
Annex D (Normative) Classification and labelling elements of skin corrosion/irritation
Annex E (Informative) Hazard statement and precautionary statement of skin corrosion/irritation
Annex F (Informative) Label example of skin corrosion/irritation
