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Rules for classification and labelling of chemicals—Part 20:Serious eye damage/eye irritation
Basic Information
Standard ID:
GB 30000.20-2013
Standard Name:Rules for classification and labelling of chemicals—Part 20:Serious eye damage/eye irritation
drafter:Qian Suhua, Wang Rong, Zhou Zhirong, Tang Lijun, Zhang Junxi, Ge Xiaojun, Li Xiaofeng
Drafting unit:Jiangsu Entry-Exit Inspection and Quarantine Bureau, China Chemical Information Center, National Dangerous Chemicals Quality Supervision and Inspection Center, Huafeng Group Co., Ltd.
Focal point unit:National Technical Committee on Hazardous Chemicals Management Standardization (SAC/TC 251)
Publishing department:General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
GB 30000.20-2013 Chemical Classification and Labelling Specification Part 20: Serious Eye Damage/Eye Irritation
GB30000.20-2013
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This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and labeling of chemicals with serious eye damage/eye irritation.
This part applies to the classification and labeling of chemicals with serious eye damage/eye irritation in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.
Chapter 4 and Chapter 6 of this part are mandatory, and the rest are recommended.
The expected structure of GB30000 "Specifications for Classification and Labelling of Chemicals" 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 GB20578-2006);
———Part 5: Oxidizing gases (replaces GB20579-2006);
———Part 6: Gases under pressure (replaces GB20580-2006);
———Part 7: Flammable liquids (replaces GB20581-2006);
———Part 8: Flammable solids (replaces GB 20582-2006);
———Part 9: Self-reactive substances and mixtures (replaces GB 20583-2006);
———Part 10: Pyrophoric liquids (replaces GB 20585-2006);
———Part 11: Pyrophoric solids (replaces GB 20586-2006);
———Part 12: Self-heating substances and mixtures (replaces GB 20584-2006);
———Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replaces GB 20587-2006);
———Part 14: Oxidizing liquids (replaces GB 20589-2006);
——Part 15: Oxidizing solids (replaces GB 20590-2006);
——Part 16: Organic peroxides (replaces GB 20591-2006);
——Part 17: Corrosive to metals (replaces GB 20588-2006);
——Part 18: Acute toxicity (replaces GB 20592-2006);
——Part 19: Skin corrosion/irritation (replaces GB 20593-2006);
——Part 20: Serious eye damage/eye irritation (replaces GB 20594-2006);
——Part 21: Respiratory or skin sensitization (replaces GB 20595-2006);
———Part 22: Germ cell mutagenicity (replaces GB 20596-2006);
———Part 23: Carcinogenicity (replaces GB 20597-2006);
———Part 24: Reproductive toxicity (replaces GB 20598-2006);
———Part 25: Specific target organ toxicity single exposure (replaces GB 20599-2006);
———Part 26: Specific target organ toxicity repeated exposure (replaces GB 20601-2006);
———Part 27: Aspiration hazard;
———Part 28: Hazard to the aquatic environment (replaces GB 20602-2006);
———Part 29: Hazard to the ozone layer;
——Part 30: Warning signs for chemical workplaces;
This part is Part 20 of GB 30000.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB 20594-2006 "Safety Specification for Classification, Warning Labels and Warning Statements of Chemicals Serious Eye Damage/Eye Irritation"
This part is consistent with the relevant technical contents of the United Nations "Globally Harmonized System of Classification and
Labelling of Chemicals, GHS" (Fourth Revised Edition).
Compared with GB20594-2006, the main technical content changes are as follows:
———The standard name has been modified. The Chinese name has been changed to "Rules for classification and labelling of chemicals—Part 20: Serious eye damage/eye irritation", and the English name has been changed to "Rules for classification and labelling of chemicals—Part 20: Serious eye damage/eye irritation";
———The scope of Chapter 1 has been modified, "warning label" has been changed to "label", and "warning instructions" has been deleted;
———The introductory words of Chapter 2 "Normative references" have been modified;
———The introductory words of Chapter 3 "Terms and definitions" have been added;
———4.1 "General principles" has been added;
———The contents of Figures 2 and 3 in Chapter 5 on decision logic are included as informative Appendix A;
———Deleted the original Chapter 7, and revised Table 6 of the original Chapter 7 as normative Appendix B according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (4th revised edition);
———In accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (4th revised edition), revised and integrated the original Chapters 6, 7 and 8 into Chapter 6; revised Table 5 as normative Appendix C;
———Deleted the original Chapter 8, and added the relevant "Hazard Statements" and "Precautionary Statements" as informative Appendix D;
——— Added informative Appendix E "Label Examples".
This part was proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251).
Drafting units of this part: Jiangsu Entry-Exit Inspection and Quarantine Bureau, China Chemical Information Center, National Hazardous Chemicals Quality Supervision and Inspection Center, Huafeng Group Co., Ltd.
The main drafters of this part are Qian Suhua, Wang Rong, Zhou Zhirong, Tang Lijun, Zhang Junxi, Ge Xiaojun and Li Xiaofeng.
Previous versions of the standards replaced by this part are:
———GB20594—2006. The following documents are indispensable for the application of this document. For any dated referenced document, only the dated version applies to this document. For any undated referenced document, the latest version (including all amendments) applies to this document.
GB13690 General Rules for Classification and Hazard Communication of Chemicals
GB30000.19—2013 Specifications for Classification and Labelling of Chemicals Part 19: Skin Corrosion/Irritation
United Nations Globally Harmonized System of Classification and Labelling of Chemicals (Fourth Revised Edition)
United Nations Recommendations on the Transport of Dangerous Goods Model Regulations (Seventeenth Revised Edition)
Some standard content:
ICS13.300 National Standard of the People's Republic of China GB30000.20—2013 Replaces GB20594-2006 Rules for classification and labelling of chemicals-Part 20: Serious eye damage/eye irritationIssued on October 10, 2013 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 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 GB20578-2006); Part 5: Oxidizing gases (replaces GB20579-2006); Part 6: Pressurized gases (replaces GB205802006); Part 7: Flammable liquids (replaces GB20581-2006); Part 8: Flammable solids Part 10: Self-ignitable liquids (replaces GB 20585-2006); Part 11: Self-ignitable solids (replaces GB 20586-2006); Part 12: Self-heating substances and mixtures (replaces GB 20584-2006); Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replaces GB 20587-2006); Part 14: Oxidizing liquids (replaces GB 20589-2006); Part 15: Oxidizing solids (replaces GB 2059 0-2006) 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 GB205932006); 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: Carcinogenicity (replaces GB20597-2006); Part 24: Reproductive toxicity (replaces GB20598-2006): Part 25: Specific target organ toxicity single exposure (replaces GB20599-2006): Part 26: Specific target organ toxicity repeated exposure (replaces GB20601-2006): Part 27: Inhalation hazard: Part 28: Hazards to the aquatic environment (replaces GB20602-2006); Part 29: Hazards to the ozone layer: Part 30: Warning signs for chemical workplaces: This part is Part 20 of GB30000. This part was drafted in accordance with the rules given in GB/T1.1-2009. GB30000.20—2013 This part replaces GB20594-2006 "Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals-Serious eye damage/eye irritation This part is consistent with the relevant technical contents of the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Globally Harmonized System. of Classification and Labelling of Chemicals, GHS) (4th revised edition). 1 GB30000.20—2013 Compared with GB20594—2006, the main technical content changes are as follows: The standard name has been modified, the Chinese name has been changed to "Rules for classification and labelling of chemicals-Part 20.Serious eye damage/eye irritation", and the English name has been changed to "Rules for classification and labelling of chemicals-Part 20.Serious eye damage/eye irritation" irritation\; Modified the scope of Chapter 1, changed "warning label" to "label", deleted "warning statement"; modified the introductory words of Chapter 2 "Normative References"; added the introductory words of Chapter 3 "Terms and Definitions"; added 4.1 "General Principles": Added the contents of decision logic in Figures 2 and 3 of Chapter 5 as informative Appendix A; deleted the original Chapter 7, and modified Table 6 of the original Chapter 7 as normative Appendix B according to the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition); Added Table 6 of the original Chapter 7 as normative Appendix B according to the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition) Chapter 1, Chapter 2, Chapter 3 and Chapter 4 were modified and integrated into Chapter 6; the original Table 5 was modified as normative Appendix C; the original Chapter 8 was deleted, and the relevant "Hazard Statements" and "Precautionary Statements" contents were included as informative Appendix D; - Informative Appendix E "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: Jiangsu Exit-Entry Inspection and Quarantine Bureau, China Chemical Information Center, National Hazardous Chemicals Quality Supervision and Inspection Center, Huafeng Group Co., Ltd. The main drafters of this part: Qian Suhua, Wang Rong, Zhou Zhirong, Tang Lijun, Zhang Junxi, Ge Xiaojun, Li Xiaofeng. History of the standards replaced by this part Version release: -GB20594—2006. 1 Scopewww.bzxz.net Chemical classification and labeling specifications Part 20: Serious eye damage/eye irritation GB30000.20—2013 This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and labeling of chemicals with serious eye damage/eye irritation This part applies to the classification and labeling of chemicals with serious eye damage and eye irritation in accordance with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (hereinafter referred to as GHS) Normative references The following documents are for The application of the document is essential. The version with the date of the referenced document is applicable to this document. For any undated referenced document, its latest version including all amendments is applicable to this document GB13690 Classification and Hazard Communication of Chemicals GB30000.19-2013 Specification for Classification and Labelling of Chemicals Part 9: Skin Corrosion United Nations Global Chemical Standardization and Labelling System (Fourth Revised Edition) United Nations Recommendations on the Transport of Dangerous Goods 3 Terms and Definitions Model Regulations GB13690 and the following terms and definitions are applicable to this document. 3.1 Serious eye damage When the test substance is applied to the front surface of the eye for exposure, it causes damage to eye tissue or serious visual impairment, which cannot be fully recovered within 21 days after exposure Eye irritation After the test substance is applied to the front surface of the eye for exposure, changes occur in the eye, and the changes that appear can completely disappear and return to normal within 21 days after exposure. 4 Classification criteria 4.1 General principles General principles for classification and labeling of serious eye damage/eye irritation are given in GB136904.2 Classification criteria for substances 4.2.1 A tiered testing and evaluation scheme should be used to combine existing information on serious visual tissue damage and eye irritation (including data from previous human or animal1 GB30000.20—2013 experience), as well as structure-activity relationship (SAR) information and valid in vitro test results to avoid unnecessary animal testing. 4.2.2 The classification recommendations for eye irritation and serious eye damage include elements that have been harmonized and used by all competent authorities, as well as optional subcategories that only some competent authorities (e.g., the management department that classifies pesticides) will use. 4.2.3 Before any in vivo serious eye damage/eye irritation test is conducted, all available information on the test substance should be reviewed. From the available data, it is often possible to make a preliminary judgment as to whether a substance will cause serious (i.e., irreversible) eye damage. If the test substance can be classified in this way, no testing is required. A tiered test strategy for serious eye damage and eye irritation should be used to evaluate existing information on the test substance or a new, unstudied substance. 4.2.4 Before conducting tests, the following factors should be considered when determining the serious eye damage or irritation potential of a substance. First, the accumulated human and animal experience should be analyzed because they can provide information directly related to eye effects. In some cases, sufficient information can be obtained from structurally related compounds to make a hazard category judgment. Similarly, serious eye damage may also occur at pH ≤ 2 and pH ≥ 11.5, especially when they are associated with significant buffering capacity. Such substances may have significant effects on the eye. Before evaluating serious eye damage/eye irritation, an assessment of the potential for skin corrosion should be made to avoid testing for local eye effects with skin corrosives. Alternative in vitro tests that have been proven to be valid and recognized can be used for classification. 4.2.5 All available information on the substance as described above should be used in determining whether in vivo eye irritation testing is necessary. Although information may be obtained from the evaluation of a single parameter within a tier (e.g. caustic alkalis with extreme pH values should be considered locally corrosive), it is still valuable to consider the totality of the information available and to weight the totality of the evidence. This is particularly true when information is available on only some parameters but not all. In general, the first emphasis should be on combining expert judgement with human experience with the substance, followed by skin irritation testing and test results from reliable alternative methods. Animal testing of corrosive substances should be avoided whenever possible. 4.2.6 As in some cases not all elements are relevant, a tiered approach may be used to evaluate the raw information. During a workshop held in Suna, Sweden, various recommendations were made by national (international) centres and committees for the determination of alternatives to animal testing, which led to the development of the tiered approach explained in Figure 1. Steps Data relevant to previous human or animal experienceNone or unknown Data relevant to previous human or animal experience+ None or unknown Data relevant to previous human or animal experienceNone or unknown Structure Activity Relationship (SAR) None or unknown Structure Activity Relationship (SAR) Serious eye damage Eye irritation Skin erosion Skin irritation Serious eye damage Eye irritation Figure 1 Conclusions of tests and assessments for serious eye damage and eye irritation Category 1 Category 2 No effect on Hattori Assessment: deemed to be Category 1 No effect on the eye Assessment: deemed to be Category 2 Category 1 No effect on the eye Assessment: deemed to be Category 2 No or unknown Structure Activity Relationship (SAR) No or unknown pH value/acid or base reserve 2 Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.