GB 30000.21-2013 Chemical Classification and Labelling Specification Part 21: Respiratory or Skin Sensitization GB30000.21-2013 |tt||Standard compression package decompression password: www.bzxz.net
This part of GB30000 specifies the terms and definitions, general description, classification criteria judgment logic, and labeling of chemicals with respiratory or skin sensitization. This part applies to the classification and labeling of chemicals with respiratory or skin sensitization in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.
Chapter 5 and Chapter 7 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 21 of GB 30000.
This part was drafted in accordance with the rules given in GB/T 1.1-2009. This
part replaces GB 20595-2006 "Safety Specification for Classification, Warning Labels and Warning Statements of Chemicals - Respiratory or Skin Sensitization".
Compared with GB 20595-2006, the main technical content changes of this part are as follows:
———The name of the standard has been modified. The Chinese name has been modified to "Rules for classification and labelling of chemicals—Part 21: Respiratory or skin sensitization" and the English name is "Rules for classification and labelling of chemicals—Part 21: Respiratory or skin sensitization"; ||tt
|| ———The relevant content of sub-categories "1A and 1B" has been added;
———The scope of Chapter 1 has been modified, "warning label" has been changed to "label", and "warning statement" 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;
———The title of Table 1 has been modified, and "category" has been changed to "classification standard";
———Modified some statements of "decision logic" and added "Figure 1" as Appendix A;
———Modified some contents of original Table 4 and Table 5 as Appendix B;
———Modified some contents of original Table 2 and Table 3, changed "graphic symbol" to "symbol", "name" to "signal word", and "hazard statement" to "hazard statement"; and added them together as Appendix C;
———Deleted the original Chapter 8, added the relevant "precautionary statement" content as informative Appendix D; and modified the original Chapter 6, Chapter 7 and Chapter 8 into Chapter 7;
———Added the label sample of respiratory or skin sensitization as informative Appendix E.
This part is consistent with the relevant technical content of the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals"
(GHS) (4th revised edition).
This part is proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251).
Drafting organizations of this part: Tianjin Entry-Exit Inspection and Quarantine Bureau, Institute of Occupational Health and Poison Control, Chinese Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Information Center.
Main drafters of this part: Zhang Yuan, Wang Hua, Liu Wei, Wang Na, Zhao Lihua, Lin Zheng, Song Wei, Li Chaolin, Liang Jin, Wu Weiai. The
previous versions of the standards replaced by this part are as follows:
———GB 20595—2006
The following documents are indispensable for the application of this document. For all dated references, only the dated versions apply to this document. For all undated references, the latest versions (including all amendments) apply to this document.
GB13690 General Rules for Classification and Hazard Communication of Chemicals
GB16483 Scope of Preparation of Safety Data Sheets for Chemicals
United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (Seventeenth Revised Edition)
United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition)

ICS13.300
National Standard of the People's Republic of China
GB30000.21—2013
Replaces GB20595—2006
Rules for classification and labelling of chemicals-Part 21:Respiratory or skin sensitization
Rules for classification and labelling of chemicals-Part 21:Respiratory or skin sensitization sensitization2013-10-10 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2014-11-01 Implementation
Chapter 5 and Chapter 7 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 (replace GB20579-2006); Part 6: Gases under pressure (replace GB20580-2006); Part 7: Flammable liquids (replace GB20581-2006); Part 8: Flammable solids (replace GB20582-2006); Part 9: Self-reactive substances and mixtures (replace GB20583-2006); Part 10: Pyrophoric liquids (replace GB20585-2006); Part 11: Pyrophoric solids (replace GB20586-2006); Part 12: Self-heating substances and mixtures (replace GB20584-2006); Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replace GB20587- 2006): Part 14: Oxidizing Liquids (Replaces GB20589-2006): Part 15: Oxidizing Solids (Replaces GB205902006); 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/Irritation (Replaces GB20594-2006); Part 21: Respiratory or Skin Sensitization (Replaces GB20595-2006); Part 22: Germ Cell Sensitization 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 21 of GB30000.
This part was drafted in accordance with the rules given in GB/T1.1-2009. GB30000.21—2013
This part replaces GB20595-2006 "Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals - Respiratory or Skin Sensitization".
Compared with GB20595-2006, the main technical content changes of this part are as follows: The name of the standard has been modified. The Chinese name has been changed to "Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization", and the English name is "Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization GB30000.21—2013
skin sensitization\
Added relevant content of sub-categories "1A and 1B", 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"; modified the title of Table 1, changed "category" to "classification standard", modified some sentences of "decision logic", and included "Figure 1" as Appendix A; modified some contents of original Table 4 and Table 5. As Appendix B; modified some contents of original Table 2 and Table 3, changed "graphic symbol" to "symbol", "name" to "signal word", "hazard statement" to "hazard statement", and included them together as Appendix C; deleted the original Chapter 8, and included the relevant "precautionary statement" content as informative Appendix D: and modified the original Chapter 6, Chapter 7, and Chapter 8 into Chapter 7;
-Added label samples for respiratory or skin sensitization as informative Appendix E. This part is consistent with the relevant technical content of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (4th revised edition). This part was proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). Drafting units of this part: Tianjin Entry-Exit Inspection and Quarantine Bureau, Institute of Occupational Health and Poisoning Control, Chinese Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Information Center. Main drafters of this part: Zhang Yuan, Wang Hua, Liu Wei, Wang Na, Zhao Lihua, Lin Zheng, Song Wei, Li Chaolin, Liang Jin, Wu Wei. The previous versions of the standard replaced by this part are as follows: GB20595-—2006
1 Scope
Chemical Classification and Labelling Specification
Part 21: Respiratory or Skin Sensitization
GB30000.21—2013
This part of GB30000 specifies the terms and definitions, general description, classification criteria, decision logic and labeling of chemicals with respiratory or skin sensitization.
This part applies to the classification and labeling of chemicals with respiratory or skin sensitization according to the United Nations "Globally Harmonized System of Classification and Labeling of Chemicals" (hereinafter referred to as GHS).
2 Normative references
The following documents are essential for the application of this document. For all references with dates, only the dated version applies to this document. For all undated references, the latest version (including all amendments) applies to this document.GB13690 General Rules for Classification and Hazard Communication of ChemicalsGB16483 Scope of Preparation of Safety Data Sheets for ChemicalsUN "Recommendations on the Transport of Dangerous Goods Model Regulations" (17th revised edition)UN "Globally Harmonized System of Classification and Labeling of Chemicals" (4th revised edition)3 Terms and Definitions
The terms and definitions defined in GB13690 and the following terms and definitions apply to this document.3.1
Respiratory SensitizersRespiratory SensitizersA substance that causes respiratory allergies after inhalation.3.2
Skin SensitizersSkin Sensitizers||tt ||Substances that cause allergies after skin contact. 4 General description
4.1 Induction consists of two stages: the first stage is the induction of specific immune memory in an individual due to contact with an allergen, and the second stage is priming, which is the cell-mediated or antibody-mediated allergic reaction in a sensitive individual due to contact with an allergen. 4.2 For respiratory sensitization, induction is followed by a priming stage, which has the same characteristics as skin sensitization. For skin sensitization, there is an induction stage for the immune system to respond; if the subsequent contact is sufficient to cause a visible skin reaction (priming stage) , clinical symptoms may occur. Therefore, predictive tests usually follow this characteristic, in which there is an induction phase, and the response to this phase is measured by a standardized induction phase, typically using a patch test. Local lymph node tests that directly measure the induced response are an exception. Evidence of human skin sensitization is usually assessed by diagnostic patch tests. 4.3 For skin sensitization and respiratory sensitization, the amount required for induction is generally lower than the amount required for induction. 4.4 Hazard category \ Respiratory or skin sensitization" is divided into: 1
GB30000.21—2013
Respiratory sensitization:
b) Skin sensitization.
5 Classification criteria
5.1 General principles
For the general principles of classification and labeling of respiratory or skin sensitization, see GB13690.5.2 Material classification criteria
5.2.1 Respiratory sensitizers
5.2.1.1 Hazard categories
5.2.1.1.1 Where the competent authority does not require a secondary classification or the data for the secondary classification are insufficient, respiratory sensitizers should be classified as Category 1.
5.2.1.1.2
If sufficient data are available and the competent authority so requires, a more accurate assessment can be made according to 5.2.1.1.3, and respiratory sensitizers can be further divided into Category A: Strong sensitizers: or Category B: Other respiratory sensitizers. 5.2.1.1.3
The effects observed in humans and animals, using the weight of evidence approach, can usually be used as the basis for the classification of respiratory sensitizers. The criteria in 1 are based on reliable and evidence seen in large case studies or epidemiological studies or appropriate animal experimental studies. Using the table
U.S. Classification A into Category IB
High-quality evidence, using the weight of evidence approach, substances can be classified into the classification criteria and categories of respiratory sensitizers!
Category 1A
Category IB
Substances are classified as respiratory sensitizers
Respiratory sensitizers
If there is human evidence that the substance may cause specific respiratory sensitization, and/or if there are positive results from appropriate animal tests! The substance shows a high incidence in humans; or based on animal or other tests, it may have a high sensitization rate in humans. It should also be combined with the severity of the reaction.
The substance shows a low to moderate incidence in humans; or based on animal or other tests, it may have a low to moderate sensitization rate in humans. It should also be combined with the severity of the reaction.
There are currently no recognized and validated animal models for conducting respiratory sensitization tests. In some cases, data from studies on animals can provide important information in making a weight of evidence assessment. 5.2.1.2 Human evidence
5.2.1.2.1
Evidence that a substance may cause a specific respiratory allergic reaction is generally based on human experience. In this regard, allergic reactions usually present as asthma, but should also be combined with other allergic reactions such as inflammation/conjunctivitis and alveolitis. Symptoms should have clinical features of allergic reactions. However, immunological mechanisms do not necessarily need to be proven. 5.2.1.2.2 When making judgments based on human evidence, classification decisions should be based on, in addition to case evidence,: a) the size of the exposed population;
b) the degree of exposure.
5.2.1.2.3 The evidence referred to above may be: a) clinical cases and data from appropriate lung function tests related to exposure to the substance, and they are confirmed by other supporting evidence2
, including:
in vivo immunological tests (such as skin prick tests): in vitro immunological tests (such as serum analysis): GB30000.21—2013
when the immunological mechanism of action has not been confirmed, such as repeated low-level stimulation, pharmacologically mediated effects, studies indicating other specific allergic reactions;
chemical structures are related to substances known to cause respiratory allergies; b) data from positive bronchial provocation tests for substances according to recognized criteria for determining specific hypersensitivity reactions. 5.2.1.2.4 Clinical cases should include both medical and occupational history to determine the relationship between exposure to specific substances and respiratory allergic reactions. Relevant information includes factors that exacerbate the condition at home and in the workplace, the occurrence and development of the disease, and the patient's family history and medical history. The medical history should also include records of other allergic or respiratory diseases in childhood and a history of smoking. 5.2.1.2.5 A positive bronchial provocation test result alone can provide sufficient evidence of diagnosis. However, it should be acknowledged that many of the tests listed above may have already been carried out.
5.2.1.3 Animal studies
Data obtained from "appropriate animal studies" indicating that a substance may cause sensitization in humans through inhalation
may include:
e.g. immunoglobulin (Ig) culture and other specific immunological parameters in mice; specific lung responses in guinea pigs
5.2.2 Skin sensitizers
Hazard categories
5.2.2.1.1
Class 1.
Where the competent authority does not require a higher classification or where there are insufficient data for a sub-classification, a skin sensitizer should be classified as a Class 1A strong sensitizer or a Class I sensitizer.
Where sufficient data are available and the competent authority has the basis to make a more accurate assessment, a skin sensitizer should be classified as a Class 1A strong sensitizer or a Class I sensitizer. B Other skin sensitizers Substances are further divided into Class 1B
5.2.2.1.3 The effects observed in humans or animals can be classified as skin sensitizers based on the weight of evidence approach. The weight of evidence approach can be used as the basis for classifying substances as skin sensitizers. According to the criteria in Table 2, substances can be classified into Class 1B. The evidence used should be reliable and of guaranteed quality as described in 5.2.2.2. The evidence can be obtained from human cases or epidemiological studies, and/or observations from appropriate animal experimental studies. Table 2 Classification criteria and categories of skin sensitizers Category 1
Substances are classified as skin sensitizers:
Skin sensitizerswwW.bzxz.Net
(a) If there is human evidence showing that a large number of people can cause allergies after skin contact; (b) If there are positive results from appropriate animal tests 1) Not yet There are recognized and validated animal models for testing respiratory allergic reactions. In some cases, data from animal studies can provide important information in the weight of evidence assessment. The mechanism by which substances cause asthma symptoms has not yet been fully clarified. For precautionary purposes, these substances can be considered respiratory sensitizers. However, if2
According to the evidence, it can be confirmed that these substances produce irritation and only cause asthma symptoms in people with bronchial hyperreactivity, then they should not be judged as respiratory sensitizers.
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Category 1
Category 1A
Category IB
5.2.2.2 Human evidence
Table 2 (continued)
Skin sensitizers|| tt||Substances show a high incidence in the human population; and/or a high probability in animals, it can be assumed that the substance has the potential to produce severe allergic reactions in humans. The severity of the reaction should also be considered. Substances show a low to moderate incidence in humans: or a low to moderate probability in animals, it can be assumed that the substance has the potential to cause allergies in humans, and the severity of the reaction should also be considered. Human evidence for Category 1A may include:
Positive reactions not greater than 500 μg/cm* (HRIPT, HMT-induction threshold): b)
Diagnostic patch test data showing a relatively low but not negligible incidence of reactions in a limited population for a lower degree of exposure;
Other epidemiological evidence showing a higher and more pronounced allergic contact dermatitis for a lower degree of exposure. 5.2.2.2.2 Human evidence for Category 1B may include: positive reactions greater than 500ug/cm (HRIPT, HMT-induction threshold); a2
diagnostic patch test data showing a low but not negligible incidence of reactions in a defined population for higher levels of exposure;
other epidemiological evidence showing that lower and more severe allergic contact c
dermatitis occurs for higher levels of exposure.
5.2.2.3 Animal Studies
5.2.2.3.1 For Category 1, skin sensitization tests using an auxiliary type of test method should be considered positive if at least 30% of the animals react, and for non-auxiliary guinea pig test methods, at least 15% of the animals react. For Category 1, an irritation index of 3 or more for the local lymph node test is considered positive. Other methods may also be used if they have valid and scientific evidence. The mouse ear swelling test (MEST) is a reliable screening test for the detection of moderate and strong allergens and can be used in the first stage to evaluate the potential for skin sensitization. 5.2.2.3.2 Table 3 lists the criteria achieved by animal allergy tests for substances classified as Category 1A. Table 3 Animal test results for Category 1A substances
Local lymph node test
Guinea pig maximum test
Buehler guinea pig test
EC3 value not greater than 2%
Not greater than 0.1% intradermal induction dose, response not less than 30% or 0.For an intradermal induction dose of 1% (not included) to 1% (inclusive), the response is not less than 60%. For a topical induction dose of not more than 0.2%, the response is not less than 15%. Or for a topical induction dose of 0.2% (not included) to 20% (inclusive), the response is not less than 60%. 5.2.2.3.3 Table 4 lists the standards achieved in animal allergy tests for substances classified as Category 1B. Test
Local lymph node test
Maximum test in rats
Buehler guinea pig test
5.2.2.4 Specific matters
EC3 value greater than 2%
Table 4 Category 1B animal test results
GB30000.21—2013
Response at intradermal induction dose of 0.1% (not included) to 1% (inclusive) is between 30% (inclusive) and 60% (not included), or at intradermal induction dose greater than 1%·response is not less than 30%Response at local induction dose of 0.2% (not included) to 26% (inclusive) is between 15% (inclusive) and 60% (not included), or at local induction dose greater than 20%, response is not less than 15%5.2 .2.4.1 The classification of substances should be based on a weight of evidence approach, which should include any or all of the following: positive data from patch tests, usually from more than one hospital; a) epidemiological studies showing that the substance causes allergic contact dermatitis: special attention should be paid when a high proportion of contacts develop characteristic symptoms, even if the number of cases is small; positive data from appropriate animal studies; e) positive data from experimental studies in humans; d) well-documented cases of allergic contact dermatitis, usually from more than one hospital; e) severity of the reaction. 5.2.2.4.2 Evidence from animal studies is usually more reliable than evidence from human contact. However, if evidence is obtained from both sources and there is a conflict between the results, the quality and reliability of the evidence from both sources should be evaluated so that the classification problem can be resolved on a case-by-case basis. Normally, human data are not generated from controlled studies in volunteers for the purpose of hazard classification, but rather as part of a risk assessment to verify the absence of effects observed in animal studies. Therefore, data on positive skin sensitization in humans are usually derived from case-control or other less rigorous studies. Human data should therefore be evaluated with caution, since, in addition to the intrinsic properties of the substance, case frequencies reflect factors such as exposure, bioavailability, individual predisposition and precautions taken. Negative human data should not normally be used to negate positive results from animal studies. For both animal and human data, the effect of the vehicle should be considered. 5.2.2.4.3 If none of the above conditions are met, then the substance should not be classified as a skin sensitizer. However, the combination of two or more of the indicators of skin sensitization listed below may change the classification decision. Such cases should be classified as individual cases. a)
Isolated cases of allergic contact dermatitis;
Epidemiological studies with limited statistical power, e.g. where chance, bias or confounding have not been adequately excluded with reasonable confidence; b)
Data from animal studies conducted in accordance with current guidelines which do not meet the criteria for a positive result as described in 5.2.2.3, but are sufficiently close to the limit to be considered valid; d) Positive data obtained by non-standard methods; e
Positive results obtained by close structural analogy. 5.2.2.4.4 Immune contact urticaria
Substances that meet the criteria for classification as respiratory sensitizers may also cause immune contact urticaria. These substances should also be judged as skin sensitizers. Substances that cause immune contact urticaria but do not meet the criteria for respiratory sensitizers should also be judged as skin sensitizers.
There is currently no recognized animal model to identify substances that cause immune contact urticaria. Therefore, classification is usually based on human evidence that is similar to human evidence for skin sensitization. KAONTKAca-
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5.3 Classification criteria for mixtures
5.3.1 Classification of mixtures when data on the mixture as a whole are available When the mixture has reliable, high-quality evidence from human experience or appropriate experimental animal studies as described in the material criteria, the mixture can be classified based on a weight of evidence assessment of these data. Care should be taken when evaluating the data on the mixture, and the doses used should not produce ambiguous results.
5.3.2 Classification of mixtures when data on the mixture as a whole are not available: bridging principles 5.3.2.1 If the mixture itself has not been tested to determine its sensitization, but there are sufficient data on the individual ingredients of the mixture and similar mixtures that have been tested to adequately determine the hazard characteristics of the core mixture, then these data will be used in accordance with the following agreed bridging principles. This ensures that the classification process uses the existing data to the greatest extent possible to determine the hazard characteristics of the mixture without the need for additional animal testing.
5.3.2.2 Dilution
If a tested mixture is diluted with a non-sensitizing diluent which does not affect the sensitizing properties of the other ingredients, the new diluted mixture may be classified in the same category as the original tested mixture. 5.3.2.3 Product batches
The sensitizing properties of a production batch tested may be considered to be substantially equivalent to the sensitizing properties of another untested batch of the same commercial product produced by or under the control of the same manufacturer for which the mixture has been tested, unless there is reason to believe that there is a significant change in the sensitizing potential of the untested batch. If the latter occurs then a new classification should be made. 5.3.2.4 Concentration of the mixture with the highest sensitization category If a tested mixture is classified as Category 1 or Category 1A and the concentration of an ingredient in Category 1 or Category 1A is increased in the tested mixture, the resulting untested mixture will be classified as Category 1 or Category 1A. No further review is required. 5.3.2.5 Interpolation from similar classes
Three mixtures with identical ingredients (AB) If mixtures A and B have been tested and are in the same class and mixture C is untested but contains the same toxicologically active ingredients as mixtures A and B and the concentration of the active ingredients is intermediate between the concentrations in mixtures A and B, then mixture C is assumed to be in the same class as A and B. 5.3.2.6 Substantially similar mixtures
Assume the following:
Two mixtures: 1) 4+B;
the concentration of component B is essentially the same in both mixtures; the concentration of component A in mixture 1) is equal to the concentration of component C in mixture 2); d) component B is a sensitizer, while components A and C are not sensitizers; d) A and C are not expected to affect the sensitization potential of B. If mixture 1) or 2) is already classified based on test data, then the other mixture can be assigned to the same hazard category. 5.3.2.7 Aerosols
If the addition of aerosol propellants does not affect the sensitization of the mixture when sprayed, the mixture in aerosol form may be classified in the same hazard category as the tested non-aerosol mixture. 5.3.3 Classification of mixtures when data are available for all or only some of the ingredients When at least one ingredient is classified as a respiratory or skin sensitizer and its content is equal to or above the specific endpoint cut-off value/concentration limit for solids/liquids and gases as shown in Table 5, the mixture should be classified as a respiratory or skin sensitizer. 6
GB30000.21—2013
Critical values/concentration limits for components of mixtures classified as respiratory or skin sensitizersTable 5
Critical values/concentration limits for classification of mixtures
Components classified as
Respiratory sensitizers
Category 1
Respiratory sensitizers
Category 1A
Respiratory sensitizers
Category IB
Skin sensitizers
Category 1
Skin sensitizers
Category 1
Skin sensitizers
Category 1B
Respiratory sensitizers Category 1
Solid/liquid
Not less than 0.1%
Not less than 1.0%
Not less than 0.1%
Not less than 1.0%
Some competent authorities
may require a safety data sheet, see 1648
Not less than 0.1%
Not less than 0.2%
Not less than 0.1%
Not less than 0
Skin sensitizer Category 1
All physical states
Not less than 0.1%
Not less than 1.0%
Less than 0.1%
Not less than 1.Between 0% and 1%
For mixtures containing ingredients with a minimum concentration of 0.1 (or for gaseous respiratory sensitizers, between 0.1% and 2%)
Requires additional labeling
Current system, but it is generally recognized that in special circumstances, information below the minimum may be required
Decision logic
Decision logic is for reference only
Although the current critical values ​​reflect
The judgment is to be made. See Appendix. It is particularly recommended that the person responsible for classification study Chapter 5 before and during the use of the decision logic.
7 Labelling
7.1 General
7.1.1 For hazard classes causing respiratory or skin sensitization, the Department may use specified pictograms, signal words, or other symbols. and hazard statements. The hazard types or categories covered by the Model Regulations should list the designated corresponding graphic symbols for each item on the label. The allocation of label elements for respiratory or skin sensitization is shown in Appendix B.
7.1.2 See Appendix C for classification and label elements for respiratory or skin sensitization. 7.1.3 The information required on the label includes hazard pictograms, signal words, hazard statements, precautionary statements, product identifiers and supplier logos. Note: For other label elements that have not yet been standardized, such as precautionary statements, they also need to be included on the label. The competent authorities may also require additional information, and suppliers may also add supplementary information.
7.2 Hazard pictograms
Hazard pictograms specified in GHS should use black symbols with a white background, and the red frame should be wide enough to make it eye-catching. rKAoNTKAca
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7.3 Signal word
Signal word refers to the words used on the label to indicate the relative severity of the hazard and to alert the reader to potential hazards. For respiratory or skin sensitization, the signal words "Danger" and "Warning" are used for different hazard categories. The signal word "Danger" is used for Category 1, Category 1A and Category 1B respiratory sensitizers. The signal word "Warning" is used for Category 1, Category 1A and Category 1B skin sensitizers. 7.4 Hazard statement
Hazard statement refers to a phrase assigned to a hazard class and category to describe the hazardous properties of a chemical and, where appropriate, its degree of hazard. Hazard statement for respiratory or skin sensitizers and precautionary statements are shown in Annex C and Annex D. 7.5 Precautionary Statements
A precautionary statement is a word (and or pictogram) used to describe the recommended measures to minimize or prevent adverse effects resulting from exposure to a hazardous product or from improper storage or handling of a hazardous product. To meet GHS requirements, there are five types of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for different hazard categories of respiratory or skin sensitizers are shown in Annex D. 7.6 Product Identifiers
7.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the Material Safety Data Sheet. If a substance or mixture is listed in the Model Regulations, the correct UN shipping name should also be used on the packaging. 7.6.2 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 should include the chemical composition of all components or alloying elements that may cause these hazards. The competent authority may also require that the chemical names of all components or alloying elements that may contribute to a hazardous mixture or alloy be listed on the label. 7.7 Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture shall be provided on the label. 7.8 Label examples
Refer to Appendix E for a sample label for respiratory or skin sensitization Appendix A
(Informative Appendix)
Decision logic for respiratory or skin sensitizers
Refer to Figure A.1 and Figure A.2 for the decision logic for respiratory or skin sensitizers. Substance: Does the substance have data on respiratory sensitization? Mixture: Does the mixture as a whole or its components have data on respiratory sensitization?
Cannot be classified
Can the bridging principle be applied?
(See 5.3.2)
Does the mixture as a whole have data on respiratory sensitization? (See 5.3.1)
a) Is there evidence in humans that the substance/mixture may cause specific respiratory sensitization:
b) Have positive results been obtained in appropriate animal studies? (See criteria in 5.2.1)
Phase
Does the mixture contain one or more ingredients classified as respiratory sensitizers in the following concentrations?
Not less than 0.1% mass fraction (solid/liquid)Not less than 1.0% mass fraction (solid/liquid)Not less than 0.1% volume fraction (gas)
Not less than 0.2% volume fraction (gas) (see 5.3.3 and Table 5)Not of this type
Decision logic for respiratory sensitizers
TrKAONTKAca-
GB30000.21—2013
Cannot be classified
Category 1
Classify into appropriate category
Category 18 Label examples
Respiratory or skin sensitization label examples are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for respiratory or skin sensitizers
Decision logic for respiratory or skin sensitizers is shown in Figures A.1 and A.2. Substance: Does the substance have data on respiratory sensitization? Mixture: Does the mixture as a whole or its ingredients have data on respiratory sensitization?
Cannot be classified
Can the bridging principle be applied?
(See 5.3.2)
Does the mixture as a whole have data on respiratory sensitization?
(See 5.3.1)
a) Is there human evidence that the substance/mixture may cause specific respiratory sensitization reactions:
b) Have appropriate animal tests obtained positive results? (See criteria in 5.2.1)
Phenyl This category
Does the mixture contain one or more ingredients classified as respiratory sensitizers with the following concentrations?
Not less than 0.1% mass fraction (solid/liquid)Not less than 1.0% mass fraction (solid/liquid)Not less than 0.1% volume fraction (gas)
Not less than 0.2% volume fraction (gas) (See 5.3.3 and Table 5) Not this category
Decision logic for respiratory sensitizers
TrKAONTKAca-
GB30000.21—2013
Cannot be classified
Category 1
Classify to appropriate category
Category 18 Label examples
Respiratory or skin sensitization label examples are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for respiratory or skin sensitizers
Decision logic for respiratory or skin sensitizers is shown in Figures A.1 and A.2. Substance: Does the substance have data on respiratory sensitization? Mixture: Does the mixture as a whole or its ingredients have data on respiratory sensitization?
Cannot be classified
Can the bridging principle be applied?
(See 5.3.2)
Does the mixture as a whole have data on respiratory sensitization?
(See 5.3.1)
a) Is there human evidence that the substance/mixture may cause specific respiratory sensitization reactions:
b) Have appropriate animal tests obtained positive results? (See criteria in 5.2.1)
Phenyl This category
Does the mixture contain one or more ingredients classified as respiratory sensitizers with the following concentrations?
Not less than 0.1% mass fraction (solid/liquid)Not less than 1.0% mass fraction (solid/liquid)Not less than 0.1% volume fraction (gas)
Not less than 0.2% volume fraction (gas) (See 5.3.3 and Table 5) Not this category
Decision logic for respiratory sensitizers
TrKAONTKAca-
GB30000.21—2013
Cannot be classified
Category 1
Classify to appropriate category
Category 1
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