Rules for classification and labelling of chemicals—Part 25:Specific target organ toxicity—Single exposure
Some standard content:
ICS13.300
National Standard of the People's Republic of China
GB30000.25—-2013
Replaces GB20599—2006
Rules for classification and labelling of chemicals-Part 25Specific target organ toxicity
Single exposure
Rules for classification and labelling of chemicals-Part 25Specific target organ toxicitySingleexposure2013-10-10 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 GB205762006); Part 3: Flammable gases (replaces GB20577-2006); Part 4: Gas bath glue (replaces GB20578-2006); Part 5: Flammable gases (replaces GB20577-2006); Part 6: Flammable gases (replaces GB20578-2006); Part 7: Flammable gases (replaces GB20578-2006); Part 8: Flammable gases (replaces GB20578-2006); Part 9: Flammable gases (replaces GB20578-2006); Part 10: Flammable gases (replaces GB20578-2006); Part 11: Flammable gases (replaces GB20578-2006); Part 12: Flammable gases (replaces GB20578-2006); Part 13: Flammable gases (replaces GB20578-2006); Part 14: Flammable gases (replaces GB20578-2006); Part 15: Flammable gases (replaces GB20578-2006); Part 16: Flammable gases (replaces GB20578-2006); Part 1 -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 GB20582-2006); Part 9: Self-reactive substances and mixtures (replaces GB20583-2006): Part 10: White flammable liquids (replaces GB20585-2006); Part 11: Self-igniting solids (replaces GB20586-2006); Part 12: Self-heating substances and mixtures (replaces GB20584-2006): Part 13: Substances and mixtures which, in contact with water, emit flammable gases Part 14: Oxidizing Liquids (Replace GB20589-2006): Part 15: Oxidizing Solids (Replace GB20590-2006): Part 16: Organic Peroxides (Replace GB20591-2006); Part 17: Metal Corrosives (Replace GB20588-2006): Part 18: Acute Toxicity (Replace GB20592-2006) Part 19: Skin Corrosion/Irritation (Replace GB20593-2006); Part 20: Serious Eye Damage/Eye Irritation (Replace GB20594-2006): Part 21: Respiratory or Skin Sensitization (Replace GB.20595-2006) 06): Part 22: Germ cell mutagenicity (replaces GB20596-2006): Part 23: Carcinogenicity (replaces GB20597-2006); Part 24: Reproductive toxicity (replaces GB205982006): 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 25 of GB3000G.
This part was drafted in accordance with the rules given in GB/T1.1--2009. GB30000.25—2013
This part replaces GB205992006 Safety rules for classification, warning labels and warning statements of chemicals - Specific target organ toxicity - Single exposure.
Compared with GB205992006, 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 25: Specific target organ toxicity - Single exposure" and the English name has been changed to "Rules for classification and labelling of chemicals Part 25: Specific target organ toxicity - Single exposure" exposure\Added relevant content of "Category 3: Transient Target Organ Effects"; modified the scope of Chapter 1, changed "Warning Label" to "Label", deleted "Warning Statement" (see Chapter 1); added Chapter 4 "General Instructions",
modified some sentences of "Decision Logic", and included "Figure 1" as Appendix A; modified part of the original Table 5 as Appendix B; modified part of the original Table 4, changed "Name" to "Signal Word" and "Hazard Statement" to "Hazard Statement" as Appendix C; deleted the original Chapter 8, added the relevant "Precautionary Statement" content as Informative Appendix D, and modified the original Chapters 6, 7, and 8 Synthesis Chapter 7;
Add labeling examples for single exposure of specific target organ toxicity as informative Appendix E. This part is 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 of the People's Republic of China, 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: Li Ningtao, Liu Ming, Sun Shujun, Zhao Lihua, Jiang Xuefeng, Ge Xiaojun, Song Wei, Lin Zheng, Li Chaolin, Wu Wei. The previous versions of the standards replaced by this part are: GB20599-2006||tt| |1 Scope
Chemical Classification and Labelling Specification Part 25: Specific target organ toxicity single exposure
GB30000.25—2013
This part of GB30000 specifies the terms and definitions, general description, classification criteria, decision logic and labeling of chemicals with specific target organ toxicity caused by single exposure. This part applies to the classification and labeling of chemicals with specific target organ toxicity caused by single exposure in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (hereinafter referred to as GHS). 2 Normative references
The following documents are indispensable for the application of this document. All dated references For referenced documents, 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 GB16483 Contents and Item Sequence of Safety Data Sheets for Chemicals GB30000.26 Safety Specifications for Classification and Labelling of Chemicals Part 26: Specific Target Organ Toxicity Repeated Exposure 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) 3 Terms and Definitions
The terms and definitions defined in GB13690 and the following terms and definitions apply to this document. 3.1
Single Exposure Specific Target Organ Toxicity
Specific, non-lethal target organ toxicity caused by repeated exposure to substances and mixtures, including all obvious health effects, noticeable and unnoticeable, immediate and delayed functional impairment. 4 General remarks
4.1 Classification Classifies a substance or mixture as a specific target organ toxicant which may produce potentially adverse health effects in persons exposed to it.
4.2 Classification depends on the availability of reliable evidence that a single exposure to the substance or mixture produces a consistent, identifiable toxic effect in humans, or a toxicologically significant effect in experimental animals (changes in tissue/organ function or morphology, or severe changes in the biochemistry or blood of an organism, which are relevant to human health. Human data will be the primary source of evidence for this hazard category.
4.3 The assessment should take into account not only significant changes in a single organ or biological system, but also less severe, generalized changes involving multiple organs.
4.4 Specific target organ toxicity may occur by any route of relevance to humans, i.e. primarily by oral, dermal or inhalation. 4.5 For the classification of specific target organ toxicity after repeated exposure, see GB30000.26. The following other specific toxic effects are evaluated separately and are therefore not included in this section.
GB 30000.25—2013
Acute toxicity;
Skin corrosion/irritation;
Serious eye damage/eye irritation;
Respiratory or skin sensitization;
Tumorigenicity;
Germ cell mutagenicity;
Reproductive toxicity;
Inhalation toxicity
4.6 This part includes the classification criteria for substance categories 1 and 2, the classification criteria for substance category 3 and the classification criteria for mixtures. See Table 1. 5 Classification criteria
General principles
Specific target organ toxicity
5.2 Classification criteria for substances
The general principles for classification and labelling for secondary exposure are shown in GB13690. 5.2.1 Category 1 and Category 2 for substances
Based on the weight of all available evidence, using expert judgement, including the use of suggested guidance values (see 5.2.1.10), substances are classified according to 5.2.1.1
immediate or delayed effects, respectively. Then, depending on the nature and severity of the effects observed, substances are assigned to Category 1 and Category 2, see Table 1.
Hazard classification for specific target organ toxicity after secondary exposure Substances that are significantly toxic to humans or that can be presumed to be potentially toxic to humans after a single exposure based on evidence from studies in experimental animals.
Substances are classified into Category 2 based on the following:
Category of the best quality evidence from human cases or epidemiological studies
Produced significant and/or severe toxic effects relevant to human health at generally low exposure concentrations in experiments based on observations from appropriate experimental animal studies Guidance dose concentration values (see 5.2.1.10) are provided below to assist in the classification.
Substances that can be presumed to be potentially harmful to human health following a single exposure based on evidence from studies in experimental animals. Substances may be classified into Category 3 based on observations from appropriate experimental animal studies
Produced significant and/or severe toxic effects relevant to human health at generally moderate exposure concentrations. Guidance dose scale values (see 5.2.1.10) are provided below to assist in the classification.
In special cases, human evidence may be used to place a substance in Category 2 (see 5.2.1.10) Transient target organ effects
Some target organ effects may not meet the criteria for placing a substance/mixture in Category 1 or Category 2 above. These effects adversely alter human function for a short period of time after exposure, but from which humans recover within a reasonable time without significant tissue or functional changes. This category includes narcotic effects and respiratory irritation. Substances/mixtures may be specifically placed in categories with these effects as discussed in 5.3.2
NOTE: For these categories, specific target organs/systems may be identified as the primary target organs/systems affected by the classified substance, or the substance may be classified as a general toxicant. Identify the primary target organ/system and classify accordingly, e.g. hepatotoxicant, neurotoxicant. Evaluate the data carefully and, if possible, do not include secondary effects, e.g. hepatotoxicants may have secondary effects on the nervous system or gastrointestinal system. 5.2.1.2 Relevant routes of exposure for the hazards produced by the classified substance should be identified. 5.2.1.3 Classification should be made using expert judgement based on a balance of all available evidence, including the guidance provided below. 5.2.1.4 Classification is made using expert judgement based on the weight of all available evidence, including the guidance provided below. The weight of evidence from all data, including incident human events, epidemiology and experimental animal studies, is used to justify the properties that warrant classification Target organ toxicity effects 5.2.1.5 The information required to assess target organ toxicity can be obtained from a single exposure in humans, for example, in the home, workplace or ambient environment, or from experimental animal studies. Standard animal studies in rats or mice that provide such information are acute toxicity studies, which may include clinical observations and detailed macroscopic and microscopic examinations to determine toxic effects on target tissues/organs. Results from acute toxicity studies in other species may also provide relevant information. 5.2.1.6 In exceptional cases, based on expert judgement, certain substances with evidence of human target organ toxicity may be placed in Category 2: a) when the weight of the human evidence is insufficient to justify placing the substance in Category 1, and/or b) based on the nature and severity of the effect.
Human dose/concentration levels should not be referenced in the classification, and any available evidence from animal studies should be consistent with a Category 2 classification. In other words, if animal data are also available for the chemical that justifies a Category 1 placement, then the substance should be classified in Category 1. 5.2.1.7 Effects considered to support Category 1 and Category 2 5.2.1.7.1 Evidence that a single exposure to a substance is associated with a
significant and identifiable toxic effect may support classification. 5.2.1.7.2 Evidence from incidental human experience is usually limited to reports of adverse health consequences, exposures are often uncertain, and do not provide the scientific detail that can be obtained from well-conducted experimental animal studies. 5.2.1.8 Evidence from appropriate experimental animal studies can provide more detailed information in the form of clinical observations, macroscopic and microscopic pathological examinations, and often can reveal hazards that may not be life-threatening but may indicate impairment of function. Details, and this is why all available evidence and its relevance to human health should be analysed during the classification process. Examples of relevant toxic effects in humans and/or animals are provided below: a) Distress resulting from contact with food and drink; b) Non-transient significant changes in the function of the respiratory, central nervous or peripheral nervous systems; b) Signs of central nervous system damage; and c) Signs of other organs or other organ systems, including effects on the special senses. Any consistent and significant adverse changes in chemistry, hematology, and urinalysis: Significant organ damage noticed and/or subsequently observed or confirmed on microscopic examination: e) Diffuse necrosis, fibrosis, or granulomatosis of vital organs with regenerative capacity; d) Morphological variations that are potentially insignificant but provide clear evidence of organ dysfunction; g) Evidence of progressive cell death (including cell degeneration and reduction in cell number) in vital organs without regenerative capacity. 5.2.1.9 Effects considered not to support classification in Category 1 and Category 2 Effects that may be observed but do not justify classification are listed below as examples of such effects in humans and/or animals: a) Clinical observations or minor changes in weight gain, food consumption or water intake that may have some toxicological significance but do not in themselves indicate "significant" toxicity; b) Minor changes in clinical biochemistry, hematology or urinalysis parameters and/or transient effects, but such changes or effects are doubtful or of little toxicological significance: changes in organ weights but no signs of organ dysfunction; d) Adaptive responses that are not considered to be toxicologically relevant; e) Species-specific toxicity mechanisms elicited by substances, i.e. toxicity mechanisms that are demonstrated with reasonable certainty to be not relevant to human health, should not be used as a basis for classification.
5.2.1.10 Guidance values to assist in the classification into Category 1 and Category 2 based on results from experimental animal studies 5.2.1.10.1 To assist in determining whether a substance should be classified and to what extent it should be classified (Category 1 or Category 2), "guidance values" are proposed to measure the dose/concentration that has been shown to cause significant health effects. The main reason for proposing such "guidance values" is that all chemicals are potentially toxic at high doses and therefore there should be a reasonable dose/concentration to determine the extent of their toxic effects.
5.2.1.10.2 In animal studies, when significant toxic effects are observed that indicate classification, analysis of the experimental exposure time and dose/concentration when these effects are observed, compared with the recommended guidance values, can provide useful information to help assess whether classification is required (because the toxic effect should be the result of the hazardous nature and the experimental exposure time and dose/concentration) 5.2.1.10.3 Applicable to acute toxicity tests, the recommended guidance value range for a single exposure dose that has produced significant non-lethal toxic effects is as shown in Table 2.
Table 2 Guidance range of single exposure dose
Route of exposure
Oral (rat)
Dermal (rat or rabbit)
Inhalation of gas (rat)
Inhalation of vapor (rat)
Inhalation of dust/smoke/mist (rat)
mL/(L.4h)
mg/(L:4h)
mg/(L.4h)
Category 1
Guidance value (C range
Category 2
2000≥300
200001000
20≥>2.5
20≥C10
Category 3
Guidance value not Applicable
The guidance values and ranges mentioned in this table are for guidance purposes only, i.e. they are used as part of a weight of evidence approach to assist in making a classification decision. They are not intended to be strict cut-off values.
bNo guidance value is provided because this classification is based primarily on human data. Animal data may be included in the weight of evidence assessment. 5.2.1.10.4 It is possible that certain toxicity characteristics may be observed below the guidance value (e.g. less than 2000 mg/kg bw, oral), but the nature of the effect may lead to a decision not to classify. Conversely, in animal studies, certain toxicity characteristics may be observed above the guidance value (e.g. not less than 2000 mg/kg bw, oral), and there may also be evidence from other sources (e.g. other single doses). 5.2.1.11 Other matters
5.2.1.11.1 When only animal data are used to characterize a substance (as is typical for new substances, but also for many existing substances), the classification process should refer to the dose/concentration guidance values as one of the elements that contribute to the weight of evidence approach. 5.2.1.11.2 A substance may be classified if there are adequate human data demonstrating that a specific target organ toxicity effect can be attributed with certainty to a single exposure to the substance. Positive human data take precedence over animal data, regardless of the likely dose. Thus, when a substance Where a substance is not classified because specific target organ toxicity is observed and is considered not relevant or important to humans, the substance should be classified if subsequent human incident data become available indicating specific target organ toxicity effects. 5.2.1.11.3 Substances that have not been tested for specific target organ toxicity may be classified in certain circumstances, based on data from validated structure activity relationships and extrapolated data from previously classified structural analogs based on expert judgement, as appropriate, with reference to other important factors such as the formation of common significant metabolites as substantial support. 5.2.1.11.4
Some regulatory systems may include saturated vapour concentration as an additional element to provide for specific health and safety protection. 5.2.2 Substance Category 3bZxz.net
Respiratory Tract Irritation Criteria
Criteria for classification of respiratory tract irritation as Category 3:
Respiratory tract irritation that impairs function and has symptoms such as cough, pain, choking and dyspnea (signs are local erythema, edema, a
pruritus and/or pain). It is recognized that the primary basis for this assessment is human data. b) Subjective human observations may be supplemented by objective measures of significant respiratory tract irritation (RTI) (e.g., electrophysiological response graphs, biomarkers of inflammation in nasal or bronchoalveolar lavage fluid). Observed human symptoms should also be those that are common to the exposed population, rather than isolated idiosyncratic reactions that may occur only in individuals with particularly sensitive respiratory tracts. Vague reports of "irritation" should be excluded. This is because the term is commonly used to describe a variety of GB30000.25—2013
sensations, including odor, unpleasant taste, itching, and thirst, which are not within the scope of this classification endpoint.
There are currently no validated animal tests specifically addressing respiratory tract irritation, however, useful information can be obtained from single and repeated inhalation toxicity studies. For example, animal studies can provide useful information on clinical signs of toxicity (dyspnea, dyspnea, etc.) and histopathology (e.g., congestion, edema, mild inflammation, thickening of the mucosal layer) because these signs are predictable and may reflect the characteristics of the clinical signs mentioned above. Such animal studies can be used as part of the weight of evidence assessment. e) This special classification is only used when more serious organ effects, including respiratory effects, are not observed. 5.2.2.2 Criteria for narcotic effects
The criteria for the classification of narcotic effects as Category 3 are:
a) Central nervous system depression includes human narcotic effects such as drowsiness, drowsiness, decreased alertness, loss of reflexes, loss of muscle coordination, dizziness, etc. These effects may also take the form of severe headache or nausea and may lead to decreased judgment, dizziness, irritability, fatigue, decreased memory function, decreased perception and muscle coordination, slowed reaction time or drowsiness 6) Narcotic effects observed in animal studies may include weakness, lack of coordination and corrective reflexes, drowsiness and motor dysfunction. If these effects are not transient, they should be classified in Category 1 or Category 2. 5.3 Classification criteria for mixtures
5.3.1 General principles
Mixtures may be classified using the same criteria as for substances, or they may be classified as described below. Like substances, mixtures may be classified as single-exposure specific target organ toxicants, repeated-exposure target organ toxicants, or both. 5.3.2 Classification of mixtures when data are available for the mixture as a whole If, as described in the criteria for substances, there is reliable and good quality evidence for the mixture from human experience or from appropriate experimental animal studies, then the mixture may be classified by a weight of evidence assessment of these data. When evaluating the data for mixtures, care should be taken that the dose, duration, observation or analysis does not render the results inconclusive. 5.3.3 Classification of mixtures when data are not available for the mixture as a whole: bridging principles 5.3.3.1 Use of data
If the mixture itself has not been tested to determine its specific target organ toxicity, but there are sufficient data on the individual ingredients and on similar tested mixtures to adequately characterize the hazards of the mixture, then these data will be used according to the agreed bridging principles 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 necessity for additional testing in animals.
5.3.3.2 Dilution
If a tested mixture is diluted with a diluent that is equal to or less toxic than the least toxic original ingredient and is not expected to affect the toxicity of the other ingredients, then the new mixture, after dilution, may be classified in the same category as the original tested mixture.
5.3.3.3 Batch
The toxicity of a tested production batch of a mixture can be assumed to be virtually equivalent to that of another untested production batch of the same commercial product produced by or under the control of the same manufacturer, unless there is reason to believe that the toxicity of the untested batch has changed significantly. If the latter occurs, a new classification is required. KAONTKAca
GB30000.25—2013
5.3.3.4 Concentration of highly toxic mixtures
If in a tested Category 1 mixture the concentration of a toxic ingredient is increased, the resulting more concentrated mixture should be classified as Category 1 without additional testing
5.3.3.5 Interpolation within one toxicity category For three mixtures with identical ingredients (A, B and C), where mixtures A and B have been tested and are in the same toxicity category, and where untested mixture C contains the same toxicologically active ingredients as mixtures A and B but the concentrations of its toxicologically active ingredients are intermediate between those of mixtures A and B, it can be assumed that mixture C is in the same toxicity category as A and B. 5.3.3.6 Substantially similar mixtures
Assume the following:
a) Two mixtures
AB, I: C+B;
The toxicity of component B is essentially the same in both mixtures;
b) The concentration of component A in
is equal to the concentration of component C in mixture II;
c) Mixtures
already have experimental data for component A and component C, and these data are essentially the same, that is, they belong to the same hazard category and are not expected to affect the toxicity of component B.
If mixture I or II has been classified based on test results. 5.3.3.7
Aerosols
The entire mixture may be classified in the same toxicity category If the added propellant does not affect the toxicity of the mixture upon spraying, the aerosol form of the mixture may be classified in the same hazard category as the tested non-aerosolized form of the mixture for oral
and dermal toxicity. The inhalation toxicity classification of an aerosolized mixture should be analysed separately. 5.3.4 Classification of mixtures when data are available for all or only some of the ingredients of the mixture 5.3.4.1 When reliable evidence or test data are not available for the specific compound itself and the bridging principle cannot be used for classification, the classification of the mixture will be based on the classification of the constituent substances. In this case, the mixture will be classified as a specific target organ toxicant single exposure (specify specific organ), a specific target organ toxicant repeated exposure (specify specific organ), or both when at least one ingredient is already classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate cut-off value/concentration limit for Category 1 and Category 2, respectively, as mentioned in Table 3.
Table 3 Cut-off values or concentration limits for ingredients in mixtures classified as Category 1 and Category 2 for specific target organ toxicants Component Classification
Target organ toxicant
Category 1
Organ toxicant
Category 2
Category 1
Category 2 Cut-off values/concentration limits for ingredients in mixtures classified as Category 2
Between 1.0% and ~10% (inclusive)
Note: This compromise classification scheme involves an analysis of differences in hazard communication practices in existing systems. It is expected that the number of mixtures affected will be small and the differences will be limited to label warnings; and this will increasingly develop into a more uniform approach. Classification of components
Category 1
Table 3 (continued)
Critical values/concentration limits of components for classification of mixtures GB30000.25-—2013
Category 2
If a component of a mixture is classified as a specific target organ toxicant Category 1 and its concentration is between 1.0% and 10%, then every government authority will require information to be provided on the product's safety data sheet (GB16483). However, label warnings are optional. When the concentration of the component in the mixture is between 1.0% and 10%, some government authorities will choose to label, while other government authorities usually do not require labeling in this case.
“If a component of the mixture is classified as a specific target organ toxicant Category 1 and its concentration is ≥10%, both a safety data sheet (GB16483) and a label are required.
If a component of the mixture is classified as a specific target organ toxicant Category 1 and its concentration is between 10% and 10%, some competent authorities will classify the mixture as a specific target organ toxicant Category 2, while other competent authorities will not do so. If a component of the mixture is classified as a specific target organ toxicant Category 2 and its concentration is between 10% and 10%, If the concentration of the ingredient in the mixture is between 1.0% and 10%, each competent authority will require information to be provided in the product's safety data sheet (GB16483). However, labeling is optional. When the concentration of the ingredient in the mixture is between 1.0% and 10%, some competent authorities will choose to label, while other competent authorities usually do not require labeling in this case. "If the mixture is classified as a specific target organ toxicant by one component and the concentration is not less than 10%, then both the safety data sheet (GB16483) and the label are required. 5.3.4.4 When toxicants affecting more than one organ/system are mixed, an analysis of potentiation or synergistic effects should be cautious, as some substances may be present at concentrations less than 1%, such as other toxicants in the mixture.
(Should, then specific target organ components are known to increase the window of toxic effects
5.3.4.5 Caution should be exercised when evaluating the toxicity of mixtures containing Category 3 ingredients. It is recommended that a cut-off value/concentration limit of 20% be used: However, it should be recognized that this critical value/concentration limit may be higher or lower depending on the category of the components and that some effects, such as respiratory tract concentrations, will not occur, while other effects, such as narcotic effects, may occur below 20%. Irritation may occur below the table
value. Expert judgement should be used as appropriate. Respiratory tract irritation and narcotic effects should be evaluated separately according to the criteria specified in 2. In classifying these hazards
, the effects of each component should be considered additive unless There is evidence that the effect is not additive. 6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is particularly recommended that personnel who classify negatively study Chapter 5 before and during the use of the decision logic.
7 Labeling
7.1 Overview
7.1.1 For labels for specific target organ toxicity single exposure, hazard categories are listed in the order of designated pictograms, signal words and hazard statements. 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 in the GHS label with the designated corresponding graphic symbols for each item. The allocation of label elements for specific target organ toxicity single exposure is shown in Appendix B.
7.1.2 Regarding specific The classification criteria and label elements for single exposure of target organ toxicity are shown in Appendix C. KAoNTKAca-
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7.1.3 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 also need to be included on the label. Government authorities may also require additional information, and suppliers may also add supplementary information.
7.2 Hazard pictograms
Hazard pictograms should use black symbols with white backgrounds, and the red frame should be wide enough to be eye-catching. 7.3 Signal words
Signal words are used on labels to indicate the relative severity of hazards and to alert readers to potential hazards. Hazard words. For Specific Target Organ Toxicity Single Exposure, the signal words "Danger" and "Warning" are used for the different hazard categories. For Specific Target Organ Toxicity Single Exposure Toxicants Category 1 substances, the signal word "Danger" is used. For Category 2 and Category 3, the signal word "Warning" is used. 7.4 Hazard Statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Hazard statements for Specific Target Organ Toxicity Single Exposure are given in C.1 and in Appendix D. 7.5 Precautionary Statements
A precautionary statement is a word (and/or pictogram) that describes the 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. To meet GHS requirements, there are 5 types of precautionary statements: general, prevention, emergency, storage and disposal. See Appendix D for precautionary statements for different hazard categories for Specific Target Organ Toxicity Single Exposure. 7.6 Product Identifiers
7.6.1 Product identifiers should be used on labels and should be consistent with the product identifiers 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 package. 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, reproductive cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitization, and target organ toxicity appear on the label, the label should include the chemical components of the components or alloying elements that may cause these hazards. Government authorities may also require that the chemical names of all components or alloying elements that may cause the hazards of the 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 should be provided on the label. 7.8 Labeling examples
Specific target organ toxicity (STOT) Labeling examples for single exposure are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for single exposure of STOT The decision logic for single exposure of STOT is shown in Figure A1. Substance: Does the substance have data and/or information to evaluate STOT after single exposure? Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate STOT after single exposure? Yes
Does the mixture as a whole have data and information to evaluate STOT after single exposure?
After single exposure
Does the substance or mixture have significant toxicity in humans or, based on evidence from studies in experimental animals, it can be presumed that the substance or mixture has the potential to produce significant toxicity in humans? (See 5.2) Fragrance
After single exposure
Based on evidence from studies in experimental animals, can the substance or mixture be presumed to have the potential to be harmful to human health?
After a single exposure
Can the substance or azeotropic compound produce transient narcotic effects or respiratory irritation, or both? See 5.2-5.3 for the criteria. The application of the criteria requires experts to make judgments using the weight of evidence Figure A, 1 Decision logic for specific target organ toxicity single exposure rKAoNTKAca
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Cannot be classified
Cannot be classified
See decision logic
Category 1
Category 2
Not of this type
Category 3
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