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Rules for classification and labelling of chemicals—Part 26:Specific target organ toxicity—Repeated exposure

Basic Information

Standard ID: GB 30000.26-2013

Standard Name:Rules for classification and labelling of chemicals—Part 26:Specific target organ toxicity—Repeated exposure

Chinese Name: 化学品分类和标签规范 第26部分:特异性靶器官毒性 反复接触

Standard category:National Standard (GB)

state:in force

Date of Release2013-10-10

Date of Implementation:2014-11-01

standard classification number

Standard ICS number:Environmental protection, health care and safety >> 13.300 Dangerous goods protection

Standard Classification Number:Comprehensive>>Marking, packaging, transportation, storage>>A80 Marking, packaging, transportation, storage Comprehensive

associated standards

alternative situation:Replaces GB 20601-2006

Publication information

publishing house:China Standards Press

Publication date:2014-11-01

other information

drafter:Li Jing, Wang Hua, Zhang Bin, Yu Yanyan, Liu Ming, Lin Zheng, Song Wei, Wu Weiai, Ge Xiaojun, Liang Jin

Drafting unit:Tianjin Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Institute of Occupational Health and Poison Control, Chinese Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Informati

Focal point unit:National Technical Committee on Hazardous Chemicals Management Standardization (SAC/TC 251)

Proposing 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

competent authority:National Technical Committee on Hazardous Chemicals Management Standardization (SAC/TC 251)

Introduction to standards:

GB 30000.26-2013 Chemical Classification and Labelling Specification Part 26: Specific target organ toxicity repeated exposure GB30000.26-2013 |tt||Standard compression package decompression password: www.bzxz.net
This part of GB30000 specifies the terms and definitions, general descriptions, classification criteria, decision logic, and labels for chemicals with specific target organ toxicity caused by repeated exposure. This part applies to the classification and labeling of chemicals with specific target organ toxicity caused by repeated exposure 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 26 of GB 30000.
This part was drafted in accordance with the rules given in GB/T 1.1-2009. This
part replaces GB 20601-2006 "Safety Specification for Classification, Warning Labels and Warning Statements of Chemicals-Specific Target Organ Systemic Toxicity Repeated Exposure".
Compared with GB 20601-2006, the main technical contents of this part have been changed 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 26: Specific target organ toxicity—Repeated exposure", and the English name has been modified to "Rules for classification and labelling of chemicals—Part 26:
Specific target organ toxicity—Repeated exposure";
———The scope of Chapter 1 has been modified, "Warning label" has been changed to "Label", and "Warning instructions" has been deleted;
———Chapter 4 "General instructions" has been added;
———Some statements in "Decision logic" have been modified, and "Figure 1" has been included as Appendix A;
———Part of the original Table 6 has been modified as Appendix B;
——Modify the contents of the original Table 5, change "name" to "signal word", change "hazard statement" to "hazard statement"; and put them together as Appendix C;
——Delete the original Chapter 8, and put the relevant "precautionary statement" content as informative Appendix D, and modify and integrate the original Chapter 6, Chapter 7, and Chapter 8 into Chapter 7;
——Add the label example of specific target organ toxicity repeated exposure 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" (Fourth Revised Edition).
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, Occupational Health and Poisoning Control Institute of China Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Information Center.
The main drafters of this part are: Li Jing, Wang Hua, Zhang Bin, Yu Yanyan, Liu Ming, Lin Zheng, Song Wei, Wu Weiai, Ge Xiaojun, Liang Jin. The
previous versions of the standards replaced by this part are:
———GB 20601—2006.
The following documents are indispensable for the application of this document. For all dated referenced documents, only the dated version applies to this document. For all undated referenced documents, 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
GB30000.25 Safety Specifications for Classification and Labelling of Chemicals Part 25: Specific Target Organ Toxicity Single 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)

Some standard content:

ICS13.300
National Standard of the People's Republic of China
GB30000.26—2013
Replaces GB20601—2006
Rules for classification and labelling of chemicals-Part 26:Specific target organ toxicityRepeated exposurePublished on October 10, 2013
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
Implementation on November 1, 2014
Chapter 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: Oxygen Part 6: Gases under pressure (replaces GB 20580-2006); Part 7: Flammable liquids (replaces GB 20581-2006); Part 8: Flammable solids (replaces GB 20582-2006); Part 9: White-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: White-hot 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: Flammable gases (replaces GB 20588-2006); Part 15: Flammable gases (replaces GB 20589-2006); Part 16: Flammable gases (replaces GB 20581-2006); Part 17: Flammable gases (replaces GB 20582-2006); Part 18: Flammable gases (replaces GB 20583-2006); Part 19: Flammable gases (replaces GB 20583-2006); Part 20: Flammable gases (replaces GB 20585-2006); Part 21: Flammable gases (replaces GB 20586-2006); Part 22: Flammable gases (replaces GB 20587-2006); Part 23: Flammable gases (replaces GB 20587-2006); Part 24: Flammable gases (replaces GB 2 006); Part 14: Oxidizing Liquids (replaces GB20589-2006); Part 15: Oxidizing Solids (replaces GB205902006); Part 16: Organic Peroxides (replaces GB205912006); 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 GB205942006); Part 21: Respiratory or Skin Sensitization (replaces GB20595-2006); Part 22: Germ Cell Mutagenicity Denaturation (replace GB20596-2006): Part 23: Carcinogenicity (replace GB20597-2006): Part 24: Reproductive toxicity (replace GB205982006); Part 25: Specific target organ toxicity single exposure (replace GB20599-2006): Part 26: Specific target organ toxicity repeated exposure (replace GB20601-2006); Part 27: Inhalation hazard;
Part 28: Hazards to the aquatic environment (replace GB20602-2006): Part 29: Hazards to the ozone layer:
Part 30: Warning signs for chemical workplaces: This part is Part 26 of GB30000.
This part was drafted in accordance with the rules given in GB/T1.1-2009. GB30000.26—2013
This part replaces GB20601—2006 Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals—Specific Target Organ Toxicity Repeated Exposure
Compared with GB20601-2006, 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 26: Specific target organ toxicity Repeated exposure" and the English name has been changed to "Rules for classification and labelling of chemicals—Part 26: Specific target organ toxicity Repeated exposure" exposure\; The scope of Chapter 1 was modified, "Warning label" was changed to "Label", "Warning statement" was deleted, and Chapter 4 "General instructions" was added;
Some sentences in "Decision logic" were modified, and "Figure 1\ was included as Appendix A; Part of the original Table 6 was modified as Appendix B; Part of the original Table 5 was modified, "Name" was changed to "Signal word", "Hazard statement" was changed to "Hazard statement", and they were included as Appendix C;
The original Chapter 8 was deleted, and the relevant "Precautionary statement content was included as informative Appendix D, and the original Chapters 6, 7, and 8 were modified and integrated into Chapter 7;
Added a label example for repeated exposure to specific target organ toxicity as informative Appendix E. This part is consistent with the United Nations "Globally Harmonized System of Classification and Labeling of Chemicals" (Globally Harmonized System of Classification and Labeling of Chemicals) This part is consistent with the relevant technical contents of the 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 Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Institute of Occupational Health and Poisoning Control of China Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Information Center. Main drafters of this part: Li Jing, Wang Hua, Zhang Bin, Yu Yanyan, Liu Ming, Lin Zheng, Song Wei, Wu Wei, Ge Xiaojun, Liang Jin The previous versions of the standards replaced by this part are: -GB20601-2006.
1 Scope
Part 26:
Specification for Classification and Labelling of Chemicals
Specific target organ toxicity repeated exposure
GB30000.26-2013
This part of GB30000 specifies chemicals with specific target organ toxicity caused by repeated exposure Terms and definitions, general instructions, classification criteria, decision logic, labeling of chemicals This part applies to the classification and labeling of chemicals with specific target organ toxicity caused by repeated exposure 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 indispensable for the application of this document. For all references with dates, only the versions with dates 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 Contents and order of items in safety data sheets for chemicals GB30000.25 Safety rules for classification and labeling of chemicals Part 25: Specific target organ toxicity single exposure
United Nations Recommendations on the Transport of Dangerous Goods Model Regulations (17th revised edition) United Nations "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
Specific target organ toxicity-repeatexposure
Specific, non-lethal target organ toxic effects caused by repeated exposure to substances and mixtures, including all significant health effects, reversible and irreversible, immediate and delayed impairment of function. 4 General remarks
4.1 The classification is determined to identify substances or mixtures with specific target organ toxicity, which may cause potential adverse effects on the health of the exposed person.
4.2 Classification depends on the existence of reliable evidence that repeated exposure to the substance or mixture produces consistent and recognizable toxic effects in humans, or toxicologically significant effects in experimental animals, significant changes in tissue/organ function or morphology, or serious changes in the biochemistry or hematology of the organism. These changes are relevant to human health. Human data will be the main source of evidence for this hazard category.
4.3 The evaluation should take into account not only significant changes in a single organ or biological system, but also general changes of less severity involving multiple organs.
GB30000.26-—2013
4.4 Specific target organ toxicants may occur through any route of relevance to humans, i.e. primarily through the mouth, skin or inhalation.
4.5 Specific target organ systemic toxicity for single exposure, see GB30000.25. Other specific toxic effects, such as acute toxicity, serious eye damage/eye irritation and skin corrosion/irritation, respiratory or skin sensitization, carcinogenicity, germ cell mutagenicity, reproductive toxicity and inhalation toxicity, are evaluated separately and are therefore not included in this section. 5 Classification criteria
5.1 General principles
Specific target organ toxicityFor the general principles of classification and labelling for repeated exposure, see GB 13690.5.2 Classification criteria for substances
Substances are classified as specific target organ toxicants based on the weight of all available evidence and the use of expert judgement, including the recommended guidance values ​​for duration of exposure and dose/concentration producing effects (see 5.29) in 5.2.1bZxz.net
and are classified into one of two categories, depending on the nature and severity of the effects observed
Classification of specific target organ toxicity after exposureSubstances that produce significant toxicity in humans
Substances that produce significant toxicity
Substances that are classified as specific target organ toxicants according to the following provisions
Category 1 Category 2 Based on evidence from studies in experimental animals, there is no likelihood of disease or serious toxicity in humans after repeated exposure. Reliable and best-quality evidence from studies in experimental animals. Observations from appropriate experimental animal studies. Significant and/or severe toxicity that is relevant to human health was observed in the studies. Guidance dose/concentration values ​​(see 5.2.9) are provided below to assist in classification.
In special cases, human evidence may also be used to assign substances to Category 2 (see 5.2.9) For both categories, specific organs may be identified that are primarily affected by the classified substance, or the substance may be classified as a general toxicant. Identify the primary toxic 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 produce secondary effects on the nervous system or gastrointestinal system. 5.2.2 Relevant routes of exposure for hazards arising from the classified substance should be identified. 5.2.3 Classification is based on the weight of all available evidence, including the guidance provided below, and is made using expert judgement: 5.2.4 The weight of evidence from all data, including human incidents, epidemiology and experimental animal studies, is used to substantiate the specific target organ toxic effects that warrant classification. For this purpose, the extensive industrial toxicology data collected over many years can be used. The evaluation should be based on all available data, published peer-reviewed studies, and other data accepted by the regulatory agency: The evaluation should be based on all available data, including published research materials and additional data accepted by the regulatory agency. 5.2.5 The information required for the evaluation of specific organ toxicity can be obtained from repeated exposure in humans, such as exposure at home, in the workplace or in the surrounding environment, or from experimental animal studies. Standard animal studies in rats or mice that provide such information are 28 days, 90 days or lifetime studies (up to 2 years). Such studies include hematology, clinical chemistry, and detailed macroscopic and microscopic examinations to determine toxic effects on target tissues/organs. Data obtained from repeated dose studies in other species can also be used. Other long-term exposure studies, such as carcinogenicity, neurotoxicity or reproductive toxicity studies, may also provide evidence for the assessment of specific target organ toxicity for classification. 5.2.6 In exceptional cases, based on expert judgement, certain substances with evidence of specific target organ toxicity in humans 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:
No reference should be made to human dose/concentration levels in the classification and any available evidence from animal studies should be consistent with a Category 2 classification. In other words, if there are also animal data on the substance that justify placement in Category 1, then the substance should be classified in Category 1. 5.2.7 Effects considered to support classification
5.2.7.1 Reliable evidence that repeated exposure to the substance is associated with consistent and identifiable perturbations may support classification. 5.2.7.2 Evidence from human experience/accidental events is usually limited to reports of adverse health effects, exposures are often uncertain, and may not provide the detailed scientific information that can be obtained from well-conducted experimental animal studies. 5.2.7.3 Evidence from appropriate experimental animal studies can be obtained in the form of clinical observations, haematology, clinical chemistry, macroscopic and microscopic pathological examinations, and this can often reveal hazards that may not be life-threatening, but may indicate impairment of function. Therefore, in providing more detailed information, all available evidence and relevance to human health should be considered. The following are examples of effects that should be considered in the classification process for relevant toxicity to humans and/or animals: a) Symptoms or death resulting from repeated or prolonged exposure, which bioaccumulate or result from repeated exposure to a toxicant b) Symptoms in the nervous system or peripheral organs, which may also result from repeated exposure, due to lower concentrations/concentrations of the substance or its metabolites exceeding the threshold for resolution. Significant dysfunction of other organ systems or their imaging and effects on special senses (e.g., hearing, hearing). Signs of central nervous system weakness, including significant and marked vital changes in clinical biochemistry, hematology, and health analysis parameters. Significant organ damage that may be noted at anatomy or subsequently detected or confirmed on microscopic examination. d) Multifocal or morphological variations with necrosis or granuloma formation that are potentially appreciable but provide clear evidence of organ dysfunction in vital organs with regenerative capacity (e.g., severe steatosis in the liver). Evidence of marked cell death (including cell degeneration and decreased cell number) in vital organs without regenerative capacity. 5.2.8 Data not supporting classification It is possible that effects may be observed that do not justify classification. Examples of such effects in humans and/or animals are listed below: Clinical observations or small changes in weight gain, food consumption or water intake may have some toxicological significance but do not a) by themselves indicate "significant" toxicity; b) small changes in clinical biochemistry, haematology or urinalysis parameters and/or transient effects. However, such changes or effects are of doubtful or toxicological significance; c) changes in organ mass but no signs of organ dysfunction: e) adaptive responses of no toxicological relevance: species-specific toxic mechanisms elicited by substances, i.e. toxic mechanisms that are demonstrated with reasonable certainty to be not relevant to human health, should not be used as a basis for classification.
5.2.9 Guidance values ​​used to assist classification based on results from experimental animal studies 5.2.9.1 In experimental animal studies, if only the observation of effects is relied upon without reference to experimental exposure time and dose/concentration, a basic concept in toxicology is neglected, that is, all substances are potentially toxic and it is the dose/concentration and exposure time that determine toxicity. In most experimental animal studies, the test guidelines use an upper dose value. 5.2.9.2 To help determine whether a substance should be classified and to what extent it should be classified (category 1 and category 2), dose/concentration "guidance values" are proposed to refer to the dose/concentration that has been shown to produce 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 as a standard to confirm the degree of their toxic effects. Additionally, repeated dose studies in experimental animals are designed to produce toxicity at the highest dose in order to optimize the study objective, so most studies will show some toxic effects at least at this highest dose. Therefore, it is important to determine not only what effects are produced, but also at what doses/concentrations the effects are produced and how relevant these are to humans. 5.2.9.3 In animal studies, when significant toxic effects are observed that indicate classification, reference to the experimental exposure time and dose/concentration at which these effects were observed, compared with the proposed guidance values, can provide useful information to assist in the assessment of whether classification is required (since the toxic effect is a consequence of the hazardous nature and of the experimental exposure time and dose/concentration). 5.2.9.4 The final decision on whether to classify may be influenced by the observation of significant toxic effects at doses/concentrations less than or equal to the guidance values. 5.2.9.5 The recommended guidance values ​​refer essentially to the effects observed in standard 90-day toxicity studies in rats. They can be used as a basis for extrapolating equivalent guidance values ​​for toxicity studies of longer or shorter duration, using a dose/exposure time extrapolation approach similar to Haher's inhalation rule, which is based on the principle that the effective dose is proportional to the exposure concentration and the duration of exposure. This assessment should be made on a case-by-case basis; for example, for a 28-day study: the guidance values ​​below can be multiplied by 3.
5.2.9.6 For Category 1 classification, the observation of significant toxic effects in 90-day repeated-dose experimental animal studies, and the occurrence of such effects at or below the (suggested) guidance values ​​shown in Table 2, would justify the classification. Table 2 Guidance values ​​to assist in Category 1 classification Route of exposure
Oral (rat)
Dermal (rat or rabbit)
Inhalation of gas (rat)
Inhalation of vapor (rat)
Inhalation of dust/fume/mist (rat)
mg/(kgd)
mg/(kg.d)
(mL/L)/(6h/d)
(mg/L)/(6h/d)
(mg/L)/(6h/d)
Guidance value (C) range
5.2.9.7 For Category 2 classification, the classification would be justified if a significant toxic effect is observed in a 90-day repeated dose experimental animal study and the effect is observed within the (suggested) guidance value range shown in Table 3: Table 3 Guidance values ​​to assist in Category 2 classification Route of exposure
Oral (rat) Rats)
Through the skin (rats or rabbits)
Inhalation of gas (rats)
Inhalation of vapor (rats)
Inhalation of dust/fume/mist (rats)
mg/(kg*d)
mg/(kg-d)
(mL/L)/(6h/d)
(mg/L)/(6h/d)
(mg/L)/(6h/d)||t t||Guidance value (C) range
10≤C≤100
20C200
0.05C0.25
GB30000.26—2013
5.2.9.8 The guidance values ​​and ranges mentioned in 5.2.9.6 and 5.2.9.7 are for guidance purposes only, i.e. as part of a weight of evidence approach to assist in making a classification decision. They are not intended to be used as strict cut-off values. 5.2.9.9 In repeated exposure animal studies, it is possible to observe specific toxicity characteristics at doses/concentrations below the guidance values ​​[e.g., less than 100 mg/(kg·d) orally], but the nature of the effect (e.g., field toxicity was only observed in a specific strain of male rats known to be susceptible to nephrotoxic effects) may lead to a decision not to classify. Conversely, in animal studies, a specific toxicity profile may be observed at doses above the guidance value (e.g., not less than 100 mg/(kg:d) oral route), and there may be additional information from other sources (e.g., other chronic administration studies, or case experience in humans) that supports the conclusion that classification is prudent given the weight of evidence. 5.2.10 Other Matters
5.2.10.1 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. 5.2.10.2 If there are well-substantiated human data demonstrating that a specific target organ toxicity effect can be reliably attributed to repeated or chronic exposure to the substance, then the substance may be classified. Positive human data take precedence over animal data, regardless of the likely dose. Therefore, when a substance is not classified because specific target organ toxicity was not observed at or below the recommended dose/concentration guidance value in animal testing, the substance should be classified if subsequent human incident data show specific target organ toxicity effects.
5.2.10.3 Substances that have not been tested for specific target organ toxicity may be classified in certain circumstances on the basis of data from validated structure activity relationships and extrapolation from previously classified structural analogs based on expert judgement, with substantial support from other important factors such as the formation of common significant metabolites. 5.2.10.4 Saturated vapour concentration may be used as an additional factor to provide for specific health and safety protection. 5.3 Classification criteria for mixtures
5.3.1 General principles
Mixtures may be classified using the same criteria as for substances or may be classified in accordance with the following clauses of this section. As with substances, mixtures may be classified as specific target organ toxicants for single exposure, target organ toxicants for repeated exposure, or both. 5.3.2 Classification of mixtures when data are available for the entire mixture If, ​​as described in the criteria for substances, there is reliable and good quality evidence for the mixture from human experience or appropriate experimental animal studies, then the mixture may be classified on the basis of a weight of evidence assessment of these data. When evaluating data on mixtures, care should be taken and the dose, duration, observation or analysis should not render the results inconclusive. 5.3.3 Classification of mixtures in the absence of data on 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 similar tested mixtures to adequately characterize the hazards of the mixture, then these data will be used in accordance with the following agreed bridging principles. This ensures that the classification process uses the available data to the greatest extent possible to characterize the hazards of the mixture without the need for additional testing in animals.
5.3.3.2 Dilution
If a tested mixture is diluted with a diluent that is as toxic as or less toxic than the least toxic of the original ingredients and is not expected to affect the toxicity of the other ingredients, then the new diluted mixture may be classified in the same category as the original tested mixture.
GB30000.26-2013

5.3.3.3 Product batches
The toxicity of a tested production batch of a mixture can be assumed to be substantially 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. 5.3.3.4 Concentrations of highly toxic mixtures
If the concentration of a toxic ingredient is increased in a tested Category 1 mixture, the resulting more concentrated mixture should be classified as Category 1 without additional testing
Interpolation within a toxicity category
Completely identical mixtures (A, B and C). Mixtures A and B were tested and belonged to the same toxicity category as the three ingredients. Mixture C was untested and contained the same toxicologically active ingredients as mixtures A and B, but the concentration of the toxicologically active ingredients was between that of mixture A and mixture B. 5.3.3.6 Substantially similar mixtures Assuming the following: Two mixtures: The concentration of component A in the mixture is substantially the same as that of component C in the mixture. Toxicity data for component A and component C are available and these data are substantially similar, i.e. they are in opposite hazard categories and are not expected to affect the toxicity of component B. If mixtures 1 or 2 are already classified based on the test results, then the mixtures can be classified in the same toxicity category. 5.3.3.7 Aerosols If the addition of a propellant does not affect the toxicity of the mixture on spraying, then the aerosol form of the mixture can be classified in the same hazard category as the tested non-aerosol form of the mixture for both dose and dermal toxicity. The inhalation toxicity classification of chemical mixtures should be analyzed separately. 5.3.4 Classification of mixtures when data are available for all ingredients or only for one ingredient 5.3.4.1 When there is no reliable evidence or test data for a specific mixture itself and the bridging principles cannot be used for classification, the classification of the mixture will be based on the classification of the component substances. In this case, when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant and its concentration is equal to or higher than the appropriate cut-off value/concentration limit for Category 1 and Category 2 respectively mentioned in Table 4, the mixture will be classified as a single-exposure specific target organ toxicant (specify specific organ), repeated-exposure specific target organ toxicant (specify specific organ), or both. Table 4 Cut-off values/concentration limits for ingredients of mixtures classified as specific target organ toxicants Classification of ingredients Target organ toxicant Category 1 Target organ toxicant Category 2 Cut-off values/concentration limits for ingredients when classifying mixtures Category 1 Category 2 1, 0% to 10% (inclusive of 1.0%) Note: This compromise classification scheme involves an analysis of differences in hazard communication implementation in existing systems. It is expected that the number of mixtures affected will be small and the differences will be limited to label warnings, which will increasingly develop into a more uniform approach. If an ingredient of a mixture is classified as a specific target organ toxicant Category 1.0 and its concentration is between 1.0, then each competent authority will require information to be provided on the product safety data sheet (GB16483). However, label warnings are optional. Some authorities will choose to apply a label when the concentration of the ingredient in the mixture is between 0% and 10%, while other authorities generally do not require labeling in this case. If one component of the mixture is classified as a specific target substance, its concentration in the safety manual (GB/T16483) also needs to be labeled. If a component of the mixture is classified as a specific target substance, its concentration should be classified in a specific document. If the mixture is classified as a Class 2 substance, other management departments will require the manufacturer to provide information on the product safety manual (GB/T16483). If the liquid concentration in the mixture is less than 1.0%, no labeling is required. |Some food and beverage departments
choose labeling etc. for other
need a safety technical statement
between 10% and
the competent authorities will
, that is, each upper control
between 4 and 10%
is an option
when the component is
connected regulatory authorities in this case usually
benefit, but at its concentration, the product needs a full technical statement. If a component of a food is classified as specific organ toxicant, such as GB1648O, it also needs labeling, etc.
5.3.4.2 These cut-off values ​​and subsequent classifications should apply equally and appropriately to single-dose and repeated-dose target organ toxicants. 5.3.4.3 A mixture should be classified independently as a Single-dose toxicity or repeated-dose toxicity, or neither. 5.3.4.4 When toxicants affecting more than
organ systems are mixed, the analysis for potentiation or synergism should be cautious because certain substances at concentrations less than 1% may produce specific target organ toxicity if other substances in the mixture are known to enhance the toxic effects of the substances.
6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is strongly recommended that the person responsible for classification study Chapter 5 before and during the use of the decision logic.
7 Labelling
7.1 Overview
7.1.1 For labels for specific target organ toxicity and repeated exposure, the hazard category is indicated by the specified pictogram. The order of pictogram, signal word and hazard statement is listed. The United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the "Model Regulations") covers the hazard types or categories. The designated corresponding graphic symbols for each item should be listed in the label. The allocation of label elements for specific target organ toxicity repeated exposure is shown in Appendix TKAONTKAca-
GB30000.26-2013
7.1.2 For the classification criteria and label elements for specific target organ toxicity repeated exposure, see Appendix C. 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 the supplier 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 words used on labels to indicate the relative severity of a hazard and to alert the reader to potential hazards. The signal words "Danger" and "Warning" are used for classification of different hazard categories for specific target organ toxicity repeated exposure. The signal word "Danger" is used for specific target organ toxicity repeated exposure category 1. The signal word "Warning" is used for specific target organ toxicity repeated exposure category 2. 7.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Specific target organ toxicity repeated exposure hazard statements are shown in Table C.1 and in Annex D. 7.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) that describes a recommended measure to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. There are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for different hazard categories for specific target organ toxicity repeated exposure 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 target organ systemic 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 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 repeated exposure labeling examples are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for specific target organ toxicity repeated exposure The decision logic for specific target organ toxicity repeated exposure is shown in Figure A.1. Substance: Does the substance have data and/or information to evaluate target organ toxicity after repeated exposure? Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate target organ toxicity after repeated exposure?
Mixture: Does the mixture as a whole have data/information to evaluate target organ longevity after repeated exposure?
After repeated exposure
Is the substance or mixture likely to produce 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) The use of this classification requires expert judgment on the strength of the evidence and the weighing of the evidence. After repeated 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? (See 5.2) The use of this criterion requires expert judgment using a weight of evidence approach. Figure A.1 Decision logic for specific target organ toxicity repeated exposure TKAONTKAca-
GB30000.26—2013
Cannot be classified
Cannot be classified
See Figure A.2
Category 1
Category 2
Not of this type2
Category 1
Category 2
Not this category2
Category 1
Category 2
Not this category262013
Cut-off values/concentration limits of ingredients of a mixture that would trigger classification of a mixture as a specific target organ toxicantTable 4
Classification of ingredients
Target organ toxicant
Category 1
Target organ toxicant
Category 2
Cut-off values/concentration limits of ingredients for classification of a mixtureCategory 1
Category 2
1, between 0% and 10% (inclusive of 1.0%)
Note: This compromise classification scheme involves an analysis of differences in hazard communication implementation 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 that this situation will increasingly develop into a more uniform approach. If an ingredient of a mixture is classified as a specific target organ toxicant of Category 1.0 and its concentration is between 1.0, then each competent authority will require information to be provided on the product safety data sheet (GB 16483). However, label warnings are optional. Some authorities will choose to label when the concentration of the ingredient in the mixture is between 0% and 10%, while other authorities generally do not require labeling in this case. If one component of the mixture is classified as a specific target substance, its concentration in the safety manual (GB/T16483) also needs to be labeled. If a component of the mixture is classified as a specific target substance, its concentration should be classified in a specific document. If the mixture is classified as a Class 2 substance, other management departments will require the manufacturer to provide information on the product safety manual (GB/T16483). If the liquid concentration in the mixture is less than 1.0%, no labeling is required. |Some food and beverage departments
choose labeling etc. for other
need a safety technical statement
between 10% and
the competent authorities will
, that is, each upper control
between 4 and 10%
is an option
when the component is
connected regulatory authorities in this case usually
benefit, but at its concentration, the product needs a full technical statement. If a component of a food is classified as specific organ toxicant, such as GB1648O, it also needs labeling, etc.
5.3.4.2 These cut-off values ​​and subsequent classifications should apply equally and appropriately to single-dose and repeated-dose target organ toxicants. 5.3.4.3 A mixture should be classified independently as a Single-dose toxicity or repeated-dose toxicity, or neither. 5.3.4.4 When toxicants affecting more than
organ systems are mixed, the analysis for potentiation or synergism should be cautious because certain substances at concentrations less than 1% may produce specific target organ toxicity if other substances in the mixture are known to enhance the toxic effects of the substances.
6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is strongly recommended that the person responsible for classification study Chapter 5 before and during the use of the decision logic.
7 Labelling
7.1 Overview
7.1.1 For labels for specific target organ toxicity and repeated exposure, the hazard category is indicated by the specified pictogram. The order of pictogram, signal word and hazard statement is listed. The United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the "Model Regulations") covers the hazard types or categories. The designated corresponding graphic symbols for each item should be listed in the label. The allocation of label elements for specific target organ toxicity repeated exposure is shown in Appendix TKAONTKAca-
GB30000.26-2013
7.1.2 For the classification criteria and label elements for specific target organ toxicity repeated exposure, see Appendix C. 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 the supplier 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 words used on labels to indicate the relative severity of a hazard and to alert the reader to potential hazards. The signal words "Danger" and "Warning" are used for classification of different hazard categories for specific target organ toxicity repeated exposure. The signal word "Danger" is used for specific target organ toxicity repeated exposure category 1. The signal word "Warning" is used for specific target organ toxicity repeated exposure category 2. 7.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Specific target organ toxicity repeated exposure hazard statements are shown in Table C.1 and in Annex D. 7.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) that describes a recommended measure to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. There are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for different hazard categories for specific target organ toxicity repeated exposure 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 target organ systemic 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 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 repeated exposure labeling examples are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for specific target organ toxicity repeated exposure The decision logic for specific target organ toxicity repeated exposure is shown in Figure A.1. Substance: Does the substance have data and/or information to evaluate target organ toxicity after repeated exposure? Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate target organ toxicity after repeated exposure?
Mixture: Does the mixture as a whole have data/information to evaluate target organ longevity after repeated exposure?
After repeated exposure
Is the substance or mixture likely to produce 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) The use of this classification requires expert judgment on the strength of the evidence and the weighing of the evidence. After repeated 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? (See 5.2) The use of this criterion requires expert judgment using a weight of evidence approach. Figure A.1 Decision logic for specific target organ toxicity repeated exposure TKAONTKAca-
GB30000.26—2013
Cannot be classified
Cannot be classified
See Figure A.2
Category 1
Category 2
Not of this type262013
Cut-off values/concentration limits of ingredients of a mixture that would trigger classification of a mixture as a specific target organ toxicantTable 4
Classification of ingredients
Target organ toxicant
Category 1
Target organ toxicant
Category 2
Cut-off values/concentration limits of ingredients for classification of a mixtureCategory 1
Category 2
1, between 0% and 10% (inclusive of 1.0%)
Note: This compromise classification scheme involves an analysis of differences in hazard communication implementation 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 that this situation will increasingly develop into a more uniform approach. If an ingredient of a mixture is classified as a specific target organ toxicant of Category 1.0 and its concentration is between 1.0, then each competent authority will require information to be provided on the product safety data sheet (GB 16483). However, label warnings are optional. Some authorities will choose to label when the concentration of the ingredient in the mixture is between 0% and 10%, while other authorities generally do not require labeling in this case. If one component of the mixture is classified as a specific target substance, its concentration in the safety manual (GB/T16483) also needs to be labeled. If a component of the mixture is classified as a specific target substance, its concentration should be classified in a specific document. If the mixture is classified as a Class 2 substance, other management departments will require the manufacturer to provide information on the product safety manual (GB/T16483). If the liquid concentration in the mixture is less than 1.0%, no labeling is required. |Some food and beverage departments
choose labeling etc. for other
need a safety technical statement
between 10% and
the competent authorities will
, that is, each upper control
between 4 and 10%
is an option
when the component is
connected regulatory authorities in this case usually
benefit, but at its concentration, the product needs a full technical statement. If a component of a food is classified as specific organ toxicant, such as GB1648O, it also needs labeling, etc.
5.3.4.2 These cut-off values ​​and subsequent classifications should apply equally and appropriately to single-dose and repeated-dose target organ toxicants. 5.3.4.3 A mixture should be classified independently as a Single-dose toxicity or repeated-dose toxicity, or neither. 5.3.4.4 When toxicants affecting more than
organ systems are mixed, the analysis for potentiation or synergism should be cautious because certain substances at concentrations less than 1% may produce specific target organ toxicity if other substances in the mixture are known to enhance the toxic effects of the substances.
6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is strongly recommended that the person responsible for classification study Chapter 5 before and during the use of the decision logic.
7 Labelling
7.1 Overview
7.1.1 For labels for specific target organ toxicity and repeated exposure, the hazard category is indicated by the specified pictogram. The order of pictogram, signal word and hazard statement is listed. The United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the "Model Regulations") covers the hazard types or categories. The designated corresponding graphic symbols for each item should be listed in the label. The allocation of label elements for specific target organ toxicity repeated exposure is shown in Appendix TKAONTKAca-
GB30000.26-2013
7.1.2 For the classification criteria and label elements for specific target organ toxicity repeated exposure, see Appendix C. 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 the supplier 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 words used on labels to indicate the relative severity of a hazard and to alert the reader to potential hazards. The signal words "Danger" and "Warning" are used for classification of different hazard categories for specific target organ toxicity repeated exposure. The signal word "Danger" is used for specific target organ toxicity repeated exposure category 1. The signal word "Warning" is used for specific target organ toxicity repeated exposure category 2. 7.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Specific target organ toxicity repeated exposure hazard statements are shown in Table C.1 and in Annex D. 7.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) that describes a recommended measure to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. There are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for different hazard categories for specific target organ toxicity repeated exposure 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 target organ systemic 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 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 repeated exposure labeling examples are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for specific target organ toxicity repeated exposure The decision logic for specific target organ toxicity repeated exposure is shown in Figure A.1. Substance: Does the substance have data and/or information to evaluate target organ toxicity after repeated exposure? Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate target organ toxicity after repeated exposure?
Mixture: Does the mixture as a whole have data/information to evaluate target organ longevity after repeated exposure?
After repeated exposure
Is the substance or mixture likely to produce 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) The use of this classification requires expert judgment on the strength of the evidence and the weighing of the evidence. After repeated 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? (See 5.2) The use of this criterion requires expert judgment using a weight of evidence approach. Figure A.1 Decision logic for specific target organ toxicity repeated exposure TKAONTKAca-
GB30000.26—2013
Cannot be classified
Cannot be classified
See Figure A.2
Category 1
Category 2
Not of this type0, then each competent authority will require information to be provided on the product safety data sheet (GB16483). However, label warnings are optional. When the concentration of the component in the mixture is between 0% and 10%, some competent authorities will choose to label, while other competent authorities usually do not require labeling in this case. If one component of the mixture is classified as a specific target substance, its concentration in the safety manual (GB/T16483) also needs to be labeled. If a component of the mixture is classified as a specific target substance, its concentration should be classified in a specific document. If the mixture is classified as a Class 2 substance, other management departments will require the manufacturer to provide information on the product safety manual (GB/T16483). If the liquid concentration in the mixture is less than 1.0%, no labeling is required. |Some food and beverage departments
choose labeling etc. for other
need a safety technical statement
between 10% and
the competent authorities will
, that is, each upper control
between 4 and 10%
is an option
when the component is
connected regulatory authorities in this case usually
benefit, but at its concentration, the product needs a full technical statement. If a component of a food is classified as specific organ toxicant, such as GB1648O, it also needs labeling, etc.
5.3.4.2 These cut-off values ​​and subsequent classifications should apply equally and appropriately to single-dose and repeated-dose target organ toxicants. 5.3.4.3 A mixture should be classified independently as a Single-dose toxicity or repeated-dose toxicity, or neither. 5.3.4.4 When toxicants affecting more than
organ systems are mixed, the analysis for potentiation or synergism should be cautious because certain substances at concentrations less than 1% may produce specific target organ toxicity if other substances in the mixture are known to enhance the toxic effects of the substances.
6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is strongly recommended that the person responsible for classification study Chapter 5 before and during the use of the decision logic.
7 Labelling
7.1 Overview
7.1.1 For labels for specific target organ toxicity and repeated exposure, the hazard category is indicated by the specified pictogram. The order of pictogram, signal word and hazard statement is listed. The United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the "Model Regulations") covers the hazard types or categories. The designated corresponding graphic symbols for each item should be listed in the label. The allocation of label elements for specific target organ toxicity repeated exposure is shown in Appendix TKAONTKAca-
GB30000.26-2013
7.1.2 For the classification criteria and label elements for specific target organ toxicity repeated exposure, see Appendix C. 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 the supplier 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 words used on labels to indicate the relative severity of a hazard and to alert the reader to potential hazards. The signal words "Danger" and "Warning" are used for classification of different hazard categories for specific target organ toxicity repeated exposure. The signal word "Danger" is used for specific target organ toxicity repeated exposure category 1. The signal word "Warning" is used for specific target organ toxicity repeated exposure category 2. 7.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Specific target organ toxicity repeated exposure hazard statements are shown in Table C.1 and in Annex D. 7.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) that describes a recommended measure to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. There are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for different hazard categories for specific target organ toxicity repeated exposure 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 target organ systemic 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 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 repeated exposure labeling examples are shown in Appendix E Appendix A
(Informative Appendix)
Decision logic for specific target organ toxicity repeated exposure The decision logic for specific target organ toxicity repeated exposure is shown in Figure A.1. Substance: Does the substance have data and/or information to evaluate target organ toxicity after repeated exposure? Mixture: Does the mixture as a whole or its ingredients have data/information to evaluate target organ toxicity after repeated exposure?
Mixture: Does the mixture as a whole have data/information to evaluate target organ longevity after repeated exposure?
After repeated exposure
Is the substance or mixture likely to produce 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) The use of this classification requires expert judgment on the strength of the evidence and the weighing of the evidence. After repeated 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? (See 5.2) The use of this criterion requires expert judgment using a weight of evidence approach. Figure A.1 Decision logic for specific target organ toxicity repeated exposure TKAONTKAca-
GB30000.26—2013
Cannot be classified
Cannot be classified
See Figure A.2
Category 1
Category 2
Not of this type0, then each competent authority will require the information to be provided on the product safety data sheet (GB16483). However, label warnings are optional. When the concentration of the component in the mixture is between 0% and 10%, some competent authorities will choose to label, while other competent authorities usually do not require labeling in this case. If one component of the mixture is classified as a specific target substance, its concentration in the safety manual (GB/T16483) also needs to be labeled. If a component of the mixture is classified as a specific target substance, its concentration should be classified in a specific document. If the mixture is classified as a Class 2 substance, other management departments will require the manufacturer to provide information on the product safety manual (GB/T16483). If the liquid concentration in the mixture is less than 1.0%, no labeling is required. |Some food and beverage departments
choose labeling etc. for other
need a safety technical statement
between 10% and
the competent authorities will
, that is, each upper control
between 4 and 10%
is an option
when the component is
connected regulatory authorities in this case usually
benefit, but at its concentration, the product needs a full technical statement. If a component of a food is classified as specific organ toxicant, such as GB1648O, it also needs labeling, etc.
5.3.4.2 These cut-off values ​​and subsequent classifications should apply equally and appropriately to single-dose and repeated-dose target organ toxicants. 5.3.4.3 A mixture should be classified independently as a Single-dose toxicity or repeated-dose toxicity, or neither. 5.3.4.4 When toxicants affecting more than
organ systems are mixed, the analysis for potentiation or synergism should be cautious because certain substances at concentrations less than 1% may produce specific target organ toxicity if other substances in the mixture are known to enhance the toxic effects of the substances.
6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is strongly recommended that the person responsible for classification study Chapter 5 before and during the use of the decision logic.
7 Labelling
7.1 Overview
7.1.1 For labels for specific target organ toxicity and repeated exposure, the hazard category is indicated by the specified pictogram. The order of pictogram, signal word and hazard statement is listed. The United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the "Model Regulations") covers the hazard types or categories. The designated corresponding graphic symbols for each item should be listed in the label. The allocation of label elements for specific target organ toxicity repeated exposure is shown in Appendix TKAONTKAca-
GB30000.26-2013
7.1.2 For the classification criteria and label elements for specific target organ toxicity repeated exposure, see Appendix C. 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 the supplier 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 words used on labels to indicate the relative severity of a hazard and to alert the reader to potential hazards. The signal words "Danger" and "Warning" are used for classification of different hazard categories for specific target organ toxicity repeated exposure. The signal word "Danger" is used for specific target organ toxicity repeated exposure category 1. The signal word "Warning" is used for specific target organ toxicity repeated exposure category 2. 7.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Spe
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