GB 30000.23-2013 Chemical Classification and Labelling Specification Part 23: Carcinogenicity GB30000.23-2013 |tt||Standard compression package decompression password: www.bzxz.net
This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and guidance, and labeling of chemicals with carcinogenicity. This part applies to the classification and labeling of chemicals with carcinogenicity in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.
Chapter 4 and Chapter 6 of this part are mandatory, and the rest are recommended.
The expected structure of GB30000 "Specifications for Classification and Labelling of Chemicals" and the national standards to be replaced are:
———Part 1: General (replaces GB13690-2009);
———Part 2: Explosives (replaces GB20576-2006);
———Part 3: Flammable gases (replaces GB20577-2006);
———Part 4: Aerosols (replaces GB20578-2006);
———Part 5: Oxidizing gases (replaces GB20579-2006);
———Part 6: Gases under pressure (replaces GB20580-2006);
———Part 7: Flammable liquids (replaces GB20581-2006);
———Part 8: Flammable solids (replaces GB 20582-2006);
———Part 9: Self-reactive substances and mixtures (replaces GB 20583-2006);
———Part 10: Pyrophoric liquids (replaces GB 20585-2006);
———Part 11: Pyrophoric solids (replaces GB 20586-2006);
———Part 12: Self-heating substances and mixtures (replaces GB 20584-2006);
———Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replaces GB 20587-2006);
———Part 14: Oxidizing liquids (replaces GB 20589-2006);
——Part 15: Oxidizing solids (replaces GB 20590-2006);
——Part 16: Organic peroxides (replaces GB 20591-2006);
——Part 17: Corrosive to metals (replaces GB 20588-2006);
——Part 18: Acute toxicity (replaces GB 20592-2006);
——Part 19: Skin corrosion/irritation (replaces GB 20593-2006);
——Part 20: Serious eye damage/eye irritation (replaces GB 20594-2006);
——Part 21: Respiratory or skin sensitization (replaces GB 20595-2006);
———Part 22: Germ cell mutagenicity (replaces GB 20596-2006);
———Part 23: Carcinogenicity (replaces GB 20597-2006);
———Part 24: Reproductive toxicity (replaces GB 20598-2006);
———Part 25: Specific target organ toxicity single exposure (replaces GB 20599-2006);
———Part 26: Specific target organ toxicity repeated exposure (replaces GB 20601-2006);
———Part 27: Aspiration hazard;
———Part 28: Hazard to the aquatic environment (replaces GB 20602-2006);
———Part 29: Hazard to the ozone layer;
———Part 30: Warning signs for chemical workplaces.
This part is part 23 of GB 30000.
This part was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB 20597-2006 “Safety Specification for Classification, Precautionary Labelling and Precautionary Statements of Chemicals - Carcinogenicity”.
Compared with GB20597-2006, 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 23: Carcinogenicity" and the English name is "Rules for classification and labelling of chemicals—Part 23: Carcinogenicity";
———The scope of Chapter 1 has been modified, "Warning label" has been changed to "Label", and "Warning statement" has been deleted;
———Chapter 2 "Normative references" has been modified, the original references have been deleted, and two normative references GB13690 and GB/T16483 have been added;
———The introduction to Chapter 3 "Terms and Definitions" has been added;
———The format of Table 2 has been modified in accordance with the fourth edition of GHS;
———Part of the content in Appendix A has been modified in accordance with the fourth edition of GHS;
——The content of Chapter 5 has been structurally adjusted;
——The labeling examples of carcinogenicity have been added as informative Appendix E.
This part is consistent with the relevant technical content of the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) (Fourth Revised Edition).
This part is proposed and managed by the National Technical Committee for Hazardous Chemicals Management Standardization (SAC/TC251).
The 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, China Chemical Information Center.
The main drafters of this part: Zhao Zhuo, Yang Jing, Ma Jun, Liu Wei, Sun Li, Ge Xiaojun, Liang Jin, Wu Weiai. The
previous versions of the standards replaced by this part are:
——GB20597-2006.
The following documents are indispensable for the application of this document. For any referenced document with a date, only the version with the date is applicable to this document. For any referenced document without a date, the latest version (including all amendments) is applicable to this document.
GB13690 General Rules for Classification and Hazard Communication of Chemicals
GB/T16483 Contents and Item Sequence of Safety Data Sheets for Chemicals
United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (Seventeenth Revised Edition)
United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition)

ICS13.300
National Standard of the People's Republic of China
GB30000.23—2013
Replaces GB205972006
Rules for classification and labelling of chemicals-Part 23:Carcinogenicity
Issued on October 10, 2013
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Administration of Standardization of the People's Republic of China
Implementation on November 1, 2014
Chapter 4 and Chapter 6 of this part are mandatory, and the rest are recommended. The expected structure of GB 30000 Chemical Classification and Labeling Specification and the national standards to be replaced are: Part 1: General (replaces GB13690-2009); Part 2: Explosives (replaces GB20576-2006); Part 3: Flammable gases (replaces GB20577-2006); Part 4: Aerosols (replaces GB20578-2006); Part 5: Oxidizing gases (replaces GB20579-2006); Part 6: Pressurized gases (replaces GB20580-2006); Part 7: Flammable liquids (replaces GB20581-2006); Part 8: Flammable gases (replaces GB20582-2006); Part 9: Flammable liquids (replaces GB20583-2006); Part 10: Flammable gases (replaces GB20584-2006); Part 11: Flammable gases (replaces GB20585-2006); Part 12: Flammable gases (replaces GB20586-2006); Part 13: Flammable gases (replaces GB20587-2006); Part 14: Flammable gases (replaces GB20588-2006); Part 15: Flammable gases (replaces GB20589-2006); Part 16: Flammable gases (replaces GB20581-2006); Part 17: Flammable liquids (replaces GB20583-2006); Part 18: Flammable gases (replaces GB20587-2006); Part 19: Flammable gases (replaces GB20587-2006); Part 20: Flammable gases Part: Flammable solids (replaces GB20582-2006); Part 9: Self-reactive substances and mixtures (replaces GB20583-2006); Part 10: Pyrophoric liquids (replaces GB20585-2006); Part 11: Pyrophoric 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 (replaces GB20587-2006); Part 14: Oxidizing liquids (replaces 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 GB20595-2006): Part 22: Germ Cell Mutagenicity (Replace GB2059 6-2006): Part 23: Carcinogenicity (replaces GB205972006): Part 24: Reproductive toxicity (replaces GB205982006); Part 25: Specific target organ toxicity single exposure (replaces GB205992006): 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 23 of GB30000. This part is drafted in accordance with the rules given in GB/T1.1-2009. GB30000.23—2013
This part replaces GB20597-2006 "Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals - Carcinogenicity"
Compared with GB20597-2006, the main technical content of this part has changed as follows: Part 23: Carcinogenicity", the English name has been changed to the name of the standard, and the Chinese name has been changed to "Rules for classification and labelling of chemicals chemicals-Part 23.Carcinogenicity\;I
GB30000.23—2013
Revised the scope of Chapter 1, changed "warning label" to "label", deleted "warning statement"; revised Chapter 2 "normative references", deleted the original references, and added two normative references GB13690 and GB/T16483;
Added the introduction of Chapter 3 "Terms and Definitions"; revised the format of Table 2 according to the fourth edition of GHS; revised some contents in Appendix A according to the fourth edition of GHS; made structural adjustments to the contents of Chapter 5;
Added the label example of carcinogenicity as an 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 (Globally Harmonized System of Classification and Labelling of Chemicals, GHS) (fourth revised edition). This part was proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). This part was drafted by: Tianjin Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Institute of Occupational Health and Poison Control of China Center for Disease Control and Prevention, China Chemical Information Center.
The main drafters of this part are: Zhao Zhuo, Yang Jing, Ma Jun, Liu Wei, Sun Li, Ge Xiaojun, Liang Jin, Wu Wei. The previous versions of the standard replaced by this part are: GB20597-2006.
1 Scope
Chemical Classification and Labeling Specification
Part 23: Carcinogenicity
GB30000.23-2013
This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and guidance, and labeling of chemicals with carcinogenicity. This part applies to the classification and labeling of chemicals with carcinogenicity 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 dated references, only the dated versions apply to this document. For all undated references, the latest versions (including all amendments) apply to this document GB13690 General Rules for Classification and Hazard Communication of Chemicals GB/T16483 Contents and Item Sequence of Chemical Safety Data Sheets United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (17th Revised Edition) United Nations "Globally Harmonized System of Classification and Labelling 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
Carcinogen
A substance or mixture that can cause addiction or increase the incidence of cancer. Substances and mixtures that induce benign and malignant tumors in well-conducted animal experimental studies are also considered to be presumed or suspected human carcinogens unless there is conclusive evidence that the mechanism of tumor formation is not related to humans. Classifying a substance or mixture as having a carcinogenic hazard is based on the properties of the substance itself and does not provide information on the high or low risk of human carcinogenesis that may arise from the use of the substance or mixture. 4 Classification criteria
4.1 General principles
For the general principles of carcinogenicity classification and labeling, see GB13690. 4.2 Classification criteria for substances
4.2.1 In order to classify substances for carcinogenicity, substances should be classified into one of two categories based on the sufficiency of evidence and additional considerations (weight of evidence), see Table 1. In some cases, classification for specific pathways may be required GB30000.23-—2013
Category 1
Category 1A
Category 1B
Category 2
Table 1 Carcinogen Hazard Classification
Known or Presumed Human Carcinogens
Substances may be classified as Category 1 on the basis of epidemiological and/or animal experimental data. Individual substances may be further classified Known to be carcinogenic to humans: the classification of the substance is based primarily on human evidence. Presumed to be carcinogenic to humans: the classification of the substance is based primarily on animal evidence,
based on the strength of the evidence and additional considerations. Such evidence may come from human studies where a causal relationship between exposure to the substance and the development of cancer in humans has been established (known human carcinogens). Alternatively, evidence may come from animal studies where animal pathogenicity has been demonstrated with sufficient evidence (prescribed human carcinogens). In addition, on a case-by-case basis, scientific judgement may be required to make a presumptive human carcinogenicity determination based on studies showing limited human carcinogenicity evidence and limited experimental animal carcinogenicity evidence. Classification: Category A and Encephalogens. Evidence from human and/or animal studies places the substance in Category 2, provided that such evidence does not convincingly place the substance in Category 1. Depending on the strength of the evidence and additional considerations, such evidence may be derived from limited carcinogenicity in human studies or limited carcinogenicity evidence in animal studies. Category Encephalogens. 4.2.2 Classification of toxicants is based on reliable and well-known properties of the substance.
The assessment should be made based on all available evidence, including internal data on the toxic effect, published peer-reviewed studies, and other data accepted by the regulatory agency. 4.2.3 Classification of substances as carcinogenic is a single-step process based on criteria that involves two interrelated decisions: an assessment of the strength of the evidence and an evaluation of all other relevant information in order to classify substances that are suspected of causing human carcinogenesis into a higher hazard category. 4.2.4 The strength of the evidence includes a listing of tumors in human and animal studies and their statistical significance. Human Exposure and Development of Cancer Treatments
Sufficient human evidence demonstrates a causal relationship between a substance and an increased incidence of tumors. A positive association between exposure and addiction may be considered limited human evidence, but does not indicate a causal relationship. If the data indicate a carcinogenic effect, this may be considered limited animal evidence, but the evidence is not sufficient. The terms "sufficient" and "limited" are used in this section in the sense defined by the International Agency for Research on Cancer (IARC), which are summarized in 5.4.2.5 Additional considerations (weight of evidence). 4.2.5.1 These factors either raise or lower the level of concern about carcinogenicity to humans. The relative emphasis given to each factor depends on the amount and relevance of the evidence associated with each factor. The information required to lower the level of concern is more comprehensive than that required to raise the level of concern. Additional considerations should be evaluated when evaluating tumor findings and other factors on a case-by-case basis. 4.2.5.2 When assessing the overall level of concern, some important factors that should be evaluated are: type of tumor and background range of effects; Www.bzxZ.net
multiple site reactions;
malignant lesion progression;
reduced tumor latency.
Additional factors that may increase or decrease the level of concern include: whether the reaction occurs in one sex or both; whether the reaction occurs in a single species or in multiple species; whether there is structural similarity to substances with sufficient evidence of carcinogenicity2
Route of exposure:
Comparison of absorption, distribution, metabolism and excretion between experimental animals and humans; the possibility of confounding effects of excessive toxicity at the test dose; GB30000.23-—2013
Mode of action and its relevance to humans, such as mutagenicity, growth-stimulating cytotoxicity, mitogenicity, immunosuppression. 4.2.5.3 Mutagenicity: It is recognized that gene activity plays a central role in the overall development of cancer. Therefore, evidence of in vivo mutagenic activity can indicate that a substance may have a carcinogenic effect. 4.2.5.4The following additional considerations can be used to classify a substance as Category 1 or Category 2. In some cases, substances that have not been tested for carcinogenicity may be classified as Category 1 or Category 2 based on tumor data obtained through structural analogy and extensive supporting information obtained through evaluation of other important factors (such as the formation of common important metabolites), such as benzidine derivative dyes. 4.2.5.5 Classification should also determine whether the substance is absorbed through a specific pathway or whether local tumors only occur at the site of administration of the tested route, while appropriate tests through other major routes show no carcinogenicity. 4.2.5.6 In making the classification, all knowledge of the physicochemical properties, toxicokinetics and toxicological properties of the substance and any existing relevant information on chemical analogs, i.e. structure activity relationships, should be determined. Some competent authorities may need greater flexibility, rather than being limited to the hazard classification scheme, and the safety data sheet 4.2.6
(GB/T16483) information can be adopted. All positive results of addiction studies that are statistically significant and conducted according to good scientific principles can be adopted. 4.2.7 The relative hazard potential of chemicals varies greatly due to their intrinsic potency, and it may be important to balance these potency differences. Work remains to be done to review the approach to potency assessment. The addictive potency used here does not exclude risk assessment. WHO/IPCS/WHO/CS Day has some scientific issues with the classification of chemicals such as liver tumors in mice, peroxisome proliferation, and mutagenicity. Therefore, it is necessary to clarify the scientific issues that have led to mutagenicity and phenotypic mutagenicity in the past, indicating that the classification of sub-chemicals has caused a decrease in somatic transmission, and that they are carcinogenic at moderate doses but have not been proven to be carcinogenic. If these scientific issues are resolved, the classification of some chemical carcinogens will have a solid basis. 4.3 Classification criteria for mixtures Classification of mixtures when data are available for the entire mixture 4.3.1 Principles required for the classification of mixtures. Once the classification of mixtures is based on the available data for the individual ingredients, using the cut-off values ​​for these ingredients: the classification can be modified on a case-by-case basis based on the available test data for the mixture as a whole. The test results for the mixture as a whole should be conclusive, taking into account the evaluation dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of the carcinogenicity test system, and appropriate documentation supporting the classification should be maintained and available for review upon request. 4.3.2 Classification of mixtures when data are not available for the mixture as a whole, bridging principles 4.3.2.1 If the mixture itself has not been tested to determine its carcinogenic hazard, and 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 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
4.3.2.2 Dilution:
If a tested mixture is diluted with a diluent that is not expected to affect the carcinogenicity of the other ingredients, then the new diluted mixture may be classified in the same category as the original tested mixture. 4.3.2.3 Product batches:
The carcinogenic potential of a tested production batch of a mixture is substantially the same as that of another untested production batch of the same commercial product produced by the same manufacturer or under his control, unless there is reason to believe that the untested batch has a significant change in its carcinogenic potential. If the latter occurs, a new classification is required. 4.3.2.4 Substantially similar mixtures:
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Assume the following:
a) Two mixtures: I: A+B, IC+B; b) The concentration of carcinogenic component B is essentially the same in both mixtures: c) The concentration of component A in mixture I is equal to the concentration of component C in mixture II: d) Toxicity data for A and C are available and are substantially the same, i.e. they belong to the same hazard category and may not affect the carcinogenicity of B.
If mixture I or II has already been classified based on test results, then another mixture may be assigned to the same hazard category. 4.3.3 Classification of mixtures when data are available for all ingredients or only for some ingredients When at least one ingredient has been classified as a carcinogen in Category 1 or Category 2.And its concentration is equal to or higher than the appropriate cut-off value/concentration limit for category 1 and category 2 shown in Table 2, the mixture should be classified as a carcinogen. Table 2 Cut-off value/concentration limit of components of mixtures classified as carcinogens Carcinogenic mixture category and its component threshold/concentration limit Component classification
Carcinogen category 1A
Carcinogen category 1B
Carcinogen category 2
Category 1A
Carcinogen category 1
Category 1B
Carcinogen category 2
If the concentration of the carcinogen category 2 component in the mixture is between 0.1% and 1%, then every competent authority will require information to be provided in the product's safety data sheet (GB/T16483). However, label warnings are optional. When the concentration of the component 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 concentration of the Category 2 carcinogen component in the mixture is not less than 1%, then generally both a safety data sheet (GB/T 16483) and a label are required.
5 Decision logic and guidance
The decision logic and guidance are for reference only. See Appendix A for the decision logic. It is particularly recommended that the person responsible for classification study Chapter 4 5.1 Human carcinogenicity before and during the use of the decision logic
Evidence on carcinogenicity in human studies can be classified into one of the following categories: Sufficient evidence of carcinogenicity: A causal relationship has been established between exposure to a substance, mixture or exposure environment and human cancer. In other words, a
that is, in studies in which chance, bias and confounding factors can be excluded with reasonable confidence, a positive association between exposure and cancer is observed.
b) Limited evidence of carcinogenicity: A positive association is observed between exposure to a substance, mixture or exposure environment and cancer. The interpretation is that the causal relationship is credible, but chance, bias and confounding cannot be excluded with reasonable confidence. In some cases, the above categories can be used to classify the degree of evidence related to carcinogenicity to specific organs or tissues. 5.2 Carcinogenicity in experimental animals
Evidence related to carcinogenicity in experimental animals is classified into one of the following categories: GB30000.23—2013
a) Sufficient evidence of carcinogenicity: A causal relationship between the substance or mixture and an increased incidence of malignant tumors or appropriate complications of benign and malignant tumors is established in the following situations: 1) Two or more animals: or
2) Two or more experiments conducted on the same animal at different times or in different laboratories or according to different protocols b) As an exception, a single study in one animal may be considered to provide sufficient evidence of carcinogenicity when malignant tumours occur to an unusual degree in terms of frequency, site, tumour type or age of onset: c) Limited evidence of carcinogenicity: the data show a carcinogenic effect but are insufficient for a definite assessment because, for example, 1) the evidence for carcinogenicity is limited to a single experiment; or there are unresolved questions about the adequacy of the design, conduct or interpretation of the study; or 2) the substance or mixture provides only the incidence of benign tumours or lesions of uncertain neoplastic potential, or only increases the incidence of certain tumours that may arise spontaneously at a high rate in certain strains. 6 Labelling
6.1 General
6.1.1 For carcinogenicity labels, the hazard categories are listed in the order of the assigned pictogram, signal word and hazard statement. The hazard types or categories covered by the United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the Model Regulations) should list the designated corresponding graphic signs for each item on the label. The allocation of carcinogenic label elements is shown in Appendix B. 6.1.2 Classification criteria and label elements for carcinogenicity are shown in Appendix C. 6.1.3 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, which also need to be included on the label, the competent authorities may also require additional information, and the supplier may also add supplementary information.
6.2 Hazard pictograms
Hazard pictograms should use black symbols with white backgrounds, and the red frame should be wide enough to be eye-catching. 6.3 Signal words
Signal words refer to the words used on the label to indicate the relative severity of the hazard and to alert readers to potential hazards. For different hazard categories of tumorigenicity, the signal words "Danger" and "Warning" are used. For carcinogen category 1, the signal word "Danger" is used. For carcinogen category 2, the signal word "Warning" is used.
6.4 Hazard Statements
Hazard statements are phrases assigned to a hazard class and category that describe the nature of the hazard of a hazardous product and, where appropriate, its degree of hazard. Hazard statements for carcinogens are given in Annex C and see Annex D6.5 Precautionary Statements
A precautionary statement is a word (and/or pictogram) that describes 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. There are five types of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for different hazard categories of carcinogenicity are given in Annex D5
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6.6 Product Identifiers
6.6.1 Product identifiers should be used on labels and should be consistent with those 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. 6.6.2 The label shall 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, respiratory or skin sensitization or specific target organ toxicity appear on the label, the label shall 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 cause the hazard of the mixture or alloy be listed on the label. 6.7
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture should be provided on the label. 6.8 Label examples
For examples of carcinogenicity labels, see Appendix E.
For carcinogenicity decision logic, see Figures A.1 to A.3. Appendix A
(Informative Appendix)
Carcinogenicity decision logic
Substance: Does the substance have carcinogenicity data?
According to the criteria (see 4.2) Substance:
1) Known to have human carcinogenic potential: or
2 Assumed to have human carcinogenic potential?
Using the nuclear criteria requires experts to make judgments using the sufficiency of evidence and weight approach.
According to the criteria see 43), is the substance a suspected human carcinogen? Using this criteria requires experts to make judgments using the sufficiency of evidence and weight approach.
Figure A: 1
Decision logic for carcinogenicity of substances
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Cannot be classified
Not of this type
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Mixtures, the classification of mixtures should be based on the existing test data for the individual components of the mixture, using the cut-off values/concentration limits of these components. The classification can be modified on a case-by-case basis based on available test data for the mixture as a whole or on bridging principles, see Figure A.3 Category 1
Does the mixture contain one or more ingredients classified as carcinogens in Category 1 at the following levels? ≥ 0.1%.
Does the mixture contain one or more ingredients classified as carcinogens in Category 2 at the following levels? 8) ≥ 0.1%:
b) ≥ 1.0%
Figure A.2 Classification based on individual ingredients of the mixture Taking into account dose and other factors such as carcinogenicity test data available for the mixture as a whole?
Duration of the system, observations and analysis (e.g. statistical analysis, test sensitivity), are the test results for the mixture conclusive?
Can bridging principles be used? (See 4.3.2) Danger
Category 2
Not of this category
Assign to appropriate category
Danger or
Warning or
Not of this category
See Figure A.2: Classification based on the individual ingredients of the mixture* If data from another mixture are used when applying the bridging principle, the data for this mixture should be conclusive according to 4.3.2. Figure A3
Modification on a case-by-case basis
Assignment of carcinogenicity label elements to Table B.1. Appendix B
(Normative Appendix)
Allocation of label elements for carcinogenicity
Allocation of label elements for carcinogenicity
Category 1A
May be carcinogenic
(If it is conclusively proved
that no other routes of exposure will cause this hazard, the route of exposure shall be stated)
Category 1B
May cause tumors
(If it is conclusively proved
that no other routes of exposure will cause this hazard, the route of exposure shall be stated)
Carcinogenicity is not required in the Model Regulations. Category 2
Suspected dementia
(If it is conclusively demonstrated that no other routes of exposure would cause the hazard, the route of exposure is stated)
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