Rules for classification and labelling of chemicals—Part 22:Germ cell mutagenicity
Some standard content:
ICS13.300
National Standard of the People's Republic of China
GB30000.22—2013
Replaces GB205962006
Rules for classification and labelling of chemicals-Part22:Germcell mutagenicity mutagenicity2013-10-10 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2014-11-01 Implementation
Chapter 4 and Chapter 6 of this part are mandatory, and the rest are recommended. The expected structure of GB30000 "Chemical Classification and Labeling Specification" and the national standards to be replaced are: Part 1: General (replaces GB13690-2009); Part 2: Explosives (replaces GB205762006); 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 GB20582-2006): Part 9: Self-reactive substances and mixtures (replaces GB20583-2006); Part 10: White flammable liquids (replaces GB20585-2006): Part 11: Self-igniting solids (replaces GB20586-2006); Part 12: Self-heating substances and mixtures (replaces GB20584-2006): Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replaces Replace GB20587-2006); Part 14: Oxidizing Liquids (Replace GB20580-2006); Part 15: Oxidizing Solids (Replace GB205902006): Part 16: Organic Peroxides (Replace GB20591-2006): Part 17: Metal Corrosives (Replace GB205882006): Part 18: Acute Toxicity (Replace GB20592-2006): Part 19: Skin Corrosion/Irritation (Replace GB205932006); Part 20: Serious Eye Damage/Eye Irritation (Replace GB205942906): Part 21: Respiratory or Skin Sensitization (Replace GB205952006 ): Part 22: Germ cell mutagenicity (replaces GB20596-2006): Part 23: Carcinogenicity (replaces GB20597-2006): Part 24: Reproductive toxicity (replaces GB20598-2006); Part 25: Specific target organ toxicity single exposure (replaces GB20599-2006); Part 26: Specific target organ toxicity repeated exposure (replaces GB206012006): 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 22 of GB30000.
This part was drafted in accordance with the rules given in GB/T 1.1-2009. GB30000.22—2013
This part replaces GB20596-2006 Safety Rules for Classification, Precautionary Labelling and Precautionary Statements of Chemicals - Germ Cell Mutagenicity. This part is consistent with the relevant technical contents of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (Fourth Revised Edition). Compared with GB20596-2006, the main technical content changes of this part are as follows: T
GB30000.22—2013
The name of the standard has been modified. The Chinese name has been changed to "Rules for classification and labelling of chemicals Part 22: Germ cell mutagenicity", and the English name has been changed to \Rules for classification and labelling of chemicals Part 22: Germ cell mutagenicity muta-genicity
The scope of Chapter 1 was modified, "warning label" was changed to "label", and "warning instructions" was deleted; Chapter 2 "Normative References" was modified, and 11 normative references such as OECD471 of the Organization for Economic Cooperation and Development were replaced by equivalent national standards and placed in the informative Appendix F, and the normative references of GB13690 were added; the introduction to Chapter 3 "Terms and Definitions" was added: Clause 4.1 was added;
The judgment flow chart and guidance of Figures 1 and 2 in the original Chapter 5 were made into informative Appendix A, and the original Figure 2 "Does the mixture contain one or more components classified as Category 2 mutagens and the concentration is: not less than 0.1%? \ was modified to "Does the mixture contain one or more components classified as Category 2 mutagens and the concentration is not less than 1.0%? " in Figure A.2. "; In addition to the original Chapter 7, Table 4 of the original Chapter 7 was modified as Normative Appendix B according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (4th revised edition);
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (4th revised edition), the original Chapter 6, Chapter 7 and Chapter 8 were modified and integrated into Chapter 6: The original Table 3 was modified as Normative Appendix C: The original Chapter 8 was deleted, and the relevant "Hazard Statements" and "Precautionary Statements Contents" were made as Informative Appendix D; Informative Appendix E "Label Examples for Germ Cell Mutagenicity" was added. This part was proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). Drafting units of this part: Jiangsu Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, China Chemical Information Center, National Quality Supervision and Inspection Center for Hazardous Chemicals, Huafeng Group Co., Ltd. The main drafters of this part: Wang Hongsong, Zhou Zhirong, Xu Yan, Gao Xiang, Zhang Junxi, Ge Xiaojun, Li Xiaofeng. The previous versions of the standard replaced by this part are as follows: GB20596—2006
1 Scope
Chemical Classification and Labeling Specification
Part 22: Germ Cell Mutagenicity
GB30000.22-—2013
This part of GB30600 specifies the terms and definitions, classification criteria, decision logic and guidance, and labeling of chemicals with germ cell mutagenicity.
This part applies to the classification and labeling of chemicals with germ cell mutagenicity in accordance with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (hereinafter referred to as GHS)
2 Normative References
The following documents are essential for the application of this document. For all references with dates, only the versions with dates apply to this document. For all references without dates, the latest versions (including all amendments) apply to this document. GB30000.23 Chemical Classification and Labelling Specifications Part 23: Carcinogenicity GB13690 General Principles for Classification and Hazard Communication of Chemicals United Nations Globally Harmonized System of Classification and Labelling of Chemicals (Fourth Revised Edition) United Nations Recommendations on the Transport of Dangerous Goods Model Regulations (Seventh 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
germ cell mutagenicity Chemicals cause mutations in human germ cells that can be passed on to offspring. When assigning substances and mixtures to this hazard category, attention is also paid to in vitro mutagenicity/genotoxicity tests and in vivo mutagenicity and genotoxicity tests in mammalian somatic cells. In this section, the terms mutagenicity, mutagen, mutation and genotoxicity are mentioned several times. "Mutation" is defined as a permanent change in the amount or structure of genetic material in a cell.
The term "mutation" applies to both heritable genetic changes that may manifest themselves in dominant forms and potential DNA modifications (e.g., known specific base pair changes and chromosomal translocations). The terms "mutagenic" and "mutagen" apply to substances that cause an increased incidence of mutations in cells and/or organisms. The terms "genotoxic" and "genotoxic" apply to substances or processes that can alter the structure, information content, or segregation of DNA, including those that cause DNA damage by interfering with normal replication processes or that can (temporarily) alter DNA replication in a non-physiological manner. Genotoxicity test results are usually used as an indicator of mutagenic effects. 4 Classification criteria 4.1 General principles For the general principles of classification and labelling of germ cell mutagenicity, see G1313690. GB30000.22—2013 4.2 Classification criteria for substances 4 .2.1 This classification system provides for two different germ cell mutagenicity hazard categories to suit the weight of evidence available, see Table 1 for details. Table 1 Classification of germ cell mutagens
Category 1: Substances known to cause heritable mutations in human germ cells or considered to have the potential to cause heritable mutations in human germ cells Category 1A: Substances known to cause heritable mutations in human germ cells, judgment criteria: Positive evidence from human epidemiological studies Category 1B: Substances that should be considered to have the potential to cause heritable mutations in human germ cells, judgment criteria:
Positive results from in vivo germ cell or mesenchymal mutation tests in mammals Positive results from in vivo germ cell mesenchymal mutation tests in mammals, combined with some evidence that the substance has the potential to cause heritable mutations Potential for mutagenicity in germ cells. This supporting evidence may come, for example, from in vivo germ cell mutagenicity/genotoxicity tests, or from demonstration that the substance or its metabolites have the ability to interact with the genetic material of germ cells: or from positive results in germ cell tests showing a mutagenic effect without demonstrating that mutations are transmitted to offspring, e.g. an increase in the rate of non-marital intercourse in human sperm cells exposed to the substance Category 2: Substances of concern due to the potential to cause heritable mutations in human germ cells Criteria Positive evidence from tests on animals or sometimes from tests on mammals in vitro These Evidence from
Other in vivo somatic cell genotoxicity tests supported by limited results from in vitro mutagenicity tests Note: Chemicals with positive results from in vitro mutagenicity tests in dairy animals that are chemically related to known minor cell-mediated mutagens should be classified as Category 2 mutagens
4.2.2 For classification, results from tests on mutagenic and/or genotoxic effects in germ cells and/or somatic cells of exposed animals should be considered. Mutagenic and/or genotoxic effects determined in vitro in vitro may also be considered. 4.2.3 The classification system is based on hazard and substances are classified according to their intrinsic ability to cause germ cell mutations. Therefore, the classification scheme is different from the risk assessment (quantitative) of chemicals. 4.2.4 Classification for human germ cell heritable effects is based on well-conducted, adequately validated tests, conducted in accordance with relevant national standards. Expert judgement should be used to evaluate the test results and the classification should be based on all available evidence. 4.2.5 The classification of individual substances requires expert judgment based on the weight of all available evidence. When classifying a substance based on a single well-conducted test data, the test should provide clear and unambiguous positive results. If new, well-validated tests are available, they can also be used to combine the total weight of evidence. Pay attention to comparing the exposure routes of the chemical in the test study with the possible exposure routes of the population to see if there is a correlation. 4.3 Classification criteria for mixtures
4.3.1 Classification of mixtures when data on the entire mixture are available Classification of mixtures should be based on the existing test data of the various components of the mixture, using the critical value concentration limits classified as germ cell mutagenic components. The classification can be revised on a case-by-case basis based on the existing data on the entire mixture. In this case, combined with dose and other factors such as duration, observation and analysis (e.g. statistical analysis, test sensitivity) of the germ cell mutagenicity test system, the test results of the mixture as a whole should be conclusive. Appropriate documents supporting the classification should be retained so that they can be provided upon request for review.
4.3.2 Classification of mixtures when data are not available for the mixture as a whole: bridging principles4.3.2.1 When the mixture itself has not been tested to determine its germ cell mutagenicity, but there are sufficient data on the individual ingredients and similar tested mixtures to characterize the hazards of the mixture, these data may 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 animal testing.
4.3.2.2 Dilution:
If a tested mixture is diluted with a diluent which is not expected to affect the germ cell mutagenicity of the other ingredients, the new diluted mixture may be classified in the same category as the original tested mixture. 4.3.2.3 Batch:
The germ cell mutagenicity of a tested
production batch of a mixture may be considered to be virtually equivalent to the germ cell mutagenicity of an untested
tested batch of the same commercial product produced
by the same manufacturer or under his control, unless there is reason to believe that the untested germ cell mutagenicity has changed significantly. In the latter case, a new classification is required. 4.3.2.4 Substantially classified mixtures Assume the following: a) Two mixtures: 1: A + BC; b) Germ cell mutagenic component A; The highest concentration of component B in both mixtures; There are toxicity data for component A and component B in the mixture that are substantially equivalent in concentration; They are in the same hazard category and are not expected to affect the germ cell mutagenicity of component B; If mixture A or B is already classified based on test results, then the other mixture may be classified in the same hazard category. 4.3.3 Classification of mixtures when data are available for all ingredients or only for some of the ingredients When at least one group has been classified as a Category 1 or Category 2 mutagen and its concentration is greater than or equal to the corresponding cut-off values/addition limits for Category 1 and Category 2 in Table 2 Cut-off values/concentration limits for ingredients classified as germ cell mutagens when classifying mixtures Component Category
Category 1A Mutagen
Category 1B Mutagen
Category 2 Mutagen
Category 1A
Category 1 Mutagen
Category 1B
Note: The cut-off values/concentration limits in the table apply to solids and liquids (mass fraction) and gases (volume fraction). TKAONTKAca-
Category 2 Mutagen
GB30000.22-—2013
5 Decision logic and guidance
Decision logic and guidance are for reference only. See Appendix A for decision logic. It is particularly recommended that the person responsible for classification study Chapter 4 before and during the use of decision logic. Decision logic is for reference only. 6 Labeling
6.1 Overview
6.1.1 For the label of germ cell mutagenicity, the hazard categories are listed in the order of the designated pictogram, signal word and hazard statement. The hazard classes or categories covered by the United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (hereinafter referred to as the Model Regulations) should be listed in the label with the corresponding graphic symbol designated for each category. The allocation of label elements for germ cell mutagenicity is shown in Appendix B. 6.1.2 The classification criteria and label elements for germ cell mutagenicity 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 that other label elements that have not yet been standardized, such as precautionary statements, also need to be included on the label. The competent authority may also require additional information, and the supplier may also add supplementary information.
6.2 Hazard pictograms
Hazard pictograms should use black symbols with a white background, and the red frame should be wide enough to be eye-catching. The colors, numbers and minimum sizes of hazard pictograms and graphic symbols specified in the Model Regulations are shown in Appendix B. 6.3 Signal words
Signal words are words used on labels to indicate the relative severity of hazards and to alert readers to potential hazards. For hazard category 1, germ cell mutagenicity, the signal word "Danger" is used; for hazard category 2, germ cell mutagenicity, the signal word "Warning". 6.4 Hazard statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous properties of a chemical and, where appropriate, its degree of hazard. Hazard statements for germ cell mutagenicity are given in Table C.1 and in Annex D. 6.5 Precautionary statements
A precautionary statement is a phrase (and/or pictogram) that describes recommended measures to minimize or prevent adverse effects that may result from exposure to the hazardous product or from improper storage or handling of the hazardous product. For this purpose, there are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Germ cell mutagenicity For precautionary statements for different hazard categories of mutagenicity, see Appendix D. 6.6 Product identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the chemical safety data sheet. If a substance or mixture is listed in the Model Regulations, the correct UN transport number should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization or specific target organ toxicity appear on the label, the label should include the chemical composition of all components or alloying elements that may cause these hazards. The competent authority may require that the chemical components that may cause the mixture or alloy be listed on the label. Chemical names of all hazardous components or alloying elements. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture should be provided on the label. Example of label
For an example of a germ cell mutagenicity label, see Appendix E. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances||tt ||Substance: Does the substance have mutagenicity data? According to the classification criteria (see 4.2), is the substance: Known to cause transmissible mutations in human reproductive cells? Should it be considered as possibly causing transmissible mutations in human reproductive cells? When applying this criterion, an expert is required to make a decision using the weight of evidence approach. According to the classification criteria (see 4.2), is the substance likely to cause transmissible mutations in human reproductive cells, which is of concern? When applying this criterion, an expert is required to make a decision using the weight of evidence approach. Figure A.1 Classification process for substances
A.1.2 Decision logic for mixtures
Not classified
Category 2
Not classified
Mixtures: Classification of mixtures should be based on available test data for the ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on available test data for the mixture as a whole or based on bridging principles. See the following modified classification based on case-by-case basis. For further details, see 43
A.1.2.1 Classification of mixtures based on ingredients Does the mixture contain one or more ingredients classified as Category 1 mutagens in a concentration of not less than 0.1%?
Does the mixture contain one or more ingredients classified as Category 2 mutagens in a concentration of not less than 1.0%?
Non-class
For specific fluidity extremes, see GHS Section 1.3, 1.3.3.2. and Table 2, Figure A2. Flowchart for classification of mixtures according to the ingredients in the mixture A.1.2.2 Modified classification based on specific circumstances The test results of the mixture may be combined with other factors such as the duration of the reproductive lipid mutagenicity test system, the observations and the test data and analysis (e.g. statistical analysis test system) of the entire mixture. Can the bridge principle be used if the bridging principle is sufficient? 4 (see 4.3.2) GB30000.22-2013 Category 1 Category 2 Classification into the appropriate category Dangerous or See above: According to the classification of the components of the mixture "If the data of other mixtures are used when applying the bridging principle, the data of the mixture should be conclusive according to 4.3.2. Figure A.3 Classification process A modified according to specific circumstances .2 Guidance
There is a growing awareness that chemical-induced tumorigenesis in humans and animals involves genetic changes in somatic pro-oncogenes and/or tumor suppressor genes. Therefore, if chemicals are proven to be mutagenic in somatic and/or germ cells in mammals, this may mean that these chemicals are likely to be classified as carcinogens, see GB30000.23 for details. TTKANTKAca
GB30000.22—2013
See Table B,1 for the allocation of label elements.
Category 1A
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard)
Category 1B
Appendix B
(Normative Appendix)
Allocation of label elements
Allocation of label elements for germ cell mutagenicityCategory 2
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause thisWww.bzxZ.net
-hazard) It is confirmed that there are no other exposure routes that cause this hazard) Suspected of causing hereditary defects (the exposure route should be stated if it is confirmed that there are no other exposure routes that cause this hazard) Germ cell mutagenicity is not required in the Model Regulations Appendix C (Normative Appendix) Classification criteria and labeling elements for germ cell mutagenicity See Table C for the classification criteria and labeling elements for germ cell mutagenicity. 1. Table c.1
Classification criteria and label elements for germ cell mutagenicity Hazard category
(IA and IB)
1. Substances and tested mixtures (see 4.2): known to cause
heritable mutations in human germ cells, or
considered to cause
heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture should contain at least If there is an ingredient classified as Category 1 at a concentration of not less than 0.1%, the mixture will be classified as Category 1
1. Substances and tested mixtures (see 4.2): of concern due to the possibility of causing heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture will be classified as Category 2 if it contains at least one ingredient classified as Category 2 at a concentration of not less than 1.0%
Graphic Symbol
Signal word
Hazard statement
Graphic symbol
Signal word
Hazard statement
TKAoNrKAca-
Label elements
GB30000.22—2013
May cause genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)
Suspected of causing genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)2 Hazard pictograms
Hazard pictograms should use black symbols with a white background, and the red frame should be wide enough to be eye-catching. The colors, numbers and minimum sizes of hazard pictograms and graphic symbols specified in the Model Regulations are shown in Appendix B. 6.3 Signal words
Signal words are words used on labels to indicate the relative severity of hazards and to alert readers to potential hazards. For hazard category 1, germ cell mutagenicity, the signal word "Danger" is used; for hazard category 2, germ cell mutagenicity, the signal word "Warning". 6.4 Hazard statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous properties of a chemical and, where appropriate, its degree of hazard. Hazard statements for germ cell mutagenicity are given in Table C.1 and in Annex D. 6.5 Precautionary statements
A precautionary statement is a phrase (and/or pictogram) that describes recommended measures to minimize or prevent adverse effects that may result from exposure to the hazardous product or from improper storage or handling of the hazardous product. For this purpose, there are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Germ cell mutagenicity For precautionary statements for different hazard categories of mutagenicity, see Appendix D. 6.6 Product identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the chemical safety data sheet. If a substance or mixture is listed in the Model Regulations, the correct UN transport number should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization or specific target organ toxicity appear on the label, the label should include the chemical composition of all components or alloying elements that may cause these hazards. The competent authority may require that the chemical components that may cause the mixture or alloy be listed on the label. Chemical names of all hazardous components or alloying elements. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture should be provided on the label. Example of label
For an example of a germ cell mutagenicity label, see Appendix E. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances||tt ||Substance: Does the substance have mutagenicity data? According to the classification criteria (see 4.2), is the substance: Known to cause transmissible mutations in human reproductive cells? Should it be considered as possibly causing transmissible mutations in human reproductive cells? When applying this criterion, an expert is required to make a decision using the weight of evidence approach. According to the classification criteria (see 4.2), is the substance likely to cause transmissible mutations in human reproductive cells, which is of concern? When applying this criterion, an expert is required to make a decision using the weight of evidence approach. Figure A.1 Classification process for substances
A.1.2 Decision logic for mixtures
Not classified
Category 2
Not classified
Mixtures: Classification of mixtures should be based on available test data for the ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on available test data for the mixture as a whole or based on bridging principles. See the following modified classification based on case-by-case basis. For further details, see 43
A.1.2.1 Classification of mixtures based on ingredients Does the mixture contain one or more ingredients classified as Category 1 mutagens in a concentration of not less than 0.1%?
Does the mixture contain one or more ingredients classified as Category 2 mutagens in a concentration of not less than 1.0%?
Non-class
For specific fluidity extremes, see GHS Section 1.3, 1.3.3.2. and Table 2, Figure A2. Flowchart for classification of mixtures according to the ingredients in the mixture A.1.2.2 Modified classification based on specific circumstances The test results of the mixture may be combined with other factors such as the duration of the reproductive lipid mutagenicity test system, the observations and the test data and analysis (e.g. statistical analysis test system) of the entire mixture. Can the bridge principle be used if the bridging principle is sufficient? 4 (see 4.3.2) GB30000.22-2013 Category 1 Category 2 Classification into the appropriate category Dangerous or See above: According to the classification of the components of the mixture "If the data of other mixtures are used when applying the bridging principle, the data of the mixture should be conclusive according to 4.3.2. Figure A.3 Classification process A modified according to specific circumstances .2 Guidance
There is a growing awareness that chemical-induced tumorigenesis in humans and animals involves genetic changes in somatic pro-oncogenes and/or tumor suppressor genes. Therefore, if chemicals are proven to be mutagenic in somatic and/or germ cells in mammals, this may mean that these chemicals are likely to be classified as carcinogens, see GB30000.23 for details. TTKANTKAca
GB30000.22—2013
See Table B,1 for the allocation of label elements.
Category 1A
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard)
Category 1B
Appendix B
(Normative Appendix)
Allocation of label elements
Allocation of label elements for germ cell mutagenicityCategory 2
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard) It is confirmed that there are no other exposure routes that cause this hazard) Suspected of causing hereditary defects (the exposure route should be stated if it is confirmed that there are no other exposure routes that cause this hazard) Germ cell mutagenicity is not required in the Model Regulations Appendix C (Normative Appendix) Classification criteria and labeling elements for germ cell mutagenicity See Table C for the classification criteria and labeling elements for germ cell mutagenicity. 1. Table c.1
Classification criteria and label elements for germ cell mutagenicity Hazard category
(IA and IB)
1. Substances and tested mixtures (see 4.2): known to cause
heritable mutations in human germ cells, or
considered to cause
heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture should contain at least If there is an ingredient classified as Category 1 at a concentration of not less than 0.1%, the mixture will be classified as Category 1
1. Substances and tested mixtures (see 4.2): of concern due to the possibility of causing heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture will be classified as Category 2 if it contains at least one ingredient classified as Category 2 at a concentration of not less than 1.0%
Graphic Symbol
Signal word
Hazard statement
Graphic symbol
Signal word
Hazard statement
TKAoNrKAca-
Label elements
GB30000.22—2013
May cause genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)
Suspected of causing genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)2 Hazard pictograms
Hazard pictograms should use black symbols with a white background, and the red frame should be wide enough to be eye-catching. The colors, numbers and minimum sizes of hazard pictograms and graphic symbols specified in the Model Regulations are shown in Appendix B. 6.3 Signal words
Signal words are words used on labels to indicate the relative severity of hazards and to alert readers to potential hazards. For hazard category 1, germ cell mutagenicity, the signal word "Danger" is used; for hazard category 2, germ cell mutagenicity, the signal word "Warning". 6.4 Hazard statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous properties of a chemical and, where appropriate, its degree of hazard. Hazard statements for germ cell mutagenicity are given in Table C.1 and in Annex D. 6.5 Precautionary statements
A precautionary statement is a phrase (and/or pictogram) that describes recommended measures to minimize or prevent adverse effects that may result from exposure to the hazardous product or from improper storage or handling of the hazardous product. For this purpose, there are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Germ cell mutagenicity For precautionary statements for different hazard categories of mutagenicity, see Appendix D. 6.6 Product identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the chemical safety data sheet. If a substance or mixture is listed in the Model Regulations, the correct UN transport number should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitization or specific target organ toxicity appear on the label, the label should include the chemical composition of all components or alloying elements that may cause these hazards. The competent authority may require that the chemical components that may cause the mixture or alloy be listed on the label. Chemical names of all hazardous components or alloying elements. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture should be provided on the label. Example of label
For an example of a germ cell mutagenicity label, see Appendix E. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances||tt ||Substance: Does the substance have mutagenicity data? According to the classification criteria (see 4.2), is the substance: Known to cause transmissible mutations in human reproductive cells? Should it be considered as possibly causing transmissible mutations in human reproductive cells? When applying this criterion, an expert is required to make a decision using the weight of evidence approach. According to the classification criteria (see 4.2), is the substance likely to cause transmissible mutations in human reproductive cells, which is of concern? When applying this criterion, an expert is required to make a decision using the weight of evidence approach. Figure A.1 Classification process for substances
A.1.2 Decision logic for mixtures
Not classified
Category 2
Not classified
Mixtures: Classification of mixtures should be based on available test data for the ingredients of the mixture, using cut-off values/concentration limits for those ingredients. The classification may be modified on a case-by-case basis based on available test data for the mixture as a whole or based on bridging principles. See the following modified classification based on case-by-case basis. For further details, see 43
A.1.2.1 Classification of mixtures based on ingredients Does the mixture contain one or more ingredients classified as Category 1 mutagens in a concentration of not less than 0.1%?
Does the mixture contain one or more ingredients classified as Category 2 mutagens in a concentration of not less than 1.0%?
Non-class
For specific fluidity extremes, see GHS Section 1.3, 1.3.3.2. and Table 2, Figure A2. Flowchart for classification of mixtures according to the ingredients in the mixture A.1.2.2 Modified classification based on specific circumstances The test results of the mixture may be combined with other factors such as the duration of the reproductive lipid mutagenicity test system, the observations and the test data and analysis (e.g. statistical analysis test system) of the entire mixture. Can the bridge principle be used if the bridging principle is sufficient? 4 (see 4.3.2) GB30000.22-2013 Category 1 Category 2 Classification into the appropriate category Dangerous or See above: According to the classification of the components of the mixture "If the data of other mixtures are used when applying the bridging principle, the data of the mixture should be conclusive according to 4.3.2. Figure A.3 Classification process A modified according to specific circumstances .2 Guidance
There is a growing awareness that chemical-induced tumorigenesis in humans and animals involves genetic changes in somatic proto-oncogenes and/or tumor suppressor genes. Therefore, if chemicals are proven to be mutagenic in somatic and/or germ cells in mammals, this may mean that these chemicals are likely to be classified as carcinogens, see GB30000.23 for details. TTKANTKAca
GB30000.22—2013
See Table B,1 for the allocation of label elements.
Category 1A
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard)
Category 1B
Appendix B
(Normative Appendix)
Allocation of label elements
Allocation of label elements for germ cell mutagenicityCategory 2
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard) It is confirmed that there are no other exposure routes that cause this hazard)
Suspected of causing hereditary defects (the exposure route should be stated if it is confirmed that there are no other exposure routes that cause this hazard)
Germ cell mutagenicity is not required in the Model Regulations Appendix C
(Normative Appendix)
Classification criteria and labeling elements for germ cell mutagenicity The classification criteria and labeling elements for germ cell mutagenicity are shown in Table C. 1. Table c.1
Classification criteria and label elements for germ cell mutagenicity Hazard category
(IA and IB)
1. Substances and tested mixtures (see 4.2): known to cause
heritable mutations in human germ cells, or
considered to cause
heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture should contain at least If there is an ingredient classified as Category 1 at a concentration of not less than 0.1%, the mixture will be classified as Category 1
1. Substances and tested mixtures (see 4.2): of concern due to the possibility of causing heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture will be classified as Category 2 if it contains at least one ingredient classified as Category 2 at a concentration of not less than 1.0%
Graphic Symbol
Signal word
Hazard statement
Graphic symbol
Signal word
Hazard statement
TKAoNrKAca-
Label elements
GB30000.22—2013
May cause genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)
Suspected of causing genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)4 Hazard Statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous properties of a chemical and, where appropriate, its degree of hazard. Hazard statements for germ cell mutagenicity are given in Table C.1 and in Annex D. 6.5 Precautionary Statements
A precautionary statement is a phrase (and/or pictogram) describing 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. For the purposes of this document, there are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for the different hazard categories of germ cell mutagenicity are given in Annex D. 6.6 Product Identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the MSDS. If a substance or mixture is listed in the Model Regulations, the correct UN shipping number should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory 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 contribute to these hazards. The competent authority may 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. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture shall be provided on the label. Example of label
See Appendix E for an example of a label for germ cell mutagenicity. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances
Substance: Does the substance have mutagenicity data? According to the classification criteria (see 4.2), the substance is: Known to cause transmissible mutations in human germ cells Should it be considered likely to cause transmissible mutations in human germ cells When applying this standard, experts are required to make a decision using the weight of evidence approach According to the classification criteria (see 4.2) Is the substance likely to cause transmissible mutations in human germ cells and cause concern? When this standard is used, an expert is required to make a judgement using the weight of evidence. Figure A.1 Classification process for substances
A.1.2 Decision logic for mixtures
Not classified
Category 2
Not classified
Mixtures: Classification of mixtures shall be based on available test data for the ingredients of the mixture, using cut-off values/concentration limits for those ingredients. Classification may be modified based on available test data for the mixture as a whole or based on bridging principles, see below for modified classification based on specific circumstances, further details in 43
A.1.2.1 Classification of mixtures based on ingredients Does the mixture contain one or more ingredients classified as mutagenic in Category 1 at a concentration of not less than 0.1%?
Does the mixture contain one or more ingredients classified as mutagenic in Category 2 at a concentration of not less than 1.0%?
Non-class
For specific fluidity extremes, see GHS Section 1.3, 1.3.3.2. and Table 2, Figure A2. Flowchart for classification of mixtures according to the ingredients in the mixture A.1.2.2 Modified classification based on specific circumstances The test results of the mixture may be combined with other factors such as the duration of the reproductive lipid mutagenicity test system, the observations and the test data and analysis (e.g. statistical analysis test system) of the entire mixture. Can the bridge principle be used if the bridging principle is sufficient? 4 (see 4.3.2) GB30000.22-2013 Category 1 Category 2 Classification into the appropriate category Dangerous or See above: According to the classification of the components of the mixture "If the data of other mixtures are used when applying the bridging principle, the data of the mixture should be conclusive according to 4.3.2. Figure A.3 Classification process A modified according to specific circumstances .2 Guidance
There is a growing awareness that chemical-induced tumorigenesis in humans and animals involves genetic changes in somatic pro-oncogenes and/or tumor suppressor genes. Therefore, if chemicals are proven to be mutagenic in somatic and/or germ cells in mammals, this may mean that these chemicals are likely to be classified as carcinogens, see GB30000.23 for details. TTKANTKAca
GB30000.22—2013
See Table B,1 for the allocation of label elements.
Category 1A
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard)
Category 1B
Appendix B
(Normative Appendix)
Allocation of label elements
Allocation of label elements for germ cell mutagenicityCategory 2
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard) It is confirmed that there are no other exposure routes that cause this hazard) Suspected of causing hereditary defects (the exposure route should be stated if it is confirmed that there are no other exposure routes that cause this hazard) Germ cell mutagenicity is not required in the Model Regulations Appendix C (Normative Appendix) Classification criteria and labeling elements for germ cell mutagenicity See Table C for the classification criteria and labeling elements for germ cell mutagenicity. 1. Table c.1
Classification criteria and label elements for germ cell mutagenicity Hazard category
(IA and IB)
1. Substances and tested mixtures (see 4.2): known to cause
heritable mutations in human germ cells, or
considered to cause
heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture should contain at least If there is an ingredient classified as Category 1 at a concentration of not less than 0.1%, the mixture will be classified as Category 1
1. Substances and tested mixtures (see 4.2): of concern due to the possibility of causing heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture will be classified as Category 2 if it contains at least one ingredient classified as Category 2 at a concentration of not less than 1.0%
Graphic Symbol
Signal word
Hazard statement
Graphic symbol
Signal word
Hazard statement
TKAoNrKAca-
Label elements
GB30000.22—2013
May cause genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)
Suspected of causing genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)4 Hazard Statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous properties of a chemical and, where appropriate, its degree of hazard. Hazard statements for germ cell mutagenicity are given in Table C.1 and in Annex D. 6.5 Precautionary Statements
A precautionary statement is a phrase (and/or pictogram) describing 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. For the purposes of this document, there are five categories of precautionary statements: general, prevention, emergency, storage and disposal. Precautionary statements for the different hazard categories of germ cell mutagenicity are given in Annex D. 6.6 Product Identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the MSDS. If a substance or mixture is listed in the Model Regulations, the correct UN shipping number should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory 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 contribute to these hazards. The competent authority may 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. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture shall be provided on the label. Example of label
See Appendix E for an example of a label for germ cell mutagenicity. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances
Substance: Does the substance have mutagenicity data? According to the classification criteria (see 4.2), the substance is: Known to cause transmissible mutations in human germ cells Should it be considered likely to cause transmissible mutations in human germ cells When applying this standard, experts are required to make a decision using the weight of evidence approach According to the classification criteria (see 4.2) Is the substance likely to cause transmissible mutations in human germ cells and cause concern? When this standard is used, an expert is required to make a judgement using the weight of evidence. Figure A.1 Classification process for substances
A.1.2 Decision logic for mixtures
Not classified
Category 2
Not classified
Mixtures: Classification of mixtures shall be based on available test data for the ingredients of the mixture, using cut-off values/concentration limits for those ingredients. Classification may be modified based on available test data for the mixture as a whole or based on bridging principles, see below for modified classification based on specific circumstances, further details in 43
A.1.2.1 Classification of mixtures based on ingredients Does the mixture contain one or more ingredients classified as mutagenic in Category 1 at a concentration of not less than 0.1%?
Does the mixture contain one or more ingredients classified as mutagenic in Category 2 at a concentration of not less than 1.0%?
Not this category
For specific fluidity extremes, see GHS Section 1.3, 1.3.3.2. and Table 2, Figure A2. Flowchart for classification of mixtures according to the ingredients in the mixture A.1.2.2 Modified classification based on specific circumstances The test results of the mixture may be modified based on the duration of the reproductive lipid mutagenicity test system, the observations and other factors such as the test data and analysis (e.g. statistical analysis test system) of the mixture as a whole. Can the bridge principle be used if the bridging principle is sufficient? 4 (see 4.3.2) GB30000.22-2013 Category 1 Category 2 Classification into the appropriate category Dangerous or See above: According to the classification of the components of the mixture "If the data of other mixtures are used when applying the bridging principle, the data of the mixture should be conclusive according to 4.3.2. Figure A.3 Classification process A modified according to specific circumstances .2 Guidance
There is a growing awareness that chemical-induced tumorigenesis in humans and animals involves genetic changes in somatic proto-oncogenes and/or tumor suppressor genes. Therefore, if chemicals are proven to be mutagenic in somatic and/or germ cells in mammals, this may mean that these chemicals are likely to be classified as carcinogens, see GB30000.23 for details. TTKANTKAca
GB30000.22—2013
See Table B,1 for the allocation of label elements.
Category 1A
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard)
Category 1B
Appendix B
(Normative Appendix)
Allocation of label elements
Allocation of label elements for germ cell mutagenicityCategory 2
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard) It is confirmed that there are no other exposure routes that cause this hazard)
Suspected of causing hereditary defects (the exposure route should be stated if it is confirmed that there are no other exposure routes that cause this hazard)
Germ cell mutagenicity is not required in the Model Regulations Appendix C
(Normative Appendix)
Classification criteria and labeling elements for germ cell mutagenicity The classification criteria and labeling elements for germ cell mutagenicity are shown in Table C. 1. Table c.1
Classification criteria and label elements for germ cell mutagenicity Hazard category
(IA and IB)
1. Substances and tested mixtures (see 4.2): known to cause
heritable mutations in human germ cells, or
considered to cause
heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture should contain at least If there is an ingredient classified as Category 1 at a concentration of not less than 0.1%, the mixture will be classified as Category 1
1. Substances and tested mixtures (see 4.2): of concern due to the possibility of causing heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture will be classified as Category 2 if it contains at least one ingredient classified as Category 2 at a concentration of not less than 1.0%
Graphic Symbol
Signal word
Hazard statement
Graphic symbol
Signal word
Hazard statement
TKAoNrKAca-
Label elements
GB30000.22—2013
May cause genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)
Suspected of causing genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)2 The label shall include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory 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 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. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture shall be provided on the label. Example of label
See Appendix E for an example of a label for germ cell mutagenicity. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances
Substance: Does the substance have mutagenicity data? According to the classification criteria (see 4.2), the substance is: Known to cause transmissible mutations in human germ cells Should it be considered likely to cause transmissible mutations in human germ cells When applying this standard, experts are required to make a decision using the weight of evidence approach According to the classification criteria (see 4.2) Is the substance likely to cause transmissible mutations in human germ cells and cause concern? When this standard is used, an expert is required to make a judgement using the weight of evidence. Figure A.1 Classification process for substances
A.1.2 Decision logic for mixtures
Not classified
Category 2
Not classified
Mixtures: Classification of mixtures shall be based on available test data for the ingredients of the mixture, using cut-off values/concentration limits for those ingredients. Classification may be modified based on available test data for the mixture as a whole or based on bridging principles, see below for modified classification based on specific circumstances, further details in 43
A.1.2.1 Classification of mixtures based on ingredients Does the mixture contain one or more ingredients classified as mutagenic in Category 1 at a concentration of not less than 0.1%?
Does the mixture contain one or more ingredients classified as mutagenic in Category 2 at a concentration of not less than 1.0%?
Non-class
For specific fluidity extremes, see GHS Section 1.3, 1.3.3.2. and Table 2, Figure A2. Flowchart for classification of mixtures according to the ingredients in the mixture A.1.2.2 Modified classification based on specific circumstances The test results of the mixture may be combined with other factors such as the duration of the reproductive lipid mutagenicity test system, the observations and the test data and analysis (e.g. statistical analysis test system) of the entire mixture. Can the bridge principle be used if the bridging principle is sufficient? 4 (see 4.3.2) GB30000.22-2013 Category 1 Category 2 Classification into the appropriate category Dangerous or See above: According to the classification of the components of the mixture "If the data of other mixtures are used when applying the bridging principle, the data of the mixture should be conclusive according to 4.3.2. Figure A.3 Classification process A modified according to specific circumstances .2 Guidance
There is a growing awareness that chemical-induced tumorigenesis in humans and animals involves genetic changes in somatic pro-oncogenes and/or tumor suppressor genes. Therefore, if chemicals are proven to be mutagenic in somatic and/or germ cells in mammals, this may mean that these chemicals are likely to be classified as carcinogens, see GB30000.23 for details. TTKANTKAca
GB30000.22—2013
See Table B,1 for the allocation of label elements.
Category 1A
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard)
Category 1B
Appendix B
(Normative Appendix)
Allocation of label elements
Allocation of label elements for germ cell mutagenicityCategory 2
May cause genetic defects
(The route of exposure should be stated if it is conclusively confirmed that no other routes of exposure cause this
-hazard) It is confirmed that there are no other exposure routes that cause this hazard) Suspected of causing hereditary defects (the exposure route should be stated if it is confirmed that there are no other exposure routes that cause this hazard) Germ cell mutagenicity is not required in the Model Regulations Appendix C (Normative Appendix) Classification criteria and labeling elements for germ cell mutagenicity See Table C for the classification criteria and labeling elements for germ cell mutagenicity. 1. Table c.1
Classification criteria and label elements for germ cell mutagenicity Hazard category
(IA and IB)
1. Substances and tested mixtures (see 4.2): known to cause
heritable mutations in human germ cells, or
considered to cause
heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture should contain at least If there is an ingredient classified as Category 1 at a concentration of not less than 0.1%, the mixture will be classified as Category 1
1. Substances and tested mixtures (see 4.2): of concern due to the possibility of causing heritable mutations in human germ cells
2. If there are no data on the mixture as a whole, use the bridging principle (see 4.3.2)
3. When the bridging principle is not applicable, the mixture will be classified as Category 2 if it contains at least one ingredient classified as Category 2 at a concentration of not less than 1.0%
Graphic Symbol
Signal word
Hazard statement
Graphic symbol
Signal word
Hazard statement
TKAoNrKAca-
Label elements
GB30000.22—2013
May cause genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)
Suspected of causing genetic defects (the route of exposure should be stated if it is confirmed that no other routes of exposure cause this hazard)2 The label shall include the chemical name of the substance. For mixtures or alloys, when acute toxicity, skin corrosion, serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory 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 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. 4
Supplier identification
The name, address and telephone number of the manufacturer or supplier of the substance or mixture shall be provided on the label. Example of label
See Appendix E for an example of a label for germ cell mutagenicity. TKAONTKAca-
GB30000.22—2013
GB30000.22—2013
A.1 Decision logic for germ cell mutagenicity
Appendix A
(Informative Appendix)
Decision logic and guidance
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A.1.1 Decision logic for substances
Substance: Does the subst
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