Rules for classification and labelling of chemicals—Part 24:Reproductive toxicity
Some standard content:
ICS13.300
National Standard of the People's Republic of China
GB30000.24—2013
Replaces GB20598—2006
Rules for classification and labelling of chemicals
Part 24: Reproductive toxicity
chemicals-Part24:Reproductivetoxicity
2013-10-10 Issued
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
Products in Authenticity
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); 2006): Part 4: Aerosols (replacing GB20578-2006): Part 5: Oxidizing gases (replacing GB20579-2006) Part 6: Pressurized gases (replacing GB20580-2006); Part 7: Flammable liquids (replacing GB20581-2006): Part 8: Flammable solids (replacing GB20582-2006): Part 9: Self-reactive substances and mixtures (replacing GB20583-2006); Part 10: Pyrophoric liquids (replacing GB20585-2006); Part 11: Pyrophoric solids (replacing GB20586-2006); Part 12: Self-heating substances and mixtures (replacing GB20584-2006): Part 13 : Substances and mixtures which, in contact with water, emit flammable gases (replace GB20587-2006); Part 14: Oxidizing liquids (replace GB20589-2006): Part 15: Oxidizing solids (replace GB20590-2006): Part 16: Organic peroxides (replace GB20591-2006): Part 17: Metal corrosion (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 GB2 0595-2006): Part 22: Germ cell mutagenicity (replaces GB205962006); Part 23: Carcinogenicity (replaces GB20597-2006); Part 24: Reproductive toxicity (replaces GB20598-2006); Part 25: Specific target organ toxicity single exposure (replaces GB20599-2006); Part 26: Specific target organ toxicity repeated exposure (replaces GB20601-2006); Part 27: Inhalation hazard; Part 28: Hazards to the aquatic environment (replaces GB20602-2006); Part 29: Hazards to the ozone layer; Part 30: Warning signs for chemical workplaces. This part is Part 24 of GB30000.
This part was drafted in accordance with the rules given in GB/T1.1-2009 GB30000.24—2013
This part replaces GB20598-2006 "Safety Specifications for Classification, Precautionary Labelling and Precautionary Statements of Chemicals - Reproductive Toxicity"
Compared with GB20598-2006, the main technical content changes of this part are as follows: The standard name has been modified. The Chinese name has been changed to "Chemical Classification and Labelling Specifications Part 24: Reproductive Toxicity", and the English name has been changed to \Rules for classificationand labelling of Chemicals—Part 24: Reproductivetoxicity\; 1
GB30000.24-—2013
Modified the scope of Chapter 1, changed "warning label" to "label" and deleted "warning statement", modified Chapter 2 "Normative references", added GB13690 normative references; added the introduction to Chapter 3 "Terms and Definitions"; added Clause 4.1;
Added the critical value of the additional category of "effects on or through lactation" in Table 3/ Concentration limit value: The contents of the decision logic in Figures 1, 2, 3 and 4 of the original Chapter 5 are included as informative Appendix A; the original Chapter 7 is deleted, and Table 6 of the original Chapter 7 is modified as normative Appendix B in accordance with the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition):
In accordance with the United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (Fourth Revised Edition), the original Chapters 6, 7 and 8 are modified and integrated into Chapter 6, and the original Tables 4 and 5 are modified as normative Appendix C; the original Chapter 8 is deleted, and the relevant "Hazard Statements" and "Precautionary Statements" are included as informative Appendix D ; Added informative Appendix E "Label Examples for Reproductive Toxicity". 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 coordinated by the National Technical Committee for the Management of Hazardous Chemicals (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 Dangerous Chemicals, Huafeng Group Co., Ltd. The main drafters of this part: Liu Junfeng, Shang Guiqin, Wu Ke, Zhang Min, Zhang Junxi, Liang Jin, Li Xiaofeng. The previous versions of the standard replaced by this part are: GB20598-2006.
1 Scope
Chemical Classification and Labeling Specification
Part 24: Reproductive Toxicity
GB30000.24—2013
This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and labeling of chemicals with reproductive toxicity. This part applies to the classification and labeling of chemicals with reproductive toxicity 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 indispensable for the application of this document. For all referenced documents with dates, only the versions with the dates apply to this document. For any undated referenced document, the latest version (including all amendments) applies to this document. Part 22: Germ Cell Mutagenicity
GB30000.22—2013 Specification for Classification and Labelling of Chemicals 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 (Seventeenth Revised Edition) 3 Terms and Definitions
GB13690 defines and the following terms and definitions apply to this document. 3.1
Reproductive toxicity Adverse effects on sexual function and fertility of adult males and females, and developmental toxicity to offspring. When classifying hazards, known genetically induced effects that can be inherited to offspring will be specified in Article 3.5 of the United Nations GHS Germ Cell Mutagenicity, because in the current classification system, it is more appropriate to classify this unique effect according to the hazard category of germ cell mutagenicity. In this classification system, reproductive toxicity is subdivided into two main aspects: harmful effects on sexual function and fertility and harmful effects on offspring development. Some reproductive toxicity cannot be clearly identified as harmful effects on sexual function and fertility or harmful effects on offspring development. However, for chemicals with such reproductive toxicity, a general hazard statement should be given. Note: For details on germ cell mutagenicity, see GB30000.22-20133.2
Adverse effects on sexual function and fertility Any effect of a chemical that interferes with sexual function and fertility includes (but is not limited to) changes in the female and male reproductive systems, adverse effects on the onset of puberty, germ cell production and transport, normal reproductive cycle, sexual behavior, fertility, parturition, pregnancy outcomes, premature aging of reproductive capacity or other changes in the integrity of the reproductive system. Adverse effects on or through lactation also fall within the scope of reproductive toxicity, but if the classification date is not reached, such effects are listed separately in this section (see 4.2). This is because it is desirable to classify the adverse effects of chemicals on lactation specifically so that the hazards of such effects can be provided to breastfeeding mothers. 3.3
adverse effects on development of the offspring
In the broadest sense, developmental toxicity includes any effect that interferes with normal fetal development before or after birth, which is caused by exposure to one parent before conception, or exposure to the developing offspring before or after birth until sexual maturity. However, the main purpose of the classification of developmental toxicity is to provide hazard warnings to pregnant women and women and men of childbearing potential. Therefore, for practical purposes of classification, developmental toxicity refers mainly to adverse effects during pregnancy or adverse effects caused by parental exposure. These effects can be manifested at any stage of the life cycle of an organism. The main manifestations of developmental toxicity include death of developing organisms, structural malformations, growth changes, and functional defects. 4 Classification criteria
4.1 General principles
The general principles for classification and labeling of reproductive toxicity are shown in GB13690. 4.2 Classification criteria for substances
4.2.1 Hazard categories
For the purpose of reproductive toxicity classification, chemical substances are divided into two hazard categories. Effects on sexual function and fertility and effects on development are evaluated separately.
In addition, effects on lactation are classified into a separate hazard category. The hazard classification criteria are shown in Tables 1 and 2.
Table 1 Classification criteria and categories of reproductive toxicants
Category 1, substances that are known or suspected to be human reproductive toxicants, or substances for which evidence from animal studies (which may be supplemented by other information on developmental effects) indicates that they have a high probability of interfering with human reproductive function. Category 1A: Known human reproductive toxicant
is a substance that is classified as a possible human reproductive toxicant based on evidence primarily from animal data (Category 1B). This category is based primarily on evidence from animal studies. Category 1B: Possible human reproductive toxicant. This category is based primarily on data from animal studies. Animal study data should provide clear evidence that the adverse effects on reproduction, if present in combination with other toxic effects, are not considered to be an unrelated secondary consequence of the other toxic effects. However, when there is information on the relevance of the suspected effect to humans, classification to Category 2 may be more appropriate.
Category 2: Suspected human reproductive toxicants
There is evidence from experimental studies in humans or animals (which may be supplemented by other information) that, in the absence of other toxic effects, substances in this category are
adverse effects on sexual function and fertility or development; or if other toxic effects occur simultaneously, it is not possible to determine that the adverse effects on reproduction are not a non-specific secondary consequence of other toxic effects, and there is insufficient evidence to support classification into the category! For example, there are deficiencies in the design of the experimental studies, resulting in less convincing evidence. In this case, it may be more appropriate to classify it in Category 2. Table 2 Classification criteria and categories for effects on lactation or effects via lactation Effects on lactation or effects via lactation
Classify effects on lactation or effects via lactation into separate categories. However, there is currently no information available for many substances. They may cause harmful effects to the offspring through breastfeeding. However, some substances may interfere with breastfeeding after being absorbed by women, or the substance (including metabolites) may appear in breast milk at a level sufficient to affect the health of breastfed infants. These substances should be classified in this category to indicate the effects on breastfed infants. This classification can be determined based on the following situations: a) studies on the absorption, metabolism, distribution and excretion of the substance have shown that its concentration in breast milk may reach a level that produces potential toxic effects; and/or b) the results of one or two generations of animal studies provide clear evidence that the substance can enter breast milk or has a harmful effect on the quality of breast milk and/or human evidence shows that the substance is harmful to breastfed infants. 4.2.2 Basis for classification GB30000.24—2013 4.2.2.1 Classification should be based on the criteria described and an assessment of the overall weight of evidence. Chemicals with the inherently specific property of producing adverse effects on reproduction should be classified as reproductive toxicants, however, if such effects occur only as a non-specific secondary consequence of other toxic effects, the chemical should not be classified as such.
4.2.2.2 The possible effects of maternal toxicity should be taken into account when evaluating toxic effects on the developing offspring4.2.2.3 If human evidence is used as the primary basis for classification into Category 1A, there should be reliable evidence that the substance has adverse effects on human reproduction. The evidence for classification should come from well-conducted epidemiological studies, including appropriate controlled trials, assessment of symmetry, and appropriate consideration of bias or confounding factors. If the data from human studies are imprecise, they should be supplemented with appropriate data from animal studies and classified in Category 1B.
4.2.3 Weight of evidence
4.2.3.1 Classification as a reproductive toxicant is based on an assessment of the overall weight of evidence. This means that all available information on effects on reproductive toxicity should be considered simultaneously. This information includes human epidemiological studies, human case reports and specific reproductive studies, as well as the results of subchronic, chronic and specific studies in animals, which should provide relevant information showing toxicity to reproduction and related endocrine organs. It may also include an assessment of substances chemically related to the substance under study, especially when information about the substance is scarce. The weight of the available evidence will be affected by various factors, such as the quality of the studies, the consistency of the results, the nature and severity of the effects, the level of statistical significance of the differences between groups, the number of endpoints affected, the relevance to the human exposure route and the degrees of freedom from bias. Positive and negative results should be combined to assess the strength of the evidence. However, a single study conducted in accordance with scientific principles and with a statistically significant or biologically meaningful positive result can be used for judgment classification (see 4.2.2.3). 4.2.3.2 Toxicokinetic studies in animals and humans, the results of studies on the site of action and the mechanism or mode of action can provide relevant information. This information can reduce or increase people's concern about human health hazards. Substances that produce adverse reproductive effects in experimental animals should not be classified if it can be demonstrated and clearly identified that the mechanism or mode of action is not relevant to humans, or if there are sufficiently significant toxicokinetic differences that it is certain that the hazard will not occur in humans. 4.2.3.3 In some experimental animal reproductive toxicity studies, only toxicologically minor or very small effects are observed, which do not necessarily provide a basis for classification. For example, small changes in semen parameters or spontaneous fetal malformations, small differences in ossification, fetal weight or postnatal development.
4.2.3.4 Animal study data should ideally provide clear evidence of specific reproductive toxicity in the absence of other systemic toxic effects. However, if offspring developmental toxicity is associated with other adverse maternal effects, the potential impact of these generalized adverse effects should be evaluated as much as possible. The preferred approach is to first consider adverse effects on the embryo/fetus and then assess maternal toxicity and other factors that may affect them as part of the weight of evidence. In general, developmental effects observed from maternally toxic doses should not be automatically deducted. Developmental effects observed at maternally toxic doses should be excluded on a case-by-case basis only when a causal relationship is established or disproven.
4.2.3.5 If appropriate information is available, it is necessary to determine whether developmental toxicity is due to specific maternal indirect mechanisms or to non-specific secondary mechanisms, such as maternal stress and disruption of homeostasis. In general, the presence of maternal toxicity should not be used to negate findings of embryo/fetal effects unless it can be clearly demonstrated that the effects are secondary and non-specific, particularly when adverse effects in the offspring are evident, such as irreversible effects such as structural malformations. In some cases, it is reasonable to consider that reproductive toxicity is due to secondary consequences of maternal toxicity and reduces the effects. For example, if the chemical is so toxic that the mother is unable to reproduce, cannot nurse the offspring, or is severely debilitated or dying. 4.2.4 Maternal Toxicity
4.2.4.1 The development of the offspring throughout gestation and the early postnatal period may be affected by maternal toxic effects, either through non-specific mechanisms related to stress and disruption of maternal homeostasis, or through specific maternal indirect mechanisms. Therefore, it is necessary to fully incorporate the possible effects of maternal toxicity when analyzing developmental results to determine the classification of developmental effects. This is a complex issue because of the uncertainty between maternal toxicity and developmental outcomes in the offspring. When analyzing the classification criteria for developmental effects, all available studies should be used to determine the extent of the effects caused by maternal toxicity using expert judgment and weight of evidence. Adverse effects on the embryo/fetus should be combined first, followed by maternal toxicity, and any other factors that may affect these outcomes, which should be used as the weight of evidence to help draw classification conclusions. 4.2.4.2 Based on actual observations, it is believed that maternal toxicity, depending on its severity, may affect development through non-specific secondary mechanisms, producing various effects, such as reduced fetal weight, delayed ossification, and possible resorption and certain malformation effects in some strains of certain species. However, the limited number of studies investigating the relationship between developmental effects and general maternal toxicity have not been able to confirm the existence of a consistent and reproducible relationship between species. Developmental effects occurring in the presence of maternal toxicity are considered evidence of developmental toxicity unless it is clearly demonstrated on a case-by-case basis that the developmental effect is secondary to maternal toxicity. In addition, classification should be considered in the context of clear offspring toxicity, e.g., structural malformations, embryo/fetal death, functional deficits evident after birth, etc. 4.2.4.3 Chemicals that produce developmental toxicity only in conjunction with maternal toxicity should not automatically be excluded from classification even if a specific maternal indirect mechanism has been demonstrated. In such cases, Category 2 is more appropriate than Category 1, but when a chemical is so toxic that the mother dies or is severely debilitated, or the mother is so debilitated that she is unable to nurse her offspring, it may be reasonable to conclude that offspring developmental toxicity is secondary to maternal toxicity and not in conjunction with offspring developmental toxicity. If minor developmental changes occur in conjunction with the developmental changes, e.g., a slight decrease in fetal/offspring weight, ossification delay) may not necessarily warrant classification. 4.2.4.4 Some endpoints for evaluating maternal toxicity are listed below. Data on these endpoints, if available, should be evaluated for statistical and dose-response significance. If an increase in maternal mortality is associated with the test substance and can be attributed to systemic toxicity of the test substance, an increase in maternal mortality in the test group compared with the control group should be considered evidence of maternal toxicity. Maternal mortality rates greater than 10% are considered non-significant and data at this level are not necessary for further evaluation. The mating index (visible sperm) or number of animals with vaginal plugs should be used as the total number of animals mated, 100. ) Fertility index (number of animals with fertilized egg beds (total number of mated animals = 100) Pregnancy time (if parturition is possible)
Weight and weight change: If maternal weight change or corrected maternal weight data are available, they should be combined as evidence for maternal equality
Calculate the change in the corrected mean maternal weight (i.e., initial and final weight minus the gestating uterine mass (total fetal mass)) to indicate whether the change is somatic or intrauterine. In rabbit experiments, weight gain is not used as an indicator of maternal toxicity because rabbits normally fluctuate in weight during the breeding period. Food and water consumption (if relevant): Observation of a significant decrease in mean food or water consumption in test dams compared with controls may be useful in assessing maternal toxicity, especially when the test substance is added to the food or drinking water. Changes in food or water consumption should be combined with maternal weight for evaluation, with attention to whether the effect is systemic or simply due to the test substance in the food or water affecting appetite.
Clinical evaluations (including clinical signs, markers, hematology, and clinical chemistry studies) An increased incidence of overt clinical signs of toxicity in test maternal dams relative to controls may be useful in assessing maternal viability. If this information is used as the basis for assessing maternal toxicity, the type, incidence, severity, and duration of clinical signs should be reported in the study. Overt clinical signs of maternal toxicity include: coma, collapse, hyperactivity, loss of righting reflex, motor dysfunction, or dyspnea. Physical examination data: Increased incidence and/or severe autopsy findings may be indicative of maternal toxicity. This may include gross or microscopic pathological findings or organ mass data, such as absolute organ mass, organ mass to body weight ratio, or organ mass to brain mass ratio. Observation of a significant change in the mean mass of a suspected target organ in test maternal dams compared to controls may be considered evidence of maternal toxicity when supported by adverse histopathological findings of the affected organ. Note: Mating index and fertility index may also be affected by males 4.2.5 Animal and experimental data
4.2.5.1 A range of test methods can be used, including: developmental toxicity test methods, prenatal and postnatal toxicity tests and first or second generation toxicity test methods.
GB30000.24—2013
4.2.5.2 Results from screening tests can also be used as the basis for classification, although it is recognized that the reliability of this evidence is not as good as the results of comprehensive studies.
4.2.5.3 Adverse effects or changes observed in short-term or long-term repeated dose toxicity studies that are considered to be likely to impair reproductive function and occur in the absence of significant generalized toxicity can be used as the basis for classification, such as histopathological changes in the gonads. 4.2.5.4 Evidence from in vitro tests or non-mammalian tests and the use of structure-activity relationships (SAR) from similar substances can help with classification. For all of the above situations, expert judgment should be used to assess the adequacy of the data. Inadequate data should not be used as the primary basis for classification
4.2.5.5 It is preferred that animal studies be conducted by an appropriate route of ingestion relevant to the likely routes of human exposure. However, in practice, reproductive toxicity studies are generally conducted by the oral route and, under normal circumstances, this approach is appropriate for evaluating the hazard of a substance to the reproductive system. However, substances that produce adverse reproductive effects in experimental animals should not be classified when there is strong evidence that the mechanism or mode of action of the substance is not relevant to humans or when toxicokinetic differences are so significant that it is certain that the hazard will not be manifested in humans.
4.2.5.6 Routes of administration such as intravenous or intraperitoneal injection may expose the reproductive organs to unrealistically high doses of the test substance or cause local damage to the reproductive organs (e.g. through irritation). Studies using these routes of administration should be interpreted with extreme caution and cannot usually form the basis of classification in themselves. 4.2.5.7 There is general agreement on the concept of a limiting dose, i.e., a dose above which an effect may be considered to be beyond the range of the dose that would cause classification. However, in the OECD Special Working Group, no dose principle has been established as a standard range for causing classification. Some test guidelines specify a "limiting dose" while others use this statement to define the limiting dose. Consensus on the limiting dose is reached. Limitation: If it is expected that humans may be exposed to very high doses that would reach adequate exposure limits, it is necessary to conduct studies at higher doses. From the following , setting a specific limit dose may not be appropriate. Analogous animal models Due to species differences in toxicokinetics, in 4.2.5.8 In principle, animal studies alone should not induce toxicokinetic information that may be more susceptible to the effects on reproduction than animals at dose levels that are more sensitive to the effects (e.g., convulsions, severe anorexia, massive mortality) Other information indicates that classification is appropriate. For example, humans can be classified as maternal toxicity. For further studies, please refer to the relevant guidance in section 4.24).9 However, the provisions on the actual limit dose will be the test method adopted to provide the test results. For example, in the test guidance for repeated exposure toxicity studies via the oral route proposed by (ECD), 1000 mg/kg is recommended as the highest beneficial dose, i.e. the limit dose, unless the expected human response indicates that a higher dose level is required.
4.2.5.10 Regarding the issue of using the specified dose in the classification principle as the limit dose introduction standard, further discussion should be made. 4.3 Classification criteria for mixtures
4.3.1 Classification of mixtures when there are no data on the entire mixture The classification of mixtures should be based on the existing test data of the various components of the mixture, using the critical values/concentration limits of the components of the mixture. It can be based on The classification may be modified on a case-by-case basis based on available data for the mixture as a whole. In this case, the test results for the mixture as a whole should be conclusive in light of dose and other factors such as duration, observations and analysis (e.g. statistical analysis, test sensitivity) of the reproduction test system. Appropriate documentation supporting the classification should be retained and made available for review upon request. 4.3.2 Classification of mixtures in the absence of data on the mixture as a whole: bridging principles 4.3.2.1 When the mixture itself has not been tested to determine its reproductive toxicity, but there are sufficient data on the ingredients and similar tested mixtures to adequately characterize the hazards of the mixture, these should be used in accordance with the following agreed bridging principles: data. This ensures that the classification process uses the existing 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:
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GB30000.24—2013
If a tested mixture is diluted with a diluent which is not expected to affect the reproductive toxicity of the other ingredients, the new diluted mixture may be classified in the same category as the original tested mixture. 4.3.2.3 Product batch
The reproductive toxicity of a production batch of a mixture on which it has been tested may be considered to be substantially the same as that of another production batch of the same commercial product produced by the same manufacturer or under its control The reproductive toxicity of two untested product batches is the same, unless there is reason to believe that the reproductive toxicity of the untested product batches has significantly changed. In the latter case, a new classification is required. 4.3.2.4 Substantially similar mixtures:
Assume the following:
a) Two mixtures: I: A+B, IC+B; the concentration of reproductively toxic component B is the same in both mixtures; b)
The concentration of component A in mixture I is equal to the concentration of component C in mixtures I and II: Toxicity data for components A and C are available and are substantially the same, i.e. they belong to the same hazard category, and d
is not expected to affect the reproductive toxicity of component B. If mixture I or II has been classified based on test results, the other mixture can be classified in the same hazard category. 4.3.3 Classification of mixtures when data are available for all ingredients or only for some ingredients 4.3.3.1 When at least one ingredient is classified as a Category 1 or Category 2 reproductive toxicant and its concentration is greater than or equal to the corresponding cut-off values/concentration limits for Category 1 and Category 2 in Table 3, the mixture should be classified as a reproductive toxicant. Table 3 Cut-off values/concentration limits for mixtures classified as reproductive toxicants, effects on or via lactation Cut-off values/concentration limits that trigger classification of the mixture Component classification
Category 1A
Reproductive toxicant
Category 1B
Reproductive toxicant
Category 2
Reproductive toxicant
Effects on or via lactation
Additional category
Category 1 Reproductive toxicant
Category 1A
Category 1B
Category 2 Reproductive toxicant
Effects on or via lactation
Additional category
If a Category 1 reproductive toxicant, ingredient that affects or via lactation is present in a mixture at a concentration between 0.1% and 0.3%, each competent authority will require a MSDS for such product. However, labeling is optional. Some authorities require labeling, while others do not. If a Category 1 reproductive toxicant or ingredient that affects or via lactation is present in a mixture at a concentration greater than or equal to 0.3%, both a MSDS and a label are usually required. If a Category 2 reproductive toxicant is present in a mixture at a concentration between 0.1% and 3.0%, each administration will require a MSDS for such products. However, labeling is optional, with some administrations requiring it and others not.
If a Category 2 reproductive toxicant is present in a mixture at a concentration of 3.0% or more, both a MSDS and a label are usually required
This compromise classification scheme combines the differences in the existing systems regarding hazard communication. The number of mixtures affected is expected to be small; differences will be limited to labelling, which will evolve over time to a more uniform approach. GB30000.24—2013
4.3.3.2 When at least one ingredient has been classified as an additional category for effects on or via lactation and its concentration is greater than or equal to the cut-off value/concentration limit for the additional category for effects on or via lactation shown in Table 3, the mixture should be classified as an additional category for effects on or via lactation. 5 Decision logic
The decision logic is provided for reference. The decision logic is provided in Annex A. It is particularly recommended that the person responsible for classification study Chapter 4 before and during the use of the decision logic.
6 Labelling
6.1 Overview
6.1.1 For the labelling of reproductive toxicity, the hazard categories are listed in the order of the designated 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 corresponding graphic signs specified for each category on the label. The allocation of reproductive toxicity label elements is shown in Appendix B. 6.1.2 The classification criteria and label elements for reproductive toxicity 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, they also need to be included on the label. The competent authorities may also require additional information, and suppliers 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 signs 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. The signal word "Danger" is used for hazard category 1, reproductive toxicity; the signal word "Warning" is used for hazard category 2, reproductive toxicity; no signal word is used for the additional category of hazard effects on or via lactation. 6.4 Hazard statements
A hazard statement is a phrase assigned to a hazard class and category that describes the hazardous nature of a chemical and, where appropriate, its degree of hazard. Hazard statements for reproductive toxicity are given in Table C.1 and refer to Annex D. Hazard statements for the additional category of hazard effects on or via lactation are given in Annex C and refer to 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. For precautionary statements for different hazard categories of reproductive toxicity, see Appendix D6.6 Product identifiers
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used in the chemical safety data sheet. If a substance or mixture is listed in the Model Regulations, the correct UN shipping name should also be used on the package. 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, reproductive 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 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 reproductive toxicity labels, see Appendix E. A.1 Decision logic for reproductive toxicity
Appendix A
(Informative Appendix)
Decision logic
Classify according to the following decision flow chart A.1, Figure A.2 and Figure A.3 A1.1
Decision logic for substances (see Figure A.1)
Does the substance have reproductive toxicity data?
According to the classification criteria for drugs (see 42) Is the substance a known human reproductive agent, or a presumed human reproductive agent?
When using this criterion, experts are required to make a judgment using the weight of evidence approach. Safety classification standard (
When using this annotation, experts need to use the weight of evidence method to make judgments. Figure A.1 Classification process of substances
A.1.2 Judgment logic of mixtures
Cannot be classified
Category 1
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Not of this category
GB30000.24—2013
Mixtures: The classification of mixtures should be based on the existing test data of each component of the mixture, using the critical value/concentration limit of this component. It can be based on the existing test data of the mixture as a whole or the bridging principle. The classification can be modified according to the specific situation. See the following classification made after modification according to the specific situation. For further details, see 4.3.1~4.3.3.TTKAONTKAca
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