GB 30000.18-2013 Chemical Classification and Labelling Specification Part 18: Acute Toxicity GB30000.18-2013 |tt||Standard compression package decompression password: www.bzxz.net
This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and labeling of chemicals with acute toxicity. This part applies to the classification and labeling of chemicals with acute toxicity in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.
Chapter 4 and Chapter 6 of this part are mandatory, and the rest are recommended.
The expected structure of GB30000 "Specifications for Classification and Labelling of Chemicals" and the national standards to be replaced are:
———Part 1: General (replaces GB13690-2009);
———Part 2: Explosives (replaces GB20576-2006);
———Part 3: Flammable gases (replaces GB20577-2006);
———Part 4: Aerosols (replaces GB20578-2006);
———Part 5: Oxidizing gases (replaces GB20579-2006);
———Part 6: Gases under pressure (replaces GB20580-2006);
———Part 7: Flammable liquids (replaces GB20581-2006);
———Part 8: Flammable solids (replaces GB 20582-2006);
———Part 9: Self-reactive substances and mixtures (replaces GB 20583-2006);
———Part 10: Pyrophoric liquids (replaces GB 20585-2006);
———Part 11: Pyrophoric solids (replaces GB 20586-2006);
———Part 12: Self-heating substances and mixtures (replaces GB 20584-2006);
———Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replaces GB 20587-2006);
———Part 14: Oxidizing liquids (replaces GB 20589-2006);
——Part 15: Oxidizing solids (replaces GB 20590-2006);
——Part 16: Organic peroxides (replaces GB 20591-2006);
——Part 17: Corrosive to metals (replaces GB 20588-2006);
——Part 18: Acute toxicity (replaces GB 20592-2006);
——Part 19: Skin corrosion/irritation (replaces GB 20593-2006);
——Part 20: Serious eye damage/eye irritation (replaces GB 20594-2006);
——Part 21: Respiratory or skin sensitization (replaces GB 20595-2006);
———Part 22: Germ cell mutagenicity (replaces GB 20596-2006);
———Part 23: Carcinogenicity (replaces GB 20597-2006);
———Part 24: Reproductive toxicity (replaces GB 20598-2006);
———Part 25: Specific target organ toxicity single exposure (replaces GB 20599-2006);
———Part 26: Specific target organ toxicity repeated exposure (replaces GB 20601-2006);
———Part 27: Aspiration hazard;
———Part 28: Hazard to the aquatic environment (replaces GB 20602-2006);
———Part 29: Hazard to the ozone layer;
--- Part 30: Warning signs for chemical workplaces; This part
is Part 18 of GB 30000.
This part was drafted in accordance with the rules given in GB/T 1.1-2009. This
part replaces GB 20592-2006 "Safety Specification for Classification, Warning Labels and Warning Statements of Chemicals - Acute Toxicity".
Compared with GB20592-2006, the main technical content of this part has been changed as follows:
———The name of the standard has been modified. The Chinese name has been changed to "Rules for classification and labelling of chemicals—Part 18: Acute toxicity" and the English name is "Rules for classification and labelling of chemicals—Part 18: Acute toxicity";
———The scope of Chapter 1 has been modified, "Warning label" has been changed to "label", and "Warning statement" has been deleted;
———The introduction of "Normative references" in Chapter 2 has been modified;
———The notes of Category 5 in Table 1 have been modified;
———The original Chapter 8 has been deleted, and the relevant "Precautionary Statements" have been included as informative Appendix D. The original Chapters 6, 7 and 8 have been modified and integrated into Chapter 6;
———The sample of acute toxicity label has been added as informative Appendix E.
This part is consistent with the relevant technical content of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (4th revised edition).
This part was proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251).
The drafting units of this part: Tianjin Entry-Exit Inspection and Quarantine Bureau, Institute of Occupational Health and Poisoning Control, Chinese Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Information Center, Guizhou Provincial Institute of Analysis and Testing. The
main drafters of this part: Jia Xiaochuan, Liu Ming, Li Xiuping, Cao Lijing, Sun Li, Lin Zheng, Song Wei, Ge Xiaojun, Wu Weiai, Tan Hong, Yang Hongbo. The
previous versions of the standards replaced by this part are:
———GB20592—2006.
The following documents are indispensable for the application of this document. For any dated referenced document, only the dated version applies to this document. For any undated referenced document, the latest version (including all amendments) applies to this document.
GB6944 Classification and product name numbering of dangerous goods
GB13690 General Rules for Classification and Hazard Communication of Chemicals
United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (17th revised edition), hereinafter referred to as "Model Regulations"
United Nations "Globally Harmonized System of Classification and Labelling of Chemicals" (4th revised edition)

ICS13.300
National Standard of the People's Republic of China
GB30000.18—2013
Replaces GB20592-2006
Rules for classification and labelling of chemicals
Part 18: Acute toxicity
chemicals-Part18：Acutetoxicity
2013-10-10 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 rules (replace GB13690-2009); Part 2: Explosives (replace GB20576-2006); Part 3: Flammable gases (replace GB20577-2006); Part 4: Aerosols (replace 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: White-reactive substances and mixtures (replaces GB20583-2006); Part 10: White-flammable liquids (replaces GB20585-2006); Part 11: Pyrophoric solids (replaces GB20586-2006); Part 12: White-hot substances and mixtures (replaces GB20584-2006); Part 13: Substances and mixtures which, in contact with water, emit flammable gases (replaces GB20587-2006) : Part 14: Oxidizing liquids (replaces GB20589-2006); Part 15: Oxidizing solids (replaces GB20590-2006): Part 16: Organic peroxides (replaces GB20591-2006); Part 17: Metal corrosion (replaces GB20588-2006): Part 18: Acute toxicity (replaces GB20592-2006): Part 19: Skin corrosion/irritation (replaces GB20593-2006): Part 20: Serious eye damage/eye irritation (replaces GB20594-2006); Part 21: Respiratory or skin sensitization (replaces GB20595-2006): Part 22: Germ cell mutagenicity (replaces GB20596-2006); Part 23: Carcinogenicity (replaces GB205972006); Part 24: Reproductive toxicity (replaces GB205982006): Part 25: Specific target organ toxicity single exposure (replaces GB20599-2006); Part 26: Specific target organ toxicity repeated exposure (replaces GB20601-2006); Part 27: Aspiration hazard:
Part 28: Hazards to the aquatic environment (replaces GB206022006):
Part 29: Hazards to the ozone layer;
Part 30: Warning signs in chemical workplaces; This part is Part 18 of GB30000
This part was drafted in accordance with the rules given in GB/T1.1-2009. GB30000.18—2013
This part replaces GB20592—2006 Safety rules for classification, warning labels and warning statements of chemicals-Acute toxicity". Compared with GB20592-2006, the main technical content changes of this part are as follows: the factory standard name is modified, the Chinese name is changed to "Safety rules for classification and labelling of chemicals-Part 18:Acute toxicity", and the English name is \Rules for classification and labelling of chemicals-Part18:AcutetoxicityI
GB30000.18—2013
The scope of Chapter 1 is modified, "warning label" is changed to "label" and "warning statement" is deleted; the introduction of Chapter 2 "Normative references" is modified; the notes of Category 5 in Table 1 are modified: the original Chapter 8 is deleted, and the relevant "Precautionary statements" content is included as informative Appendix D. The original Chapter 6, Chapter 7 and Chapter 8 were revised and integrated into Chapter 6;
acute toxicity label samples were added as informative Appendix E. This part is consistent with the relevant technical content of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (Fourth Revised Edition). This part was proposed and managed by the National Technical Committee for Hazardous Chemicals Management Standardization (SAC/TC25I). Drafting units of this part: Tianjin Entry-Exit Inspection and Quarantine Bureau, Institute of Occupational Health and Poisoning Control, Chinese Center for Disease Control and Prevention, Pony Testing Technology Co., Ltd., China Chemical Information Center, Guizhou Provincial Institute of Analysis and Testing. The main drafters of this part: Jia Xiaochuan, Liu Ming, Li Xiuping, Cao Lijing, Sun Li, Lin Zheng, Song Wei, Ge Xiaojun, Wu Wei, Tan Hong, Yang Hongbo. The previous versions of the standards replaced by this part are: GB20592-2006.
1 Scope
Chemical Classification and Labelling Specification
Part 18: Acute Toxicity
GB30000.18—2013
This part of GB30000 specifies the terms and definitions, classification criteria, decision logic and labeling of chemicals with acute toxicity. This part applies to the classification and labeling of chemicals with acute toxicity in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (hereinafter referred to as GHS).
2 Normative References
The following documents are indispensable for the application of this document. For all dated references, only the dated version applies to this document. For all undated references, the latest version (including all amendments) applies to this document. GB6944 Classification and product name numbering of dangerous goods GB13690 General rules for classification and hazard communication of chemicals United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations" (17th revised edition), hereinafter referred to as "Model Regulations" United Nations Globally Harmonized System of Classification and Labelling of Chemicals (4th revised edition) 3 Terms, definitions and abbreviations
The terms, definitions and abbreviations defined in GB13690 and the following apply to this document. 3.1
Acute toxicityacutetoxicity
Acute harmful effects of a substance given orally or through the skin as a single dose or multiple doses given within 24 hours, or 4 hours of inhalation exposure.
3.2 Abbreviations
ATE: Acute Toxicity Estimate) QECD: Organization for Economic Co-operation and Development 4 Classification Standards
4.1 General Principles
For the general principles of classification and labeling of acute toxicity, see GB13690. 4.2 Material Classification Standards
4.2.1 The establishment of a unified classification system for acute toxicity is to meet the needs of existing systems. The acute toxicity table includes five categories. The classification basis is shown in Table 1.
GB 30000.18—2013
Table 1 Classification and definition of acute toxicity hazards Acute toxicity estimate (ATE) for each category Exposure route
Oral 6
Dermal
Vapor abcd.
Dust and mist bc
Category 1
(The acute toxicity estimate (ATE) for classifying substances can be used as Category 2
Category 3
LDLC value as
6For a substance in a mixture, its acute toxicity estimate (ATE) can be deduced based on the following values. Fragrance
1) The LD/LC
can be obtained from the test results of the reduction range. Appropriate conversion value, or 2) from Table 2 for the relevant toxicity
3) from Table 2 for the absorption bZxz.net
divided by the factor
# Now recognized
substances
"Dust
Enzymatic
US category appropriate conversion value:
Category 4
Category 5
See specific standards
See specific standards?
The critical value is based on the 4h exposure test, and is calculated based on the existing inhalation toxicity data generated by 1h exposure. For gases and vapors, the same smoke should be divided by 4. The saturated gas concentration is used as an additional factor, which provides undetermined health and safety protection. The test substance is not only classified as a gas when it consists of vapor close to the gas phase, but also a mixture of liquid phase and gas. The following is a more detailed description of the definition of the terms "smoke" and "vapor" as follows: Dust refers to the dust floating in a gas. The dust refers to the dust floating in a gas. The dust refers to the dust floating in a gas. The dust refers to the dust (0.5ml Category 32.5ml), Category 4 (20mL/s) is usually a solid material in the air or a mixture of air. | Gas) or liquid
vapour of wet
substances refers to the gaseous form released from a substance or mixture
in a solid or solid state 3)
Dust is usually formed by mechanical processes, and mist is usually formed by condensation of vapor or by the physical action of liquids. The dust and mist values ​​should be reviewed to adapt to any future changes in the OECD test guidelines on the concentration of respirable dust and mist in terms of production standards and measurement technology limits:
, the criteria for Category 5 are intended to identify substances with relatively low acute toxicity hazards, but which may pose a hazard to vulnerable groups of people under certain circumstances. The oral or dermal L for such substances ranges from 2.000mg/kg to 5000mg/kg body weight, and the inhalation route is the equivalent dose described above. The specifics of Category 5 The standard is:
1) If there is reliable evidence that the upper D (or LC%) is within the value range of Category 5 or other animal studies or human toxic effects indicate that the acute effect on human health is of concern, then the public substance Shenzhen Meiming will classify the substance into this category through extrapolation, evaluation or measurement data, but the premise is that there is no sufficient reason to classify the substance into a more dangerous category, 2)
And:
The existing reliable information shows that there are significant toxic effects in humans; when tested by oral inhalation or dermal routes, death can be observed at doses reaching Category 4 values; when the test dose reaches Category 4 values, expert judgment confirms that there are obvious clinical signs of toxicity, except diarrhea, ruffled hair or removal of external dirt:
Expert judgment confirms that in other animal studies, there is reliable information indicating that there may be potential for significant acute effects. For the protection of animals, animals should not be tested within the scope of Category 5: Such tests should only be considered when there is a high probability that the test results are directly related to the protection of human health. Note: The kg unit in the oral and dermal ATE refers to body weight. 2
GB30000.18-—2013
4.2.2 The preferred test species for evaluating acute toxicity by oral and inhalation routes is the rat, while the preferred test species for evaluating acute dermal toxicity is the rat or rabbit. Chemical classification test data obtained by recognized test methods should be recognized when reclassifying these chemicals according to the unified method. If acute toxicity test data are available for multiple animal species, scientific judgment should be used to select the most appropriate LD50 value from valid and well-conducted tests. 4.2.3 Category 1 is the most toxic category, and its cut-off values ​​(see Table 1) are currently used mainly by transportation departments to classify packaging groups. 4.2.4 Category 5 is suitable for substances with relatively low acute toxicity, but which have a dangerous tendency to vulnerable populations under certain circumstances. In addition to Table 1, identification criteria for Category 5 substances are also provided. The oral or dermal LD ​​values ​​of these substances are expected to range from 2000mg/kg to 5000mg/kg body weight, and the inhalation exposure route is the equivalent dose mentioned above. Note: Explanation of the acute inhalation toxicity category 5 value: The OECD Harmonized Classification and Labelling Group did not include the acute inhalation toxicity category 5 values ​​in Table 1 above, but instead specified an "equivalent" dose range of 2000 mg/kg to 5000 mg/kg body weight for oral or dermal routes (see Table 1 in the figure). 4.2.5 Factors for judging inhalation toxicity
4.2.5.1 Inhalation toxicity values ​​are based on 4 tests on laboratory animals. When the test value is obtained for a 1h contact test, the 1h test value can be converted into an 1h equivalent value by dividing it by a factor. For gases and vapors, the factor is 2, and for dusts and mists, the factor is 4.
4.2.5.2 The unit of inhalation toxicity is related to the form of the inhaled substance. For dust The values ​​for gases are expressed in mL/L. The values ​​for vapors are used to recognize that it is difficult to test vapors (vapors are composed of a mixture of liquid and gas phases. The values ​​provided in the table are expressed in mL/L. The unit is mg/L. However, the classification of vapors close to the gas phase should be based on use. As the inhalation test methods are updated, OECD and other test guideline schemes will need to compare hot gases with smoke to increase the degree of clarity. 4.2.5.3 Vapor inhalation values ​​are intended to use the acute toxicity classification of some parts as an additional element for delineating the packaging groups of chemicals to classify powders and mists as highly toxic. (MMAD) is used with a clear pain. A 4m large inhalation particle will be about 0.1% in the rat's instantaneous inhalation tract. The maximum dose is 2mg/1. In order to make the animal test applicable to the transport sector, the saturated vapor concentration of the chemical is also used as a numerical value. The average mass aerodynamic concentration of this particle size range corresponds to the general category of exposure. The dust and mist used in the rat test is preferably within the daily toxicity range measured under the condition of exposure. The critical values ​​of dust and mist in the table can make a clear distinction between the substances. Utilize all test conditions. The dust and mist values ​​should be reviewed in the future to adapt to any changes in the technical limitations of dust and mist concentrations in the future. OTOD or other test criteria should be used in the production, maintenance, and measurement of respirable powders. 4.2.5.5 In addition to the classification of inhalable toxicity, if the data obtained are in the table Where the mechanism of action of a substance or mixture is corrosive, some authorities may also choose to classify it as a "respiratory corrosive". Respiratory corrosivity is determined in the same way as skin abrasion: damage to respiratory tissue is measured after a single, limited duration exposure: this includes damage to mucous membranes. The assessment of corrosiveness may be based on expert judgement using evidence from human and animal experience, available (in vitro) data, pH, information from similar substances or any other relevant data.
4.3 Classification criteria for mixtures
4.3.1 Classification criteria for substances Acute toxicity is classified using lethal dose data (experimental or extrapolated). For mixtures, information should be available or extrapolated to enable these criteria to be applied to the classification of the mixture. The classification approach for acute toxicity is hierarchical and depends on the amount of information available on the mixture itself and its ingredients. The flow chart in Figure 1 summarizes the classification process. 3
TKANTKAca-
GB 30000.18—2013
There are sufficient data on similar
mixtures to estimate the hazard classification
Data are available for all ingredients
Other data can be used to estimate the classification conversion value
Convey
Test data for the mixture as a whole for the known ingredients
Use the bridging principle in 43.5
Use
in 43.6.1
Use
in 4.3.6.1
Use the formula in 4.3.6.1
(unknown ingredient ≤ 10%)
Use the formula in 4.3.6.2.3
(unknown ingredient > 10%)
Figure 1 Classification of mixtures by acute toxicity (hazard)
4.3.2 Classification of the acute toxicity of a mixture may be made for each route of exposure, but if all ingredients have one route of exposure (estimated or determined experimentally) and there is no relevant evidence that acute toxicity has multiple routes of exposure, then only that route of exposure needs to be classified. If there is relevant evidence that toxicity has multiple routes of exposure, all relevant routes of exposure should be classified. All available information must be taken into account. The pictogram and signal word should reflect the most serious hazard category and all relevant hazard statements should be used. 4.3.3 In order to use all available information to classify the hazards of a mixture, certain assumptions are made and applied, as appropriate, in a tiered approach: a)
A "relevant ingredient" of a mixture is a component present in a concentration of not less than 1% (mass fraction for solids, liquids, dusts, mists and vapors and volume fraction for gases), unless there is reason to suspect that the component at a concentration of less than 1% is still relevant to the acute toxicity classification of the mixture. This is particularly relevant when classifying untested mixtures containing ingredients classified in Category 1 and Category 2.
If a classified mixture is used as an ingredient of another mixture, the actual or derived acute toxicity estimate (ATE) of the mixture may be used when calculating the classification of the new mixture using formula b) in 4.3.6.1 and 4.3.6.2.3.
If the converted acute toxicity point estimates for all ingredients of the mixture are in the same category, the mixture is classified in that category.
If only range estimates (or acute toxicity hazard category information) are available for the ingredients of the mixture, they may be converted to point estimates in accordance with Table 2 when calculating the classification of the new mixture using the formulas in 4.3.6.1 and d). Table 2
Exposure routes
Dermal
Dust/mist
GB30000.18—2013
Convert the acute toxicity range obtained from the test into the acute toxicity point estimate unit for the corresponding exposure route
Note: The kg in the ATE unit for oral and dermal refers specifically to body weight. Classification category or test-derived
Acute toxicity estimate
0 Category 1≤5
5 Category 250
50<Category 3300
300~Category 4≤2000
2000 Category 5≤5000
0×Category 1 50
50 Category 2200
200-Category 31000
1000 Category 42000
2000 Category 5≤5900
0≤Category 1≤0.1
0.1~Category 20.5
0.5Category 32.5
2.5~Category 4≤20.0||tt| |Category 5 (see Note to 4.2.4)
0×Category 10.5
0.5×Category 22.0
2.0Category 310.0
10.0Category 4≤20.0
Category 5 (see Note to 4.2.4)
0<Category 10.05
0.05Category 2≤0.5
0.5Category 3≤1.0
1.0≤Category 4≤20.0
Category 5 (see Note to 4.2.4)
Converted acute toxicity point
Estimate
Category 5 is suitable for mixtures with relatively low acute toxicity but which may be hazardous to susceptible populations in certain environments. The LD values ​​for these mixtures are estimated to be in the range of 2.000 mg/kg to 5000 mg/kg bw via the osmotic or dermal route, with equivalent doses for other routes of exposure. For animal protection reasons, testing in animals within the Category 5 range should not be conducted; however, such testing should only be considered when there is a high probability that the results of such testing will be directly relevant to the protection of human health.
These values ​​are intended to be used in the calculation of acute toxicity estimates for the classification of mixtures based on their ingredients and do not represent test results. These values ​​are conservatively set at the lower end of the range used for Categories 1 and 2 and at a point approximately 1/10 of the way to the lower end of the range for Categories 3-5. 4.3.4 Classification of mixtures with complete acute toxicity test data If the mixture itself has been tested to determine its acute toxicity, the mixture may be classified according to the same criteria as described in Table 1 for substances. If no test data are available for the mixture, the procedures described in 4.3.5 and 4.3.6 should be followed. 4.3.5 Classification of mixtures for which no acute toxicity test data are available as a whole: bridging principles 4.3.5.1 Where the mixture itself has not been tested to determine its acute toxicity, but sufficient data are available on the individual ingredients and on tested similar mixtures to characterize the hazards of the mixture appropriately, then these data will be used in accordance with the following agreed bridging principles. This ensures that the classification process uses the available data as far as possible to characterize the hazards of the mixture without the need for additional testing in animals.
4.3.5.2 Dilution
If a tested mixture is diluted with a diluent that has an equal or lower toxicity classification than the least toxic of the original ingredients and that does not affect the corrosiveness/irritation of the other ingredients, then the new diluted mixture may be classified as equivalent to the original tested mixture. Formula (1) can also be used. 4.3.5.3 Product batches
A production batch of a mixture that has been tested for toxicity can be considered to be virtually equivalent to another untested batch of the same commercial product produced by the same manufacturer or under its control, unless there is reason to believe that the toxicity of the untested batch has changed significantly. If the latter situation occurs, a new classification is required. 4.3.5.4 Degree of high toxicity mixtures
A tested mixture is classified as Category 1. If the number of ingredients belonging to Category 1 in the mixture is increased, the resulting untested mixture will remain classified without further testing. Toxicity category extrapolation method
4.3.5.5 Mixtures with three identical ingredients (AB and C) Mixtures A and B have been tested and are in the same toxicity category, while mixture C has not been tested but has the same toxicologically active ingredients as mixtures A and B and the concentrations of the active ingredients are very similar to those in mixtures A and B, then the mixture should be classified in the same hazard category as B. 4.3.5.6
Substantially similar mixtures
Assume the following situation:
Two mixtures:
b) The concentrations of the ingredients in both mixtures are essentially the same: the concentration of ingredient A in mixture A is equal to the concentration of the ingredient in mixture B: d) Toxicity data for A and C are available and are substantially the same, i.e. they are of similar hazard categories and are unlikely to affect the toxicity of B
If the mixtures are already classified based on test data, then the other mixture can be classified in the same hazard category. 4.3.5.7 Aerosols
If the added gas-poor propellant does not affect the toxicity of the mixture when sprayed, the oral and dermal toxicity of the aerosol or mixture may be classified in the same hazard category as the tested non-aerosol mixture. The inhalation toxicity classification of the aerosol type should be considered separately.
4.3.6 Classification of mixtures by components (Additivity formula) 4.3.6.1 Data available for all components
To ensure accurate classification of mixtures and to ensure that only one calculation is required for all systems, sectors and categories, the acute toxicity estimates (ATE) of the components shall be calculated based on the following factors: Components with known acute toxicity that fall into any acute toxicity category of the harmonized classification method shall be factored in; Components without acute toxicity (e.g. water, sugars) shall not be factored in; If the available data are from a limiting dose test (upper limit of Category 4 in Table 1) and no acute toxicity is shown, this factor shall not be included in the calculation
Components falling within the scope of this paragraph may be considered as components with known acute toxicity estimates (ATE). How to correctly apply known data in the following equations, see Note b of Table 1 and 4.3.3, as well as equations (1) and (2) According to equation (1), determine the ATE of the mixture for oral, dermal or inhalation toxicity by calculating the ATE values ​​of all relevant components:
Where:
Concentration of component;
n components, and i is from 1 to n;
Acute toxicity estimate (ATE) of the component. C
4.3.6.2 No data are available for one or more components of the mixture GB30000.18—2013
4.3.6.2.1 There is no ATE for the individual components of the mixture, but the following information can be used to derive conversion values, the formula can be used as formula (1). This may include an assessment of the following:
Extrapolation between oral, dermal and inhalation acute toxicity estimates. Such an assessment may require appropriate pharmacodynamic and pharmacokinetic data:
Evidence from human exposure indicates that there is a lethal effect, but no data on the lethal dose are provided; Evidence from other toxicity test analyses indicates that the substance has an acute renal effect, but the values ​​do not necessarily provide evidence of lethal dose data:
Data obtained from very similar substances through structure-activity relationships require a lot of supplementary technical information and a well-trained and experienced expert to be reliable in this method.
If such information is not available, then go to the provisions of 3.623 to estimate acute toxicity.
If there is a concentration in the mixture that is not small, then go to the provisions of 3.623 to estimate acute toxicity. 4.3.6.2.2 Where there is no known acute activity estimate for a substance, in this case the components of unknown toxicity make up x% of the mixture. 4.3.6.2.3 If the total activity of the components from the acute toxicity perspective is greater than 5%, then the decision logic states that no information is available for classification of the components. The mixture should be classified based on the known components only and the total activity should be calculated based on the unknown components. If the total activity of the components is less than 5%, then the decision logic should be used. If the components of unknown toxicity are compared to the corrected components, then the decision logic is for reference only. See Annex A for the decision logic. It is particularly recommended that the person responsible for classification study the following before and during the use of decision logic: Chapter 4
6 Labelling
6.1 Overview
6.1.1 For labels for acute toxicity, 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 Model Regulations shall be listed on the label with the designated corresponding pictogram for each item. The allocation of label elements for acute toxicity is shown in Annex B.
6.1.2 For classification criteria and label elements for acute toxicity, see Annex C. 6.1.3 The information required on the label includes hazard pictograms, signal words, hazard statements, precautionary statements, product identifiers and supplier identification. Note: For other label elements that have not been standardized, such as precautionary statements, they also need to be included on the label. The competent authority may also require additional information, and the supplier may add supplementary information
6.2 Hazard pictograms
Hazard pictograms should use black symbols with a white background and a red frame that is wide enough to be eye-catching. TKAONTKAca-
GB30000.18—2013
6.3 Signal words
Signal words are words used on labels to indicate the relative severity of a hazard and to alert the reader to potential hazards. The signal words used are "Danger" and "Warning". The signal word "Danger" is used for acute toxicity of categories 1, 2 and 3. The signal word "Warning" is used for acute toxicity of categories 4 and 5. 6.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous properties of a hazardous product and, where appropriate, its degree of hazard. Acute toxicity hazard statements and precautionary statements are shown in Table C.1 in Appendix C and in Appendix D. 6.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) that describes recommended measures to minimize or prevent adverse effects resulting from exposure to a hazardous product or improper storage or handling of a hazardous product. There are five types of precautionary statements: general, prevention, emergency, storage and disposal. See Appendix D for acute toxicity precautionary statements. 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 Material Safety Data Sheet. If a substance or mixture is listed in the Model Regulations, the correct UN shipping name should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute 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 also require that the chemical names of all components or alloying elements that may contribute to the hazards of the mixture or alloy be listed on the label. 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
See Appendix E for examples of acute toxicity labels. A.1 Decision logic for acute toxicity of substances
The decision logic for acute toxicity of substances is shown in Figure A.1
Appendix A
(Informative Appendix)
Decision logic and guidance
Substance: Are there data and/or information for evaluating acute toxicity? Mixture: Are there data/information for evaluating acute toxicity of the mixture as a whole or its components?
Mixture: Are there data/information for evaluating acute toxicity of the mixture as a whole?
From Appendix B47
According to the classification criteria of 4.2~4:3.4, are there the following acute toxicity data? Oral LD50≤5mg/kg
Dermal LDso≤50mg/kg
Inhalation (gas) LC50≤0.1mL/L
Inhalation (vapor) LC50≤0.5mg/L
Inhalation (dust and mist) LCs0≤0.5mg/1L? Fragrance
According to the classification standards 4.2--4.3.4, are there any acute toxicity data for the following? Oral 53 Signal words
Signal words are words used on labels to indicate the relative severity of a hazard and to alert the reader to a potential hazard. The signal words used are "Danger" and "Warning". The signal word "Danger" is used for acute toxicity categories 1, 2 and 3. The signal word "Warning" is used for acute toxicity categories 4 and 5. 6.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Hazard statements and precautionary statements for acute toxicity are given in Table C.1 in Annex C and refer to Annex D. 6.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) describing a recommended measure to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. There are five categories of precautionary statements: general, prevention, emergency, storage and disposal. See Annex D for precautionary statements for acute toxicity. 6.6 Product Identifier
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the Material Safety Data Sheet. If a substance or mixture is listed in the Model Regulations, the correct UN shipping name should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute 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 also require that the chemical names of all components or alloying elements that may contribute to the hazards of the mixture or alloy be listed on the label. 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 Example
See Appendix E for an example of an acute toxicity label. A.1 Decision logic for acute toxicity of substances
The decision logic for acute toxicity of substances is shown in Figure A.1
Appendix A
(Informative Appendix)
Decision logic and guidance
Substance: Are there data and/or information for evaluating acute toxicity? Mixture: Are there data/information for evaluating acute toxicity of the mixture as a whole or its components?
Mixture: Are there data/information for evaluating acute toxicity of the mixture as a whole?
From Appendix B47
According to the classification criteria of 4.2~4:3.4, are there the following acute toxicity data? Oral LD50≤5mg/kg
Dermal LDso≤50mg/kg
Inhalation (gas) LC50≤0.1mL/L
Inhalation (vapor) LC50≤0.5mg/L
Inhalation (dust and mist) LCs0≤0.5mg/1L? Fragrance
According to the classification standards 4.2--4.3.4, are there any acute toxicity data for the following? Oral 53 Signal words
Signal words are words used on labels to indicate the relative severity of a hazard and to alert the reader to a potential hazard. The signal words used are "Danger" and "Warning". The signal word "Danger" is used for acute toxicity categories 1, 2 and 3. The signal word "Warning" is used for acute toxicity categories 4 and 5. 6.4 Hazard statements
Hazard statements are phrases assigned to a hazard class and category that describe the hazardous nature of a hazardous product and, where appropriate, its degree of hazard. Hazard statements and precautionary statements for acute toxicity are given in Table C.1 in Annex C and refer to Annex D. 6.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) describing a recommended measure to minimize or prevent adverse effects resulting from exposure to the hazardous product or from improper storage or handling of the hazardous product. There are five categories of precautionary statements: general, prevention, emergency, storage and disposal. See Annex D for precautionary statements for acute toxicity. 6.6 Product Identifier
6.6.1 The product identifier should be used on the label and should be consistent with the product identifier used on the Material Safety Data Sheet. If a substance or mixture is listed in the Model Regulations, the correct UN shipping name should also be used on the packaging. 6.6.2 The label should include the chemical name of the substance. For mixtures or alloys, when acute 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 also require that the chemical names of all components or alloying elements that may contribute to the hazards of the mixture or alloy be listed on the label. 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 Example
See Appendix E for an example of an acute toxicity label. A.1 Decision logic for acute toxicity of substances
Decision logic for acute toxicity of substances is shown in Figure A.1
Appendix A
(Informative Appendix)
Decision logic and guidance
Substance: Are there data and/or information for evaluating acute toxicity? Mixture: Are there data/information for evaluating acute toxicity of the mixture as a whole or its components?
Mixture: Are there data/information for evaluating acute toxicity of the mixture as a whole?
From Appendix B47
According to the classification criteria of 4.2~4:3.4, are there the following acute toxicity data? Oral LD50≤5mg/kg
Dermal LDso≤50mg/kg
Inhalation (gas) LC50≤0.1mL/L
Inhalation (vapor) LC50≤0.5mg/L
Inhalation (dust and mist) LCs0≤0.5mg/1L? Fragrance
According to the classification standards 4.2--4.3.4, are there any acute toxicity data for the following? Oral 5
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