Safety rules for classification、precautionary labelling and precautionary statements of chemicals - Germ cell mutagenicity
Some standard content:
ICS13.30C
National Standard of the People's Republic of China
GB20596—2006
Safety specifications for classification, precautionary labelling and precautionary statements of chemicals-Germ cell mutagenicityIssued on October 24, 2006
Digital anti-counterfeiting
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaAdministration of Standardization of the People's Republic of China
Implementation on January 1, 2008
Chapter 4, Chapter 6, Chapter 7 and Chapter 8 of this standard are mandatory, and the rest are recommended. GB20596—2006
The consistency of this standard with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is not equivalent. Its relevant technical contents are consistent with those in GHS. The standard text format is in accordance with GB/T 1, 1. I make sub-editorial changes
This standard is proposed and managed by the National Technical Committee for Standardization of Dangerous Chemicals Management (SAC/TC251). The responsible drafting unit of this standard is: Jiangsu Entry-Exit Inspection and Quarantine Bureau. The participating drafting units of this standard are: China Center for Disease Control and Prevention, Sinochem Chemical Standardization Research Institute. The main drafting persons of this standard are: Xu Yan, Wu Liche, Qian Jin, Bai Boqin, Fu Zuqing, Wang Rong, Zhang Junwang, Bai This standard will be implemented in the production field from January 1, 2008; it will be implemented in the circulation field from December 31, 2008, and the transition period for the implementation of the standard will be from January 1 to December 31, 2008. 1 Scope
Safety Specification for Classification, Warning Labels and Precautionary Statements of Chemicals Germ Cell Mutagenicity
GB20596—2006
This standard specifies the terms and definitions, classification, determination process and guidance, categories and warning labels, configuration of categories and label elements and general provisions for warning statements of germ cell mutagenicity caused by chemicals. This standard applies to the hazard classification, warning labels and warning statements of germ cell mutagenicity caused by chemicals in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals. 2 Normative References
The clauses in the following documents become the clauses of this standard through reference in this standard. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest versions shall apply to this standard. GB20597-2006 Chemical classification, warning labels and warning statements Safety regulations Carcinogenicity United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GIIS) United Nations Recommendations on the Transport of Dangerous Goods Model Regulations OECD471 Newcomer Mutation Test
OECD473
OECD474
OECD475
OFCD476
OECD478
OECD483
OECD484
OECD485
OECD4S6||tt| |3 Terms and definitions
In vitro mammalian cell chromosome aberration test, mammal erythrocyte micronucleus test
Mammal bone marrow chromosome aberration test
In vitro mammalian cell gene mutation test, rodent dominant lethal mutation test
Mammalian spermatogonia chromosome aberration test, mouse swallow test
Mouse genetic translocation test
In vivo mammalian liver cell unscheduled DNA synthesis (UDS) test Germ cell mutagenicity refers mainly to chemicals that can cause mutations in human germ cells and can be inherited to offspring. However, in vitro mutagenicity/genotoxicity tests and in vivo tests on mammal resting cells are also considered when substances and mixtures are classified in this hazard category. In this standard, the terms mutagenicity, mutagen, mutation and genotoxicity are mentioned many times. "Mutation" is defined as a permanent change in the amount or structure of genetic material in a cell. "Mutation" applies to heritable genetic variation, including both manifestations of phenotypic changes and significant DNA modifications found (for example, including heterosexual base pair changes and chromosomal translocations). "Mutagenic" and "catastrophic" are used for substances that cause an increase in the number of mutations in cells and/or biological populations.
"Genotoxic" and "genotoxic" apply to substances that cause changes in the structure, information content, or segregation of DNA, including DNA damage caused by substances that interfere with the normal replication process or (temporarily) alter its replication in a non-physiological manner. Genotoxicity test results are usually used as indicators of mutagenic effects.
GB20596—2006
4 Classification
4.1 Classification of substances
4.1.1 This classification system provides two different categories of germ cell mutations to accommodate the balance of evidence. The two-category system is defined as follows, see Table 1.
Hazard categories for germ cell mutations
Category A:
Category 1B:
Category 2:
Chemicals known to cause heritable mutations in human germ cells or likely to cause heritable mutations. Chemicals known to cause heritable mutations in human germ cells. Indicator: Positive evidence from human epidemiological studies: Chemicals that should be considered likely to cause heritable mutations in human germ cells. Indicator
Positive results in in vivo heritable germ cell mutation tests in mammals: or positive results in in vivo somatic cell mutagenicity tests in mammals, combined with some evidence that the substance induces germ cell mutations. This and supporting data, for example, can be derived from in vivo mutagenicity/genotoxicity tests in germ cells, or confirmed by the interaction of the substance or its metabolites with germ tissue, or positive results from tests showing human germ cell mutagenic effects that are not passed on to offspring, such as an increase in aneuploidy in seminal mitochondria of the population exposed to the substance.
Chemicals of concern because of their potential to induce transmissible mutations in human germ cells. Indicators
Indicators derived from tests on mammals and/or in some cases from in vitro tests; from somatic cell mutagenicity tests in mammals; or from in vivo somatic cell genotoxicity tests supported by positive results from other in vitro mutagenicity tests. Note: Chemicals that are positive in in vitro mammalian cell mutagenicity tests and are known to be germ cell mutagens from a chemical structure activity relationship should be considered as Class 2 mutagens.
4.1.2 For classification purposes, test results of mutagenic and/or genotoxic effects in germ and/or somatic cells of exposed animals are considered. Mutagenic and/or genotoxic effects determined in vitro may also be considered. 4.1.3 The classification system is based on hazard, and chemicals are classified according to their inherent ability to induce germ cell mutagenesis. Therefore, the classification scheme does not imply a hazard evaluation of the chemical. 4.1.4
Classification for heritable effects in human germ cells is based on well-validated, adequately validated tests. Examples of in vivo heritable germ cell mutagenicity tests are as follows: Rodent dominant lethal mutation test (OECD478) Mouse heritable translocation test (OECD485) Mouse specific site test
4.1.6 Examples of in vivo somatic cell mutagenicity tests are available: Mammalian bone marrow chromosome aberration test (OECD475) Mouse spot test (OECD484)
Mammalian erythrocyte micronucleus test (OECD474) 4.1.7 Examples of germ cell mutagenicity/genotoxicity tests are as follows: a) Mutagenicity test
Mammalian spermatogonia chromosome aberration test (OECD483) Sperm cell micronucleus test
b) Genotoxicity test
Spermatogonia sister chromatid exchange test Unscheduled DNA synthesis test (UDS) in spermatogonia 4.1.8 Examples of somatic cell genotoxicity tests are as follows: Unscheduled DNA synthesis (UDS) test in mammalian liver cells (OECD486) Sister chromatid exchange test (SCE) in mammalian bone marrow 4.1.9 Examples of in vitro mutagenicity tests are as follows: In vitro mammalian cell chromosome aberration test (OECD473) In vitro mammal cell gene mutation test (QECD476) Bacterial reverse mutation test (OECD471)
GB20596-2006
4.1.10 Classification of each substance should be based on expert judgement, weighing the available evidence. Where classification is based on a single test, the test should provide clear and unambiguous positive results. If new, well-validated test results are available, these should also be used in the balance of evidence. Consideration should also be given to whether the exposure routes used in the study are relevant to those of the human population. 4.2 Classification of mixtures
4.2.1 Classification of mixtures when data are available for the mixture as a whole Classification of mixtures will be based on available test data for the ingredients of the mixture, with classification based on the cut-off values/concentration limits for the ingredients that are germ cell mutagenic. Classification may be based on data for the mixture itself, on a case-by-case basis. In this case, the test results for the mixture itself must be conclusive, taking into account dose and other chemical factors such as test duration, observations from the germ cell mutagenicity test system and analysis (e.g. statistical analysis, test sensitivity). Documentation of the resulting classification should be maintained and available for review in the event that it is necessary. 4.2.2 Classification of mixtures when data are not available for the mixture as a whole: bridging principle 4.2.2.1 When the mixture itself has not been tested and has not demonstrated a germ cell mutagenicity hazard, but sufficient data are available from the individual ingredients and similar tested mixtures to demonstrate the hazard of the mixture, these data may be used in the bridging principle. This ensures that the existing available data are used to the greatest extent possible in the classification process without the need for additional testing in animals. 4.2.2.2 Dilution
If a mixture is diluted with a diluent that is not expected to affect the germ cell mutagenicity of the other ingredients, the new mixture may be classified as the original mixture. 4.2.2.3 Product batches
The germ cell mutagenicity of a production batch of a complex mixture may be assumed to be the same as the germ cell mutagenicity of another production batch of the same commercial product or produced under the control of the same manufacturer, unless there is reason to believe that the germ cell mutagenicity of the batch has significantly changed. In the latter case, a new classification must be made 4.2.2.4 Substantially similar mixtures, given the following: a) Two mixtures: 1) A + B 2) C + B;
b) The concentration of mutagenic component B is the same in both mixtures; The concentration of component A in mixture 1) is equal to the concentration of component C in mixture 2); e
d) Germ cell mutagenicity data for components A and C are available and these data are substantially equivalent, i.e. they are in the same category and are not expected to affect the germ cell mutagenicity of B. If mixture 1) has been classified by testing, mixture 2) can be classified in the same category. 4.2.3 Classification of mixtures when data are available for all ingredients of the mixture or only for some ingredients The mixture should be classified as a mutagenic when at least one ingredient has been classified as a Category 1 or Category 2 mutagen and the appropriate cut-off/concentration limits are shown in Table 2 for Category 1 and Category 2, respectively, or above. 3
GB20596-—2006
Table 2 Cut-off values/concentration limits for mixture ingredients classified as germ cell mutagens when initiating classification of mixtures Classification
Category 1 Mutagens
Category 2 Mutagens
Cut-off values/concentration limits for classification of mixtures
Category 1 Mutagens
Note: The cut-off values/concentration limits in the table apply to solids and liquids (selected volume fractions) and gases (volume fractions) Decision process and guidance
Category 2 Mutagens
The following decision process and guidance are not part of the harmonized classification system, but are provided as additional guidance. It is particularly recommended that the classification responsible person study the classification before and during the use of the decision process. 5.1 Decision process
Classify according to the following decision process Figures 1 and 2. 5.1.1 Decision process for substances
Substance: Does the substance have mutagenicity data? Yes
According to the classification (see 4.1), does the substance cause any of the following? Known to cause heritable mutations in human germ cells, or presumed to cause heritable mutations in human germ cells. Use of this classification requires an expert judgement on the balance of evidenceAccording to the classification (see 4.1), does the substance cause any concern due to the potential for heritable mutations in human germ cells? Use of this classification requires an expert judgement on the balance of evidenceYes
Figure 1 Germ cell mutagenicity determination flow
5.1.2 Determination flow for mixtures
Classification not possible
Category 1
Category 2
Not classified
Mixtures: The classification of mixtures shall be based on the available test data for the ingredients of the mixture, in particular using the cut-off values/concentration limits for those ingredients. Existing classifications may be adjusted on a clause-by-clause basis, based on the available test data for the mixture as a whole or on a bridging basis. See below for integrated classification on a clause-by-clause basis. Further details can be found in 4.2. Classification based on individual ingredients of the mixture Does the mixture contain one or more ingredients classified as Category 1 mutagenic at a concentration of: ≥ 0.1%? Does the mixture contain one or more ingredients classified as Category 2 mutagenic at a concentration of: ≥ 0.1%*? Does the integrated classification on a clause-by-clause basis take into account the characteristics of the mixture itself? Are there test data for the entire mixture? Do the results of the reproductive cell mutagenicity tests factor in to dose and other factors such as time, observations and analysis (e.g. statistical analysis, test sensitivity) in the test system? Can the compound be used? (See 1.2.2) Not classified
Category 1
Category 2
Classify to the appropriate
Category Danger or Warning or Not classified
GB20596—2006
See above: Classify according to the ingredients of the mixture For specific concentration limits, see Table 2.
b If data from other mixtures are used in the bridging principle, the data for this mixture must comply with the provisions of 4.2.1 and are conclusive. Figure 2 Flowchart for determination of germ cell mutagenicity of mixtures 5.2 Guidance
The theory that chemicals induce tumors in humans and animals involves genetic mutation of proto-oncogenic genes and/or cancer suppression of resting cell genes is increasingly accepted. Therefore, confirmation of the mutagenicity of chemicals in somatic and/or germ cells of mammals can lead to the classification of these chemicals as potential carcinogens: see also GB20597-2006. 6 Categories and warning labels
Categories and warning labels for germ cell mutagenicity See clause 3. GB20596-2006
Hazard categories
(1 phase)
Table 3 Categories and warning labels for germ cell mutagenicity
Graphic number
Substances known to cause heritable mutations in human reproductive tissues or believed to cause heritable mutations in human germ cells (see clauses 1 to 3)
or compounds containing not less than 0.1% of such substances Substances that are of concern to people because they may cause heritable mutations in human germ cells (see clause 4), or compounds containing not less than 0.1% of such substances1% filtrate category and label element configuration
Hazard statement
Graphic symbol
Hazard statement
Warning label element
Can cause genetic defects (if it is concluded that no other exposure pathways will produce this
hazard, the exposure route should be stated
Suspected of causing genetic defects If it is concluded that no other exposure pathways will produce this
hazard, the exposure route should be stated) For chemical classification and warning labels, each category of hazard types is listed in the order of designated graphic symbols, names and hazard statements. Hazard categories involved in the United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations": According to the United Nations "Globally Harmonized System of Classification and Labeling of Chemicals" (GIIS) requirements, the designated corresponding graphic signs for each category are listed below. Germ cell mutagenicity category label element configuration is shown in Table 4.
Configuration of germ cell mutagenicity categories and label elements Table 4
Category 1A
May cause genetic defects
(If it is concluded that no other exposure routes will cause this hazard, the exposure route should be stated)
Category 18
May cause genetic defects
(If it is concluded that no other exposure routes will cause this hazard, the exposure route should be stated)
Category 2
Suspected of causing genetic defects
(If it is concluded that no other exposure routes will cause this hazard, the exposure route should be stated)
Indicate the route of contact)
Not required in the United Nations "Recommendations on the Transport of Dangerous Goods Model Regulations8 Warning Statements
GB20596-2006
This standard provides some common warning statements. Its purpose is to provide instructions that can be suitable for labels provided for specific substances or mixtures. Those warning statements that are most suitable for specific circumstances should be used. When there are words in brackets in the warning statements, any words in the brackets can be used to supplement the core content contained in the sentence or replace that content. 8.1 Instructions to prevent possible misuse and exposure to health effects 8.1.1 Ventilation control
Use only in well-ventilated areas.
Use only with appropriate ventilation [or closed system ventilation device]. Do not enter the use area and storage area without proper ventilation. Use only under conditions of sufficient wind (or closed system ventilation) to keep harmful substances (dust, smoke, vapor, etc. in the air) below the recommended exposure limit.
Use appropriate ventilation to remove vapors (smoke, dust, etc.). Use appropriate ventilation and/or engineering controls during high temperature operations to avoid exposure to vapors. Avoid vapor accumulation during and after use by providing appropriate ventilation. [When using, use a ventilation device], local exhaust ventilation [or take respiratory protection]. Do not use in areas without proper ventilation. Do not breathe (dust, vapor or spray). 8.1.2 Hygiene measures
Do not smoke or eat during use, Drinking. Do not eat, drink or smoke during work. Wash hands before eating, drinking or smoking
Wash thoroughly after handling.
Avoid all contact. Maintain good hygiene habits. Avoid contact with skin and eyes.
Prevent skin contact.
Prevent splashing into eyes.
Wash thoroughly with soap and water after handling and before eating, drinking or smoking. Wash thoroughly with soap and water after handling.
Prevent contact with skin, eyes and clothing. Prevent contact with skin (eyes or clothing). Prevent splashing into eyes (skin) or clothing. 8.1.3 Personal protective equipment
Wear appropriate protective clothing, gloves and goggles/mask]. Wear protective clothing and gloves (specify the type of protective clothing and gloves). Wear protective eyewear (goggles, mask or safety glasses). Wear appropriate personal protective equipment to avoid direct contact. 8.1.4 Respiratory protection
In case of insufficient ventilation, wear appropriate respiratory equipment. During fumigation/spraying, appropriate breathing equipment should be worn (appropriate instructional language specified by the manufacturer). When using this chemical, an effective emergency self-contained respirator or full-face air-circuit respirator is required. Self-contained respirator or full-face air-circuit respirator should be worn when using this chemical. GB20596—2006
8.2 Instructions for appropriate measures in the event of an accident 8.2.1 Leakage
In case of leakage, evacuate the danger zone.
In case of leakage, consult an expert.
Clean the ground and all items contaminated by the use of this material (specified by the manufacturer). Cover with absorbent or put into containers. Collect and dispose. Cover the leaked material with [.
Absorb the residue in sand or inert absorbent and move to a safe place. Treat the remaining liquid with
1.
Wash away the remaining leaked liquid with plenty of water]. Do not flush into the sewer.
Avoid drains and sewers
Remove dry cold spills immediately.
Allow product to cool/solidify, pick up when solidified
Sweep up and remove immediately
Use non-sparking utensils when handling flammable spills, remove all sources of ignition. Ensure adequate ventilation to remove vapors, fumes, dust, etc. Collect leaking liquid in sealed (metal/plastic) containers. Carefully collect leaking liquid
Collect seepage and leakage as much as possible in sealed (metal, plastic) containers. Do not return leaks to their original containers.
Vacuum up leaks
Sweep leaks into factory containers.
Sweep leaks into containers; wet first if necessary to avoid dust. Carefully neutralize the residue, then rinse with plenty of water. Collect the residue carefully.
Wipe off the residue, place in a cooler, and move to a safe place. Do not use sawdust or other flammable absorbents to absorb. Do not use water directly on the liquid.
8.2.2 Fire Fighting
In case of fire, use (specify the exact type of fire fighting equipment). Do not use water if water will increase the hazard. Use carbon dioxide, dry powder or foam.
Water may be used to cool or protect exposed materials. If the airflow cannot be cut off, allow the gas to burn. Cut off the source; if this is not possible or there is no danger to the surroundings, let the fire burn out by itself; otherwise, use a door to extinguish the fire. If the fire is around: All extinguishing agents may be used. If the fire is around: (Use appropriate extinguishing agents) Firefighters should wear complete protective clothing, including self-contained breathing apparatus. 8.3 First Aid
8.3.1 General
In case of accident or physical discomfort, seek medical help immediately (post medical labels where possible). When calling a poison control center, emergency station or doctor for treatment, the product container or label should be with you. 8
8.3.2 Accidents due to inhalation
In case of inhalation, move the victim to fresh air and keep quiet. If inhaled, seek medical attention immediately.
[Move the victim to] fresh air and let it rest]. Lift to fresh air immediately. Medical attention should be sought immediately. If symptoms or signs continue to occur, seek medical attention immediately. If breathing has stopped, give artificial respiration. If breathing is difficult, give oxygen.
Adopt a semi-supine position.
Use artificial respiration if necessary.
Do not use mouth-to-mouth respiration.
If inhaled, provide oxygen or perform artificial respiration and call a doctor. If inhaled, use amyl nitrite and call a doctor. Lift the victim to fresh air.
Call 120 emergency telephone or call an ambulance, then give artificial respiration, preferably mouth-to-mouth respiration if possible. Call the poison control center or a doctor for further treatment. 8.3.3 Accidents caused by ingestion
If ingested, seek medical attention immediately.
If swallowed, do not induce vomiting, seek medical attention immediately, and show the container or label. If swallowed, seek medical attention immediately, and show the container or label. If swallowed, vomit, rinse mouth with water (only if the victim is conscious). If swallowed, vomit, and the victim is conscious and awake, induce vomiting immediately as directed by the doctor. (Do not induce vomiting). (If the victim is conscious, give two glasses of water and get medical attention immediately). Drink (one glass) (two glasses) of water. Call a doctor (or poison control center immediately), rinse mouth
Give activated charcoal slurry.
Induce vomiting (only for conscious breathing). Do not induce vomiting.
Do not give anything to drink.
Drink plenty of water.
Rest.
Wear protective gloves when inducing vomiting.
If ingested, drink lukewarm water, induce vomiting, gastric lavage, call a doctor. If ingested, drink lukewarm (water), induce vomiting, clean the intestines, call a doctor. If ingested, drink vegetable oil, induce vomiting, call a doctor. If ingested, rinse mouth with water, drink milk or egg white. If ingested, gastric lavage with 5% sodium thiosulfate aqueous solution. If ingested, gastric lavage with 1% sodium thiosulfate aqueous solution. If ingested, induce vomiting, gastric lavage with sodium bicarbonate aqueous solution. If ingested, induce vomiting, gastric lavage with vegetable oil enema and bowel lavage. If ingested, immediately gastric lavage with 2% copper sulfate aqueous solution. If ingested, induce vomiting, gastric lavage with sodium sulfate aqueous solution, clean the intestines and stomach. If ingested, induce vomiting, gastric lavage with potassium permanganate aqueous solution. GB20596—2006
GB20596—20C6
If ingested, drink milk or egg white, gastric lavage, call a doctor. If ingested, call the poison control center or doctor immediately for treatment advice. If the victim can swallow, let him drink a glass of water in gulps. Do not induce vomiting. Wash out the ingested substance in the mouth with water. If there are no symptoms of irritation, gastric lavage can be performed. If ingested, vomiting occurs, gastric lavage with 60 mL of 1% potassium iodide solution. Call a poison control center or doctor.
Do not give anything by mouth to an unconscious patient. 8.3.4 Accidents caused by skin contact
After contact with the skin, immediately remove all contaminated clothing and immediately wash with large amounts of (products specified in the manufacturer's regulations). (If irritation develops and persists, give medical treatment).
If irritation develops and persists, seek medical treatment immediately. Immediately wash with a soft soap solution, then wash with running water for 15 minutes or rinse with large amounts of water (If irritation develops and persists, seek medical treatment immediately). wwW.bzxz.Net
Immediately rinse the skin with large amounts of water and remove contaminated clothing. If irritation (redness, rash, blisters) deepens, seek medical treatment immediately. Before reuse, wash contaminated clothing, remove clothing and wash thoroughly before reuse. Remove contaminated clothing and wash before reuse. Rinse contaminated body parts with plenty of water. Rinse contaminated body parts with clean fresh water. If direct contact with the body, seek medical attention. If contact with skin or eyes, rinse with fresh water. If frostbite occurs, seek medical attention immediately.
If contact with skin, immediately apply 2% silver nitrate aqueous solution and remove contaminated clothing.
Immediately rinse skin with plenty of water for 15min~~20min. 8.3.5 Accidents caused by eye contact
Immediately rinse eyes with plenty of (manufacturer specified solution) for at least 15min. Then seek medical attention immediately. Wash eyes with water for at least 15min. If eye irritation deepens or persists, seek medical attention immediately. Separate the eyelids and rinse eyes with plenty of water for at least 15min. Then seek medical attention immediately. Separate the eyelids and rinse eyes with water for at least 15min. Contact lens wearers should remove their lenses and seek medical attention immediately. First rinse with plenty of water for several minutes (remove contact lenses if convenient) and then seek medical attention immediately. In case of direct contact with eyes, rinse thoroughly with slow-flowing clean water. Keep eyes open and rinse slowly and gently with water for 15min to 20min. Contact lens wearers should remove contact lenses after the first 5 minutes and then continue to rinse eyes.
8.4 Instructions for environmental protection and appropriate disposal
8.4.1 Environmental protection
Use appropriate sealing measures to avoid environmental contamination and avoid release into the surrounding environment. (Refer to the safety data sheet of the chemical). Prevent release into the surrounding environment.
Use appropriate sealing measures.
Do not allow this chemical/product to enter the surrounding environment. Do not add directly to water, or areas with surface water, or wet areas below the mean high water mark. 10
Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.