Safety rules for classification、precautionary labelling and precautionary statements of chemicals - Respiratory or skin sensitization
Some standard content:
ItS13.300
National Standard of the People's Republic of China
GB20595-2006
Safely rules for classification, precautionary labeling and precautionary statements of chemicals
Respiratory or skin sensitization
Safely rules for classification, precautionary labeling and precautionary statements of chemicals-Respiratory or skin sensitization2006-10-24Promulgated
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
Precautionary parts
2008-01-01Implementation
Chapter 4, Chapter 6, Chapter 7 of this standard Chapter 1 and Chapter 8 are mandatory, and the rest are recommended. GB20595-2006
This standard is not equivalent to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in terms of consistency: its relevant technical content is consistent with GHS, and the text format of the chemical standard has been revised according to GR7T1.-20U. This standard was proposed by the National Technical Committee for the Management of Dangerous Chemicals (SAC/TC: 251). Who is responsible for drafting this standard: Tianyang Exit Inspection and Quarantine Bureau. Participating drafting units of this standard: China Center for Disease Control and Prevention, China Chemical Standardization Research Institute. The main drafters of this standard are Xia Li, Shang Wei, Yu Tuojun, Zun Fangjing, Pingang, Chaohao Libao, Xia Zhishi. 4 The standard will be implemented in the production field from January 1, 2008: it will be implemented in the flow field from December 31, 2019, and the transition period for the implementation of the standard will be from January 1 to December 31, 2098. 1 Scope
Safety Specification for Classification, Precautionary Labels and Precautionary Statements of Chemicals
Respiratory or Skin Sensitization
GB 20595--2006
This standard specifies the terminology and meaning, classification, determination process and guidance, categories and warning labels, configuration of category and label elements and general specifications for warning statements of respiratory or skin sensitization caused by chemicals. This standard applies to the following chemicals that cause respiratory or skin sensitization according to the hazard classification, warning labels and warning statements of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.
2 Normative References
The provisions of the following documents become the clauses of this standard through reference in this standard: For any dated referenced document, all subsequent amendments (excluding revisions) or revisions are not applicable to this standard. However, it is encouraged that the latest versions of these documents be used by the parties to the agreement on the basic standard. For any undated referenced document, the latest version shall apply to this standard. United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Joint United States on the Construction of Emergency Goods Standards 3 Terms and Definitions Respiratory sensitizers are substances that cause respiratory sensitization after contact with the skin. 3.2 Skin sensitizers are substances that cause allergic reactions after skin contact. 4 Classification 4.1 Classification of substances 4.1.1 Respiratory sensitizers 4.1.1.1 Hazard categories Substances are classified as respiratory sensitizers (categories): if there is evidence in humans that the substance can cause specific respiratory sensitization and/or there are results from appropriate animal tests. 4.1.1.2 Evidence in humans 4.1.1.2.1 There is evidence, usually based on human experience, that the substance causes specific respiratory sensitization. In this category, allergies usually present as asthma. Other allergic reactions include rhinitis/conjunctivitis and nasal conjunctivitis. Patients with this condition may have clinical features of an allergic reaction, however, an immunological mechanism has not been demonstrated. 4.1.1.2.2 Reference to human evidence When determining the award, consider the source of the infection - the size of the population exposed
- the extent of exposure
4.1.1.2.3 [The evidence for improvement may be a history of exposure to the substance and appropriate clinical data. Other supporting evidence for further confirmation. Order includes:
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In vivo immunological tests (e.g., skin scratch tests): - In vitro immunological tests (e.g., biological analysis); - When the immunological mechanism of the sensitization is not clear, other specific allergic reactions can be excluded, such as repeated levels of stimulation, drug-mediated effects:
. Chemical structures related to substances known to cause respiratory allergies: Data obtained from positive bronchial provocation tests on substances based on the generally accepted principles for determining specific allergic reactions. 4.1.1.2.4 Clinical findings from medication history and occupational exposure history to determine the relationship between exposure to specific substances and the development of respiratory allergies: Relevant information should include exacerbating factors in the home and work environment, onset and progression, family history and medical history. The medical history should also include records of other allergies or respiratory diseases since childhood, as well as respiratory history, 4.1.2,5 The results of the bronchial provocation test can provide sufficient evidence for the classification of the allergic substance. However, in practice, many of the tests listed above should be performed first. 4.1.1.3 Animal studies Several animal studies have been conducted to test whether inhalation substances cause sensitization in humans, including: determination of immunoglobulin F (IF) and other immunological parameters such as specific lung responses in mice and guinea pigs.
Note: The mechanism by which substances cause asthma is not fully understood. For protective purposes, these substances are considered respiratory sensitizers. However, if there is sufficient evidence that the substance stimulates bronchial hyperreactivity in humans and causes respiratory symptoms, then the substance is not considered a respiratory sensitizer.
Note 2: There are currently no animal models available for testing inhalation allergy reactions. Under certain circumstances, animals can be used for testing, for example, in mice to test the mechanism of hypersensitivity to proteins. However, these tests still need to be further verified for their effectiveness. 4.1.2 Skin sensitizers
4.1.2.1, Hazard categories
A substance is classified as a contact sensitizer according to the following principles: if there is human evidence that the substance causes allergies in many people through skin contact or if there is a protective effect from animal tests
4. 1.2.2 Special considerations
4.1.2.2.1 For classification of a substance, it must contain evidence of one or more of the following: - Positive data from patch tests: usually a clinically relevant dermatological finding; epidemiological studies showing that the substance causes allergic contact dermatitis: specific symptoms occur in most cases of contact under specific observation, even if the number of cases is small:
- Positive data from appropriate animal studies:
Closed-ended experimental data from human subjects:
Well-established allergic contact dermatitis data, usually from multiple infectious disease clinics. 4.1.2.2.2 Positive results from either human or animal studies are not sufficient for classification of a substance. Evidence from animal studies is usually much more reliable than evidence from human exposure; however, evidence may come from both sources, and sometimes there is a conflict between the two results, so the reliability of the evidence from both sources must be evaluated so that the classification problem can be resolved on a case-by-case basis. Normally, human data are not derived from controlled volunteer studies conducted at the date of hazard classification, but are only used as part of the risk evaluation to confirm that the effects of animal studies were insufficient. Therefore, human contact sensitization data are often obtained from controlled or other uncontrolled studies. Therefore, the evaluation of human data must be carefully based on the magnitude of the situation. In addition, the chemical properties of the substance and other factors such as exposure conditions, bioavailability, individual liability and preventive measures taken should also be considered. Human data should not normally be used to determine the results of animal studies.
4.1.2.2.3 If none of the conditions mentioned in 1.2 is met, the substance need not be classified as a contact sensitizer. However, the combination of two or more of the contact sensitization criteria listed below may change the classification decision. This requires consideration on a case-by-case basis. A case of contact dermatitis caused by excessive tenderness GE 20595-2006
Limited epidemiological studies. For example, when the standard has not been able to completely exclude accidental events, variability or confounding factors with reasonable confidence: - Data from animal experiments based on current guidelines that do not meet the criteria for the detailed conclusions described in 1.1.2.4.1 of this chapter,It is close enough to the effective limit; the number of positives obtained by non-standard methods is similar to the average result:
4.1.2.3 Immune contact urticaria Substances that meet the criteria for respiratory sensitization are called immune contact urticaria. These substances should also be considered as contact sensitizers. Substances that cause immune contact urticaria but do not meet the criteria for respiratory sensitization should also be considered as contact sensitizers. There is currently no recognized animal model for the evaluation of immune contact urticaria substances. Therefore, classification is usually based on the evidence of skin hypersensitivity reactions.
4.1.2.4 Animal studies
4.1.2.4.1 Skin allergy When using the wound test, at least 30% of the animals should show a reaction. For the non-adjuvant test method, if at least 15 animals react, it is considered positive. The skin allergy test method is defined as the repulsive tissue test (guinea pig maximum reaction test and 1Uchler sham test and Guideline 429 lymph node test). Other methods may be used provided they are well validated and widely tested: the mouse sensitizer test (MEST) has been shown to be a reliable screening test for the detection of moderate to strong sensitizers and can be used as a first step in the evaluation of skin sensitization potential, which can obviate the need for a further guinea pig test when the latter test is responsive.
4.1.2.4.2 In the evaluation of animal data from skin sensitization tests in accordance with the (FCD) domain equivalent guidelines, the ratio of irritated animals should be considered. This ratio is the sensitizing potential of the substance in relation to its moderate irritant dose: this dose may vary with the substance: if the substance is dose-sensitive, a more appropriate assessment of the sensitizing potential of the substance can be made. This is an area that requires further development. 4.1.2.4.3 There are substances that are extremely sensitizing at low doses. In contrast, other substances require high doses and prolonged exposure to determine sensitization. This may be better for the classification of hazard types: sensitizers and moderate sensitizers. 4.2 Classification of mixtures
4.2.1 Classification of mixtures when data are available for the mixture as a whole When there is reliable and good evidence from human experience or studies in appropriate experimental animals, the mixture can be classified based on a balance of evidence from these data. Care should be taken in assessing the data for the mixture to use a stated dose rather than to draw uncertain conclusions.
4.2.2 Classification of mixtures when data are not available for the mixture as a whole: bridging principles 4.2.2.1 When the mixture itself has no known sensitizing properties, but there is adequate data on the efficacy of the individual ingredients or similar test systems for the mixture, this data can be used by following an agreed bridging process. This ensures that the hazard classification of the mixture is based on the maximum possible use of the available data, and that additional or no testing of the mixture is required. 4.2.2. 2 Dilution
The allergenicity of a non-tenderizer is not expected to be affected by the dilution: the new mixture is classified as the same as the original mixture.
4.2.2.3 Production batches
The allergenicity of a production batch of a complex mixture can be assumed to be substantially equivalent to that of another production batch of the same commercial product or produced under the same control, unless there is reason to believe that the production of the batch has changed and there is no expected change in allergenicity. If this occurs, reclassification is required. 4.2.2.4 Substantially similar mixtures
Given the following conditions:
a) Two mixtures: 1) A+R,2+B:
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h) The concentration of component 1 is substantially the same in both mixtures; c) The concentration of component A in mixture 1) is equal to that in mixture 2) 4.2.2.5 Aerosols Aerosol mixtures may be classified in the same hazard category as tested non-aerosol mixtures provided that the added propellant does not affect the sensitization properties of the mixture. 4.2.26 Classification of mixtures when data on all ingredients of the mixture are not available or when data on the efficacy of some ingredients are not available and at least one ingredient has been classified as a respiratory or skin sensitizer: The mixture may be classified as a respiratory or skin sensitizer when the liquid/gas meets or exceeds the narrow end point cut-off/concentration limits shown in Table 1 Table 1 Cut-off/concentration limits for ingredients of mixtures classified as skin sensitizers or respiratory sensitizers Classification of mixtures when data on all ingredients of the mixture are available or when data on the efficacy of some ingredients are available and at least one ingredient has been classified as a respiratory or skin sensitizer: The mixture may be classified as a respiratory or skin sensitizer when the liquid/gas meets or exceeds the narrow end point cut-off/concentration limits shown in Table 1 |tt||Skin sensitizer
Respiratory sensitizer
Skin sensitizer
Solid/liquid
Standard sensitizer
If a skin sensitizer is present as a component in a compound and its concentration is above 1.1%, then generally speaking, a safety data sheet (B/117519) is required as well as a label: Although the 1% limit value before H reflects the current formulation, in special cases, it may be necessary to select a lower limit of 1.5%. |tt||If a skin sensitizer is present as a component in a compound and its concentration is not less than 0.1% within two days, then a safety data sheet (GH/T 1.1) If a solid or liquid respiratory sensitizer is present as a component in the mixture and its concentration is between 0.1% and 1%, then generally both a safety data sheet (GB/T17319.1) and a warning label are required. Although the above critical values reflect the current system, in special cases, low-concentration information may also need to be transmitted. If a solid or liquid respiratory sensitizer is present as a component in the mixture and its concentration is not less than 0.1%, then a safety data sheet (GB/T17319.1) and a warning label are required. If a solid or liquid respiratory sensitizer is present as a component in the mixture and its concentration is between 0.1% and 0.2%, then both a safety data sheet (GB/T17319.1) and a warning label are required. 1) Although the threshold values are not in line with the current system, in special cases, it is also necessary to provide information below this level. If a gaseous respiratory sensitizer is present as a component in a mixture, and its concentration is not less than 0.2, the safety data sheet (GB/T17519.1) should be issued. 5 Decision process The following decision process is not part of the coordinated classification system, but is provided as additional guidance. It is recommended that the person responsible for classification should conduct research on the classification before and during the use of the decision process. 5.1 Decision process for respiratory sensitizers Substance: Does the substance have any respiratory data? Mixture: Does the mixture have any respiratory data? Can the classification rule be applied if it is not clear?
(see 4.2.2)
Does the mixture have any data/data on its use as a sleep sensitizer? (see 4.2.1) Is there evidence in humans that the mixture may cause specific respiratory sensitization, and,
are there positive results from an appropriate (general) animal test (see 4.1.1)www.bzxz.net
Not classified
Are the concentrations of one or more respiratory sensitizers below 1% [solid/liquid fraction by weight), 30.2% [gas fraction by volume)? (.4, 2.2.6) Section
Not classified
Figure 1 Flowchart for determining respiratory sensitizers
Classification is not possible
Category 1
Classification
Appropriate category
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Flowchart for determining skin sensitizers
Substance: Does the substance have skin irritation data/information? Compound: Does the substance as a whole or its components have skin irritation/information?
Not classifiable
Does the compound as a whole have skin irritation data/information? (See 4.2.1)
Is there human evidence that the drug/compound can cause sufficient respiratory damage in many people through the skin environment, or
are there positive results in appropriate (or inappropriate) animal tests?
3.1 and 4.1, 2.
Does fentanyl
|be a bridge principle
[See 4.2.2]
The filtrate contains one or more active ingredients and has 1% (solid/volume fraction, or
>0.2% [*[volume fraction])? (See 4.2. 2.6) Small points
Figure 2 Determination process of skin sensitizers
Impossible to classify
Category 1
Appropriate category
Category and warning label
Respiratory or skin application category and alternative label are shown in Table 2 and Table 3 Table 2 Respiratory allergy category and alternative label
Hazard category
1) Applicable to substances and test mixtures with the following characteristics: If there is human evidence that the substance can cause specific respiratory allergies. And/or
There are positive results from appropriate animal tests;
2) If these mixtures meet one of the following "bridging principle\ provisions: (n) Dilution:
(h) Product batch
(r) Substantially similar mixtures;
3) If the bridging principle does not apply - if the respiratory sensitizer component in the mixture reaches the following concentration, it can be classified: || tt||Not less than 1.03, solid/liquid,
Not less than 0.2%, gas
Table 3 Skin allergy categories and warning labels
"Hazard category
1) Substances and test mixtures with the following characteristics under appropriate conditions; if there is evidence that the various substances can cause allergic reactions in most people by skin contact, or
there are appropriate animal test results;
2) If these source compounds meet the following "bridging principle" provisions under the following circumstances:
(a) Dissolution;
(h) Product drink:
(c) Substantially similar mixture:
3) The bridging principle does not apply. If the skin sensitizer of the various substances in this case is small, it can be classified if the concentration reaches the following: not less than 1. Solid/liquid/gas
Classification and labeling elements matching
GB 20595--2006
Label elements
Graphic symbols
Hazard
Inhalation may cause allergies
or asthma symptoms
or breathing difficulties
Warning label elements
Graphic symbols
Hazard
May cause skin allergy
Allergic reaction
For "Chemical Classification and Warning Labeling", each category of hazard type is listed in the order of designated graphic symbols, names and hazard statements. The United Nations Recommendations on the Transport of Emergency Goods Model Regulations "hazardous categories" are listed below according to the United Nations "Globally Harmonized System of Classification and Labeling of Chemicals" (GIJS) requirements. The configuration of respiratory or skin allergy categories and label elements is shown in Tables 4 and 5.
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Category 1
Can cause allergy
or asthma symptoms
Respiratory sensitization category and label elements configuration table 4
In combination. Recommendations on the transport of dangerous goods 1 Table 5
Category 1
May cause
allergic skin reaction
Required in the model regulations
The configuration of skin sensitization categories and label elements is not required in the United Nations Recommendations on the Transport of Dangerous Goods Warning Statements
Heat shock. This standard provides some common warning statements, which provide statements that can be suitable for the standard provided for a specific substance or mixture. Those warning statements that are most suitable for the specific situation should be used. When the warning statement is used with words in brackets, any words in the brackets are used to supplement the core content contained in the sentence or replace the content. 8.1 Prevent possible misuse and exposure to health effects 8.1.1 Ventilation control
Use only in well-ventilated areas,
Use with proper ventilation or closed system ventilation device 7. Before proper ventilation, it is forbidden to enter the use area and storage area. It can only be used under sufficient ventilation (or closed system ventilation) to keep the harmful substances (dust, smoke, steam, etc. in the air) below the established exposure limit.
Use proper ventilation to remove steam (smoke, dust, etc.), 9
Use proper ventilation and/or process control during high temperature operation to avoid exposure to steam. During and after use, provide appropriate wind to avoid steam accumulation. [Use sanitary ventilation device 1, local ventilation, or take respiratory protection, and prohibit use in areas without proper ventilation. Do not inhale (dust, steam or mist). 8.1.2 Hygiene measures
Do not inhale, eat or drink during use. ! Do not eat, drink or smoke during operation.
Wash hands before eating, drinking or washing.
Wash thoroughly after changing,
Avoid contact. Maintain good hygiene habits to avoid contact with skin and eyes.
Avoid contact with skin and
Avoid contact with human body.
Wash thoroughly with soap and water after operation and before eating, drinking or smoking. Wash thoroughly with soap and water after operation:
Avoid contact with skin, eyes and clothes, avoid contact with skin (eyes and objects), avoid splashing of skin (skin) or clothes
8. 1.3 Personal protective equipment
Wear protective clothing and gloves (specify the type of protective clothing and related equipment). Wear protective mask (goggles, mask or safety glasses), wear appropriate personal protective equipment, and avoid direct contact. 8.1.4 Respiratory protection
In case of insufficient ventilation, appropriate breathing equipment should be used. During spraying/atomizing, wear appropriate breathing equipment (the manufacturer shall specify appropriate respiratory equipment). When using this chemical, an effective emergency self-contained respirator or full-face air-circuit respirator is required. When using the chemical, a self-contained respirator or full-face air-circuit respirator should be worn. 8.2 Instructions for appropriate measures in the event of an accident 8.2. 1 Leakage
In case of leakage, please consult an expert.
Clean the ground and all articles contaminated by the use of this material (as specified by the manufacturer). Cover with absorbent or put into a container. Collect and dispose of. Cover the leaked material,
Absorb the remaining objects with sand or absorbent and move them to a safe place. Dispose of the remaining liquid
Wash away the leaked material with plenty of water! 1,
Do not flush it down the drain
Avoid it from flowing into drains and sewers
Clean up the leaked material immediately,
Allow the product to cool/solidify before picking it up.
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Sweep and clean immediately.
When handling flammable leaks, use non-sparking equipment and remove all ignition sources. Ensure adequate ventilation to remove vapors, mist, dust, etc. Collect leaking liquid in a sealable (metal/plastic) container. Carefully neutralize leaking secretions.
Collect leaks and leaks in a sealable (metal, plastic) container as much as possible. It is forbidden to collect leaks and leaks. Ask the original seal!
Use a vacuum cleaner to clean up the leak
Sweep the leaked material into the [
Benefactor-
1 container; if necessary, first moisten to avoid dust, carefully neutralize the residue, then rinse with water and collect the residue.
Wipe off the residue, place
7, and then move to a safe place.
Do not use unburned or other flammable materials Absorbent absorbs makeup. Do not use water to spray liquid directly.
8.2.2 Extinguishing
In case of fire, use (specify the specific type of fire extinguisher attached). Do not use water if it will increase the hazard. Use carbon dioxide, powder foam
Water can be used to cool the exposed material. If the air flow cannot be cut off: cut off the source. If it is impossible or there is no danger to the surroundings, let the fire burn for 15 days; otherwise, use If the fire is around: all extinguishing agents can be used. If the fire is around: use appropriate extinguishing agents. Firefighters should wear complete protective clothing, but 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 treatment label where possible) call poison control center, emergency station or doctor before seeking treatment. This should be carried with you. 8.3.2
Accidents caused by inhalation
In case of inhalation accident, move the victim to fresh air and keep quiet. If inhalation is dangerous, give first aid immediately
Move the victim to fresh air and rest
Remove the victim to fresh air immediately. Get medical treatment immediately: If symptoms or signs continue to appear, seek medical attention immediately. If breathing stops: 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 breathing.
If inhaled, provide oxygen or perform artificial respiration, call for help. If inhaled, use amyl nitrite, call for a doctor: Remove the victim to fresh air.
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