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GB 30000.25-2013: Rules for classification and labelling of chemicals -- Part 25: Specific target organ toxicity -- Single exposure
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Rules for classification and labelling of chemicals -- Part 25: Specific target organ toxicity -- Single exposure
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Basic data | Standard ID | GB 30000.25-2013 (GB30000.25-2013) | | Description (Translated English) | Rules for classification and labelling of chemicals -- Part 25: Specific target organ toxicity -- Single exposure | | Sector / Industry | National Standard | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300 | | Word Count Estimation | 22,282 | | Older Standard (superseded by this standard) | GB 20599-2006 | | Quoted Standard | GB 13690; GB 16483; GB 30000.26; United Nations ' Recommendations on the Transport of Dangerous Goods Model Regulations " (seventeenth revised edition); United Nations ' Globally Harmonized System of Classification and Labelling " (fourth revised edition) | | Regulation (derived from) | National Standards Bulletin No. 21 of 2013 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies: a first contact with the cause specific target organ toxicity Chemicals terms and definitions, general description, classification, decision logic, labels. This standard applies to: a first contact with the cause specific target o | GB 30000.25-2013: Rules for classification and labelling of chemicals -- Part 25: Specific target organ toxicity -- Single exposure
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Rules for classification and labelling of chemicals.Part 25. Specific target organ toxicity.Single exposure
ICS 13.300
A80
National Standards of People's Republic of China
Replacing GB 20599-2006
Chemical classification and labeling Part 25.
Specific target organ toxicity - single exposure
Rulesforclassificationandlabelingofchemicals-Part 25.
Issued on. 2013-10-10
2014-11-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
Part 5, Chapter 7 are mandatory, the rest are recommended.
GB 30000 "chemical classification and labeling norms," the expected structure and national standards will be replaced as follows.
--- Part 1. General (instead of GB 13690-2009);
--- Part 2. Explosives (instead of GB 20576-2006);
--- Part 3. flammable gases (instead of GB 20577-2006);
--- Part 4. Aerosol (instead of GB 20578-2006);
--- Part 5. oxidizing gas (instead of GB 20579-2006);
--- Part 6. pressurized gas (instead of GB 20580-2006);
--- Part 7. flammable liquids (instead of GB 20581-2006);
--- Part 8. Flammable solids (instead of GB 20582-2006);
--- Part 9. Self-reactive substances and mixtures (instead of GB 20583-2006);
--- Part 10. Pyrophoric liquids (instead of GB 20585-2006);
--- Part 11. Spontaneous solid (instead of GB 20586-2006);
--- Part 12. Self-heating substances and mixtures (instead of GB 20584-2006);
--- Part 13. water, emit flammable gases and mixtures (instead of GB 20587-2006);
--- Part 14. oxidizing liquid (instead of GB 20589-2006);
--- Part 15. oxidizing solids (instead of GB 20590-2006);
--- Part 16. Organic peroxide (instead of GB 20591-2006);
--- Part 17. metallic corrosion products (instead of GB 20588-2006);
--- Part 18. Acute toxicity (instead of GB 20592-2006);
--- Section 19. Skin corrosion/irritation (instead of GB 20593-2006);
--- Part 20. Serious eye damage/eye irritation (instead of GB 20594-2006);
--- Part 21. respiratory or skin sensitization (instead of GB 20595-2006);
--- Part 22. germ cell mutagenicity (instead of GB 20596-2006);
--- Part 23. carcinogenic (instead of GB 20597-2006);
--- Part 24. Reproductive toxicity (instead of GB 20598-2006);
--- Part 25. Specific target organ toxicity - single exposure (instead of GB 20599-2006);
--- Part 26. Specific target organ toxicity, repeated exposure (instead of GB 20601-2006);
--- Part 27. Inhalation Hazard;
--- Part 28. harmful to the aquatic environment (instead of GB 20602-2006);
--- Part 29. harmful to the ozone layer;
--- Part 30. Chemical workplace warning signs.
This section of Part 25 GB 30000.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 20599-2006 "chemical classification, precautionary labeling and precautionary statements Specific target organ systems
Toxic first contact. "
This section compared with GB 20599-2006, the major technical changes as follows.
--- Changing the name of the standard, the Chinese name changed to "chemical classification and labeling Part 25. a specific target organ toxicity
Exposure ", the English name changed to" Rulesforclassificationandlabelingofchemicals─Part 25. Specifictarget
organtoxicity-Singleexposure ";
--- Add "Category 3. transient target organ effects" related content;
--- Modify the scope of content Chapter 1, the "warning labels" to "tag" Delete "Precautionary Statements" (see Chapter 1);
--- Increase the Chapter 4, "General Description";
--- Revised "decision logic" part of the statement, and "1" as Appendix A;
--- Modify the original part of Table 5, attached as Appendix B;
--- Modify the original table 4 parts, the "name" to "signal words", "hazard statements" to "hazard statements", as Appendix C;
--- Deleted the original chapter 8, the relevant "precautionary statements" content as informative annex D, and the original Chapter 6, Chapter 7, Chapter 8 repair
Change integrated into Chapter 7;
--- Add tags exemplary specific target organ toxicity single exposure as informative Appendix E.
This part of the National Chemicals Management Standardization Technical Committee dangerous (SAC/TC251) and focal points.
This section was drafted by. People's Republic of China Tianjin Entry-Exit Inspection and Quarantine Bureau, Chinese Center for Disease Control and Prevention, Occupational Health and Poison
Control, PONY Test Technology Co., Ltd., China National Chemical Information Center.
The main drafters of this section. Lining Tao, Liu Ming, Sun Shujun, Zhao Lihua, Jiang Xuefeng, Ge Xiaojun, Song Wei, Zheng Lin, Chao-lin, WU Wei Ai.
This part of the standard replaces the previous editions are.
--- GB 20599-2006.
Chemical classification and labeling Part 25.
Specific target organ toxicity - single exposure
1 Scope
GB 30000 provisions of this section having a specific target organ toxicity caused by the contact of the terms and definitions chemicals, general says
Ming classification criteria, decision logic, tags.
This section applies to exposure caused by having a specific target organ toxicity of chemicals by the United Nations' Globally Harmonized System of Classification and
Labelling "(hereinafter referred to as the GHS) of classification and labeling.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB 13690 chemical classification and hazard communication General
GB 16483 MSDS Content and Order
GB 30000.26 classification and labeling of chemicals safety specifications - Part 26. Specific target organ toxicity - Repeated exposure
United Nations "on the Recommendations on the Transport of Dangerous Goods Model Regulations" (Seventeenth revised Edition)
The United Nations' Globally Harmonized System of Classification and Labelling "(fourth revised edition)
3 Terms and Definitions
GB 13690 and defined by the following terms and definitions apply to this document.
3.1
Specific target organ toxicity - single exposure specifictargetorgantoxicity-singleexposure
First contact with the substance and specificity mixture induced target organ toxicity nonfatal, including all significant health effects, can be
Inverse and irreversible, immediate and delayed functional impairment.
4 General Description
4.1 The classification of the substance or mixture classified as a specific target organ toxicant, or mixtures of these substances may be contacts of the potential health risks have
Detrimental effects.
4.2 Classification depends upon the availability of reliable evidence that a single exposure to the substance or mixture has produced a consistent human, recognizable toxicity
Effects on experimental animals or changes affect the organization has toxicological significance/organ function or morphology, or the organism students
Chemically or serious blood changes, and these changes are correlated to human health. Human data will be the main danger in this category
Sources of evidence.
4.3 Assessment not only to combine in a single organ biological system or a significant change, but also combined with severe nature involving several organs lower
Widespread change.
4.4 Specific target organ toxicity can occur by any route associated with humans, ie principally by oral, dermal or inhalation occurs.
4.5 to repeated exposure Specific target organ toxicity classification see GB 30000.26. The following other specific toxic effects are to be respectively commentary
Assessment is therefore not included in the inner portion.
--- Acute toxicity;
--- Skin corrosion/irritation;
--- Serious eye damage/eye irritation;
--- Respiratory or skin sensitization;
--- Carcinogenic;
--- Germ cell mutagenicity;
--- Reproductive toxicity;
--- Inhalation toxicity.
4.6 part including material Category 1 and Category 2 classification criteria, classification criteria and Category 3 Classification criteria for mixtures. Table 1.
5 Taxonomy
5.1 General principles
General principles specific target organ toxicity single exposure classification and labeling see GB 13690.
5.2 Classification criteria for substances
5.2.1 Substance Category 1 and Category 2
5.2.1.1 In all available weight of evidence, based on expert judgment, including the use of recommended guidance values (see 5.2.1.10), respectively, according to
Immediate or delayed effects of the substance should be classified. Then, based on observations of the nature and severity of effects, the substances classified as category 1 and category 2, see
Table 1.
Table 1 after the first contact with specific target organ toxicity hazard classification
Category 1
Humans produce significant toxic substances, or according to experimental evidence from animal studies, may be assumed after the first contact
Human significant toxic substances.
The substance is classified according to the following categories 1.
--- Human cases or reliable and good quality evidence obtained in epidemiological studies;
--- Appropriate observation studies in experimental animals. In the trial, at generally low exposure concentrations produced human health
Off significant and/or severe toxic effects. Guidance dose/concentration values are provided below (see 5.2.1.10) can be used to the weight of evidence
Use part of the assessment
Category 2
According to experimental evidence from animal studies it can be assumed after a contact may produce substances on human health hazards.
According to observations appropriate studies in experimental animals substance is classified in Category 2, generally moderate exposure concentrations produced with people
Class health-related significant and/or severe toxic effects. The following provides guidance for the dose/concentration values (see 5.2.1.10), to help feed
Classify.
In exceptional cases, human evidence can also be used substance is classified in Category 2 (see 5.2.1.10)
Category 3
Transient target organ effects
Some target organ effects may not meet the criteria of the substance/mixture classified above Category 1 or Category 2 standards. After contacting these effects
Harmful changes in human functions within a short time, but humans may recover without leaving significant organization or work within a reasonable period of time
Changed. This category only includes narcotic effects and respiratory tract irritation. Substances/mixtures may be classified according to specific discussion in 5.3.2
The effect of having these categories
NOTE. For these categories, it can be determined mainly by the influence of substances classified Specific target organ/system, or may be a substance classified as a general poison. Really
Given the major target organ/system and classify, such as liver poison, nerve poison. Carefully evaluate the data and, where possible, not include secondary
It shall take effect, such as the liver or nervous system toxicant may produce secondary effects in the gastrointestinal system.
5.2.1.2 should determine the classification of hazardous substances relevant route of exposure.
5.2.1.3 should be based on weighing all available evidence, including the guidance provided below, by expert judgment to classify.
5.2.1.4 Classification of all evidence available to the right weight (including the guidance provided below) basis, based on expert judgment. Even containing human
Events and epidemiological and experimental animal studies, including all data, weight of evidence, to demonstrate that it is necessary to classify specific target organ toxicity
Effect.
5.2.1.5 target organ toxicity assessments required information can be obtained from the first contact with humans, for example, at home, in the workplace or the environment
The contact can also be obtained from experimental animal studies. Standard animal studies provide such information is a rat or mouse acute toxicity studies, this
Class can include clinical observations and detailed macroscopic and microscopic examination to enable the toxic effects on target tissues/organs. Other species
Results of acute toxicity studies conducted may also provide relevant information.
5.2.1.6 In exceptional cases, based on expert judgment, there may be some substance human evidence of target organ toxicity classified Category 2.
a) when the weight of human evidence is not sufficiently convincing to warrant Category 1; and/or
b) Depending on the nature and severity of effects.
In the classification should reference the human dose/concentration levels in animal studies and any available evidence should be consistent with the Category 2 classification.
In other words, if there are also animal data available on the chemical that warrant Category 1 is justified, then the substance should be classified as Category 1.
5.2.1.7 support is considered Category 1 and Category 2 Effect
5.2.1.7.1 show the first contact with the substance of the evidence is consistent and identifiable toxic effect of an association can give support for the classification.
5.2.1.7.2 evidence of human experience/incidents is usually restricted to sporadic adverse health consequences of the report, exposure is often not determined,
And will not provide the scientific detail that can be obtained from well-conducted studies in experimental animals.
Evidence 5.2.1.8 appropriate experimental animal studies may be based on clinical observations, macroscopic and microscopic pathological examination forms to provide more detailed
Details, and this can often exhibit may not be life-threatening, but it may indicate that the risk of dysfunction. Therefore, in the classification process
Analysis of all available evidence, and relevance to human health. The following provides examples of human and/or animal-related toxic effects.
a) contacting a condition arising;
b) significant non-transitory function of the respiratory system, central nervous system or peripheral nervous systems, other organs or other organ systems change
Technology, including signs of central nervous system depression and affect the organoleptic (for example, vision, hearing and sense of smell);
c) clinical biochemistry, hematology, and urinalysis parameters and any significant deleterious changes consistent;
d) may be noted necropsy and/or subsequently observed in microscopic examination to confirm or significant organ damage in the body;
e) ability to regenerate vital organs in the multifocal or dispersed necrosis, fibrosis or granuloma formation;
f) potentially reversible but provide clear evidence of a significant organ dysfunction morphological variation;
g) regeneration of vital organs without apparent evidence of cell death (including cell degeneration and reduce the number of cells).
5.2.1.9 are not considered support effect Category 1 and Category 2 classification
There may not be seen as a classification basis effect Listed below are examples of humans and/or animals such effects.
a) weight gain, food consumption or water intake that clinical observations or small changes may have some toxicological importance but that
By itself it does not indicate "significant" toxicity;
b) small changes in clinical biochemistry, hematology or urinalysis parameters and/or transient effects, but the effects of such changes it is pregnant or
Suspect or toxicological significance is small;
c) changes in organ weight, but there is no evidence of organ dysfunction;
d) is that there is no toxicological relevance of adaptive response;
e) substance-induced mechanisms of toxicity of a particular species, that contain reasonable certainty proved no correlation between machine and human health toxicity
System, should not be classified according to.
5.2.1.10 for the results of experimental animal studies with the help of Category 1 and Category 2 classification guidance value
5.2.1.10.1 to help determine whether the substance should be classified, and to what degree classified (Category 1 or Category 2),
That "guidance values" to measure the dose/concentration, and measurement/concentration has been shown to cause significant health effects. Make such "guidance values" of
The main reason is that all chemicals are potentially toxic at high doses, so that there should be a reasonable dose/concentration as the standard to confirm their toxicity
Effect of degree.
5.2.1.10.2 In animal studies, when significant toxic effects observed indicate classification, according to the suggested guidance values, Concept Analysis
Duration of experimental exposure and dose/concentration at which these effects observed, can provide useful information to help assess the need to classify (since the toxic effect
It should be the consequence of the hazardous nature, but also the results of experimental exposure and the dose/concentration).
5.2.1.10.3 for acute toxicity testing, as it has been a significant first contact with the lethal dose of non-toxic effects of exposure recommendations finger
Guide value range, as shown in Table 2.
Table 2 doses of first contact with the guidance of a range of values
Route of exposure Units
Guidance values (C) range
Category 1 Category 2 Category 3
Oral (rat) mg/kg C≤300 2000≥C > 300
Through the skin (rat or rabbit) mg/kg C≤1000 2000≥C > 1000
Suction gas (rat) mL/(L · 4h) C≤2.5 20≥C > 2.5
Inhalation of vapors (rat) mg/(L · 4h) C≤10 20≥C > 10
Inhalation of dust/smoke/fog (rat) mg/(L · 4h) C≤1.0 5.0≥C > 1.0
Guidance values do not apply b
A guidance values and ranges mentioned in this table are for guidance purposes only, that is used as part of weight of evidence approach to help make classification decisions. They can not be used as
Strict demarcation values.
b Guidance values are not provided since this classification is primarily based on human data. Animal data may be included in the weight of evidence assessment.
5.2.1.10.4 below the guidance values (such as less than 2000mg/kg body weight, orally) toxicity observed specific characteristics is possible, however, effect
Corresponding properties may result in the decision not to classify. Conversely, in animal studies, it may be higher than the guideline value (for example, not less than
2000mg/kg body weight, orally) specific toxicity was observed, and in addition, but also from other sources (such as other single dose studies, or
Human case experience) supplementary information to support the conclusion that, given the weight of evidence, the classification is prudent practice.
5.2.1.11 Other matters
5.2.1.11.1 When using only animal data to determine the nature of the substance (of the new material is a typical practice for many existing substances, also
Is so), the classification process would include reference to dose/concentration guidance values, they are considered one of the elements that contribute to the weight of evidence approach.
5.2.1.11.2 If you already have well-substantiated human data indicate specific target organ toxic effects can certainly be attributed to the material
Disposable contact to the substance should be classified. If human data show positive, regardless of the possible dose, take precedence over the number of animals
according to. Thus, when a substance because specific target organ toxicity observed was considered not relevant or important to humans but not classified, if
Human episode data subsequently showed a specific target organ toxic effect, to deal with the substance should be classified.
5.2.1.11.3 did not conduct specific target organ toxicity test substance may in some cases, classified as appropriate proved to be
Effective data structure activity relationships and expert judgment based on data from a structural analogue has been previously classified extrapolated based
Basis, together with substantial support, but also with reference to other important factors such as formation of common significant metabolites.
5.2.1.11.4 some regulatory systems may be saturated vapor concentration as an additional element to provide for specific health and safety protection.
5.2.2 Category 3
5.2.2.1 respiratory irritation standard
Respiratory tract irritation classified as Category 3 criteria.
a) functional damage and symptoms of cough, pain, choking, and breathing difficulties and other respiratory tract irritation (characterized by localized redness, edema,
Pruritus and/or pain). It recognized that this evaluation is based primarily on human data.
b) subjective human observations could be supplemented to clear respiratory tract irritation (RTI) objective measurement (such as electrophysiological responses, nose or
Bronchoalveolar lavage fluid biomarkers of inflammation).
Human symptoms c) should also be symptoms observed in the exposed population will usually produce, not just particular individuals with hypersensitive airways
Isolated idiosyncratic reaction will produce. Just say "stimulus" Ambiguous reports should be excluded. As the term is generally used to describe various
Variety of sensations including smell, unpleasant taste, itching and thirst, etc., which do not belong to this classification endpoint
range.
d) There is no specific respiratory irritation involves effective animal tests, however, from the first and repeated inhalation toxicity tests to get there
With information. For example, animal studies may be clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology (for example charge
Blood, edema, slight inflammation, thickened mucous layer) to provide useful information, since these symptoms are reversible and may be reflective
Characteristics of the clinical symptoms. Such animal studies can be used as part of the right to re-evaluate the evidence.
e) This special classification would not only observed when more severe organ effects including respiratory effects use.
5.2.2.2 narcosis standard
Narcotic effects as Category 3 criteria.
a) central nervous system depression including narcotic effects humans such as drowsiness, narcosis, reduced alertness, reflection funeral
Loss, lack of muscle coordination, and vertigo are included. Manifestation of these effects may be severe headache or nausea, and can lead
Caused by reduced judgment, dizziness, irritability, fatigue, impaired memory function, perception and slow muscle coordination, reaction time, or sleepiness.
b) Narcotic effects observed in animal studies may include lethargy, lack of coordination righting reflex, narcosis, and loss of motor function
Tone. If these effects are not transient in nature, then they should be classified as Category 1 or Category 2.
5.3 Classification criteria for mixtures
5.3.1 General Principles
The mixture can be used the same criteria with substance classification, or alternatively as described below classification. With substances, mixtures
Can be classified as a specific target organ toxicant exposure, repeated exposure target organ toxicant, or both.
5.3.2 There mixture Classification of mixtures when data
If, as the criteria for substances, mixtures are reliable and good quality evidence of experience or appropriate studies in experimental animals from humans, that
What can re-assessment of the mixture was classified by weight of evidence data. When evaluating data on mixtures should be careful, dose, duration,
Observation or analysis, do not render the results inconclusive.
No mixture 5.3.3 Classification of mixtures when data are. bridging principles
5.3.3.1 Data Use
If the mixture itself has not been tested to determine its specific target organ toxicity, but the individual components of the mixture has been done and
Similar testing of the mixture have been mastered sufficient data to adequately characterize the hazards of the mixture, then in accordance with the following agreed bridging
The principle of the use of these data. This ensures that the classification process to maximize the use of existing data to determine the hazardous properties of the mixture without the necessity for
Additional testing in animals.
5.3.3.2 Dilution
If the tested mixtures to be diluted with a diluent, the diluent toxic and least toxic original ingredient in the same category or specific
It is less, and is not expected to affect the toxicity of other ingredients, then the new diluted mixture may be classified as the original tested mixtures to the same
category.
5.3.3.3 Batches
The mixture had done a production batch of toxicity tests can be considered substantially the same manufacturer or under their control swells
Another production of the same commercial product without testing the toxicity of the same production batch, unless there is reason believe that the untested productio...
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