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GB 30000.26-2013: Rules for classification and labelling of chemical -- Part 26: Specific target organ toxicity -- Repeated exposure
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Rules for classification and labelling of chemical -- Part 26: Specific target organ toxicity -- Repeated exposure
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Basic data
| Standard ID | GB 30000.26-2013 (GB30000.26-2013) |
| Description (Translated English) | Rules for classification and labelling of chemical -- Part 26: Specific target organ toxicity -- Repeated exposure |
| Sector / Industry | National Standard |
| Classification of Chinese Standard | A80 |
| Classification of International Standard | 13.300 |
| Word Count Estimation | 21,253 |
| Older Standard (superseded by this standard) | GB 20601-2006 |
| Quoted Standard | GB 13690; GB 16483; GB 30000.25; 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 repeated exposure cause specific target organ toxicity Chemicals terms and definitions, general description, classification, decision logic, labels. This standard applies to: a repeated exposure cause specific target organ toxic |
GB 30000.26-2013: Rules for classification and labelling of chemical -- Part 26: Specific target organ toxicity -- Repeated 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 chemical.Part 26. Specific target organ toxicity.Repeated exposure
ICS 13.300
A80
National Standards of People's Republic of China
Replacing GB 20601-2006
Chemical classification and labeling specifications - Part 26.
Specific target organ toxicity - Repeated exposure
Rulesforclassificationandlabelingofchemicals-Part 26.
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 26 GB 30000.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 20601-2006 "chemical classification, precautionary labeling and precautionary statements Specific target organ systems
Repeated exposure toxicity. "
This section compared with GB 20601-2006, the major technical changes as follows.
--- Changing the name of the standard, the Chinese name changed to "chemical classification and labeling specifications - Part 26. Specific target organ toxicity
Repeated exposure, "the English name changed to" Rulesforclassificationandlabelingofchemicals-Part 26.
Specifictargetorgantoxicity-Repeatedexposure ";
--- Modify the scope of content Chapter 1, the "warning labels" to "tag" Delete "precautionary statements";
--- Increase the Chapter 4, "General Description";
--- Revised "decision logic" part of the statement, and "1" as Appendix A;
--- Modify the original part of Table 6, attached as Appendix B;
--- Modify the original part of Table 5, the "name" to "signal words", "hazard statements" to "Hazard statement"; and together
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
Modify integrated into Chapter 7;
--- Add tags exemplary specific target organ toxicity, repeated exposure, as the informative Appendix E.
This part of the United Nations' Globally Harmonized System of Classification and Labelling "(Globaly HarmonizedSystem of
ClassificationandLabelingofChemicals, GHS) (fourth revised edition) about the technical content of the same.
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. Li Jing, Wang Hua, Zhang Bin, in Yan Yan, Liu Ming, Lin Zheng, Song Wei, Wei Wu Ai, Ge Xiaojun, Liang Jin.
This part of the standard replaces the previous editions are.
--- GB 20601-2006.
Chemical classification and labeling specifications - Part 26.
Specific target organ toxicity - Repeated exposure
1 Scope
GB 30000 provisions of this section having a specific target organ toxicity, repeated exposure of terms and definitions chemicals, general says
Ming classification criteria, decision logic, tags.
This section applies to have repeated exposure of 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 30000.25 chemical classification and labeling Safety Part 25. Specific target organ toxicity - single 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, repeated exposure specifictargetorgantoxicity-repeatexposure
Repeated exposure to the substance and specificity of the mixture caused by target organ toxicity nonfatal, including all significant health effects, can be
Inverse and irreversible, immediate and delayed functional impairment.
4 General Description
4.1 classification can be done to determine the substance or mixture having a specific target organ toxicity, such substances or mixtures may be healthy for people who are exposed
Potentially harmful effects.
4.2 Classification depends upon the availability of reliable evidence that repeated exposure to the substance or mixture to humans produced a consistent and identifiable toxic
Effects on experimental animals or significant changes affect the organization has toxicological significance/organ function or morphology, or of the organism
Biochemical or hematological serious changes, and these changes are correlated to human health. Human data will be the dangerous category
The primary source 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
General changes.
4.4 specific target organ toxicant by any possible way correlated with humans, ie mainly through oral, dermal or inhalation
occur.
Specific target organ toxicity single exposure 4.5 See GB 30000.25. Other specific toxic effects, such as acute toxicity, serious eye
Damage/eye irritation and skin corrosion/irritation, respiratory or skin sensitization, carcinogenicity, germ cell mutagenicity, reproductive toxicity and inhalation toxicity
Sex, are to be assessed separately, and therefore not included in this Part in.
5 Taxonomy
5.1 General principles
General principles specific target organ toxicity, repeated exposure classification and labeling see GB 13690.
5.2 Classification criteria for substances
5.2.1 All available weight of evidence, based on expert judgment, including the dose and duration of exposure have an effect/concentration
Recommended guidance values (see 5.2.9), a substance classified as a specific target organ toxicant, and according to the nature and severity of the observed effects of the substance
Quality in one of two categories as shown in Table 1.
Table 1 specific target organ toxicity after repeated exposure Classification Standard
Category 1
Humans produce significant toxic substances, or the basis of evidence obtained from studies in experimental animals, can be assumed after repeated exposure possible for people
Class of 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
Correlation significant and/or severe toxic effects. Guidance dose/concentration values are provided below (see 5.2.9) can be used as weight of evidence
Use part of the assessment.
Category 2
According to experimental evidence from animal studies it can be assumed that after repeated exposure may be hazardous to human health substances.
According to observations appropriate studies in experimental animals will be classified as a Category 2 substance. In the experiment, generally moderate exposure concentrations
Produces human health correlated significantly and/or severe toxic effects. The following provides guidance on dose/concentration values (see 5.2.9),
In order to help in classification.
In exceptional cases, human evidence can also be used a substance classified as Category 2 (see 5.2.9).
A specific target organ both categories can be determined mainly by the impact of classified material or substance can be classified as general poison. Identify key
Target organ toxicity (system) and classify, such as liver poison, nerve poison. Carefully evaluate the data and, where possible, not include secondary entry into force
It should be, such as the liver or nervous system toxicant may produce secondary effects in the gastrointestinal system.
5.2.2 should determine the classification of hazardous substances relevant route of exposure.
5.2.3 Classification of existing heavy weight of all evidence (including the guidance provided below) basis, based on expert judgment.
5.2.4 The weight of evidence of all data, including human contingencies, epidemiological and experimental animal studies, including the weight, it is necessary to confirm points
Specific target organ toxicity effect class. To do this, use a large number of industrial toxicology data collected over the years. Assessment should be based on all existing data,
Published peer-reviewed studies and additional data accepted by regulatory agencies as the basis. Should be evaluated based on all existing data,
Including additional data published studies and regulatory agencies adopt.
5.2.5 Specific organ toxicity assessment of the required information can be obtained from repeated exposure in humans, such as the home, the workplace or the surrounding environment
Contact, or from experimental animal studies. The standard animal studies provide such information rats or mice is 28d, 90d or end
Health Study (up to 2 years), this study include hematology, clinical chemistry and detailed macroscopic and microscopic examination to determine the target tissue /
Toxic effects of organs. Data repeated dose studies conducted in other species may also be used to get. Other long-term exposure studies, for example,
Such as carcinogenicity, neurotoxicity or reproductive toxicity, may also provide evidence for classification evaluate specific target organ toxicity.
5.2.6 In special cases, based on expert judgment, can have some human material specific target organ toxicity evidence 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 on the substance that warrant Category 1 is justified, then the substance should be classified as Category 1.
5.2.7 Effect of support is considered classified
5.2.7.1 show that repeated exposure to the substance with a consistent and identifiable toxic effect of an association of reliable evidence, the classification can be supported.
Evidence 5.2.7.2 human experience/incidents is usually restricted to sporadic adverse health consequences of the report, the contact is often uncertain, and
And may not provide detailed scientific information that can be obtained from well-conducted studies in experimental animals.
5.2.7.3 Clinical observation form may be suitable experimental animal studies, and hematology, clinical chemistry, macroscopic and microscopic pathological examination
Provide further details, and this can often exhibit may not be life-threatening, but it may indicate the hazard function injury. Thus, in
Classification process should refer to all available evidence, and relevance to human health. The following provides a human and/or animal-related toxicity
Effect Example.
Conditions a) repeated or prolonged exposure generated or death. Even repeated exposure to low doses/concentrations, due to the substance or its metabolite
Bioaccumulation, or due to repeated exposure to toxic doses than make the process of detoxification, can also cause illness or death.
b) the central nervous system or peripheral nervous systems or other organ systems function in a significant change, including central nervous system depression track
And like influence organoleptic (such as sight, hearing and smell).
c) any significant and harmful changes consistent clinical biochemistry, hematology, and urinalysis parameters.
d) may be noted at necropsy and/or subsequently observed in microscopic examination to confirm or significant organ damage.
e) multifocal necrosis or dispersed vital organs have the ability to regenerate, fibrosis or granuloma formation.
f) potentially reversible but provide clear evidence of a significant organ dysfunction Morphological variations (such as severe liver steatosis).
g) regeneration of vital organs without apparent evidence of cell death (including cell degeneration and reduce the number of cells).
5.2.8 does not support the classification effect
There may not be seen as a basis for classification of effects are listed below 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 quality, but there is no evidence of organ dysfunction;
d) no toxicological relevance of the 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.
5.2.9 for the results of experimental animal studies Guidance values to assist with classification
5.2.9.1 In experimental animal studies, if only rely on observation of effects alone, without reference duration of experimental exposure and dose/concentration, that is negligence
A basic concept of toxicology, ie all substances are potentially toxic, and what determines the toxicity is dose/concentration and contact time. In most
Points from animal studies, the test guidelines use upper limit dose value.
5.2.9.2 In order to help determine whether to classify a substance, and should be classified on the extent to (category 1 and category 2),
Proposed dose/concentration "guidance values", the reference has been shown to produce significant health effects of dose/concentration. Make such "guidance values" in the main
To 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. In addition, animal studies using repeated dose study was designed to produce toxicity at the highest dose, in order to optimize the test objective, therefore, most of the
Studies show some toxic effect at least at this highest dose. Therefore, to determine not only produce what effect, but the effect is
At what dose/concentration generated and their relevance to humans and how.
5.2.9.3 In animal studies, when viewed in the display can be categorized significant toxic effects, and recommend guidance values, reference is observed
Duration of experimental exposure and dose/concentration at which these effects can provide useful information to help assess the need to classify (since the toxic effects are
Results dangerous nature, but also the duration of exposure and the dose/concentration).
5.2.9.4 final decision on whether to classify the effects observed significant toxic effects when the subject is less than or equal to the dose/concentration guidance value possible.
5.2.9.5 recommended guidance values refer basically 90d standard toxicity studies in rats the effect observed. They can be based, outside
Equivalent guidance values push longer or shorter toxicity studies using a similar Haber's rule for inhalation dose/exposure time extrapolation outside the
The basic point of the rule is that the effective dose is directly proportional to the exposure concentration and contact time. Assessment should be a case by case basis; for example, for 28d
Study the guidance values below multiplicative 3.
5.2.9.6 for Category 1 classification, in the 90d experiment repeated dose animal studies observed significant toxic effects, and equal to or less
As shown in Table 2 (suggested) guidance values observed to occur this effect, would justify classification.
Table 2 Guidance values to assist in Category 1 classification
Route of exposure Units Guidance values (C) range
Oral (rat) mg/(kg · d) C≤10
Through the skin (rat or rabbit) mg/(kg · d) C≤20
Suction gas (rat) (mL/L)/(6h/d) C≤0.05
Inhalation of vapors (rat) (mg/L)/(6h/d) C≤0.2
Inhalation of dust/smoke/fog (rat) (mg/L)/(6h/d) C≤0.02
5.2.9.7 for Category 2 classification, in the 90d experiment repeated dose animal studies observed significant toxic effects, and as shown in Table 3
(Recommendation) within the guidance value ranges observed to occur this effect, it would justify classification.
Table 3 Guidance values to assist in Category 2 classification
Route of exposure Units Guidance values (C) range
Oral (rat) mg/(kg · d) 10 \u003cC≤100
Through the skin (rat or rabbit) mg/(kg · d) 20 \u003cC≤200
Suction gas (rat) (mL/L)/(6h/d) 0.05 \u003cC≤0.25
Inhalation of vapors (rat) (mg/L)/(6h/d) 0.2 \u003cC≤1.0
Inhalation of dust/smoke/fog (rat) (mg/L)/(6h/d) 0.02 \u003cC≤0.2
5.2.9.6 and 5.2.9.8 in a guidance values and ranges mentioned in 5.2.9.7 for guidance purposes only, that is used as a weight of evidence approach
He points to help make classification decisions. They do not have as strict demarcation values.
5.2.9.9 In animal studies repeated exposure, dose below the guidance value/concentration [for example, less than 100mg/(kg · d), orally] Observation
Specific toxicity profile is possible, but the nature of the effect (for example, only in male rats known to be susceptible renal toxic effect of specific strains
Observed in renal toxicity) 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 100mg/(kg · d), by the oral route] specific toxicity was observed, and in addition, but also from other sources (such as other long-term administration RESEARCH
Studies, or population-based case experience) supplementary information to support the conclusion that, given the weight of evidence, the classification is prudent practice.
5.2.10 Other matters
5.2.10.1 When using only animal data to determine the nature of the substance (of the new material is a typical practice for many existing substances is also
So), the classification process would include reference to dose/concentration guidance values, they are regarded as one of the elements of the weight of evidence approach helps.
5.2.10.2 If you have a well-substantiated human data indicate specific target organ toxic effects can be reliably attributed to repeated exposure
Or long-term exposure to the substance, then the substance may be classified. Regardless of possible dose, positive human data take precedence over animal data.
Thus, when a substance because at or below the recommended dose animal testing/concentration guidance values when there is no specific target organ toxicity was observed
While no classification, if subsequent human episode data showing a specific target organ toxic effect, to deal with the substance
classification.
5.2.10.3 did not conduct specific target organ toxicity test substance may in some cases, the classification has proved to be appropriate,
Efficient data structure activity relationships and expert judgment based on data from a structural analogue previously been classified on the basis of extrapolation,
Together with substantial support, but also with reference to other important factors such as formation of common significant metabolites.
5.2.10.4 saturated vapor concentration may be as an additional element to provide for specific health and safety protection.
5.3 Classification criteria for mixtures
5.3.1 General Principles
The mixture can be used with the same criteria as substances are classified or can also be classified under this section the following terms. As with substances, mixed
Composition can be classified as a specific target organ toxicant exposure, target organ toxicant repeated exposure, 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 the frame in accordance with the following agreed
Bridge principle to use these data. This ensures that the hazardous properties classification process to maximize the use of available data to the mixture, without
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 production batch
Toxicity has changed significantly. If the latter occurs, a new classification is required.
5.3.3.4 Concentration of highly toxic mixtures
If the tested mixture of Category 1, a method of increasing the concentration of toxic components, then the higher the concentration of the resulting mixture should be classified in
Of category 1, do not need another test.
Interpolation within one toxicity category 5.3.3.5 within rang...
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