This standard specifies the terms and definitions, classification, determination process, categories and warning labels, configuration of categories and label elements and general provisions for warning statements of specific target organ systemic toxicity caused by chemicals due to repeated exposure. This standard applies to the hazard classification, warning labels and warning statements of specific target organ systemic toxicity caused by chemicals due to repeated exposure according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals. GB 20601-2006 Safety Specifications for Classification, Warning Labels and Warning Statements of Chemicals Specific Target Organ Systemic Toxicity Repeated Exposure GB20601-2006 Standard Download Unzip Password: www.bzxz.net
This standard specifies the terms and definitions, classification, determination process, categories and warning labels, configuration of categories and label elements and general provisions for warning statements of specific target organ systemic toxicity caused by chemicals due to repeated exposure. This standard applies to the hazard classification, warning labels and warning statements of specific target organ systemic toxicity caused by chemicals due to repeated exposure according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals.

National Standard of the People's Republic of China
GB20601--2006
Safety rules for classification, precautionary labelling and precautionary stalements of chemicals-
Specific target organ systcmic toxicity-Repeated exposure
Safety rules for classification, precautionary labelling and precautionary stalements of chemicals-
Specific targct organ systcmic toxicity-Repeated exposure
Promulgated on October 24, 2006
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Standardization Administration of the People's Republic of China
2008-01-01Implementation
Chapter 4, Chapter 6, Chapter 7 and Chapter 8 of this standard are mandatory. The rest are recommended. B 20601—2006
This standard is equivalent to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (Globally Harmonized System of Classification and Labelling of Chemicals). Its relevant technical content is edited according to TIS GHT1.1.200G: The revision was made by the National Technical Committee on the Management of Extremely Hazardous Chemicals (SATC). The responsible drafting units are: National Inspection and Quarantine Bureau, China Center for Disease Control and Prevention, China Chemical Standardization Research Institute. The main contributors of this standard are: Gong Libing, Shang Wei, Zhang Chuan, Liu Cong, Li Ning, Yu Yanjun, Wen Suqin. This standard shall be implemented in the production field from January 2008: Implementation or implementation from February 31, 2008. 231H is the implementation transition period.
1 Scope
Safety Specifications for Classification, Warning Labels and Warning Statements of Chemicals
Specific Target Organ Systemic Toxicity - Repeated Exposure GB20601—2006
This standard specifies the terms and definitions, classification, determination process, toxicants and warning labels, configuration of specific action labels and alternative statements for specific target organ systemic toxicity - repeated exposure of chemicals. This standard applies to chemicals that cause specific target organ systemic toxicity - repeated exposure, hazard classification, warning labeling and warning statements in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals. 2 Normative References
The clauses in the following documents are cited in this standard and become the clauses of this standard. All subsequent amendments (excluding those with postal errors) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest version of this document can be used. For any other documents not specified, their latest versions shall apply to the standard G20599230 Classification, warning labels and warning statements of chemicals - Specification for safety - Specific target organ systemic toxicity - Secondary exposure
United Nations Medical Association "Globally Harmonized System of Classification and Labelling of Chemicals (GIIS)" United Nations "Specific target organ systemic toxicity - Repeated exposure spreifictargetorgansystemic toxicityreptatedrxposurtNan non-toxic target organ system substances that can cause and/or induce reversible neutralization reactions that can cause significant health effects in cattle. 3.2 Essential elements
3.2.1 The substance can be said to have: - a specific target organ system effect, therefore, it can be said that exposure to the substance can produce health effects in cattle
3.2.2 The most reliable basis for the question is that the substance can cause significant changes in tissue/organ function or structure in humans or experimental animals after repeated exposure. These biochemical or biological changes in animals are related to human health. 3.2.3 The evaluation should not only consider changes in a single organ or biological system, but also general changes that are not serious in individual organs:
3.2.4 Can it be said that it can produce specific target organ systems through various pathways, that is, it must be a clinical evaluation! 3.2.5 The non-lethal effects observed after exposure to chemicals are not included in the certification, see 9-2. Nor are other sexual effects included: such as acute mortality, toxicity, serious damage to eyes, inhalation irritation, skin irritation, respiratory sensitization, madness, degeneration and reproductive toxicity. 4 Classification
4.1 Classification of substances
4.1.1 The guidance value selected for the substance is based on a balance of all available evidence, including the exposure limit concentration GB20601-2006
In order to classify substances into two categories, according to the nature and severity of the effects observed, see table 1. Table 1: Specific target organ toxicity - categories 1. Substances that have produced signs of target organ toxicity in humans after repeated exposure. Based on available experimental data, it can be inferred that they may produce specific organ toxicity in humans. The substances are classified into the second category if there is reliable evidence from case reports or epidemiological studies; or from experimental observational data from which the substances have produced serious specific organ systemic effects in humans at low concentrations. The following are all guidance values ​​for the evaluation of the use of evidence: 2. Based on the experimental results of the actual experimental research, the concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: The concentration values ​​provided below are the reference values ​​for the evaluation of the use of evidence: 4.1.2 Determine the potential for adverse effects on the nervous system or gastrointestinal system. 4.1.3 Classification should be based on a balance of all available evidence, including the guidance provided below, and the use of expert judgement. 4.1.4 The evidence base for specific target organ systemic toxicity should be weighed against all data demonstrating that the target organ has a specific target organ systemic toxicity, including major incident events, epidemiological studies in animals. This requires the collection of a robust body of clinical evidence - including published studies - and the use of additional data by regulatory agencies. 4.1.5 The information needed to assess age-specific systemic toxicity comes from replication in humans (e.g. exposure in the home, in low-lying environments, etc.). Animal studies. Studies in standard animals such as mice or rats provide general information, including 2s (1, 90 days) or lifetime studies (up to 2 years). Data from repeated dose studies in other animals, other long-term exposure studies such as carcinogenicity, neurotoxicity or mycotoxicity can provide evidence of target organ systemic toxicity and can be used for scoring. 4.1. 6 For special circumstances, based on expert judgement, some substances may be classified in Category 1 if there is sufficient evidence of human effects and/or severity of effects to warrant classification. The level of efficacy/severity of the effect on humans does not warrant classification as Category 2, and any evidence from animal studies should be consistent with classification as Category 2. If the number of animals available for the chemical can warrant classification as Category 1, then the chemical should be classified as Category 2.
4.1.7 Effects supporting classification
4.1.7.1 Evidence of identifiable toxic effects after repeated exposure to the substance may support classification. 4.1.7.2 Evidence from human experience/conservative studies is limited to reports of adverse health effects. The follow-up situation is often of little certainty. The scientific evidence required for the optimal experimental animals cannot be provided. 4.1.7.3. Evidence from experimental animal studies can provide detailed information, including clinical observations and pathological findings from oral and microscopic examinations. These often reveal information that may not be life-threatening but may indicate potential damage. Therefore, all available data relevant to human health must be considered in the analysis of the inflammatory response. The following are examples of toxic effects relevant to humans and/or animals: a) Morbidity or mortality resulting from repeated or prolonged exposure, which is caused by accumulation of the substance or its metabolites at lower dose concentrations or by adverse reactions that exceed those caused by similar processes: significant functional changes in the central or peripheral nervous system or other myeloid systems, including symptoms of systemic dysfunction and effects on specific senses (e.g. vision, hearing and sensation); b) significant changes in clinical biochemistry, hematology, and urine analysis parameters (small or significant changes); c) significant organ damage detected or confirmed by physical examination and/or subsequent microscopic examination; 20601—2006
Multifocal or diffuse necrosis Fibrosis or myeloma formation in a critical organ that is not reproducible Reversible morphological changes that provide clear evidence of organ function (e.g., severe fatty changes) Significant cell death (evidence of cell deformation and decrease in cell number) in a critical organ that is not regenerative 4.1.8 General effect classification
It is recognized that some effects cannot be judged as categorized. The following are some examples of effects produced by human agents and/or animals: Clinical cases Small changes in body weight, food consumption or water intake have no clinical value, but these themselves cannot be used to classify Signs of toxicity: Mild changes in biochemistry, haematology and urinalysis parameters and/or transient effects when the toxicological significance of these changes or effects is doubtful or minor: Moderate changes in organs without evidence of other organ dysfunction; Adaptive responses not considered to be physiologically relevant; Homogeneous induction of species-specific maternal effects; Changes not considered to be of concern to human health should not result in the supplement being reclassified. 4.1.9 Guidance for the conclusion of the classification in experimental animals 4.1.9.1 If half of the time in experimental animal studies If we ignore the experimental health effects and the maximum dose/concentration, we will forget the basic concept of physiology, that is, all substances are potentially harmful. The efficacy is determined by the relationship between dose/concentration and time of exposure. In most animal studies, the test guidance value uses the upper limit of the dose. 4.1.9.2 For the classification of different substances and the degree of hazard of classification (category "or category 2", the guidance value of the base dose/concentration is listed in Table 2, which refers to the dose/concentration that has produced obvious health effects. The ten main reasons for the recommendation of such guidance values ​​are that all substances can be used, so a suitable dose list must be established: Hunger: Still below this dose: concentration: time The strength of the toxic effect is known: the highest dose in experimental animal toxicity studies is the dose that produces the effect. It is also intended to optimize the test and at least at this highest dose some effect will be observed in the study. Therefore, the effect is not the same as the effect in humans. It is also the dose concentration used and its relevance to humans. 4.1.9.3 Therefore, when a significant toxic effect is observed in animal studies, it can be indicated that the relationship between the contact time and dose concentration in the toxicity test and the established reliable value can provide the required effective information to help estimate the effect (because the effect is a consequence of nature and is also a direct result of the simple dose/concentration relationship in mice) 4. 1.9.4 Toxic effects seen at dose/concentration values ​​lower than the reference value could influence classification. 4.1.9.5 The recommended values ​​are based on efficacy findings from standard studies in rats. These guidance values ​​should not be used as a guideline for extrapolation to longer or more invasive toxicity studies. Extrapolation based on the dose/concentration time of the agent in humans does not demonstrate that the efficacy of the agent is proportional to the exposure concentration and exposure time. Assessments should also be made based on case studies. However, guidance can be used based on case studies. 4.1. 9.6 For Category 1 classification, when effects equal to those shown in Table 2 are observed in experimental animals in studies on escaped tissue, they may be classified as follows: Table 2 Guidance values ​​for Category 1 classification By route: Transdermal (macroscopic) (rat or mouse) (human rat) Transdermal (rat or mouse) (human rat) Air
Inhalation (human), dust lake
as kg -d
(ne Ihe +'t
tng'l:.t: h el
guidance dose concentration)
4.1.9.7 For Category 2 classification, when significant effects are observed in 900 replicate dose studies in experimental animals and toxic effects are observed using the (suggested) guidance values ​​in GR20601-2006
or Table 3 of Appendix 1, classification is justified. Table 3 Guidance values ​​for category 2
Oral (rat)
Oral peptide (rat or rabbit)
Inhalation (human and rat) Gas position
Inhalation human team) British gas
Inhalation (rat powder smoke: fog
(eng kyi/e:
Snglghid
arl./1.376 hzel
Cnglort hedl
The suggested values ​​are based on the efficacy points found in standard studies conducted in rats. These guidance values ​​should not be used as a guideline for extrapolation to longer or more extended contact toxicity studies. Extrapolation based on the current dose and exposure time does not demonstrate that the effective dose is proportional to the exposure concentration and exposure time. Evaluations based on the current data are also required. Guidance can be obtained based on the current data. 4,1.9.6 For Category 1 classification, when effects are observed in experimental animals in multiple exposure studies and are equal to the recommended guidelines described in Table 2, they can be classified as reverse categorization. Table 2 Guidance values ​​for Category 1 classification
By route
Transdermal (rat or mouse)
and human (rat ... -d
(ne Ihe +'t
tng'l:.t: h el
guidance dose concentration)
4.1.9.7 For Category 2 classification, when significant toxic effects are observed in 900 replicate dose studies in experimental animals and when toxic effects occur using the (suggested) guidance values ​​in GR 20601-2006
or Table 3, the classification is justified. Table 3 Guidance values ​​for category 2
Oral (rat)
Oral peptide (rat or rabbit)
Inhalation (human and rat) Gas positionwww.bzxz.net
Inhalation human team) British gas
Inhalation (rat powder smoke: fog
(eng kyi/e:
Snglghid
arl./1.376 hzel
Cnglort hedl
The suggested values ​​are based on the efficacy points found in standard studies conducted in rats. These guidance values ​​should not be used as a guideline for extrapolation to longer or more extended contact toxicity studies. Extrapolation based on the current dose and exposure time does not demonstrate that the effective dose is proportional to the exposure concentration and exposure time. Evaluations based on the current data are also required. Guidance can be obtained based on the current data. 4,1.9.6 For Category 1 classification, when effects are observed in experimental animals in multiple exposure studies and are equal to the recommended guidelines described in Table 2, they can be classified as reverse categorization. Table 2 Guidance values ​​for Category 1 classification
By route
Transdermal (rat or mouse)
and human (rat ... -d
(ne Ihe +'t
tng'l:.t: h el
guidance dose concentration)
4.1.9.7 For Category 2 classification, when significant toxic effects are observed in 900 replicate dose studies in experimental animals and when toxic effects occur using the (suggested) guidance values ​​in GR 20601-2006
or Table 3, the classification is justified. Table 3 Guidance values ​​for category 2
Oral (rat)
Oral peptide (rat or rabbit)
Inhalation (human and rat) Gas position
Inhalation human team) British gas
Inhalation (rat powder smoke: fog
(eng kyi/e:
Snglghid
arl./1.376 hzel
Cnglort hedl
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