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GB 30000.24-2013: Rules for classification and labelling of chemicals -- Part 24: Reproductive toxicity
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Rules for classification and labelling of chemicals -- Part 24: Reproductive toxicity
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Basic data | Standard ID | GB 30000.24-2013 (GB30000.24-2013) | | Description (Translated English) | Rules for classification and labelling of chemicals -- Part 24: Reproductive toxicity | | Sector / Industry | National Standard | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300 | | Word Count Estimation | 25,287 | | Older Standard (superseded by this standard) | GB 20598-2006 | | Quoted Standard | GB 30000.22-2013; GB 13690; United Nations ' Globally Harmonized System of Classification and Labelling "(fourth revised edition); United Nations ' Recommendations on the Transport of Dangerous Goods Model Regulations " (Seventeenth 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 reproductive toxicity Chemicals terms and definitions, classification criteria, decision logic and labels. This standard applies to: a reproductive toxicity chemical by the United Nations ��Globally Harmonized System of Classific | GB 30000.24-2013: Rules for classification and labelling of chemicals -- Part 24: Reproductive toxicity
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Rules for classification and labelling of chemicals.Part 24. Reproductive toxicity
ICS 13.300
A80
National Standards of People's Republic of China
Replacing GB 20598-2006
Chemical classification and labeling specifications
Part 24. Reproductive Toxicity
Part 24. Reproductivetoxicity
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 4 of this chapter 6 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 24 GB 30000.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 20598-2006 "chemical classification, precautionary labeling and precautionary statements of norms reproductive toxicity."
This section compared with GB 20598-2006, the major technical changes as follows.
--- Modify the standard name, Chinese name was changed to "chemical classification and labeling specifications - Part 24. Reproductive toxicity", the English name
Amended to "Rulesforclassificationandlabelingofchemicals-Part 24. Reproductivetoxicity";
--- Modify the scope of content Chapter 1, the "warning labels" to "tag" Delete "precautionary statements";
--- Revised Chapter 2, "Normative references" adds GB 13690 normative references;
--- Increased Chapter 3, "Terms and definitions" in the introductory phrase;
--- Increased Clause 4.1;
--- In Table 3, an increase on the "impact of breast-feeding or via lactation" Additional category of critical values / concentration limits;
--- Original Chapter 5. Figs. 1, 2, 3 and 4 on the determination of the content of the logical data as Appendix A;
--- Deleted the original Chapter 7, according to the United Nations' Globally Harmonized System of Classification and Labelling "(fourth revised edition) Chapter 7 of the original
Table 6 modified as a normative appendix B;
--- According to the United Nations' Globally Harmonized System of Classification and Labelling "(fourth revised edition) original Chapter 6, Chapter 7, Chapter 8 modify the whole
Synthesis Chapter 6; Tables 4 and 5 of the original and modified as a normative Annex C;
--- Deleted the original Chapter 8, "hazard statements" and the related "precautionary statements" content as informative annex D;
--- Increase the informative Appendix E "tag example reproductive toxicity."
This part of the United Nations' Globally Harmonized System of Classification and Labelling "(Globaly HarmonizedSystem of
ClassificationandLabelingofChemicals, GHS) content (fourth revised edition) technical consensus.
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 Jiangsu Entry-Exit Inspection and Quarantine Bureau, China National Chemical Information Center, the national hazardous chemical quality
Supervision, Inspection Center, Huafeng Group Limited.
The main drafters of this section. Liu Junfeng, your suppliers Qin, Wu Ke, Zhang Min, Zhang Jun Xi, Liang Jin, Li Xiaofeng.
This part of the standard replaces the previous editions are.
--- GB 20598-2006.
Chemical classification and labeling specifications
Part 24. Reproductive Toxicity
1 Scope
GB This section 30000 specifies the terms and definitions reproductive toxicity of chemicals, classification criteria, decision logic and labels.
This section applies to reproductive toxicity of chemicals by the United Nations' Globally Harmonized System of Classification and Labelling "(hereinafter referred to as
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 30000.22-2013 chemical classification and labeling specifications - Part 22. germ cell mutagenicity
GB 13690 chemical classification and hazard communication General
The United Nations' Globally Harmonized System of Classification and Labelling "(fourth revised edition)
United Nations "on the Recommendations on the Transport of Dangerous Goods Model Regulations" (Seventeenth revised Edition)
3 Terms and Definitions
GB 13690 and defined by the following terms and definitions apply to this document.
3.1
Reproductive toxicity reproductivetoxicity
Harmful effects on adult male and female sexual function and fertility, and offspring developmental toxicity. Conducting hazard classification
When, on the known genetic offspring to induce heritable effects will make regulations in Article 3.5 of the UN GHS in germ cell mutagenicity
Be, because in the current classification system, the effect is more appropriate in accordance with this unique germ cell mutagenicity hazard classification. In sub
Class system, reproductive toxicity is subdivided into two main areas. the adverse effects on sexual function and fertility, and on development of offspring harmful Movies
ring. Some reproductive toxicity is unable to clear harmful effects of sexual function and fertility or harmful effects on development of offspring. but,
For chemicals with such reproductive toxicity, should be given a general description of the harm.
Note. For details of germ cell mutagenicity visible GB 30000.22-2013.
3.2
Adverseeffectsonsexualfunctionandfertility harmful effects on sexual function and reproductive capacity
Any effect of chemicals interfere with sexual function and fertility, including (but not limited to) the female and male reproductive system changes to green
Beginning of the spring, germ cell production and transport, reproductive cycle normality, sexual behavior, fertility, childbirth, the harmful effects of pregnancy outcomes,
Premature or change other features related to the integrity of the reproductive system and reproductive capacity.
Harmful effects on the harmful effects of lactation by lactation produced or belong to the scope of reproductive toxicity, but for classification purposes, such
Effect In this section are listed separately (see 4.2). This is because the adverse effects of chemicals hoping lactation for classification as a special order
The hazards of this effect is provided to the nursing mother.
3.3
Harmful effects on the development of offspring adverseeffectsondevelopmentoftheoffspring
In the broadest sense, developmental toxicity includes prenatal or postnatal interfere with any affect normal fetal development, this effect
It was the result of contact with a parent before conception or developing offspring before or after birth before the sexual maturity
The contact period. However, developmental toxicity classification, its main purpose is for pregnant women and women of childbearing potential and men provide risk warnings
Advertisement. Thus, for practical purposes in terms of classification, developmental toxicity mainly refers to the harmful effects during pregnancy or due to contact parents caused
Harmful effects. These effects can be revealed at any stage of the life cycle of the organism. The main manifestations of developmental toxicity include development
The death of the organism, structural abnormality, altered growth and functional defects.
4 Classification Standard
4.1 General principles
General principles of classification and labeling of reproductive toxicity See GB 13690.
4.2 classification standard substance
4.2.1 Hazard category
For classification purposes, reproductive toxicity, chemical substances are divided into two hazard categories. On sexual function and fertility and hair
Effect of Fertility was evaluated separately. Moreover, the impact on lactation individually into a dangerous category, hazard classification criteria in Table 1 and
Table 2.
Table 1 reproductive toxicant classification criteria and categories
Category 1. Known or presumed human reproductive toxicant
This category includes known to human sexual function and fertility or developmental effects harmful substances, or animal research evidence (there may be other information as
Supplement) showed it to interfere with reproduction in humans is very likely substances. According to classified evidence, mainly from human data (Category 1A) or from animal
Data (Category 1B), the substance may be further divided.
Category 1A. Known human reproductive toxicant
The material in this category is largely based on human evidence.
Category 1B. presumably human reproductive toxicant
The substance in this category is largely based on animal data. Data from animal studies should provide clear evidence that in the absence of other toxic effects
Under the circumstances, the sexual function and fertility or have harmful effects on development, or if occurring together with other toxic effects, harmful effects on reproduction
It is not considered a non-specific consequence of other toxic effects. However, when there is mechanistic information for suspecting that influence and relevance of the human will
Its classification to Category 2 may be more appropriate.
Category 2. Suspected human reproductive toxicant
The substance in this category are some of the human or animal studies evidence (there may be other information supplemented) show that in the absence of other toxic effects,
On sexual function and fertility or development have harmful effects; or if concurrently with other toxic effects, but it can determine the harmful effects on reproduction is not
Other non-specific consequence of toxic effects, and there is no sufficient evidence to support divided into categories 1. For example, the presence of a lack of experimental study design, the guide
Convincing evidence caused poor. At this point it should be classified in Category 2 may be more appropriate.
Table 2 Effect of nursing or classification criteria and categories affected by breast-feeding
Effect of breastfeeding or via lactation
It will affect breastfeeding or via lactation is divided into separate categories. Although many substances there is no information that they may have through breast-feeding
Have harmful effects on the progeny, but there may be some substances interfere with breast-feeding women action after being absorbed, or the substances (including metabolites) may appear in the milk,
In an amount sufficient to affect the breast-fed baby's health, these substances should be classified into this category, in order to show the impact of breast-fed infants caused. This classification can
Determined according to the following.
a) the absorbing material, metabolism, distribution and excretion studies have shown that the concentration in breast milk may reach the level of potentially toxic effects;
and/or
b) the results of one or two generations animal studies provide clear evidence that, since the substances can enter breast milk, or harmful effect on the quality of breast milk
DESCENDANTS a detrimental effect; and/or
c) evidence in humans that substances harmful to nursing infants.
4.2.2 The basis of classification
4.2.2.1 classification should be based on the standards and the overall weight of evidence assessment. Having a detrimental effect on the internal reproductive
The specific nature of the chemicals should be classified as reproductive toxicants, however, if such effect is non-specific consequence of other toxic effects produced
, The chemicals should not be classified as such.
4.2.2.2 In the evaluation of toxic effects on the developing offspring, should be adopted that may affect maternal toxicity.
4.2.2.3 If human evidence Category 1A classification as the main basis, should be reliable evidence of the harmful substances on reproduction in humans
influences. Evidence used for classification should be from well conducted epidemiological studies which include the use of appropriate controls, balanced assessment, and appropriate
When combined with bias or confounding factors. If the data from human studies is not very accurate, you should use the proper data from animal studies as a supplement, and should
Classified as category 1B.
4.2.3 The weight of evidence
4.2.3.1 classified as reproductive toxicants to the overall weight of evidence assessment. This means that the need to determine the combined reproductive toxicity
All existing information about the impact. This information includes human studies, human case reports and studies of specific reproductive epidemiology, as well as animals Asia
Chronic, chronic and specificity of the findings, these results should provide information related to reproductive and endocrine organ toxicity. and also
May include assessing the relevance of chemical substances on the substance of the research, particularly in the information on the substance is scarce time. Available evidence
Weights can be affected by various factors, such as the nature and severity of the quality of the studies, consistency of results, the effect of differences between groups is statistically significant
Level, the number of affected endpoints, routes of exposure associated with human bias and freedom. Positive and negative results should be combined to
Assess the strength of the evidence. However a single study, conducted according to scientific principles and is statistically significant or biologically significant positive results
Analyzing classification can be used (see 4.2.2.3).
4.2.3.2 animal and human toxicokinetics research findings site of action and mechanism or mode of action may provide relevant information,
This information can be reduced or increased attention to human health hazards. If it can really prove and clearly identify the mechanism or mode
Nothing to do with humans, or there are very significant differences in toxicokinetics, that may determine this risk will not effect on humans, then the experimental animals
Matter produces reproductive harmful effects should not be classified.
4.2.3.3 In some reproductive toxicity studies in experimental animals, observed only small or very small effect on the toxicological significance, and therefore may not necessarily
As a basis for classification. For example, small changes in semen parameters or fetal malformation spontaneous ossification retardation, fetal weight or postnatal development of micro
Small differences.
4.2.3.4 Data from animal studies should preferably be able to provide clear evidence that the system in the absence of other toxic effects of the situation, there are specific
Reproductive toxicity. However, if the offspring developmental toxicity and other harmful effects associated with maternal appear together, as far as possible these should be combined with the universalization have
The potential impact of harmful effects assessed. The preferable method is to first combine the deleterious effects on the embryo/fetus, and then evaluate maternal toxicity
, As well as other factors that may affect them as a part of the weight of evidence. In general, affect the development of maternal toxicity was observed from the dose does not
It shall be automatically deducted. Only causal relationship is determined or negative, can not bind at maternally toxic doses observed in a case by case basis
Developmental effects.
4.2.3.5 If you acquire the appropriate information, it is necessary to determine whether developmental toxicity is due to a specific parent indirect mechanism or to a non-specific relay
Onset mechanism caused, for example, maternal stress and the disruption of homeostasis. In general, the presence of maternal toxicity should not be used to deny the discovery of embryonic /
Fetus, unless it can be clearly demonstrated that this effect is minor and non-specific, particularly harmful effect in the offspring is obvious, for example,
Irreversible effects malformations like. In some cases, reason to believe that reproductive toxicity is due to a secondary consequence of maternal toxicity and reduce
The impact of, for example, if the highly toxic chemical may cause the mother can not reproduce, the offspring can not breast-feeding or severe weakness or dying parent.
4.2.4 maternal toxicity
4.2.4.1 offspring may be affected by maternal toxicity effects throughout pregnancy and birth in the early stages of development, either through tight
And maternal homeostasis destroy non-specific mechanisms, or by specific maternally indirect mechanism. Therefore, the analysis of the developmental outcome to
Determine classification for developmental effects it is necessary to fully integrate maternal toxicity may affect. This is a complex issue, because maternal toxicity and
There is uncertainty among offspring developmental outcome. When analyzing the standard classification for developmental effects, should make use of all existing studies, the use of expert
Judgment and weight of evidence to determine the extent caused by the influence of maternal toxicity. We should first binding harmful effects on the embryo/fetus terms, then
Maternal toxicity, as well as any other factors that may affect these results, use them as weight of evidence, to help a conclusion about classification.
4.2.4.2 based on actual observations, convinced maternal toxicity depends on its severity, may affect the development via non-specific secondary mechanisms, producing
Health and various effects, such as decreased fetal weight, delayed ossification, and suck back some of the effects of certain malformations in some species of the family may occur. however,
A limited number, the relationship between developmental effects and maternal toxicity usual research, between species could not confirm the existence of a consistent reproducible energy
relationship. Even developmental effects occurring in the presence of maternal toxicity, and is also considered to be evidence of developmental toxicity, unless the by-case analysis
Clearly demonstrated that the developmental effects are secondary to maternal toxicity effects. In addition, the classification should be combined with significant toxic effects on the offspring of, for example,
Structural malformations, embryo/fetal deaths, birth defects and other significant features of irreversible effects.
4.2.4.3 produced only with respect to maternal toxicity and developmental toxicity of chemicals, even if a parent has proved to be specific indirect mechanisms, nor should
Automatic classification does not consider. In this case, the classification to category 2 to category 1 is more appropriate. However, when a chemical is toxic as well as very large
In maternal death or severe weakness, or breast-feeding mother has been unable to weak offspring, the offspring developmental toxicity can be reasonably certain that only the parent drug
Of secondary results without binding offspring developmental toxicity. If minor developmental changes (such as a slight decrease in fetal/Aberdeen weight, ossification
Delay) with maternal toxicity appear together, it may not necessarily be classified.
4.2.4.4 Evaluation of some maternal toxicity endpoints as follows. Data on these end points, if available, the need for statistical data
Or biological significance and dose response relationship shall be assessed.
--- Maternal mortality. maternal mortality and if the test substance dose-related and can be attributed to the systemic toxicity of the test substance,
It should be tested maternal mortality rate higher than the control group viewed as evidence of maternal toxicity. Maternal mortality greater than 10% is considered
To be very large, and this dose level data is not necessary for further evaluation.
--- Mating index (visible sperm or vaginal plugs animals number/total number of animals used for mating × 100).
--- Fertility index (number of animals have fertilized egg implantation/total number of animals mated × 100).
--- Time to pregnancy (if childbirth).
--- Body weight and body weight change. if the maternal weight data maternal body weight change and/or corrected available, as should be combined with its mother
Evaluating the evidence of toxicity. Maternal body weight change corrected mean calculated that the initial and final weight minus the pregnant uterus quality
Amount (or the total mass of the fetus), indicating that the change is possible within the uterus or the mother. In rabbit trials, weight gain can be
Not used as indicators of maternal toxicity, this is because the rabbit weight normally fluctuate during pregnancy.
--- Food and water consumption (if relevant). test parent observed compared with the control group, the average consumption of food or water significantly reduced,
Assessment of maternal toxicity may be useful, especially when the test substance is added to food or drinking water when. Food or water consumption
Changes should be combined and used to assess the maternal body weight up, should pay attention to whether the influence of maternal toxicity, or simply because the food or
Water test substance affect appetite.
--- Clinical assessment (including clinical signs, markers, hematology and clinical chemistry disease). measured by the parent with respect to the control group, Ming
The significant increase in the incidence of clinical signs of toxicity may be useful for the assessment of maternal toxicity. If this information is used to assess maternal toxicity
Based on the type should be reported in the study of clinical symptoms, incidence, degree and duration. The obvious clinical signs of maternal intoxication
Conditions include. coma, exhaustion, hyperactivity, loss of righting reflex, ataxia, or difficulty breathing.
Data --- check body. increased incidence and/or severity of the autopsy results may be indicative of maternal toxicity. This may include
Pathological findings or organ quality data as a whole or microscopic, such as organ absolute quality, and quality of organs or organ weight ratio
Quality and the ratio of brain mass. When receiving organs affected deleterious histopathological findings support the observed test parent
Suspicious target organs compared with the control group had an average quality significantly changed, it can be seen as evidence of maternal toxicity.
NOTE. Mating index and the Fertility index may be affected by the impact of male
4.2.5 Animal and experimental data
4.2.5.1 can be a series of test methods, including. developmental toxicity test methods, prenatal and postnatal toxicity tests and toxicity generation or second-generation
experiment method.
4.2.5.2 screening test results are also used as the basis of the classification, although recognized that the reliability of the evidence is not as comprehensive study
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