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SN/T 2180-2014: Toxicokinetics test
Status: Valid SN/T 2180: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| SN/T 2180-2014 | English | 579 |
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Toxicokinetics test
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SN/T 2180-2014
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| SN/T 2180-2008 | English | 319 |
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Toxicokinetics test
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SN/T 2180-2008
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PDF similar to SN/T 2180-2014
Basic data | Standard ID | SN/T 2180-2014 (SN/T2180-2014) | | Description (Translated English) | Toxicokinetics test | | Sector / Industry | Commodity Inspection Standard (Recommended) | | Classification of Chinese Standard | C70 | | Classification of International Standard | 13.300 | | Word Count Estimation | 22,271 | | Date of Issue | 4/9/2014 | | Date of Implementation | 11/1/2014 | | Older Standard (superseded by this standard) | SN/T 2180-2008 | | Quoted Standard | GB 14924.1; GB 14925; GB/T 21605; GB/T 27825 | | Regulation (derived from) | State inspection certification (2014) 210 | | Issuing agency(ies) | General Administration of Customs | | Summary | This standard specifies the terms and definitions chemicals toxicokinetic tests, laboratory animals, test methods, sample collection and results of the evaluation. This standard applies to chemicals toxicokinetic tests. | SN/T 2180-2014: Toxicokinetics test---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.
Toxicokinetics test
People's Republic of China Entry-Exit Inspection and Quarantine Standards
Instead of the SN/T 2180-2008
Toxicokinetics test
Issued on. 2014-04-09
2014-11-01 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms, Definitions and Abbreviations 1
4 Method 2
4.1 Pre-Test 2
4.2 Animal Selection 2
4.2.1 Species 2
4.2.2 Age and line 2
4.2.3 Number and sex of animals 2
4.2.4 rearing conditions 2
4.3 test substance 3
4.4 Dose Selection 3
4.4.1 Pre-test 3
4.4.2 Test 3 official
4.5 test substance exposure 4
4.6 Measuring 4
4.6.1 Mass Balance 4
4.6.2 Absorption 4
4.6.3 Bioavailability 5
4.6.4 Tissue distribution 5
4.6.5 Metabolism 5
4.6.6 excretion 6
4.7 Time Course Test 6
4.7.1 Plasma/Hemodynamics 6
4.7.2 Other organizational dynamics 7
4.7.3 enzyme induction/inhibition 7
4.8 Supplementary Methods 7
4.8.1 In vitro application information 7
4.8.2 Toxicity test using toxicokinetic data as supplementary information 8
4.8.3 toxicokinetic model application 8
8 4.9 Other routes of exposure
4.9.1 percutaneous route 8
4.9.2 inhalation route 9
5 Data and Reports 9
5.1 Data Summary 9
5.2 Reporting format 9
5.2.1 Summary 9
5.2.2 Introduction 9
5.2.3 Materials and Methods 9
10 5.2.4 Results
5.2.5 Discussion and conclusions 11
Related terms in Appendix A (informative), Definitions and Abbreviations 12
References 16
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
SN/T 2180-2008 "Toxicokinetics" modify the use of the United Nations Organisation for Economic Co-operation and Development (OECD) chemical testing means
South No.417 "toxicokinetics Test" (1984). OECD 2010 Guidelines for the Testing of Chemicals No.417 "Toxicokinetics"
(Toxicokinetics) (1984) have been revised. The technical content of the standard OECD Test Guidelines 417 chemicals "in metabolic power
Science "(Toxicokinetics) (2010) are basically the same, therefore, also SN/T 2180-2008" Toxicokinetics "has been revised. this
Compared with mainly standard SN/T 2180-2008 "metabolic dynamics poison" following differences.
--- Increased introduction;
--- Age of experimental animals have clear requirements;
--- It should be clearly labeled using 14C radioisotope test, but canceled the determination of sensitivity, accuracy and precision
Clear requirements of;
--- On the exposure dose and exposure pathways have a more detailed description of test methods and adds complementary;
--- Of the measure has been adjusted to cancel the test process dynamics model, increased the percentage of absorption and bioavailability
Indicators and corresponding formulas;
--- Summary of the contents of the report and the results were refined.
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted. People's Republic of China Ningbo Exit Inspection and Quarantine.
The main drafters of this standard. Chen Xiaoqing, Mazhong Chun, Zhang Sheng Qiao, Sun Yun, Tan Yao, Chen Dan Chao, Yu Weina.
This standard replaces the standards previously issued as follows.
--- SN/T 2180-2008.
Introduction
Sufficient information excretion, which can be dose or concentration and the observed toxicity associated also help explore the mechanism of toxicity. By Comments
Price exposure on laboratory animals to the test substance produced by the test substance and reveal whether cyclical (parent substance/metabolite), TK RESEARCH
Study also helps to explore other toxicological studies. Basic TK parameters obtained from the above studies in the evaluation of tissue and/or organs of the test substance
The possibility of accumulation and biotransformation likelihood of exposure to the test substance after aspect can provide valuable information.
TK data can help assess the adequacy and relevance of animal toxicity data extrapolation to humans hazards and/or risk assessment when. In addition,
TK also for research to determine the toxicity of the dose level (linear and nonlinear dynamics), exposure pathways, bioavailability and the study design
Some issues related to providing useful information. TK type of data that can be used physiologically toxicokinetic (physiologicaly based
basedtoxicokinetic, PBTK) development model.
Metabolite/TK data has prompted important potential toxicity, the role model and the associated aspects of their dose levels and exposure pathways
effect. In addition, data can also be used to evaluate the metabolic toxicologically significant exposure to exogenous chemical metabolites.
TK data can be sufficient enough for further QSAR acceptability and applicability, cross-references and material safety in
Between the two groups on the evaluation to provide strong support treatment. The kinetic data are also used to measure other studies (such as in vivo/in vitro) toxicology
Studies on the correlation.
Unless explicitly mentioned another exposure route (see 7.1, 7.2), this standard generally refers to oral administration of the test substance.
The competent authorities of different levels of chemicals (such as pesticides, fungicides, industrial chemicals, etc.) toxicokinetic parameters and measuring end
Different requirements. Unlike most Test Guidelines (TestGuideline, TC) it is different, TK test described in this standard includes a plurality of measurement
Amount and destination. In the future, OECD will be enacted several new testing guidelines and/or guidance documents (GuidanceDocument, GD) for each
A test endpoints described individually and strive detail. Purposes of this standard, the test method or evaluation method in accordance with the special administrations
Given the demand and/or need to make.
For administrative purposes, the evaluation of a chemical TK behavior, can be a variety of studies. But for some specific management needs or
The status quo, not all studies can be used to evaluate chemicals. Sometimes, you have to be flexible in considering the technology in toxicokinetic study design
Chemical properties. Sometimes, in order to solve chemicals-related hazards and risks concern the need to design a series of specific problems. In some cases,
TK collected data can also be used as part of other toxicology assessment. In some other cases, the need for regulatory and/or of
Chemicals assessment there are some new problems, the need for additional and/or more extensive study of TK.
To improve the quality of research and to avoid unnecessary use of animals, before such research should take full account of chemicals and related metabolites
All the available information and the like, including access from other test methods (in vivo tests, in vitro tests and/or computer evaluation)
The data. Physical and chemical characteristics, such as octanol - water partition coefficient (expressed in logPow), pKa, water solubility, vapor pressure, molecular mass
And other research programs for the design and interpretation of results helps. These parameters by using OECD Test Guidelines method is obtained.
Potential This standard does not apply to certain special circumstances described, such as pregnant or lactating animals and their offspring, or comment after food animals
Residues. However, the data obtained in this standard test method may provide background information for the design of these studies. This standard does not apply
For testing nanomaterials. OECD pre-made nanomaterials suitability reports indicate that this standard does not apply to nanomaterials 1).
This test should be carried out to consider animal welfare. No. OECD19 guidance document 2) humane treatment of animals has significance. This standard
All in vivo and in vitro studies are described in the recommended number OECD19 guidance document.
1) References [1].
2) Reference [2].
Toxicokinetics test
1 Scope
This standard specifies the terms and definitions chemicals toxicokinetic tests, laboratory animals, test methods, sample collection and results
Evaluation.
This standard applies to chemicals toxicokinetic tests.
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 14924.1 animal feed common quality standards
GB 14925 Laboratory Animal Facilities and Environment
Toxicity test method GB/T 21605 Chemical Acute inhalation (OECDTG403)
In vivo test method GB/T 27825 chemicals absorbed through the skin (OECDTG427)
3 Terms, definitions and abbreviations
As defined in Appendix A and the following terms, definitions and abbreviations apply to this document.
3.1
Bioavailability bioavailability
Exogenous chemical exposure from the site into the systemic circulation rate and extent. Generally refers to the exposure dose into the systemic circulation or may be used
That part of the physiologically active sites. Typically, the bioavailability of a substance refers to the parent compound, but may also involve its metabolites, not
Too, considering only one chemical form. It should be noted that the bioavailability and absorption are different concepts. Such as oral absorption (it appears in the intestinal wall and
Portal circulation) and bioavailability (ie, present in the blood and body tissues) difference between the two is mainly due to metabolic or intestinal efflux transport
Chemical back in the intestine or liver before metabolic system caused by the degradation of 3). In the human risk assessment (from high to low dose infer different way
Path between inference), the bioavailability of the toxic ingredient (parent compound or metabolite) is a critical parameter, can not be seen from the outside
Adverse Effect Level (noobservedadverseeffectlevel, NOAEL) and application benchmark dose (benchmarkdose, BMD) seeking
The internal value. When evaluated by oral administration of liver effects can be evaluated only oral absorption. But if all you want to evaluate the impact of the biological
Utilization is a more reliable parameter can be further applied to risk assessment, but it can not absorb.
3) Reference [3].
3.2
Plasma concentration - time curve area under areaundertheplasmaconcentration-timecurve; AUC
The area under the plasma concentration of a substance that changes with time curve, reflected at a pre-determined time, the total material to be absorbed by the body
the amount. Online conditions, regardless of how the rate of absorption, AUC (from zero to unlimited in time) to the total and the total amount of substance absorbed by the body
It is proportional.
3.3
Mass balance massbalance
Test substance entering and leaving the number of systems. And "mass balance", respectively.
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