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GB/T 35520-2017: Chemicals -- Embryotoxicity -- Embryonic stem cell test
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| GB/T 35520-2017 | English | 439 |
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Chemicals -- Embryotoxicity -- Embryonic stem cell test
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GB/T 35520-2017
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Basic data | Standard ID | GB/T 35520-2017 (GB/T35520-2017) | | Description (Translated English) | Chemicals -- Embryotoxicity -- Embryonic stem cell test | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300; 11.100 | | Word Count Estimation | 22,294 | | Date of Issue | 2017-12-29 | | Date of Implementation | 2018-07-01 | | 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 | GB/T 35520-2017: Chemicals -- Embryotoxicity -- Embryonic stem cell 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.
Chemicals-Embryotoxicity-Embryonic stem cell test
ICS 13.300; 11.100
A80
National Standards of People's Republic of China
Chemical embryotoxicity embryonic stem cell test
Published on.2017-12-29
2018-07-01 Implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is proposed and managed by the National Standardization Technical Committee for Hazardous Chemicals Management (SAC/TC251).
This standard was drafted by. China Academy of Inspection and Quarantine, China Chemical Industry Economic and Technological Development Center, Changzhou Import and Export Industry, and Consumption.
Product Safety Testing Center, Ningbo Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this standard. Li Haishan, Chen Huiming, Han Hui, Cui Yuan, Wang Xiaobing, Liu Junfeng, Chen Xiaoqing, Cheng Yan, Ai Wenchao, and Xie Wenping.
Introduction
Embryonic stem cells (ES) differentiate into different embryonic tissues under different culture conditions. because
In this regard, some groups used mouse ES cells for in vitro embryo toxicity testing. Laschinski et al. [1] compared ES cells and mouse fibers.
The cytotoxicity of the virosomes to assess the potential embryotoxicity of the teratogenicity. Heuer et al [2-3] compared the cytotoxicity and differentiation of ES cells
inhibition. Newal and Beedles [4] measured the effects of teratogenicity on the cytotoxicity and colony forming ability of ES cells after 7 days of culture.
This applies to routine testing because the end of colony formation can be automated. Of all these tests, only some embryotoxic
Enough to be classified correctly. This may be due to the fact that selecting two endpoints in the ES trial is not sufficient to assess embryo toxicity.
In order to overcome the limitations of the above ES cell test, Spielmann et al. [5] identified three different test endpoints (half differentiation inhibition concentrations,
D3 cell half growth inhibitory concentration and 3T3 cell half growth inhibitory concentration). According to these end points, 3 variables can be derived. Obtained
Three variables were used as the basis for the test to classify the endotoxicity levels of the three individuals. This method is conducive to give embryonic and adult tissue
The difference in the sensitivity of the compound to cytotoxic damage. In fact, the use of discriminant analysis has correctly classified 16 test chemicals into known
Three in vivo embryotoxicity grades [5-6]. This is the first in vitro embryotoxicity of an embryonic tissue obtained from a non-pregnant animal and cultured in vitro.
Sex test.
The standard operating procedures developed for validation studies in this standard overcome the problem of maintaining ES status in the laboratory. ES cells usually tilt
Spontaneous differentiation.
In addition, according to the established performance standards, the European Centre for the Validation of Alter-
NativeMethods, ECVAM) validation studies show a good correlation between in vitro and in vivo data (accuracy 78%).
According to reports, the predictability (100%) of strong embryotoxic chemicals is excellent and accurate (81%) is good. According to reports, no embryotoxic substances and embryos
The predictability of the less toxic substances (72% and 70%, respectively) and the accuracy (70%) of the non-embryonic toxic substances were higher (≥65%) [7].
However, one exception occurred in the misclassification of the strong embryotoxic chemical Chloride methylmercury, in 4 out of 8 trials,
It is predicted that there will be no embryotoxic chemicals, not strong embryotoxic chemicals. This misclassification may be due to the establishment of pre-
The model-trained training set did not include chemicals with similar cytotoxicity patterns [6].
Chemical embryotoxicity embryonic stem cell test
1 Scope
This standard specifies the terms and definitions, test principles, test methods, quality control and knots for the embryonic stem cell test for chemical embryotoxicity.
Fruit evaluation.
This standard applies to embryotoxicity using test embryonic stem cell test chemicals.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Half-differentiation inhibitory concentration medianinhibitionofdifferentiation
ID50
The chemical inhibits the concentration of 50% of ES cells that differentiate into cardiomyocytes.
2.2
D3 cell half growth inhibitory concentration medianinhibitionofgrowthofD3
IC50D3
The concentration at which the chemical inhibits the growth and activity of 50% of the ES cell line D3.
2.3
3T3 cell half growth inhibitory concentration medianinhibitionofgrowthof3T3
IC503T3
The concentration of the chemical that inhibits the growth and activity of 50% of 3T3 cells.
3 Test principle
Embryonic toxicity test or in vivo test with pregnant animals, or using cultured embryos and embryonic tissues and cells taken from pregnant animals
In vitro tests. Both pregnant and in-vitro tests have to be performed on pregnant animals [8]. Use of Embryonic Stem Cells to Culture in Vitro
The potential of this method is to propose an in vitro embryotoxicity assay using mouse immortalized cell lines, the embryonic stem cell assay [9].
This test is based on the most important indicator of embryotoxicity, that is, the test substance is sensitive to the toxic damage to the embryonic and adult tissues.
Perceptual differences, this difference is closely related to inhibition of embryonic differentiation. Two immortalized mouse cell lines, ES cells (D3) and fibroblasts were used
The cells (3T3 cells) represent embryonic and adult tissues, respectively. Only in culture conditions where mouse leukemia inhibitory factor (mLIF) was added,
ES cells remain in the undifferentiated stage to perform this test. In the undifferentiated state, ES cells form embryoid bodies (EBs) and are
Under the conditions differentiated into the main embryonic tissue.
Cytotoxicity data indicate that ES cells are more sensitive to toxic agents than adult cells [1]. ES cell differentiation inhibition and ES cells with 3T3
Inhibition of cell growth is the 3 selected endpoints for predicting potential embryotoxicity of chemicals in ESTs.
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