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Rat whole embryo culture test after implantation embryo toxicity of chemicals
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Basic data
| Standard ID | SN/T 3527-2013 (SN/T3527-2013) |
| Description (Translated English) | Rat whole embryo culture test after implantation embryo toxicity of chemicals |
| Sector / Industry | Commodity Inspection Standard (Recommended) |
| Classification of Chinese Standard | G09 |
| Classification of International Standard | 13.300 |
| Word Count Estimation | 16,136 |
| Regulation (derived from) | AQSIQ notification issued in 2013 on the first batch of 179 entry-exit inspection and quarantine of industry standards; industry standard for filing Notice 2013 No. 9 (No. 165 overall) |
| Issuing agency(ies) | General Administration of Customs |
| Summary | This standard specifies the method for detecting toxic chemicals whole embryo culture embryo implantation in rats after the purpose, methods, principles, test descriptions, test systems, data analysis/prediction model, test substances, materials, methods, |
SN/T 3527-2013: Rat whole embryo culture test after implantation embryo toxicity of chemicals
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Rat whole embryo culture test after implantation embryo toxicity of chemicals
People's Republic of China Entry-Exit Inspection and Quarantine Standards
After the chemical toxicity testing implantation rat embryo
Whole embryo culture
Issued on. 2013-03-01
2013-09-16 implementation
People's Republic of China
The State Administration of Quality Supervision, Inspection and Quarantine released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference European alternatives to animal testing methods Research Centre (EuropeanCentrefortheValidationofAlternative
Methods, ECVAM) "after implantation whole embryo in vitro culture of rat embryo toxicity test" (DB-ALM. INVITTOXprotocol
embryotoxicitytestinginpost-implantationembryocultureINVITTOXn ° 123) (English Version)
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted. Chinese Academy of Inspection and Quarantine.
The main drafters of this standard. Cheng Yan, Cui Yuan, Xie Wenping, Falls Apart, Alvin Chao, Ma Ping.
After the chemical toxicity testing implantation rat embryo
Whole embryo culture
1 Scope
This standard specifies the method for detecting toxic chemicals embryo after implantation whole embryo culture method of rat purpose, principle of the method, test description,
Test system, data analysis/prediction model, test substances, materials, methods, and potential embryo toxicity prediction, evaluation.
This standard applies to chemical toxicity screening embryonic.
2 Terms and definitions
The following terms and definitions apply to this document.
2.1
Half teratogenic concentration IC50 formalformations; IC50
50% of the embryos deformity test concentration.
2.2
3T3 cells IC50 IC50 (3T3) forinhibitionofthegrowthof3T3cels; IC50 (3T3)
50% of the 3T3 cell growth inhibition by the test substance concentration.
2.3
The maximum concentration of teratogenic ICmax formalformations; ICmax
Resulting in the lowest concentration of the test substance highest rate of deformity.
2.4
Overall Rating morphological no-effect concentration ICNOEC fortotalmorphologicalscore; ICNOEC
Overall morphology scores were not the highest test substance concentration effects.
Objective 3
Embryotoxicity detected after implantation whole embryo culture method is to identify the cause malformations in rats eventually lead to embryotoxic substances.
4 principle of the method
4.1 rat embryos used in the experiment contain 1 to 5 somites, more sensitive than the use of embryonic greater period of exogenous substances. In 48h
The training process is an important period of organ formation, such as heart development, neural tube closure, ear eye formation, brachial artery and limb bud formation. Suffer
Test was carried out at this stage exposure can cause the body's growth and development retardation or deformities caused by one or more organs.
4.2 embryos were cultured in a rotary incubator, helping to train the gas above the liquid to exchange. Because embryonic development for oxygen
Need more and more, for optimal gas exchange of oxygen saturation of the culture medium is very important.
4.3 After the test is completed, the assessment of embryo morphology of the embryos in the control group and the test groups were compared, the results obtained embryo toxicity test substance.
5 Test description
5.1 end point and end point detection
5.1.1 rat embryo morphology. morphological changes (embryonic overall observation, including the number of somites differentiation lag specific deformity).
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