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Chemical - In vitro skin irritation - Reconstructed human epidermis test method
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SN/T 3948-2014
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Basic data Standard ID | SN/T 3948-2014 (SN/T3948-2014) | Description (Translated English) | Chemical - In vitro skin irritation - Reconstructed human epidermis test method | Sector / Industry | Commodity Inspection Standard (Recommended) | Classification of Chinese Standard | G09 | Classification of International Standard | 13.300 | Word Count Estimation | 12,122 | Date of Issue | 4/9/2014 | Date of Implementation | 11/1/2014 | Quoted Standard | GB/T 27830-2011 | Regulation (derived from) | State inspection certification (2014) 210 | Issuing agency(ies) | General Administration of Customs | Summary | This standard specifies the principles of testing chemicals in vitro human epidermal skin irritation test, the test procedure and data and reports. This standard applies to the United Nations Globally Harmonized System of Classification and Labelling (ref |
SN/T 3948-2014: Chemical - In vitro skin irritation - Reconstructed human epidermis test method---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 in vitro skin irritation. Recombinant Human Epidermal test)
People's Republic of China Entry-Exit Inspection and Quarantine Standards
Chemicals in vitro skin irritation. Recombinant human epidermal 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
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard technical content and Organisation for Economic Co-operation and Development (OECD) Chemicals Test Method 439 "In Vitro Skin Irritation. recombinant human form
Intradermal test "(Invitroskinirritation. reconstructedhumanepidermistestmethod) (2010) The content of the.
This standard is proposed and managed by the National Certification and Accreditation Administration Committee.
This standard was drafted. People's Republic of China Shanghai Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this standard. Yao Lifang, Taohai Hua, Li Ning, Miao Wenbin Jiang Wei, Li Wei, Zhu Hongkun, Qing Zhao Yi, Zheng Hua.
Chemicals in vitro skin irritation. Recombinant human epidermal test
1 Scope
This standard specifies the principles of testing chemicals in vitro human epidermal skin irritation test, the test procedure and data and reports.
This standard applies to the United Nations Globally Harmonized System of Classification and Labelling (referred to as the GHS) and the European Union classify substances and mixtures, labeling
And Packaging Regulation (called CLP) Category 2 irritant chemicals (chemical irritants) classification assessment.
This standard does not apply to UN GHS Category 3 (mild irritant) classification assessment.
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.
Human skin model test method GB/T 27830-2011 chemicals vitro skin corrosion
3 Terms and Definitions
GB/T 27830-2011 define the following terms and definitions apply to the text element.
3.1
Cell activity celviability
Index measuring overall cell population viability [e.g. mitochondrial dehydrogenase reducing activity tetrazolium dye (3- (4,5-dimethyl-thiazol-2) -
2,5-diphenyl tetrazolium bromide, MTT) (CASN o.298-93-1) capacity], depending on the endpoint measured and the indicators used in the design
Program, and with the total number of cells and/or the number of active cells.
[GB/T 27830-2011, Definition 2.2]
3.2
The median effective time medianeffectivetime; ET50
Given concentration, resulting in decreased cell viability by 50% the time required.
3.3
IC50 halfmaximalinhibitoryconcentration; IC50
Under certain exposure time, the concentration of cells resulting in reduced activity by 50%.
3.4
Skin irritation skinirritation
4h after contact with the test substance, causing irreversible damage skin. Skin irritation is a local non-immunogenic reaction, stimulated
After a short time it will happen. The main features are reversible, including inflammation and irritation associated with the inflammation process of clinical symptoms (red
Plaques, edema, itching and pain).
3.5
Optical density opticaldensity; OD
The ratio of the intensity of incident light and the transmitted light intensity of the common logarithm. It represents the optical density of the absorption of the test substance. A specific wavelength, with
One kind is the concentration of the test object and the energy is absorbed into the quantitative relationship.
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