GB/T 27829-2011 English PDFUS$349.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 27829-2011: Chemicals -- In vitro test of skin corrosion -- Membrane barrier method Status: Valid
Basic dataStandard ID: GB/T 27829-2011 (GB/T27829-2011)Description (Translated English): Chemicals -- In vitro test of skin corrosion -- Membrane barrier method Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A80 Classification of International Standard: 13.300; 11.100 Word Count Estimation: 15,136 Date of Issue: 2011-12-30 Date of Implementation: 2012-08-01 Regulation (derived from): Announcement of Newly Approved National Standards No. 23 of 2011 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 the chemical barrier membrane in vitro skin corrosion test method definitions of terms and acronyms, test theory, test methods, test data and reports. This standard applies to skin corrosion testing of chemicals. GB/T 27829-2011: Chemicals -- In vitro test of skin corrosion -- Membrane barrier 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 test of skin corrosion. Membrane barrier method ICS 13.300; 11.100 A80 National Standards of People's Republic of China Chemicals vitro skin corrosion Membrane barrier test method Issued on. 2011-12-30 2012-08-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. The Standards and Organisation for Economic Co-operation and Development (OECD) Chemicals testing guidelines No.435 (2006) "in vitro skin corrosion barrier film Test Method "(in English) is consistent technical content. This standard configuration and do the following editorial changes. --- Increasing the range a chapter; --- The original OECD435 the "Introduction" section of this standard into the introduction; --- The OECD435 description in "Appendix. Definitions" as part of the contents of this standard "2 terms, definitions and abbreviations"; --- Change the unit of measure of legal units of measurement. This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points. This standard was drafted. Chinese Center for Disease Prevention and Control of Occupational Health and Poison Control, Shanghai Entry-Exit Inspection and Quarantine of China Engineering Technology Development Center. The main drafters of this standard. Liuqing Jun, Qiu Lu, Wang Xiaobing, Li Xiaolin, Yang Ting, Jiang Jing.IntroductionSkin corrosion refers to the role of the test substance, the skin appears irreversible damage, characterized by necrotic epidermis into the dermis of the [United Nations (UN) Globally Harmonized System of Classification and Labelling (GHS) [1]]. This test method does not use live animals in vitro method. The original test method is an in vivo test methods for the selection of rabbit skin (OECDTG404) [2]. OECD made a lot In vitro test methods for the detection of corrosive substances, as an alternative to the original in vivo tests. Artificial membrane in vitro membrane barrier method used Corrosive substances react with the animals are exposed parts of the skin similar to the reaction of corrosive substances. The traditional method is to test skin corrosion test substance is applied to the skin of live animals, after a certain time, by evaluating the organization Evaluate the extent of damage to the skin corrosion test substance [2-3]. UN GHS classification system for skin corrosion testing and evaluation strategies And allows the use of in vitro testing methods accepted validated [1]. In this placement test and evaluation methods in vitro test result is positive by Test substance can be determined to corrosive substances, it does not require animal testing, thus reducing and optimizing the use of the test animals. According to this policy Slightly, the in vitro test results were negative for the test, the need for additional test [1]. Thus, using an in vitro test method for detecting test substances Corrosive to avoid the pain and injury caused by animal testing. Corrositex® already validated and in vitro membrane barrier test method commercially available [4-6]. Given its proven effectiveness is reasonable, This test method has been recommended for evaluating chemicals skin corrosive hazardous part of the placement test strategy [5]. New in vitro membrane barrier test Shall determine the reliability of the method before a method for skin corrosion detection, correlation (accuracy) and its limitations, and other methods to ensure that the test Certified reference method over comparable [7-10]. Limitations of this approach is that [5]. Based on the initial results of the compatibility test, many non-corrosive chemicals or mixtures thereof, and certain Corrosive chemicals or mixtures can not use this method for testing. While 85% aqueous solution pH of 4.5 to 8.5 of the chemicals of Animal test results are non-corrosive [5], but an aqueous solution of chemicals within the above pH range is generally not suitable for in vitro membrane barrier into law Row detector. In vitro membrane barrier test method can be used to detect solid (including soluble in water and insoluble in water), liquids (including aqueous and non-aqueous Solution), and emulsions. However, compatibility tests, many test chemical or mixture does not appear detectable change [ie in the reference method Chemical Detection System (CDS) has changed color], and therefore does not apply to the film barrier methods, and other test methods should be selected. Test substance It may be pure, dilution, preparation or waste. Without sample pretreatment. OECD provided a total of three detection in vitro test methods for skin corrosion, in addition to this standard, the other two are based on human recombinant Skin Model (OECDTG431) [11] and isolated rat skin model (OECDTG430) [12] Test Method. Chemical skin corrosion In vitro membrane barrier test method can be used to further the GHS system corrosive substances classified (subclass) and the United Nations Transport of Dangerous Goods package Loading classification (TransportPackingGroups) Classification corrosive hazardous. This method is applicable to corrosive chemicals or mixtures of discrimination, and the GHS system corrosive substances classified further fine Technology (see text table 1). In addition, this method can also be used to determine certain types of chemicals in accordance with the corrosive or non-corrosive Transport substances, such as certain organic and inorganic acids, acid derivatives, alkali. This test procedure is similar to a validated reference test method. Chemicals vitro skin corrosion Membrane barrier test method1 ScopeThis standard specifies the definitions of terms and acronyms, test principle, in vitro test methods for skin corrosion chemical membrane barrier test method Test data and reports. This standard is applicable to the detection of chemical skin corrosion. 2 terms, definitions and abbreviations 2.1 Terms and Definitions The following terms and definitions apply to this document. 2.1.1 Skin corrosion skincorrosion The role of the test substance cause irreversible damage to the skin, from the epidermis into the dermis showed obvious necrosis. 2.1.2 Accuracy accuracy Results Test Method acceptable degree of matching between the reference value, is a measure of the test method of operation, the correlation is One aspect. "Accuracy" often with "consistency" are used interchangeably, refers to a method of test results obtained with the actual results in line Proportion [7-8,10]. 2.1.3 False negative rate falsenegativerate All real positive (activity), is determined according to the test result is negative ratio. False negative rate is an indicator of operating tests. 2.1.4 False positive rate falsepositiverate All actually negative (non - active), and the test is determined according to the proportion of positive results. The false positive rate is a test operation index. 2.1.5 Laboratory reproducibility between inter-laboratoryreproducibility trial Evaluation between different laboratories using the same method for the same test was subjected to the same tests to obtain the quality and quantity of similar knot The degree of fruit. Determine reproducibility between laboratories prior to verification and validation phase, the reproducibility of the test showed that between the two laboratories to The extent of the power of mutual recognition between the two refers to repetitive laboratory experiments. 2.1.6 References performancestandards Based on the standard as a reference method after verification. For the recommended approach in similar functions and mechanisms, this standard provides assessment Its "comparable" basis. Note. The contents include. Component (1) essential test method; (2) the list of chemicals acceptable operator selects a minimum number of reference from the reference method used to prove Thereof; and (3) the accuracy and reliability of the appropriate level should be based on comparison with those after the verification reference method, the proposed method should be established by using Minimum number of reference materials to evaluate the test. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 27829-2011_English be delivered?Answer: Upon your order, we will start to translate GB/T 27829-2011_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 27829-2011_English with my colleagues?Answer: Yes. 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