GB/T 21827-2008 English PDFUS$154.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 21827-2008: Chemicals -- Test method of skin sensitization -- Local lymph node assay (LLNA) Status: Valid
Basic dataStandard ID: GB/T 21827-2008 (GB/T21827-2008)Description (Translated English): Chemicals -- Test method of skin sensitization -- Local lymph node assay (LLNA) Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A80 Classification of International Standard: 13.300; 11.100 Word Count Estimation: 8,843 Date of Issue: 2008-05-12 Date of Implementation: 2008-09-01 Adopted Standard: OECD No.429-2002, IDT Regulation (derived from): Announcement of Newly Approved National Standards 2008 No. 8 (No. 121 overall) 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 skin allergy test the scope of regional lymph node method, testing the basic principles, test methods, test data and reports. This standard applies to detect chemicals cause skin allergic effect, ie detection of skin allergy reactions induced lymphocyte proliferation phase, can provide assessment of dose response quantitative data. GB/T 21827-2008: Chemicals -- Test method of skin sensitization -- Local lymph node assay (LLNA)---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. Test method of skin sensitization. Local lymph node assay (LLNA) ICS 13.300; 11.100 A80 National Standards of People's Republic of China Chemical skin allergy test Regional lymph node method (LLNA) Posted 2008-05-12 2008-09-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released ForewordThis standard is identical with the Organisation for Economic Co-operation and Development (OECD) Chemicals testing guidelines No. 429 (2002), "allergy skin test Local lymph node test method test "(in English). This standard made the following editorial changes. --- To increase the "scope" chapter; --- A unit of measurement instead of legal units of measurement; --- Deleted the reference section of the OECD. This standard is managed by the National Standardization Technical Committee chemicals dangerous (SAC/TC251) and focal points. This standard is drafted by. China Center for Disease Control and Prevention of Occupational Health and Poison Control. Participated in the drafting of this standard. Shanghai Entry-Exit Inspection and Quarantine Bureau, Ningbo CIQ. The main drafters of this standard. Liuqing Jun, Qiu Lu, Sun Jinxiu Shi Xiao , Ma Zhongchun. OECD Introduction 1. OECD Test Guideline based on scientific and technological progress and from the perspective of animal welfare, the establishment and optimize the detection method for regular review Check to determine whether to update the existing methods or create new methods guide. For this purpose, a new method, namely the use of Analyzing method of skin allergy in mice --- local lymph Act (LLNA) has been sufficiently validated and accepted to become the new The OECD guidelines. It is the second assessment of chemicals on the skin sensitization of animal testing guidelines currently published. Another is the use of The maximum reaction test and partial closure coated skin test guidelines of guinea pigs. 2. LLNA advantage is that not only embodies the progress of science, but also take into account the issues of animal welfare. It is a skin allergy test lure Pilot phase of lymphocyte proliferation may be provided to assess the dose - response quantifiable data. About LLNA validation process and related work Review has been published. In addition, it is worth noting that, in light tested in guinea pigs recommended - intensity of the positive control allergens in the LLNA The same applies to the test. 3. LLNA is one of discriminating skin sensitization optional chemical methods, it can identify skin sensitizing chemicals, it is possible to determine Given that no significant skin sensitization active chemicals. Of course, this does not mean that in all cases LLNA test guinea pig may be substituted, However, this method has some advantages, is one of the allergy test alternative methods, generally do not need to re-enter positive and negative results Step confirmation. 4. LLNA is an in vivo test, it is inevitable to use a certain amount of animal, but can reduce the number of animals used LLNA, and And optimizes exposure to animal test substance. LLNA is established based on the induction phase under chemical stimulus sensitization reactions. And guinea pig Different test, LLNA does not need to stimulate skin hypersensitivity; tested in guinea pigs and does not require the maximum reaction, so do not use the rank and file Agent, thus it is reducing the suffering of animals. Although the LLNA over traditional guinea pig tests with these advantages, but also must recognize LLNA Also it has some flaws (such as. false-negative results in the test found some metal species, the false positive in certain skin irritants test Outcomes), then the need for traditional guinea pig tests. Chemical skin allergy test Regional lymph node method1 ScopeThis standard specifies the scope of skin allergy test --- regional lymph nodes law, the basic principles of the test, test methods, and test data report. This standard is applicable to the detection of chemical induced skin allergy effect, namely the detection of skin allergy induction phase of the anti-lymphocyte proliferation It should, be provided to assess the dose - response of the quantized data.2 test basic principlesThe basic principle is that within the LLNA sensitizing chemicals after exposure, can induce exposed parts of the draining lymph node lymphocyte proliferation. Proliferative response and dose of chemicals (and allergen sensitization force) proportional, so you can get an objective, quantitative sensitized by a simple method Test Data. LLNA test sample by comparing the test group with the control group proliferation dose - response relationship to assess the proliferation status. Correct Test sample test group and the control group, the proliferation rate of the solvent, i.e. the stimulation index (SI) were compared, when the index is greater than or equal test samples 3.00 It can act as a potential skin allergen for further evaluation. LLNA method described herein is radiolabeled by cell proliferation assay. You can also use other means to evaluate the toxicity endpoint detection Cell proliferation, but it must provide adequate justification and scientific evidence, including a description of the methodology and complete references.3 Test Method3.1 test substance The test sample can be liquid, solid and granular. Excipients should be selected in consideration of the maximum test concentration and soluble, based on the solution/suspension form suitable for use. recommend Excipients in order of preference are. acetone/olive oil (4.1, volume fraction), dimethylformamide, methyl ethyl ketone, propylene glycol and dimethylsulfoxide, such as a Prepare sufficient scientific evidence, other excipients may also be used. In some cases it is necessary to increase the vehicle or clinical test substance used merchandise As an additional control of the preparation. Particular attention should be to make the hydrophilic substance dispersed in the vehicle system, so that both moist skin, it will not stand That loss, but only to avoid the use of an aqueous vehicle. 3.2 Experimental animals and breeding environment 3.2.1 animal species Choose not given birth and non-pregnant adult female mice (CBA/Ca or CBA/J strain). Start of the test rats aged 8 weeks to 12 weeks, body weight variation should be less than 20% of average weight. Should choose a different species or male animals have ample evidence that in this test Species and gender differences do not exist. 3.2.2 Animal Feeding Caged animal, laboratory animal room temperature should be 23 ℃ ± 3 ℃, in addition to cleaning up animal room, the relative humidity should be at other times Between 30% to 70%, preferably at 50% to 60%. Artificial lighting should be used every day 12h alternating light and dark. Using conventional laboratory feed Material, no restrictions on drinking water. 3.2.3 Number of animals Each dose should be at least four animals, the test was set up at least three dose groups, a vehicle negative control group should also consider, as appropriate Establish a positive control group. Data collected from each animal, the number of animals in each group at least five. 3.3 dose design Dose concentration may be selected from the series. 100%, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% and so on. In selecting three ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 21827-2008_English be delivered?Answer: Upon your order, we will start to translate GB/T 21827-2008_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 21827-2008_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 21827-2008_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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