GB/T 35526-2017 English PDFUS$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 35526-2017: Chemicals -- A short-term screening assay for (anti) androgenic properties -- Hershberger bioassay in rats Status: Valid
Basic dataStandard ID: GB/T 35526-2017 (GB/T35526-2017)Description (Translated English): Chemicals -- A short-term screening assay for (anti) androgenic properties -- Hershberger bioassay in rats Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A80 Classification of International Standard: 13.300; 11.100 Word Count Estimation: 10,183 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 35526-2017: Chemicals -- A short-term screening assay for (anti) androgenic properties -- Hershberger bioassay in rats---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 - A short-term screening assay for (anti) androgenic properties - Hershberger bioassay in rats ICS 13.300; 11.100 A80 National Standards of People's Republic of China Chemical (anti) male sexual characteristics short-term screening test Rat Hershberger bioassay Chemicals-Ashort-termscreeningassayfor (anti) androgenic properties- 2017-12-29 Posted 2018-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard and the Organization for Economic Co-operation and Development (OECD) chemical test NO.441 "rat Hershberger biological test. (Anti-male sexual characteristics of short-term screening test "[Hershbergerbioassayinrats. Ashort-termscreeningassayfor (anti) androgenicpropertiest] (2009) the same technical content. This standard by the National Standardization Technical Committee of hazardous chemicals management (SAC/TC251) and focal point. This standard was drafted. Shanghai Exit Inspection and Quarantine of People's Republic of China, Inspection and Quarantine of China Academy of Sciences, Fudan University. The main drafters of this standard. Yao Lifang, Chen Jun water, Jiang Wei, Chen Xiang, Chen Huiming, Zhang Jing, Li Wei, Mu Wenbin, Zhao Yiqing, Zheng Hua, Wu Chunhua.IntroductionIn.1998, the OECD began to revise and develop test methods for the detection and screening of endocrine disruptors. One of the above activities has been developed Rat Hershberger Biological Screening Test Method. After decades of use in the pharmaceutical industry, the method was first officially licensed in 1962 The Industry Committee serves as a standard screening tool for androgenic chemicals..2001 -.2007, Hershberger biological screening test into A large number of validation projects. including method background information research, summary of specific test methods, the development of anatomical techniques and laboratory internal and Verification of test method reliability and reproducibility between laboratories. The validation study used androgen reference (testosterone propionate), Two synthetic androgens (norepinephrine acetate and methyltestosterone), antiandrogenic drugs (flutamide), androgenic androgenic (Finasteride), several weak anti-androgenic insecticides (liraglutide, vinclozolin, krelin and p, p'-DDE) and 5α-reductase Inhibitors (finasteride) and two negative controls (dinitrophenol and nonylphenol). This standard is a long-term biological identification test and verification Experimental experience summary. The Hershberger Biological Screening Test is a short-term in vivo screening method that uses tissues from the male reproductive system. Test begins In the 1930s and 1940s, androgen-responsive muscle in the male reproductive system was increased. In the 1960s, standards were used Methods More than 700 possible androgenic hormones were evaluated. This standard is based on the detection of castrated male rats in vivo five male hormones A screening method that relies on changes in tissue quality. This method is used to assess chemical androgen-like androgen-like androgen antagonists 5α-reductase inhibitor. The five androgen-dependent tissues are ventral prostate (VP), seminal vesicle (SV) (including fluid and Coagulation gland), levator ani muscle-muscle complex (LABC muscle), paired urethral bulb (COW) and glans (GP). Male in castration Rats, by the impact of male hormones, the quality of the above five organizations will have a corresponding increase. The same animal to be tested, using the male hormone reference The quality of all five tissues increased, and the use of androgen antagonists decreased the quality of all five tissues. three phases Validation test confirmed that the preferred animal model for the Hershberger biological screening test is castrate pre-adolescent male rats. The Hershberger Biological Screening Test is a screening of androgen receptor agonists, androgen antagonists and 5α-reductase inhibitors Election method. In vivo screening assays that provide data on a single endocrine mechanism are included in the OECD Endocrine Disruptors Testing and Assessment Framework Level 3. This test is included in the endocrine disruptor in vivo and in vitro series of tests, used to determine whether the test substance Potential interference with endocrine system, leading to human health and environmental hazards. Taking into consideration animal welfare, un-castrated weanling male rats can also be used as alternative animal models for Hershberger bio-screening type. This approach is also validated, however, in a microanimal anti-androgenic study, unmounted, freshly weaned male rats are not able to produce A consistent response. Therefore, this standard does not include the contents of this test. As androgen receptor receptors, androgen receptor agonists and antagonists may activate or inhibit receptor-controlled gene transcription, respectively. In addition, some chemicals in the androgen-targeted tissues inhibit the conversion of testosterone to the more active dihydrotestosterone (5a-reductase inhibition Agent). These substances can have adverse effects on reproduction and development. Therefore, there is a need to rapidly assess and evaluate whether a chemical is an androgen Receptor agonist, antagonist or 5 [alpha] -reductase inhibitor. Although detected by transcriptional activation of receptor-binding in vitro reporter genes, The affinity of the androgen receptor for the receptor has a relationship with the harm it produces, but it is not the decisive factor for potential harm. other factors Also included are metabolic activation, inactivation, distribution in target organs, and clearance in vivo after entry into the body. This requires screening chemistry The product is carried out under the relevant conditions and exposure. If the chemical absorption-distribution-metabolism-clearance (ADME) is known, then the body The assessment is relatively unimportant. In androgen-stimulated male androgen-dependent tissue cells in pre-adolescent male rats Long fast, obviously. Rodents, especially rats, are widely used in toxicological hazard studies. Therefore, in this experiment, castrated adolescence was used Pre-male rats and five target tissues were screened for androgen receptor agonists, antagonists and 5α-reductase inhibitors. The credibility and repeatability of this standard have been verified through the comparison of internal and laboratory OECD laboratories. All male shocks The procedures for the determination of androgen antagonists are reflected in this standard. Although in the test for the detection of anti-androgen test, different laboratories use testosterone propionate different doses, namely 0.2 mg/(kg · d) or 0.4 mg/(kg · d) (injected subcutaneously), but the detection of strong antiandrogens and weak antiandrogens Fruit indicates no difference in testosterone propionate test results. However, it should be clear dose of testosterone propionate should not be too high, so as to avoid filming The effect of attenuating androgen receptor antagonists should not be too low. Otherwise, even in the absence of androgen antagonists, androgen-dependent groups Weaving does not occur quality changes. The growth response of a single androgen-dependent tissue is not exclusively caused by androgens. That is, other than male hormone agonist compound Material may change the quality of a particular tissue. However, several organizations reacted simultaneously, demonstrating the specific response mechanism of androgens. E.g. High doses of estrogen can increase the quality of seminal vesicles, but will not increase the quality of other androgen-dependent tissues. Anti-androgenic chemicals It may be an androgen receptor antagonist or a 5α-reductase inhibitor. Different tissues into different dihydrotestosterone, so 5α- Reductase inhibitors have different effects on different tissues. Anti-5α-reductase anti-male compared to androgen antagonist flutamide Hormones finasteride greater effect on the ventral prostate. This difference can be used to distinguish whether the androgen receptor-mediated response is 5α- Reductase-mediated reaction. In addition, in biological evolution, androgen receptor and steroid hormones and other hormones, such as strengthening the solid Alcohol metabolism, lower serum testosterone levels, may also inhibit androgen-dependent tissue growth, therefore, Hershberger biological screening test Of any positive results should be combined with androgen receptor and estrogen receptor binding assay, transcriptional activation analysis and other in vitro tests or detection In vivo tests of androgen-like target organs, such as the male animal developmental test, the 15-day adult male animal test, the 28-day or 90-day repellent The amount of tests conducted a comprehensive evaluation. Experience has shown that androgen is more rare than anti-androgen. Therefore, Hershberger biological screening test is more widely used in anti-male Screening of sex hormones. However, the androgen test method can be used for steroidal or steroidal chemicals or in framework documents Level 1 or 2 Grade test results show the detection of chemicals with suspected androgen action. Similarly, the hazards associated with (and) androgen may be Level 5 test was observed for the assessment of whether the hazards of chemicals and endocrine-related. All animal-related procedures should comply with local animal protection standards and the animal protection and use standards described in this standard are the most Low standards, can be replaced by local regulations. Chemical (anti) male sexual characteristics short-term screening test Rat Hershberger bioassay1 ScopeThis standard specifies the chemical (anti) male sexual characteristics of short-term screening test of the terms and definitions of Hershberger bioassay in rats, the test Principle, test methods and procedures, data and reports. This standard applies to assess the chemical similar male hormone agonist, androgen antagonist or 5α-reductase inhibitor biological activity.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 14925 laboratory animal environment and facilities3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Androgenicity Promoting effects of chemicals on androgen-dependent tissues. 3.2 Antiandrogenicity Anti-androgenic effect Effect of chemicals on the activity of testosterone propionate (TP, CAS number 57-82-5) in mammals. 3.3 Dose dose The amount of test substance given. The daily body weight of animals given to the quality of the test object to that, that mg/(kg · d). 3.4 Dosage dosage Including dose, frequency of exposure and exposure time.4 test principle4.1 To assess whether a chemical is an androgen agonist by testing the changes in the quality of the five androgen-dependent tissues before and after treatment Sex hormone antagonist or 5α-reductase inhibitor. The five androgen-dependent tissues include ventral prostate (VP), seminal vesicle (SV) (including Fluid and coagulated gland), levator ani muscle constrictor (LABC), paired urinary bulb (COW) and glans (GP). 4.2 The growth response of a single androgen-dependent tissue is not exclusively caused by androgens, however, several tissues grow simultaneously Reaction, you can prove that the male hormone effect. In order to achieve its sensitivity, this standard castration male rats, which is because castrated male large Low levels of endogenous androgens in blood circulation in the rat make the hypothalamic-pituitary-gonadal axis unable to compensate by compensatory mechanisms, making The organization maximizes the response to chemicals and, after castration, minimizes the quality of its target tissue, making the difference in initial tissue quality most ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 35526-2017_English be delivered?Answer: Upon your order, we will start to translate GB/T 35526-2017_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 35526-2017_English with my colleagues?Answer: Yes. 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