GB/T 35525-2017 English PDFUS$519.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 35525-2017: Chemicals -- Extended one-generation reproductive toxicity study Status: Valid
Basic dataStandard ID: GB/T 35525-2017 (GB/T35525-2017)Description (Translated English): Chemicals -- Extended one-generation reproductive toxicity study Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A80 Classification of International Standard: 13.300; 11.100 Word Count Estimation: 26,275 Date of Issue: 2017-12-29 Date of Implementation: 2018-07-01 Regulation (derived from): National Standards Bulletin 2017 No. 32 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 35525-2017: Chemicals -- Extended one-generation reproductive toxicity study---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 - Extended one-generation reproductive toxicity study ICS 13.300; 11.100 A80 National Standards of People's Republic of China Generation of chemicals Expanded generation toxicity test 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 Directory Foreword Ⅲ Introduction IV 1 Scope 1 2 Abbreviations 1 3 principle 1 4 Method Description 2 4.1 Experimental animals 2 4.1.1 Animal Species and Lines 2 4.1.2 age, weight and inclusion criteria 2 4.1.3 breeding conditions 2 4.1.4 Animal quantity and identification 2 4.2 test substance 2 4.2.1 Test article available information 2 4.2.2 Application Route 3 4.2.3 Solvent Selection 3 4.3 dose selection 3 4.4 limit test 4 4.5 program 4 4.5.1 Progeny Exposure 4 4.5.2 Schedule and dose of exposure 4 4.5.3 Mating 5 4.5.4 Number of children 5 4.5.5 weaning after weaning choices (see Figure 1) 5 4.5.6 Parental mating 6 4.6 Live Observation 6 4.6.1 Clinical observation 6 4.6.2 Weight and Food/Water Consumption 6 4.6.3 estrus cycle 7 4.6.4 Mating and Pregnancy 7 4.6.5 Generation parameters 7 4.6.6 Evaluation of Neurodevelopmental Toxicity of the Parent (Queues 2A and 2B) 7 4.6.7 Evaluation of Potential Immune Developmental Toxicity (Cohort 3) 8 4.6.8 Potential Reproductive Toxicity Follow-up Evaluation (Cohort 1B) 8 4.7 Final Observations 8 4.7.1 Clinical Biochemistry/Hematology 8 4.7.2 sperm parameters 9 4.7.3 General anatomy 9 4.7.4 organ weighing and tissue preservation --- parent and F1 adult animals 9 4.7.5 Organ Weighing and Tissue Preservation --- Weaned F1 only 4.7.6 Histopathology --- parents 10 4.7.7 Histopathology --- F1 generation 10 5 Report 11 5.1 Data 11 5.2 Results Evaluation 12 5.3 Test Report 12 5.3.1 Basic Requirements 12 5.3.2 Test substance 12 5.3.3 Solvent (if any) 12 5.3.4 Experimental animals 12 5.3.5 Test conditions 12 5.3.6 Results (Data by Sex and Dose) 13 5.3.7 Queue 2 parameters 13 5.3.8 Queue 3 parameter 14 5.4 Results Discussion 14 5.5 Interpretation of results 14 5.5.1 Exposure Effects Information 14 5.5.2 Test substance related information 14 5.5.3 Cohort 2 (neurodevelopmental toxicity) 14 5.5.4 Cohort 3 (Developmental Immunotoxicity) 15 Appendix A (informative) Functional observation test portfolio contains the observation and inspection items 16 References 17 Figure 1 Expanded Generation Reproduction Toxicity Schedule 6 Table A.1 Observation of observation and inspection items included in the functional observation test combination (Queue 2A) 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 (Organization for Economic Cooperation and Development, OECD) TG443. Extended Generation-Generation Reproductive Toxicity Study (English version) The same technical content. This standard by the National Standardization Technical Committee of hazardous chemicals management (SAC/TC251) and focal point. This standard drafting unit. China Inspection and Quarantine Science Institute, Ningbo Exit Inspection and Quarantine, Shanghai Testing Center, Changzhou Inspection and Quarantine Bureau. The main drafters of this standard.Song Nai Ning, Chen Huiming, Li Haishan, Cui Yuan, Chen Xiaoqing, Liang Yihuai, Yin Haowen, Liu Junfeng, Cheng Yan, Zhang Jing, Wang 琤.IntroductionThis standard for research and design made some improvements and instructions for flexible application, and stressed the existing cognitive as a research-based The importance of beginning and using in vivo observations to guide and adjust the test. This standard specifies the expanded generation of reproductive toxicity studies Implementation of the situation. This standard describes three cohort studies of sub-generation animals. Cohort 1. Assess reproductive/developmental endpoints; this cohort study can be extended to the second generation. Cohort 2. Assess the potential effects of chemical exposure on nervous system development. Queue 3. Assess the potential impact of chemical exposure on immune system development. Decision-making in deciding whether to conduct second-generation assessments and whether to omit developmental neurotoxic and/or developmental immunotoxicity cohorts It should be possible to reflect the current perception of the chemicals being evaluated and the needs of the regulatory authorities. This standard is intended to detail how to conduct research Study, and how to evaluate each cohort study. For regulators using internal triggers, guideline 117 [1] describes the determination of internal triggers for second-generation studies Procedures. Generation of chemicals Expanded generation toxicity test1 ScopeThis standard specifies the acronyms, principles, method descriptions and reports of reproductive toxicity tests of chemicals extended generation. This standard applies to the proliferation of chemicals to reproduce the toxicity test.2 AbbreviationsThe following abbreviations apply to this document. ADME. Absorption, distribution, metabolism, excretion LOAEL. The lowest observed dose (Lowestobservedadverseeffectlevel) NOAEL. No effect observed dose (Noobservedadverseeffectlevel) SARs. Structure-activityrelationships TK. Toxicokinetics3 principle3.1 Extended Primary Reproductive Toxicity The primary purpose of the test is to evaluate the special stages of life (not included in other toxicity studies) and Test the possible effects of chemical exposure before and after birth. For the end of breeding, as a first step, repeat dose exposure test (including breeding / Developmental Toxicity Screening Tests, such as Guideline 422) [2] or short-term endocrine disruptor screening tests (eg Uterine Proliferation Test Guideline Document 440, Hershberger's Test Guideline Document 441) [3-4] can be used to detect effects on male and female reproductive organs including male spermatogenesis (testis Pelvic histopathology), female estrus cycle, number of follicles/oocyte maturation and ovarian integrity (histology). Expanded generation reproductive toxicity test The test requires the testing of reproductive endpoints for the interaction of female-male, female-embryo, female-offspring/sexual maturity subfamilies (F1) [5]. 3.2 This test assesses the effect of chemicals on development before and after birth, as well as the comprehensiveness of young and adult offspring of pregnant and nursing mothers and their offspring Systemic toxicity. Detailed examination of important developmental endpoints, such as offspring viability, newborn offspring health, developmental status at birth, pre-adult body The development of somatic and functional genes facilitates the identification of specific target organs of offspring. In addition, the test may provide and/or confirm that the test substance is specific to adult males and females Information on the effects of sexual reproductive system integrity and reproductive behavior. Specific indicators are as follows. gonadal function, estrus cycle, epididymal maturation, mating Behavior, pregnancy, pregnancy, childbirth and breastfeeding, but not limited to the above indicators, while from neurodevelopmental toxicity and immune developmental toxicity evaluation obtained The information can be used to assess the potential impact of the test substance on such systems. The above experimental data can be used to determine unobservable end points for various observations (NOAEL), the lowest observed dose (LOAEL) and/or baseline dose for the lesion, The effect detected in a quantitative exposure test, or as a basis for subsequent testing. 3.3 The extended generation reproductive toxicity test procedure is shown in Figure 1. Groups of sexually mature male and female animals are continued in progressive doses Toxicity. The parental (P) was exposed before mating (at least 2 weeks) and mating (2 weeks). The male parent continues to infect at least the offspring (F1 generation) milk. Male for at least 10 weeks. If you need to study the impact on reproduction, you can extend the exposure time. Parental female from gestation and breastfeeding Period continued exposure until its offspring offspring (that is, 8 weeks to 10 weeks). F1 generation from weaning to adulthood continued exposure. If you evaluate the second generation (F2 generation) [1], F1 generation should be maintained until F2 weaning or end of the trial. 3.4 All animals were subjected to clinical observation and pathological examination to determine toxic signs, especially male and female reproductive system integrity and complexity Proliferation and the health, growth, development and function of offspring. After weaning, F1 generation is assigned to specific subgroups for further observation, including sex Mature, reproductive organ integrity and reproductive function, nerve and behavioral endpoints, and immune function. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 35525-2017_English be delivered?Answer: Upon your order, we will start to translate GB/T 35525-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. 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