{"title":"'Evaluation of reproductive toxicology studies according the OECD Guidance Document 443 - claim and reality'.","authors":"Munder Antje, Kloth Christina, Lewin Geertje","doi":"10.1016/j.reprotox.2024.108752","DOIUrl":null,"url":null,"abstract":"<p><p>The ECHA's work aims to establish uniform procedures for the authorization or restriction of the use of chemicals in the European Union. Studies conducted in accordance with OECD Guidance Document 443, in which, among others, the evaluation of pituitary and thyroid hormones and fertility under high-dose exposure are used as read-out parameters. Since 2022, ECHA has been compiling such extended one-generation reproductive toxicity (EOGRT) study data and publishing its assessments with regard to design, study conduct and toxicological results. Based on this, since then the authority has made demands on EOGRT study performers that are excessive, sometimes contra productive, may hamper data interpretation and lead neither to an improved validity of the studies nor to better animal welfare. Here, we explicitly address the physiological variability of pituitary hormone values and the interaction of reproductive toxicity with high dose exposure scenarios.</p>","PeriodicalId":21137,"journal":{"name":"Reproductive toxicology","volume":" ","pages":"108752"},"PeriodicalIF":3.3000,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Reproductive toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.reprotox.2024.108752","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"REPRODUCTIVE BIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The ECHA's work aims to establish uniform procedures for the authorization or restriction of the use of chemicals in the European Union. Studies conducted in accordance with OECD Guidance Document 443, in which, among others, the evaluation of pituitary and thyroid hormones and fertility under high-dose exposure are used as read-out parameters. Since 2022, ECHA has been compiling such extended one-generation reproductive toxicity (EOGRT) study data and publishing its assessments with regard to design, study conduct and toxicological results. Based on this, since then the authority has made demands on EOGRT study performers that are excessive, sometimes contra productive, may hamper data interpretation and lead neither to an improved validity of the studies nor to better animal welfare. Here, we explicitly address the physiological variability of pituitary hormone values and the interaction of reproductive toxicity with high dose exposure scenarios.
期刊介绍：
Drawing from a large number of disciplines, Reproductive Toxicology publishes timely, original research on the influence of chemical and physical agents on reproduction. Written by and for obstetricians, pediatricians, embryologists, teratologists, geneticists, toxicologists, andrologists, and others interested in detecting potential reproductive hazards, the journal is a forum for communication among researchers and practitioners. Articles focus on the application of in vitro, animal and clinical research to the practice of clinical medicine.
All aspects of reproduction are within the scope of Reproductive Toxicology, including the formation and maturation of male and female gametes, sexual function, the events surrounding the fusion of gametes and the development of the fertilized ovum, nourishment and transport of the conceptus within the genital tract, implantation, embryogenesis, intrauterine growth, placentation and placental function, parturition, lactation and neonatal survival. Adverse reproductive effects in males will be considered as significant as adverse effects occurring in females. To provide a balanced presentation of approaches, equal emphasis will be given to clinical and animal or in vitro work. Typical end points that will be studied by contributors include infertility, sexual dysfunction, spontaneous abortion, malformations, abnormal histogenesis, stillbirth, intrauterine growth retardation, prematurity, behavioral abnormalities, and perinatal mortality.
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