Reproductive and developmental toxicity testing: Examination of the extended one-generation reproductive toxicity study guideline

Abstract

An important aspect of safety assessment of chemicals (industrial and agricultural chemicals and pharmaceuticals) is determining their potential reproductive and developmental toxicity. A number of guidelines have outlined a series of separate reproductive and developmental toxicity studies from fertilization through adulthood and in some cases to second generation. The Extended One-Generation Reproductive Toxicity Study (EOGRTS) is the most recent and comprehensive guideline in this series. EOGRTS design makes toxicity testing progressive, comprehensive, and efficient by assessing key endpoints across multiple life-stages at relevant doses using a minimum number of animals, combining studies/evaluations and proposing tiered-testing approaches based on outcomes. EOGRTS determines toxicity during preconception, development of embryo/fetus and newborn, adolescence, and adults, with specific emphasis on the nervous, immunological, and endocrine systems, EOGRTS also assesses maternal and paternal toxicity. However, EOGRTS guideline is complex, criteria for selecting doses is unclear, and monitoring systemic dose during the course of the study for better interpretation and human relevance is not clear. This paper discusses potential simplification of EOGRTS, suggests procedures for relevant dose selection and monitors systemic dose at multiple life-stages for better interpretation of data and human relevance.

Reproductive/developmental toxicity screening test of kovir capsules in mice

“…Although only 2 -4% of congenital developmental defects in children are caused by known chemical or physical exposure during pregnancy or even before, the aftereffects of such exposure can be miserable. 5 Harmful effects may exhibit pre-or postnatally, such as developmental and growth retardation, malformations, functional defects, and even death. 8 and 5 show that the harmful impacts of Kovir on pregnancy rates, the number of implantations, and live fetuses were not remarked.…”

“…A crucial aspect of chemical safety assessment (industrial and agricultural chemicals and pharmaceuticals) is the identification of their potential reproductive and developmental toxicity. Evaluation of reproductive toxicity includes probable effects of the chemical on fertility, embryonic and fetal development, prenatal and postnatal development, and parental function 5,6. To further characterize the toxicity potential associated with Kovir, we performed this study to examine the potential reproductive and developmental toxicity of Kovir and to determine the relative vulnerability of males and females in Swiss mice according to the OECD guideline for reproductive/ developmental toxicity screening test.…”

Design of Computer Management System for Reproductive Toxicity Tests

“…Therefore, each hospital requires a set of hospital information system to meet the needs of the hospital to collect and manage information [4][5][6][7]. Improving hospital management level, improving the quality of medical services and promoting the pace of clinical medical research are the further improvement of hospital internal competitiveness [8][9][10][11]. In the process of drug development, the aim of reproductive toxicity research is to investigate the effects of the subjects on reproductive function and development of mammals through animal experiments, and to predict the possible adverse effects on reproductive function of the parents such as germ cells, pregnancy, childbirth and breast-feeding, as well as on embryo-fetal development and postnatal development of the offspring [12][13][14][15].…”