Résumé
OBJECTIVE: To establish the background data on SD rat embryo-fetal development toxicity studies by Shanghai Institute of Planned Parenthood Research (National Evaluation Center for Toxicology of Fertility Regulating Drugs), and provide reference for reproductive toxicology research. METHODS: From the embryonic-fetal developmental toxicity tests of SD rats between 2010 and 2018, the index data on embryo development and fetal growth and development of pregnant rats was selected, including pregnancy body mass and pregnancy outcomes (average of corpora lutea, implantation, live fetuses, absorptions and dead fetuses), the growth and development of fetuses (fetal body mass, body length and tail length) and fetal appearance, viscera, and skeleton. The data was statistically analyzed, and the mean, standard deviation and coefficient of variation were calculated. RESULTS: Totally 217 pregnant rats and 2506 fetuses were included. The body mass of pregnant rats on gestation day 0 (GD0) was (222±22) g, while the food consumption of GD0-1was (18.9±3.8) g·d-1. The body mass of GD20 was (353±30) g and the food consumption of GD19-20was (26.2±4.0) g·d-1. GD20euthanasia cesarean section examination showed that the pregnancy rate was 95.2%, and that the average of corpora lutea, implantation and live fetuses was 12.8±2.1, 11.8±2.8 and 11.5±2.8, respectively. The rate of live fetuses and absorption rate was 97.9% and 2.1%, respectively. Among the fetal development indexes, the body mass and placental mass were 3.6±0.3 and (0.5±0.1) g, respectively. The body length was (35.7±1.5) mm, the tail length was (12.9±0.4) mm, and the sexual ratio (male/female) was 1.0 (1227/1279). The external, visceral and skeletal variations were 0.2%, 0.5% and 7.4%, respectively. CONCLUSION: The background data on embryo-fetal toxicity studies of SD rats has been established, which can provide reference for reproductive toxicity research.
Résumé
OBJECTIVE To summarize the data on embryo-fetal developmental toxicity study of rabbits, and to establish the background data so as to provide reference for drug reproductive toxicology research. METHODS From the embryo-fetus developmental toxicity study of rabbits in our laboratory between 2011 and 2018, all the data on control groups was selected, including rabbits' pregnancy mass, outcomes of pregnancy (the average number of corpus lutea, implantation, live fetuses, fetal absorption rate, fetal live rate, fetal absorption rate), fetal growth and development (mass, crown-rump length and tail length) and fetal variation (appearance, viscera and skeleton). The mean and standard deviations of each index were calculated. RESULTS The embryo-fetal development indexes of 149 pregnant rabbits and 1097 fetuses were summarized. The gestational age of rabbits was about 3-5 months, and the body mass was (3.0±0.3) kg on gestation day 0 (GD0), and (3.5±0.4) kg on GD28. These rabbits were euthanized and cesarean section examination showed that the pregnancy rate was 85.6%, the average of corpus lutea number was 8.0±2.1, the average number of implantations was 7.6±2.1, the average number of live fetuses was 7.4±2.1, the live rate was 96.2%, the absorption rate was 1.9%, and the death rate was 1.8%. Among the fetal development indicators, fetal body mass was (33.4±5.0) g, placental weight was (4.0±0.8) g, crown-rump length was (86.3±5.9) mm, tail length was (11.3±0.8) mm, and sex ratio (male/female) was 1.0 (550/547). The rate of appearance variation (or malformation) was 0.18%, skeleton variation (or malformation) was 33.5%, and visceral variation (or malformation) was 0.09%. CONCLUSION The background data of the embryo-fetal developmental toxicity study of rabbits is established in our laboratory. The changes of each index are stable, and the spontaneous deformity rate of fetuses is low.
Résumé
In vivo Mammalian Bone Marrow Micronucleus Test is included in the standard battery genotoxicity testing,with great application prospects in medicine,public health,food and drug safety evaluation fields.Establishing standardized experimental methods and conditions in GLP condition and accumulating a certain range of background data could effectively ensure the reliability of the test system,and also provide strong basis to support the experimental data.We herein summarized the background data of mouse and rat bone marrow micronucleus tests performed from 2007 to 2015,to expound the standardized data collection method for rodent animal bone marrow micronucleus test.
Résumé
Objective To explore the growth and developmental parameters and behavioral characteristics of rhesus monkeys during the first year of birth and to establish the background data.Methods A total of 18 (♂=11,♀=7 ) infant rhesus monkeys born from individually caged mothers and with known genetic background and postnatal days were monitored monthly for body weight, body height, head circumference, chest circumference, forelimb length, hind limb length, crown-rump length, tail length and anal-genital distance from postnatal day ( PND) 1 to 360, while hematology, blood chemistry and lymphocyte subsets were examined on PND 28, 175 and 360, and finger maze test was carried out on PND 208.Results The body weight showed linear growth with no significant difference between genders (P>0.05). Except for the anal-genital distance of male infants was significantly greater than that of female infants ( P0.05).Compared with that at PND28, TP and BUN were significantly increased (P0.05) at PND 175 and 360.Compared with that at PND28, CD4 +and CD4 +/CD8 +were significantly decreased ( P<0.01) while CD8+significantly increased ( P<0.01) at PND175 and 360.The number of sessions to solve task 2 in learning test was significantly greater than other tasks with females significantly less than males ( P<0.05) .The females had higher correct rate than males in the 2-day random memory test (P<0.05).Conclusions Body weight and morphological parameters show a linear growth.The PND.The RBC, HGB, LYMPH, TP, BUN, ALP, CD4 +, CD8 +and CD4 +/CD8+in hematology, blood chemistry and lymphocyte subsets show relevant changes to the growth and development of organs and systems in infants, which should be highly concerned in drug evaluation.The finger maze test indicates that female infants have better reversal learning and long-term memory than male infants.Background data and behavioral characteristics of infant rhesus monkeys during the first 12 months of birth are established in this study, which provide useful reference and support the evaluation of developmental and reproductive toxicity of drugs in rhesus monkeys.