Historical control data on prenatal developmental toxicity studies in rabbits

Abstract

Historical control data on rabbit prenatal developmental toxicity studies, performed between 1994-2010, were obtained from 20 laboratories, including 11 pharmaceutical and chemical companies and nine contract laboratories, in Japan. In this paper, data were incorporated from a laboratory if the information was based on 10 studies or more. Japanese White rabbits and New Zealand White rabbits were used for prenatal developmental toxicity studies. The data included maternal reproductive findings at terminal cesarean sections and fetal findings including spontaneous incidences of morphological alterations. No noticeable differences between strains or laboratories were observed in the maternal reproductive and fetal developmental data. The inter-laboratory variations in the incidences of fetal external, visceral, and skeletal alterations seem to be due to differences in the selection of observation parameters, observation criteria, and classification of the findings, and terminology of fetal alterations.

Toxicity of graphene-family nanoparticles: a general review of the origins and mechanisms

“…Second, different observational criteria, parameters and selection of experimental methods might induce large inter-laboratory variations [220, 221]. For example, the MTT assay always fails to accurately predict graphene toxicity because the spontaneous reduction results in a false positive signal.…”

Using zebrafish in systems toxicology for developmental toxicity testing

“…Traditional toxicity testing requires data collection on one chemical at a time using common laboratory animal species, such as rat or rabbit (Ema et al. , ). Developing a new drug requires a large number of rodents for a teratogenicity safety assessment.…”

“…According to international regulatory guidelines, each drug in development for administration to women of childbearing potential must be tested for developmental toxicity in rodent and non-rodent species (ICH 2005;ICH 2015). Traditional toxicity testing requires data collection on one chemical at a time using common laboratory animal species, such as rat or rabbit (Ema et al 2012(Ema et al , 2014. Developing a new drug requires a large number of rodents for a teratogenicity safety assessment.…”

Historical control data on developmental toxicity studies in rodents

“…We previously reported historical control data between 1994 and 2010 for developmental toxicity studies of rabbits (Ema et al. ). Recent historical control data for rodents between 1994 and 2010 were collected and summarized in this paper.…”

“…Therefore, examining changes in data over time within historical control data and comparing study control data with recent as well as cumulative historical control data are of importance. We previously reported historical control data between 1994 and 2010 for developmental toxicity studies of rabbits (Ema et al 2012). Recent historical control data for rodents between 1994 and 2010 were collected and summarized in this paper.…”