In Europe, the developmental toxicity testing (including teratogenicity) of new cosmetic ingredients is performed according to the Cosmetics Directive 76/768/EEC: only alternatives leading to full replacement of animal experiments should be used. This chapter presents the th ...
Preventative and therapeutic vaccines are increasingly used during pregnancy and present special considerations for developmental toxicity testing. The various components of the vaccine formulation (i.e., protein or polysaccharide antigen, adjuvants, and excipients) ...
The developmental and reproductive toxicity testing (including teratogenicity) of new foods and food additives is performed worldwide according to the guidelines given in the FDA Redbook. These studies are not required for substances that are generally recognized as safe, accord ...
REACH guidelines may require teratology testing for new and existing chemicals. This chapter discusses procedures to assess the need for teratology testing and the conduct and interpretation of teratology tests where required.
In many countries the process of toxicity testing of environmental chemicals is ruled by a framework of OECD guidelines. The present paper will give an overview over the relevant OECD guidelines and guidance documents and mainly focus on methodological issues related to the prenatal toxi ...
The characteristics of biologic drugs, as compared with small molecules, confer significant advantages for both the drug developer and the prospective patients. The necessity for, and the timing of, developmental toxicity testing in the preclinical program must be considered. Choi ...
It is close to 60 years since thalidomide was created by the German company, Chemie-Gr�nenthal, and launched as “Contergan.” This was soon to be followed in England by the launch of “Distaval.” Of all the drugs developed in the intervening years, thalidomide has undoubtedly had the greatest influe ...
Human health risk assessment for pesticides is based mainly on animal studies submitted by the applicant and aims to determine safe exposure levels for operators (farmers and agricultural workers) and consumers of all age groups. Critical effects, including those resulting from repr ...
In 2007, a new European chemicals legislation was implemented: Regulation (EC) No. 1907/2006, also known as “REACH.” It obliges companies to take the main responsibility for the valid information on the safe use of the chemicals they manufacture and/or place on the European market. So they must, for ...
This chapter outlines a regulator’s personal approach to the assessment of reproductive toxicology data in the context of the assessment of the overall nonclinical data package for pharmaceutical agents. Using as a framework the International Conference on Harmonisation Common T ...
The current political and societal climate is driving the science of toxicology towards developing non-animal testing methodologies. Though alternative and in vitro tests have always been a mainstay for toxicological testing, technological advances in the last decade have allo ...
The emergence of toxicogenomic applications provides new tools to characterize, classify, and potentially predict teratogens. However, due to the vast number of experimental and statistical procedural steps, toxicogenomic studies are challenging. Here, we guide researche ...
The rat whole embryo culture (WEC) system has been used extensively for characterizing teratogenic properties of test chemicals. In this chapter, we describe the methodology for culturing rat embryos as well as a new morphological score system, the Dysmorphology Score (DMS) system for as ...
India and China have booming chemical, agrochemical, and pharmaceutical industries. Both countries also represent expanding markets for foreign chemical and healthcare companies. All such products require reproductive toxicity testing before marketing. The ICH testing g ...
Frog embryo teratogenesis assay on Xenopus (FETAX) has been routinely used in our laboratory for the last 12 years as a routine developmental toxicity screening test for pharmaceutical candidate compounds. To date, out of more than 400 candidates tested in FETAX, around 60 have also been evalu ...
As a model for teratogenicity research, zebrafish are gaining popularity and creditability. Zebrafish embryos have been proven to be a highly valuable tool in genetics and developmental biology research and have advanced our understanding of a number of known developmental toxican ...
The embryonic stem cell test is an animal-free alternative test method for developmental toxicity. Mouse embryonic stem cells are cultured in a hanging drop method to form embryoid bodies. These embryoid bodies, when plated on tissue culture dishes, differentiate to form contracting my ...
Understanding the potential health risks posed by environmental chemicals is a significant challenge elevated by the large number of diverse chemicals with generally uncharacterized exposures, mechanisms, and toxicities. The ToxCast computational toxicology research ...
Toxicological hazard assessment currently finds itself at a crossroads where the existing classical test paradigm is challenged by a host of innovative approaches. Animal study protocols are being enhanced for additional parameters and improved for more efficient effect asses ...
Although demonstration of some degree of maternal toxicity is required in regulatory developmental toxicology studies, marked maternal toxicity may be a confounding factor in data interpretation. Reduction in maternal body weight gain is the far most frequently used endpoint of to ...
