The Development of New Concepts for Assessing Reproductive Toxicity Applicable to Large Scale Toxicological Programmes

Abstract

Large scale toxicological testing programmes which are currently ongoing such as the new European chemical legislation REACH require the development of new integrated testing strategies rather than applying traditional testing schemes to thousands of chemicals. The current practice of requiring in vivo testing for every possible adverse effect endanger the success of these programmes due (i) to limited testing facilities and sufficient capacity of scientific/technical knowledge for reproductive toxicity; (ii) an unacceptable number of laboratory animals involved (iii) an intolerable number of chemicals classified as false positive. A key aspect of the implementation of new testing strategies is the determination of prevalence of reproductive toxicity in the universe of industrial chemicals. Prevalences are relevant in order to be aware on the expected rate of false classification during the toxicological testing and to implement appropriate measures for their avoidance. Furthermore, a detailed understanding on the subendpoints affected by reproductive toxicants and the underlying mechanisms will lead to more science based testing strategies integrating alternative methods without compromising the protection of consumers.

Immunotoxicology: challenges in the 21st century and in vitro opportunities

“…two decades ago, luster et al (1992) investigated the relationship aspect cannot be satisfied without the use of additional animal groups savings in animals and costs will be minimal compared to the two-generation study. It has to be recalled that this represents one of the largest animal consuming tests and a key burden of the ReACH program Rovida and Hartung, 2009;Bremer et al, 2007;Rovida et al, 2011).…”

Critical evaluation of the use of dogs in biomedical research and testing in Europe

“…In europe there is the Council of europe Convention etS 123 and european Community Directive 2010/63/eU, which will be enacted on January 1, 2013, and more internationally there are the Organization for economic Co-operation and Development (OeCD), (Bremer et al, 2007). this is already assessed in general toxicity repeat-dose studies and is easier to model in vitro than the whole reproductive cycle.…”

How are reproductive toxicity and developmental toxicity addressed in REACH dossiers?

“…This is not what we see in the database of the US EPA for 2,000 HPV substances, where very little test information for reproductive toxicity is available (Bremer et al, 2007). Thus it appears that studies of lesser relevance have now been brought forward, but this cannot be confirmed at this stage.…”