New approaches to the assessment of eye and skin irritation

Skin irritation: prevalence, variability, and regulatory classification of existing in vivo data from industrial chemicals

“…ScientiWc concerns about the variability (Gilman et al, 1978;Weil and Scala, 1971;Worth and Cronin, 2001) and predictive capacities of this animal test in terms of human health eVects (Calvin, 1992;Campbell and Bruce, 1981;Robinson et al, 2000) are raised regularly. In addition, animal welfare and more recently political pressure in Europe, e.g., chemicals and cosmetics legislation, decree the development of appropriate and validated alternative in vitro test methods (Hartung et al, 2003).…”

“…An international eVort has resulted in a harmonised classiWcation scheme for chemicals known as the Globally Harmonised System (GHS) including skin irritation, which is generally based on the Draize scores obtained in the traditional animal test (OECD, 2001;UN, 2003). Furthermore, testing strategies incorporating historical data, (quantitative) structure activity relationship ((Q)SAR) methods, in vitro and also in vivo tests, have been developed which should signiWcantly reduce or replace animal testing (Calvin, 1992;EC, 2004;Gerner and Schlede, 2002;OECD, 2002a;Robinson et al, 2002;UN, 2003). Hitherto however, only a limited technical literature is available, e.g., an approach modelling a strategy for skin corrosion (Worth et al, 1998) and an OECD review considering the GHS approach for skin irritation (OECD, 1999).…”

Humane Endpoints and Acute Toxicity Testing

“…Calvin (1992) discusses some of the modifications to skin testing procedures directed toward the 3 Rs. For certain materials, either the fuzzy rat or the hairless guinea pig may prove to be acceptable alternatives to the rabbit in dermal testing (replacement with animals deemed lower on the phylogenetic tree).…”

Assessment of dermal irritation potential of MWCNT

“…The Draize skin test has been regarded as the standard in vivo irritation model for acute cutaneous evaluations 6,7 . However, ethical concerns for using animal model and the necessity for more efficient and costeffective tests have developed alternative systems of assessing skin toxicity, and in particular, the human skin equivalent model (HSEM) is known to be a useful alternative model in terms of predicting irritation potentials 6,8 .…”