A recent special issue of Regulatory Toxicology and Pharmacology is devoted to QRAs in relation to skin sensitizers, and how these methods can be used in the safety assessment of fragrance ingredients. As explained in the introduction to the issue, QRA methodology is considered “scientifically defensible” by the US Research Institute for Fragrance Materials (RIFM) Expert Panel, and has now been adopted as the core strategy for the primary prevention of dermal sensitization to fragrance materials in consumer products (Api A.M. and Vey M., Regulatory Toxicology and Pharmacology 2008, 52,1; http://dx.doi.org/10.1016/j.yrtph.2008.08.016) {180384}. Among the papers included in the issue is a review on dose metrics in skin sensitization that concluded that “under most normal conditions of exposure it is the dose per unit area of chemical that has over-riding impact on the effectiveness of sensitization”…the exception being where the application area drops below a certain critical level (Kimber I. et al., ibid. 2008, 52, 39; http://dx.doi.org/10.1016/j.yrtph.2008.01.010) {180364}. Another paper featured describes a review of the dermal sensitization data from human and animal studies on the common fragrance citral. This included both published data and unpublished reports from RIFM’s toxicologic database and determined that, based on a weight of evidence approach, the human No-Observed-Effect Level for the induction of dermal sensitization to citral was 1400 μg/cm2 (Lalko J. and Api A.M., ibid. 2008, 52, 62; http://dx.doi.org/10.1016/j.yrtph.2008.01.006) {180341}.

The above item was taken from the February 2009 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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