Designation of substances as skin sensitizing chemicals: a reply

Abstract

Sir -A recent commentary in this journal1 addressed the rationale behind the classification and subsequent designation of substances as skin sensitizing chemicals proposed by the 'MAK Commission't of the Deutsche Forschungsgemeinschaft.2 Although appreciating the standardization effort, Kimber et a]. disagree with a number of criteria the MAK Commission employs in the classification process and propose an alternative algorithm. We assume that the apparently different approaches of Kimber et a]. and our group are due to a * different scope and context of classification and subsequently a * different understanding of the terms 'designation'and 'evidence'.

Classification of dermal sensitizers in pharmaceutical manufacturing

“…In context with the quantitative aspect of risk assessment for skin sensitizers, the same authors stated in 2005 that ''until quantitative data on potency and exposure become a formal part of the classification and regulation process, which is clearly an important aim, the surrogate of clinical experience and expert judgment should not be disregarded'' (Schnuch et al, 2005). Finally, the DFG-MAK commission states that ''it is still not possible to determine (and document scientifically) generally applicable threshold concentrations either for the induction of an allergy (sensitization) or for triggering the allergic reaction (elicitation) in an already sensitized person'' (DFG, 2014;page 182).…”

Clinical update on contact allergy

“…As a novel screening method, the analysis of genes pertaining to dendritic cell maturation has been proposed [65 ], but not yet evaluated on a larger scale. In spite of these advances, however, human data will remain the 'gold standard' for regulatory decisions [66].…”

The critical review of methodologies and approaches to assess the inherent skin sensitization potential (skin allergies) of chemicals Part II

“…In order to make the procedure of classification of substances in the List of MAK and BAT Values (i) more rational, (ii) more consistent, (iii) more comprehensible, and also (iv) more transparent for outsiders, criteria for the designation of a substance with 'Sh' and 'Sa' have been elaborated, published, and discussed (110)(111)(112). The working group considered it necessary to differentiate between (1) the quality of the evidence for allergenicity of a substance (resulting in graded levels of evidence sufficient or not sufficient for designation) and (2) the algorithm used to decide whether or not a substance is designated as an allergen.…”

“…In order to make the procedure of classification of substances in the List of MAK and BAT Values (i) more rational, (ii) more consistent, (iii) more comprehensible, and also (iv) more transparent for outsiders, criteria for the designation of a substance with ‘Sh’ and ‘Sa’ have been elaborated, published, and discussed (110–112). The working group considered it necessary to differentiate between…”