Amylase, gluco-

Respiratory sensitisation

Administrative data

Endpoint:

respiratory sensitisation, other

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

No animal models have been validated to test the ability of a protein to induce respiratory allergy. For enzyme protein respiratory allergens, a DMEL for workers and consumers has been summarised and discussed in literature (Basketter et al. 2010). The conclusion is drawn from a thorough review of existing occupational and consumer data on exposure by inhalation from the involved industrial partners in combination with medical data. As no valid animal models exist to test and rank respiratory sensitisers, the human surveillance data are the core of such evaluation. Any sub-categorisation based on relative potency is not feasible (Basketter et al. 2011). References: -Basketter DA, Broekhuizen C, Fieldsend M, Kirkwood S, Mascarenhas R, Maurer K, Pedersen C, Rodriguez C, Schiff HE (2010).Defining occupational and consumer exposure limits for enzyme protein respiratory allergens under REACH. Toxicology, 268(3):165-170. - Basketter DA, Kimber I. (2011). Assessing the potency of respiratory allergens: Uncertainties and challenges. Regul. Toxicol. Pharmacol., 61, 365-372.