Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

respiratory sensitisation, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion