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EC number: 232-565-6
CAS number: 9000-90-2
The ability of enzymes to elicit respiratory sensitization is well known and the classification of enzymes as respiratory sensitizers is widely accepted. However, when exposure is controlled and limited, experience demonstrates that enzymes can be used safely.
ability of enzymes to elicit respiratory sensitisation is well known.
Occupational surveillance programs have identified occupational enzyme
allergy cases, however, mostly resulting from exposure to dusty enzymes
prior to modern advancements in product formulation (encapsulation) and
industrial hygiene (ref. 1).
enzymes, it is also well known that the sensitizing dose level is lower
than the dose that elicits symptoms (ref. 2). This means that a dose
level which does not sensitise the exposed people will not elicit any
allergy-related clinical reactions in already sensitized individuals.
From the studies of consumer exposure it is possible to identify
exposure levels to enzymes that do not lead to sensitisation. The
exposure that leads to sensitisation in the occupational setting is an
unknown combination of exposure level, exposure duration, exposure
interval (i.e. frequency) and individual susceptibility (ref. 1). For
the occupational exposure, a derived minimal effect level (DMEL) of 60
ng/m3 has been provided (ref. 1). For consumers, a DMEL of 15 ng/m3 has
been proposed (ref. 1). Application of the two effect levels has been
shown to lead to safe occupational environment and safe consumer use of
enzymes (ref. 1, 2).
Basketter D.A., C. Broekhuizen, M. Fieldsend, S. Kirkwood, R.
Mascarenhas, K. Maurer, C. Pedersen, C. Rodriguez, and H.E. Schiff,
2010. Defining occupational and consumer exposure limits for enzyme
protein respiratory allergens under REACH. Toxicology , 268:165–170.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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