Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Enzymes are well documented not to be skin sensitisers in humans. Therefore, it can be concluded that enzymes should not be classified as skin sensitisers according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
From occupational data it is well known that active enzymes regardless of the catalytic activities are potential respiratory sensitisers. However, decades of experience have shown that enzymes can be used safely by ensuring that exposure is limited, supported by DMEL for workers and consumers.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The skin sensitisation potential of enzymes has been reviewed in several publications indicating that enzymes should not be considered skin sensitisers [1-5; 11, 12]. In addition, there is an unequivocal statement from AMFEP (www.amfep.org) on this topic indicating that enzymes do not have skin sensitising potential. The lack of skin sensitising potential is substantiated by evidence from robust human experimental data and extensive in-use human studies performed with detergents containing enzymes [6-10; 12-17]. Together, these studies confirm that the presence of enzymes in the detergents does not result in Allergic Contact Dermatitis, including those conducted with atopic individuals.
After review of the available evidence, it can be concluded that enzymes should not be classified as skin sensitizers according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
References
1) Association Internationale de la Savonnerie et de la Detergence (AISE)/AMFEP. (1995). Enzymes: Lack of skin sensitisation potential.
2) Basketter DA, English JS, Wakelin SH, White IR (2008). Enzymes, detergents and skin: facts and fantasies. Br. J. Dermatol., 158 (6):1177-1181.
3) Basketter D, Berg N, Broekhuizen C, Fieldsend M, Kirkwood S, Kluin C, Mathieu S, Rodriguez C (2012a). Enzymes in Cleaning Products: An Overview of Toxicological Properties and Risk Assessment/Management. Regul. Toxicol. Pharmacol., 64(1):117-123.
4) HERA. Human and environmental risk assessment on ingredients of household cleaning products -alpha-amylases, cellulases and lipases. Edition 1.0. November 2005.
5) HERA. Human and environmental risk assessment on ingredients of household cleaning products - Subtilisins (Proteases). Edition 2.0. February 2007.
6) Bannan EA, Griffith JF, Nusair TL, Sauers JL, Jackson EM. (1992). Skin testing of laundered fabrics in the dermal safety assessment of enzyme containing detergents. J. of Toxicol. – Cutan. Ocul. Toxicol. 11(4):327-339.
7) Griffith JF, Weaver JE, Whitehouse HS, Poole RL, Newmann EA, Nixon GA. (1969). Safety Evaluation of Enzyme Detergents Oral and Cutaneous Toxicity, Irritancy and Skin Sensitization Studies. Food Cosmet. Toxicol., 7(6):581-593.
8) Rodriguez C, Calvin G, Lally C, LaChapelle JM. (1994). Skin effects associated with wearing fabrics washed with commercial laundry detergents. J. of Toxicol. – Cutan. Ocul. Toxicol., 13(1):39-45.
9) Cormier EM, Sarlo K, Scott LA, MacKenzie DP, Payne NS, Carr GJ, Smith LA, Cua-Lim F, Bunag FC, Vasunia K. (2004). Lack of type 1 sensitization to laundry detergent enzymes among consumers in the Philippines: results of a 2-year study in atopic subjects. Ann. Allergy Asthma Immunol., 92(5):549-557.
10) White IR, Lewis J, el Alami A. (1985). Possible adverse reactions to an enzyme-containing washing powder. Contact Dermatitis, 13(3):175-179.
11) Basketter D, Berg N, Kruszewski FH, Sarlo K, Concoby B (2012b). The Toxicology and Immunology of Detergent Enzymes. J. Immunotoxicol., 9(3):320-326.
12) Andersen PH, Bindslev-Jensen C, Mosbech H, Zachariae H, Andersen KE. (1998). Skin symptoms in patients with atopic dermatitis using enzyme-containing detergents. A placebo-controlled study. Acta Derm. Venereol., 78(1):60-62.
13) Belsito DV, Fransway AF, Fowler JF Jr, Sherertz EF, Maibach HI, Mark JG Jr, Mathias CG, Rietschel RL, Storrs FJ, Nethercott JR. (2002). Allergic contact dermatitis to detergents: a multicenter study to assess prevalence. J. Am. Acad. Dermatol., 46(2):200-206.
14) Lee MY, Park KS, Hayashi C, Lim HH, Lee KH, Kwak I, Laurie RD. (2002). Effects of repeated short-term skin contact with proteolytic enzymes. Contact Dermatitis, 46(2):75-80.
15) Pepys J, Wells ID, D'Souza MF, Greenberg M. (1973). Clinical and Immunological Responses to Enzymes of Bacillus Subtilis in Factory Workers and Consumers. Clin. Allergy, 3(2):143-160.
16) Peters G, Johnson GQ, Golembiewski A. (2001). Safe use of detergent enzymes in the workplace. Appl. Occup. Environ. Hyg., 16(3):389-395.
17) Zachariae H, Thomsen K, Rasmussen OG. (1973). Occupational enzyme dermatitis. Results of patch testing with Alcalase. Acta Derm. Venereol., 53(2):145-148.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
From occupational data it is well known that active enzymes regardless of the catalytic activities are potential respiratory sensitisers. All enzymes must therefore be classified as respiratory sensitisers, “H334: Hazard Category 1: May cause allergy or asthma symptoms or breathing difficulties if inhaled” in accordance with the CLP Regulation.
For enzyme protein respiratory allergens, a DMEL for workers and consumers has been summarized 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 sensitizers, 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.
Justification for classification or non-classification
Beta-mannosidase should not be classified as a skin sensitiser.
Beta-mannosidase is classified as a respiratory sensitiser.
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.
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