Registration Dossier

Administrative data

Description of key information

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 depth by Basketter et al. 2008 and in other publications (Anderson, 1998, Basketter, 2012b and HERA, 2007) revealing that enzymes should not be considered skin sensitisers. In addition, there is an unequivocal statement from the trade organization of enzyme manufacturers AMFEP (www.amfep.org) on this topic showing 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 (Anderson, 1998, Bannan, 1983 and Rodriquez, 1994). All of these studies including those conducted with atopic individuals confirmed that the presence of enzymes in the detergents did not result in contact skin sensitisation.

References:

1) Basketter, D.A., English,J.S., Wakelin,S.H., and White,I.R. (2008) Enzymes, detergents and skin: facts and fantasies. British journal of dermatology 158, 1177-118

2) Basketter, D., Berg, N., Kruszewski F.H., Sarlo, K., and Concoby, B. (2012) The toxicology and immunology of detergent enzymes. J Immunotoxicology, early online: 1-7

3) HERA (2007) Human and environmental risk assessment on ingredients of household cleaning products - subtilisins (protease).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
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 a recent publication (Ref. 1). 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 is the core of such evaluation. Any sub-categorization based on relative potency is not feasible (Ref. 2).

References

1.Basketter DA, Broekhuizen C, Fieldsend M, Kirkwood S, Mascarenhas R, Maurer K, Pedersen C, Rodriguez C, Schiff HE: Defining occupational and consumer exposure limits for enzyme protein respiratory allergens under REACH. Toxicology. 268:165-170, 2010.

2. Basketter D.A., Kimber I. (2011) Assessing the potency of respiratory allergens: Uncertainties and challenges. Regul. Toxicol. Pharmacol., 61, 365-372.

Justification for classification or non-classification

Due to its enzymatic properties, thermomycolin (CAS 52233-31-5) is not regarded as skin sensitiser. Thermomycolin is however classified as a respirtory sensitiser. H334: Hazard Category 1: May cause allergy or asthma symptoms or breathing difficulties if inhaled