Registration Dossier

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 expericence 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

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (LLNA)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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

Catalase should not be classified as a skin sensitiser.

Catalase is classified as a respiratory sensitiser.