Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-577-1 | CAS number: 9001-05-2
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 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
- 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:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation, other
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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.
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.
