Registration Dossier
Registration Dossier
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EC number: 235-747-3 | CAS number: 12650-88-3
Endpoint summary
Administrative data
Description of key information
Not expected to be skin/eye/respiratory irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are substantial in vivo animal data on all industrially applied enzyme classes, as well as in vitro data performed before formal validation, for both skin and eye irritancy.
These data document that enzymes are not irritating, with the exception of proteases. Non-proteases lack the potential to be skin and eye irritants but proteases show a range of effects from no irritation to moderate irritation. It is, however, only the most concentrated and reactive samples which show an effect which is transient in nature and commonly is classified as mild irritation [1 and 2]; in-house industrial data]. This is also the outcome of clinical investigations [3 -5], confirming that enzymes at the product use concentration, even with exaggerated exposures, do not give rise to any occupational or consumer risk of skin or eye irritation.
Given the above, ‘in vitro’ irritation testing is not considered to add any scientific value nor lead to a change in the classification adopted from existing data (in-house industrial data).
Reference
[1] AMFEP. Amfep paper on safety evaluation of technical enzyme products with regards to the REACH legislation. 2009. AMFEP.
[2] HERA Human and environmental risk assessment on ingredients of household cleaning products - alpha-amylases, cellulases and lipases. 2005.
[3] 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, 1177-1181
[4] Griffith, J.F., Weaver, J.E., Whitehouse, H.S., Poole, R.L., and Newmann EA Nixon, G.A. (1969) SAFETY EVALUATION OF ENZYME DETERGENTS ORAL AND CUTANEOUS TOXICITY IRRITANCY AND SKIN SENSITIZATION STUDIES. Food and Cosmetics Toxicology 7, 581-593
[5] White, I.R., Lewis, J., and el, A.A. (1985) Possible adverse reactions to an enzyme-containing washing powder. Contact Dermatitis 13, 175-179
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Lysozyme is not classified for skin/eye/respiratory irritation.
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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