Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
There are substantial in vivo animal data on all industrially applied enzyme classes, as well as in vitro data performed before formal validation, for skin irritancy. These data document that enzymes are not irritating, with the exception of proteases. Transaminase is not a protease. Non-proteases lack the potential to be skin 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. This is also the outcome of clinical investigations, confirming that enzymes at the product use concentration, even with exaggerated exposures, do not give rise to any occupational or consumer risk of skin 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).*
*Enzymes REACH Consortium, ERC Data waiving argumentation for technical enzymes

Justification for selection of eye irritation endpoint:
There are substantial in vivo animal data on all industrially applied enzyme classes, as well as in vitro data performed before formal validation, for eye irritancy. These data document that enzymes are not irritating, with the exception of proteases. Transaminase is not a protease. Non-proteases lack the potential to be 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. This is also the outcome of clinical investigations, confirming that enzymes at the product use concentration, even with exaggerated exposures, do not give rise to any occupational or consumer risk of 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).*
*Enzymes REACH Consortium, ERC Data waiving argumentation for technical enzymes

Justification for classification or non-classification