Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Data from OECD 404 guideline studies on MI3 and X14DesB30 indicate no potential for skin irritation. Due to very close structural similarity to Insulin Human methylester, a lack of skin irritation potential can be concluded for Insulin Human methylester as well.

Data from OECD 405 guideline studies on MI3 and X14DesB30 indicate no potential for eye irritation. Due to very close structural similarity to Insulin Huma methylester, a lack of eye irritation potential can be concluded for Insulin Human methylesteras well.

For further read-across justification see docoment attached to section 13.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Insulin Human methylester is based on read-across from in vivo data on MI3 and X13DesB30 not considered to be a skin or eye irritant. Thus, no CLP-classification should apply for skin and eye irritation of the substance.