Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Data from OECD 406 guideline studies on MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin Human methylester, a lack of skin sensitising potential can be concluded for Insulin Human methylester as well.

See further read-across justification in document attacthed in section 13.

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Data from OECD 406 guideline studies on MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin Human methylester, a lack of skin sensitising potential can be concluded for Insulin Human methylester as well.

Thus, Insulin Human methylester is not to be classificied as skin sensitiser according to the CLP-criteria.