Registration Dossier

Administrative data

Description of key information

No data is available for Liraglutide precursor.

Data from OECD 404 guideline studies on MI3 (S3) and X14DesB30 (S4) indicate no potential for skin irritation. Due to very close structural similarity to Liraglutide precursor, a lack of skin irritation potential can be concluded for Liraglutide precursor as well.

Data from OECD 405 guideline studies on MI3 (S3) and X14DesB30 (S4) indicate no potential for eye irritation. Due to very close structural similarity to Liraglutide precursor, a lack of eye irritation potential can be concluded for Liraglutide precursor as 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

Based on read-across from in vivo data on MI3 (S3) and X13DesB30 (S4) Liraglutide precursor is not considered to be a skin or eye irritant. Thus, no CLP-classification should apply for skin and eye irritation of the substance.