Registration Dossier

Administrative data

Description of key information

No data is available for Liraglutide precursor.

In a 4 week inhalation study female and male rats were subjected to 0.5 h of daily inhalation exposure to Semaglutide aerosols in the concentration range of 50.7 up to 920 mg/m3. There were no adverse effects of treatment. Based on the highest concentration tested which did not cause any adverse effects, the No Observed Adverse Effect Concentration (NOAEC) for Semaglutide (S2) was 920 mg/m3, although slight reductions in liver and heart weight was noted .Due to very close structural similarity to Liraglutide precursor a NOAEC of 920 mg/m3can be concluded for this substance as well.

See read-across template and justification attached in section 13

 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
920 mg/m³
Study duration:
subchronic
Species:
monkey
System:
other: Mortality
Organ:
not specified

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

In a 4 week inhalation study female and male rats were subjected to 0.5 h of daily inhalation exposure to Semaglutide aerosols in the concentration range of 50.7 up to 920 mg/m3.

There were no adverse effects of treatment. Based on the highest concentration tested which did not cause any adverse effects, the No Observed Adverse Effect Concentration (NOAEC) for Semaglutide (S2) was 920 mg/m3, although slight reductions in liver and heart weight was noted. Due to very close structural similarity to Liraglutide precursor a NOAEC of 920 mg/m3can be concluded for this substance as well.

Based on read-across and evidence that indicte that the Liraglutide precusor does not induce adverse effects, thus, the Liraglutide precusor should not be classified with STOT RE according to the CLP-criteria.