Registration Dossier
Registration Dossier
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EC number: 944-552-9 | CAS number: -
Endpoint summary
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.
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