Registration Dossier
Registration Dossier
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EC number: 944-552-9 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No data exists for the target substance (liraglutide precursor). The conducted in vitro mutagenicity testing on MI3 (S3), X14DesB30 (S4) and Liraglutide (S1) do not indicate any mutagenic or clastogenic potential of the substances. Due to very close structural similarity to Liraglutide precursor a lack of mutagenic and clastogenic potential in vitro can be concluded for this substance as well.
See read-across template and justification attached in section 13
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
No data exists for the target substance (liraglutide precursor).
The conducted in vivo study on Liraglutide (S1) does not indicate any genotoxic/clastogenic potential of the substance. Due to very close structural similarity to Liraglutide precursor a lack of genotoxic/ clastogenic potential in vivo can be concluded for this substance as well.
See read-across template and justification attached in section 13
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Overall, the conducted in vitro mutagenicity testing on MI3 and X14DesB30 and thein vitro studies and the in vivo study on liraglutide do not indicate any mutagenic or clastogenic potential of the substances. Due to the close structural similarity and similar physicochemical properties a lack of mutagenic and clastogenic potential can be concluded for liraglutide precursor as well.
Thus, no classification for mutagenicity according to the CLP-criteria applies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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