Registration Dossier
Registration Dossier
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EC number: 944-548-7 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The conducted in vitro mutagenicity testing on MI3, X14DesB30 and insulin aspart do not indicate any mutagenic or clastogenic potential of the substances. Due to very close structural similarity to insulin aspart ethyl ester 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
The conducted in vivo study on insulin aspart does not indicate any genotoxic/clastogenic potential of the substance. Due to very close structural similarity to insulin aspart ethyl ester 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
Based on a consistent pattern of negative test results in in vitro mutagenicity testing of the three read-across substances inuslin aspart, MI3 and X14DeB30 and negative results in in vivo testing of insulin aspart a lack of genotoxic potential can be concluded for insulin aspart ethyl ester as well. Thus, no classification for mutagenicity according to the CLP-criteria applies.
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