Registration Dossier
Registration Dossier
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EC number: 944-549-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Data on fertility and development is only available on the active pharmaceutical ingredient insulin aspart in connection with subcutaneous injections. The effects seen in relation to maternal toxicity, fertility and development are overall considered as a consequence of the hypoglycaemic mode of action of the substance and as secondary effects of the maternal toxicity.
Insulin aspart precusor is due to its spatial molecular structure not able to bind to the insulin receptor and thus will not induce hypoglycaemia.
Thus, the effects seen from subcutaneous injection of insulin aspart is not likely to occur in relation to oral, dermal or inhalational exposure to insulin aspart precusor.
Effects on developmental toxicity
Description of key information
Data on fertility and development is only available on the active pharmaceutical ingredient insulin aspart in connection with subcutaneous injections. The effects seen in relation to maternal toxicity, fertility and development are overall considered as a consequence of the hypoglycaemic mode of action of the substance and as secondary effects of the maternal toxicity.
Insulin aspart precusor is due to its spatial molecular structure not able to bind to the insulin receptor and thus will not induce hypoglycaemia.
Thus, the effects seen from subcutaneous injection of insulin aspart is not likely to occur in relation to oral, dermal or inhalational exposure to insulin aspart precusor.
Justification for classification or non-classification
Based on weight of evidence Insulin aspart precusor is not to be classified for reproductive toxicity according to the CLP-criteria.
Additional information
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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