Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

carcinogenicity, other
subcutaneous injections
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
The information has been assessed and approved by the European Medicines Agency

Data source

Reference Type:
other company data

Materials and methods

Principles of method if other than guideline:
Carcinogenicty data generated according to the requirement for approval of medicines i.e. 2-years carcinogenicity studies in rats and mice and an additional study in monkeys

Test material

Specific details on test material used for the study:
liraglutide (API)

Test animals

other: rats and mice and monkeys

Administration / exposure

Route of administration:

Results and discussion

Applicant's summary and conclusion

Thyroid C-cell tumours have been observed in carcinogenicity studies using subcurtaneosu administration of liraglutide to mice and rats caused by a GLP1 receptor-mediated mechanism. As rodents are shown to be particularly sensitive to this type of tumours and as monkeys did not develop these tumors the fndings are considered of limited relevance to humans.
When using a read-across approach to liraglutide precursor the data is not considered conslusive and not sufficient for a cancer classificatioon according to the CLP criteria.
Executive summary:

Non-lethal thyroid C-cell tumours were seen in 2 year carcinogenicity studies in rats and mice using subcutaneous administration. In rats, a no observed adverse effect level (NOAEL) was not observed. These tumours were not seen in monkeys treated for 20 months. These findings in rodents are caused by a nongenotoxic, specific GLP1 receptor-mediated mechanism to which rodents are particularly sensitive. The relevance for humans is likely to be low but cannot be completely excluded. No other treatment-related tumours have been found.