Hazard 4 P 3 B 0 T 1 Risk Insignificant
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from Fass.
Below are assessment reports for Januvia (sitagliptin).
Persistence: "Sitagliptin is not readily biodegradable. The MAH (Marketing Authorisation Holder, ed. note.) submitted the results of a test on the aerobic and anaerobic transformation in aquatic sediment systems according to OECD 308. According to these results the submission of a sediment toxicity test deemed necessary. The MAH provided the results of a sediment toxicity test according OECD 218." (Assessment report 29 July 2009, EMEA/517697/2009.)
Bioaccumulation: Log Kow = - 0,25 vid pH 7. "Citation, study report is missing." (Assessment report 02 June 2009
Doc. Ref: EMEA/363653/2009.)
Toxicity: There are data for 2 trophic levels, most sensitive fish (Pimephales promelas) NOEC 9.2 mg/L. "The MAH has committed to perform and submit the results of an algae growth inhibition test (OECD 201) by July 2009." (Assessment report 02 June 2009 Doc. Ref: EMEA/363653/2009.) "The MAH has submitted in July 2009 the requested new algal study pursuant to the latest OECD 201. The CHMP concluded that the test was valid and that the risk to the surface water of sitagliptin can be assumed to be negligible." (Assessment report september 2009, Doc. Ref: EMEA/777097/2009)
"The comparison of the predicted concentration in surface water with the predicted no effect concentration did not result in risk quotients above 1 (for algae, fish and water flea) or 0.1 (for micro-organisms)." (Assessment report 29 July 2009, EMEA/517697/2009.)
Fass environmental information
Fass environmental information for Januvia from MSD (downloaded 2019-10-15).
Persistence: "Biotic degradation: Test results 7 % degradation in 28 days (OECD 302B). Test results 75% elimination (loss of parent) at Day 28, 40% evolved as CO2. DT50 for loss of parent = 21.1 hours; DT50 for CO2 production = 108 days. (OECD 314).
Abiotic degradation: Hydrolysis: No significant degradation (Half life = 895 days at pH 7) (OECD 111).
Photolysis: No potential for phototransformation between 295 and 800 nm (OECD 316).
"The phrase “Sitagliptin is potentially persistent in the environment” was thus chosen."
Bioaccumulation: Log Kow = -0.03 at pH 7 (OECD 107).
Toxicity: There are data for 3 trophic levels, most sensitive algae (Pseudokirchneriella subcapitata) NOEC 840 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.002 which gives the risk insignificant.
- European Medicines Agency. European public assessment report (EPAR). Januvia (sitagliptin) 02 June 2009, Doc. Ref: EMEA/363653/2009.
- European Medicines Agency. European public assessment report (EPAR). Januvia (sitagliptin) 29 July 2009, EMEA/517697/2009.
- European Medicines Agency. European public assessment report (EPAR). Januvia (sitagliptin) 11 September 2009, Doc. Ref: EMEA/777097/2009.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm