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Tapentadol

Summary

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.

Fass environmental information

Fass environmental information for Palexia (tapentadol) (downloaded 2019-04-25).

Hazard

Persistence: OECD Guideline 308 och bland annat "DT50 for the aerobic primary degradation of [14C]tapentadol in the water/sediment test systems ranged from 41 days to 126 days. [...] DT50 for the anaerobic primary degradation of [14C]tapentadol in the water/sediment test systems ranged from 51 days to 60 days." See additional data for OECD 308 in the environmental information for Palexia. "The phrase ‘Tapentadol is slowly degraded in the environment’ is chosen."

Bioaccumulation: "Log Kow for tapentadol is 2.89 ... which is below 4."

Toxicity: There are data for 3 trophic levels, most sensitive fish NOEC (Pimephales promelas) OECD 210 = 530 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.00077432 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm