Hazard 4* P 3 B 0 T 1* Risk See below
The T-value in the PBT index refers to acute toxicity.
The data on hazard are based on previous environmental information on fass.se. Environmental information is missing on fass.se (2019-11-07). It is voluntary for manufacturers to provide information about environmental impact on fass.se.
Fass environmental information for Orudis (ketoprofen) from Sanofi AB (downloaded 2018-03-19).
Persistence: "Ready degradability: Test showed 0% degradation in 29 days (protocol: ISO9439). Ketoprofen fails to pass the ready degradation test according to OECD criteria, which justifies the phrase “Ketoprofen is potentially persistent.”"
Bioaccumulation: Log Kow = 1.65 at pH 7 (protocol: OECD
Acute toxicity: There is data for 1 trophic level, crustacean (Daphnia magna) > 97 000 microg/L.
Risk of environmental impact of ketoprofen cannot be excluded, since there is not sufficient ecotoxicity data available.
Ketoprofen has been detected in treated wastewater in Region Stockholm during 2012–2016.
Large margin between concentrations in the environment and the concentration that affects the environment from a Swedish perspective. However, ketoprofen appears to accumulate more in fish if exposure is effected through wastewater. The possibility is that the risk is underestimated.
Comparative assessment of environmental risk when using diclofenac, naproxen, ibuprofen, ketoprofen, etoricoxib, celecoxib and paracetamol from a Swedish perspective (Report Goodpoint 2019). From an environmental risk point of view, the exchange of diclofenac is recommended for any of the other investigated NSAIDs/analgesics. [...] Paracetamol is a very safe alternative from an environmental point of view. The others are also considered to pose low environmental risk, but slightly increased for ketoprofen. The risk factors for ketoprofen, naproxen, ibuprofen, celecoxib, etoricoxib and paracetamol are not considered so great that an exchange with another substance is recommended. Environmental measurements as well as efficacy studies of both celecoxib and etoricoxib are required."
Author: Health and Medical Care Administration, Region Stockholm