Hazard 3 P 3 B 0 T 1 Risk Insignificant
The T-value in the score for hazard refers to acute toxicity. Underlying data for P, B, T and risk are from Fass environmental information for Rocephalin med lidokain.
Fass environmental information for lidocaine from Rocephalin med lidokain (ceftriaxone, lidocaine), Roche (downloaded 2019-07-08).
Persistence: "Degradation in surface water t½ = 92 d (laboratory, 23 °C, in the dark), t½ = 110 d (field, 2–28 °C, in the dark). Abiotic Degradation: Photodegradation: t½ = 0.4 d (laboratory, light), t½ = 1.3 d (field, light). Lidocaine is neither readily, nor inherently biodegradable. This justifies the phrase 'Lidocaine is potentially persistent.'"
Bioaccumulation: "logPOW 1.66 QSAR; logPOW 2.44 method unknown; logDOW 1.63 (pH 7.4, 25 °C); logDOW 1.66 (phosphate buffer, pH 7.4, 25 °C); KOC ≤420 QSAR; BCF <20 QSAR. Lidocaine has low potential for bioaccumulation (log DOW <4 at pH 7.4)."
Acute toxicity: There are data for 3 trophic levels, most sensitive fish (Danio rerio) LC50 24 h (mortality) = 23 mg/L (OECD 236, adapted).
PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.014 which gives the risk insignificant.
Fass environmental information for lidocaine from Doloproct (fluocortolone pivalate, lidocaine) from Bayer (downloaded 2019-07-08).
Persistence: No data.
Bioaccumulation: "Log DOW = 1.57; calculated according to ACD/Labs’ ACD/PhysChem Suite lidocainhydrochloride has a low potential for bioaccumulation."
Acute toxicity: There is data for 1 trophic level, crustacean (Daphnia magna) 32 mg/L.
Risk of environmental impact of lidokainhydrochloride cannot be excluded, since there is not sufficient ecotoxicity data available.
The various pharmaceutical companies document environmental effects for their pharmaceuticals with the guidance of “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The independent party, the Swedish Environmental Research Institute (IVL), reviews the information but does not have the task of coordinating/harmonizing environmental information from various pharmaceutical companies for the same active substance.
Author: Health and Medical Care Administration, Region Stockholm