Gemcitabine

Detailed information

Comment on Fass environmental information

Gemcitabine has different classifications on fass.se. According to Lif (the trade association for the research-based pharmaceutical industry in Sweden) the various pharmaceutical companies compile environmental information for their active substances based on internal studies and published data. Based on data, which may thus differ between different pharmaceutical companies, the companies assess the environmental risk with guidance from “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The Swedish Environmental Institute (IVL) reviews the assessment but does not have the task of coordinating/harmonizing environmental information from different pharmaceutical companies for the same active substance.

Fass environmental information Gemcitabine Accord

Fass environmental information for Gemcitabine Accord (retrieved on 2025-07-07).

Hazard

Persistence: Gemcitabine shows 45 % degradation in 40 days in the ready biodegradability test (OECD 301D) and 50 % degradation in 40 days in the inherent biodegradability test (OECD 302B). As the substance does not meet the criteria for either ready or inherent degradability, the phrase “Gemcitabine is potentially persistent.” is used.

Bioaccumulation: Log P_ow = -1,5 at 7 (predicted value by ChemAxon).

Chronic toxicity: There are data for 2 trophic levels, most sensitive crustacean (Daphnia magna) LOEC > 1 000 microg/L. Comment: A rough estimate of the NOEC is LOEC/2, i.e. > 500 µg/L. Values reported as greater than are not in accordance with the guidelines. The actual value may be lower.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.0003, indicating insignificant risk. If calculated from the NOEC as described above: PEC/PNEC = 0.00055, which also indicates insignificant risk.

Fass environmental information Gemkabi

Fass environmental information for Gemkabi (gemcitabin) from Fresenius Kabi (retrieved on 2025-07-07).

Hazard

Persistence: Gemcitabine has been evaluated in several degradation studies. According to the FDA 3.11 test, the substance is classified as not readily biodegradable, with 70 % of the parent compound remaining after 28 days. In the OECD 301D test, 42 % degradation was observed after 28 days, which does not meet the criteria for ready biodegradability. In the OECD 302B test, 45 % degradation was observed after 4 days and 50 % at the end of the test (28 days), indicating that the substance is not inherently biodegradable either. The biological degradation half-life (DT₅₀) was estimated at 0.0049 days based on five cycles of two-day activated sludge incubation. For hydrolysis, the DT₅₀ was 0.28 days in the dark at 22 °C, although the pH was not reported. Since gemcitabine does not meet the criteria for biodegradability and no simulation studies or analytical monitoring data are available to demonstrate elimination within ECHA’s persistence half-life thresholds, the phrase “Gemcitabine is potentially persistent.” is used.

Bioaccumulation: Log P = 0.14, BCF = 3.

Acute toxicity: There are data for 2 trophic levels, most sensitive algae (Desmodesmus subspicatus) LOEC 10000 microg/L. Comment: A rough estimate of the NOEC is LOEC/2, i.e. 5000 µg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2020. PEC/PNEC = 0.00028 which gives the risk insignificant. If calculated from the NOEC as described above, PEC/PNEC = 0.00056, which also indicates negligible risk. The AF (assessment factor) used is 1000. According to the guidelines, at least one short-term L(E)C50 value should be available from each of the three trophic levels (fish, invertebrates – preferably Daphnia – and algae). However, data are only available for two trophic levels: algae and crustaceans.