Methotrexate

Summary

Hazard 5* P 3 B 0 T 2* Risk See below

Data as basis for P, B and T are from the assessment report for Jylamvo (methotrexate) 26 January 2017, EMA/78284/2017, see further below. The T-value refers to acute toxicity.

Exceptional good margin between exposure and the concentration that is considered to give environmental impact.

Assessment report

Below is Hazard according to data from the assessment report for Jylamvo (metotrexat) 26 January 2017, EMA/78284/2017.

Persistence: "EPI* (EPA) – BIOWIN v4.10: Not readily biodegradable", i.e. P. EPI (Estimation Program Interface) BIOWIN is a computer program for QSAR calculations (Quantitative Structure Activity Relationship: quantitative mathematical connection between the chemical structure/physicochemical properties of the various substances and their biological and chemical activities).

Bioaccumulation: BCF = 3.162 L/Kg wet-wt. Conclusion B (N).

Acute toxicity: There are EC50 values ​​for algae and crustaceans, lowest for algae 10 mg/L. Since data is missing for one trophic levels, the conversion factor 2 is used and results in the score 2 *, i.e. 2 uncertain.

"Methotrexate is a cytotoxic substance the applicant followed the request of the CHMP to include the following sentence into SmPC (point 6.6) and package leaflet (point 5): “Any unused product or waste should be disposed of in accordance with local requirements for cytotoxic products”."

Fass environmental information

Risk from Fass environmental information for Methotrexate Teva (downloaded 2018-05-29). Manufacturer has on fass.se stated that data about the environmental impact is missing for the substance so that the environmental risk cannot be calculated. It is voluntary for manufacturers to provide information on the environmental impact.