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Mercaptopurine

Hazard 4* P 3 B 0 T 1* Risk Cannot be excluded

Information

The data on hazard (P and T) and risk are based on previous environmental information on Fass.se. Environmental information is missing on fass.se (2019-03-13). It is voluntary for manufacturers to provide information about environmental impact on fass.se. Data for B from the assessment report and is also supported by Fass's environmental information.

Assessment report

Assessment report forr Mercaptopurine Nova Laboratories 21 July 2011 EMA/CHMP/668488/2011.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = 0.71; -0.17 at pH 5.7 and – 0.37 at pH 7.4; 0.01 at pH 7.4. "The log partition coefficient in octanol/water (log Kow) values of 6-mercaptopurine is < 4.5, such that this drug substance does not present any hazards with respect to bioaccumulation and persistence."

Toxicity: No data.

Risk

"PECsurfacewater values for 6-mercaptopurine has been calculated to be 0.00116 μg/L. This value is nearly 10 times lower than the action limit of 0.01 μg/L. Therefore, Phase II environmental fate and effects assessments were not considered necessary, which is acceptable and in line with the aforementioned guideline."

References

  1. Stockholms läns landsting. Miljöklassificerade läkemedel 2014–2015. Stockholm; 2014.
  2. European Medicines Agency. European public assessment reports (EPAR).

Author: The Pharmaceutical unit of Region Stockholm