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Docetaxel

Antineoplastic Agents
CATEGORIES

Antineoplastic Agents


ALIASES

DOCETAXEL KABI, Docetaxel Accord, Docetaxel Actavis, Docetaxel Amring, Docetaxel Ebewe, Docetaxel Pfizer, Docetaxel Teva, TAXOTERE, Taxotere®


SUBSTANCES

docetaxel, docetaxel trihydrate


ENVIRONMENTAL CONCERN: MODERATE
Docetaxel is a clinically well established anti-mitotic chemotherapy medication used mainly for the treatment of breast, ovarian, and non-small cell lung cancer. Docetaxel binds to microtubules reversibly with high affinity and has a maximum stoichiometry of one mole docetaxel per mole tubulin in microtubules.

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MODERATE
Underlying data for B comes from the assessment report and the article Fick J et al 2010. Information about P, ​​T and risk comes from Fass.

Below is Hazard and Risk from assessment report for Docetaxel Winthrop, Doc. Ref No.: EMA/449127/2010, 20.05.2010


Hazard
Persistence: No data.

Bioaccumulation: "The log Kow of the active ingredient is 3.2 (calculated)."

Toxicity: "The MAH (Marketing authorization holder, red. kommentar) has further provided information on fate (sorption, hydrolysis, aerobic biodegradation) and effects (acute toxicity test on Daphnia, minimal inhibiting concentration for micro-organisms) of docetaxel in the environment without submitting any study report." No data is available in the report.

Other information
"The MAH has predicted an environmental concentration in surface water of 3.9 10-4 μg/l and concluded that no further environmental risk assessment is necessary."

Below is Hazard and Risk from Fass environmental information for Doxetaxel Actavis (downloaded 2018-11-01)


Hazard
Persistence: No data.

Bioaccumulation: No data.

Toxicity: No data.

Risk
Risk of environmental impact of docetaxel cannot be excluded, since no ecotoxicity data are available.

Article Predicted critical environmental concentrations for 500 pharmaceuticals
Critical effect concentration (CEC) for doxetaxel is 6 518 ng/L. Log P is set to 2.8.

REFERENCES

  1. European Medicines Agency. European public assessment reports (EPAR).
  2. Fass.se för vårdpersonal
  3. Fick J, Lindberg RH, Tysklind M, Larsson DG. Predicted critical environmental concentrations for 500 pharmaceuticals. Regul Toxicol Pharmacol. 2010;58:516-23.