Posakonazol

Assessment report

Data från assessment report för Noxafil (posakonazol) 24 Juli 2014 EMA/CHMP/75051/2015 och 20 Februari 2014 EMA/159150/2014.

Fara

Persistens: "The half-life of the parent posaconazole in two river sediments was calculated to be 20.4 and 21.1 days. The half-lives of the two major transformation products in in two river sediments were calculated to be 38 and 106.7 (metabolite M2) and 358.1 and 108.1 (M3). The Applicant states that the metabolites (M2 and M3) could not be named according to chemical nomenclature as their definitive structures are unknown. However, different half-lives for the fate of the major transformation products (elucidated structure) of posaconazole in water/sediment systems have been calculated. Nevertheless, all three transformation products show persistence in sediment with half-lives >120 d. Posaconazole is therefore classified as being persistent."

Bioackumulation: "The Phase I screening for persistence, bioaccumulation and toxicity (PBT) indicates that further evaluation of posaconazole is not warranted due to a log K_ow < 4.5." "Based on the Phase II–Tier A assessment, posaconazole is unlikely to represent a risk to surface water, ground water micro-organisms and sediment dwelling organisms. Posaconazole is not likely to bioconcentrate in aquatic organisms and is not a PBT compound (BCF < 2000), indicating little risk to the aquatic and sediment environments."

Toxicitet: Inga data.

Risk

Risken, PEC/PNEC, från ett europeiskt perspektiv:

PEC = 760 mikrog/kg.

PNEC = 8,06 mikrog/kg. Uträkningen av PNEC framgår inte.

PEC/PNEC = 0,01 vilket ger risken försumbar.

Fass miljöinformation

Fass miljöinformation för Noxafil (hämtad 2018-09-05).

Fara

Persistens: "Posaconazole has a half-life less than 32 days.The phrase “Posaconazole is degraded in the environment is thus chosen."

Bioackumulation: "Posaconazole has a measured bioconcentration factor (BCF) of 20 (OECD 305)."

Kronisk toxicitet: Finns NOEC för 3 trofinivåer, lägst NOEC för alg (Selenastrum capricornutum) 41 mikrog/L.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2015. PEC/PNEC = 0,00067 vilket ger risken försumbar.