Aciclovir

Detailed information

Comment on Fass environmental information

Aciclovir 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 for Geavir

Fass environmental information for Geavir (aciclovir) from Sandoz (downloaded 2022-11-29). The environmental information for aciclovir is produced by the company GlaxoSmithKline for Zovirax (aciclovir).

Hazard

Persistence: "Biotic degradation. Ready degradability: 0.7% degradation in 28 days (TAD 3.11). Inherent degradability: 100% primary (loss of parent) degradation in 14 days (OECD 302B).

Abiotic degradation. Hydrolysis: Half-life, pH 7 > 1 year (TAD 3.09). Photolysis: Half-life, pH 7 = 3.5 hours (TAD 3.10).

Aciclovir is not readily biodegradable nor inherently biodegradable. The phrase “Aciclovir is potentially persistent” is thus chosen."

Bioaccumulation: "Log P_calc = -1.55. (Chemaxon)."

Chronic toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia dubia) NOEC > 10 000 microg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.

Risk

PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 0.001 which gives the risk insignificant.

Fass environmental information for Aciclovir Pfizer

Fass environmental information for Aciclovir Pfizer from Pfizer (downloaded 2022-11-29).

Hazard

Persistence. It cannot be excluded that aciclovir is persistent, due to the lack of data.

Bioaccumulation. It cannot be excluded that aciclovir bioaccumulates, due to the lack of data.

Toxicity. It cannot be excluded that aciclovir is toxic, due to the lack of data.

Risk

Risk of environmental impact of aciclovir cannot be excluded, due to the lack of environmental toxicity data.

The 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 on fass.se.