Granisetron
Summary
Persistence. The potential for persistence of granisetron cannot be excluded, due to lack of data.
Bioaccumulation. Granisetron has low potential for bioaccumulation.
Toxicity. It cannot be excluded that granisetron is toxic, as data are lacking.
Risk. Risk of environmental impact of granisetron cannot be excluded, due to the lack of environmental toxicity data.
This summary information comes from assessment report and fass.se.
Detailed information
Assessment report
Assessment report for Sancuso (granisetron), 16 February 2012, EMA/228344/2012.
The applicant experimentally determined the octanol-water partition coefficient (log Kow) for granisetron using the shake-flask method, resulting in a value of 2.84 ± 0.25, below the PBT threshold of > 4.5. Thus, the substance is not considered PBT.
For PECsw calculation, both the total amount of granisetron in the patch (TDS) and the amount released during use were considered. CHMP used the more conservative approach, assuming the full patch content may enter the environment.
Based on a cancer prevalence of 3.2 million in the EU and a dosing regimen of 7 patches/week over 12 courses per year, Fpen was calculated as 0.0064 and PECsw as 0.025 µg/L, exceeding the action limit of 0.01 µg/L. Therefore, a Phase II environmental risk assessment (ERA) is required.
Although actual use is likely much lower, it is currently considered that granisetron TDS poses a low environmental risk. Disposal recommendations are included in the product information. CHMP recommends a literature-based Phase II ERA to support potential updates to the handling and disposal guidance. No Phase II data were found during a search of the EMA website (2025-07-07).
Fass environmental information Sancuso
Fass environmental information for Sancuso from Grunenthal Swedenretrieved on 2025-07-07).
Hazard
Persistence: No data.
Bioaccumulation: Log Kow = of 2.84 ± 0.25 at pH 7 (experimentally determined in line with OECD 107).
Toxicity: No data.
Risk
Risk of environmental impact of granisetron cannot be excluded, due to the lack of environmental toxicity data.
Fass environmental information Granisetron Hameln
Fass environmental information for Granisetron Hameln (granisetron) from hameln pharma (retrieved on 2025-07-07).
Hazard
Persistence: No data.
Bioaccumulation: Log Pow = 1.9 (experimental by unknown method).
Toxicity: No data.
Risk
Risk of environmental impact of granisetron cannot be excluded, due to the lack of environmental toxicity data.
Author: Health and Medical Care Administration, Region Stockholm