Baclofen
Summary
Persistence. Baclofen is potentially persistent.
Bioaccumulation. Baclofen has low potential for bioaccumulation.
Toxicity. Baclofen has low acute toxicity, fish.
Risk. Risk of environmental impact of baclofen cannot be excluded, since there is not sufficient ecotoxicity data available.
This summary information comes from Fass.
Detailed information
Comment on Fass environmental information
Baclofen 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 Lioresal
Fass environmental information for Lioresal (baclofen) from Novartis (downloaded 2024-07-04).
Hazard
Persistence: "11.1 % degradation in 28 days, not readily biodegradable (OECD301D). (Ciba-Geigy, Test No. 81 17 86) Justification of chosen degradation phrase: Baclofen does not pass the criteria for ready biodegradation. Therefore, it can be classified as ‘Baclofen is potentially persistent.’"
Bioaccumulation: Log Pow = 0.11 (23°C, experimentally determined, method unknown).
Toxicity: There are data for 1 trophic level, fish (Brachydanio rerio, zebra fish) "LC50 96 h (mortality) > 580.0 mg/L (OECD203).
Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.
Risk
Risk of environmental impact of baclofen cannot be excluded, since there is not sufficient ecotoxicity data available.
Fass environmental information for Gablofen
Fass environmental information for Gablofen (baclofen) from Aguettant Nordic (downloaded 2024-07-04).
Hazard
Persistence: No data.
Bioaccumulation: Log D = -0.94 vid pH 7.4.
Toxicity: Not data.
Risk
Risk of environmental impact of baclofen cannot be excluded, since there is not sufficient ecotoxicity data available.
References
Author: Health and Medical Care Administration, Region Stockholm