Testosterone

Detailed information

Fass environmental information

Fass environmental information for for Testogel (testosterone) company Laboratoires Besins and Tostrex (testosterone) Kyowa Kirin AB (downloaded 2023-06-19) with reference to the company Bayer for Androgel (testosterone). Androgel has been withdrawn from the market.

Hazard

Persistence: "Biotic degradation. Ready degradability: not ready biodegradable. Testosterone enantate was studied for aerobic biodegradability in water in a manometric respiration test according to guideline OECD TG 301F ... It was degraded to 60 % after 28 days. The degradation, however, proceeded slowly and did not fulfill the ready degradability criteria of OECD TG 301. Abiotic degradation. Hydrolysis: Testosterone enantate has a hydrolytical half-life of 218–374 days at pH 9 and 25°C and is stable at pH values ≤ 7. ... Justification of chosen degradation phrase: Since the biodegradation rate was 60% in a ready biodegradation test, but the stringent criteria for ready biodegradability was not met, and the substance is hydrolytically stable, the phrase “Testosterone is slowly degraded in the environment” is justified."

Bioaccumulation: "Log K of 7 at 7 and 25°C for enantate (Shake flask method, OECD TG 117)."

Acute toxicity: There are data for 2 trophic levels, most sensitive algae ≥ 1000 microg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.

Risk

Risk of environmental impact of testosterone cannot be excluded, since there is not sufficient ecotoxicity data available.