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Netarsudil

Summary

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

Bioaccumulation. Netarsudil is not considered to have the potential to bioaccumulate.

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

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

 

This summary information comes from assessment report.

Detailed information

Assessment report

Assessment report for Roclanda (latanoprost, netarsudil) about netarsudil, 12 November 2020, EMA/CHMP/637805/2020.

Hazard

Persistence: No data.

Bioaccumulation: "The mean log Pow of netarsudil at pH 4.5 was determined to be 2.38 ± 0.03, using the shake flask method, and the mean log Pow at pH 7 and pH 9 was determined to be 3.14 ± 0.045 and >4.20 ±0.001, respectively, using the slow stir method. ... The log Pow value at pH 9 is considered of less biologically relevance, especially considering the large difference between the log Pow values at pH 7 and pH 9, 3.14 vs >4.20 and that the log Pow value at pH 7 is not close to the trigger value. Thus, even though the log Pow at pH 9 could not be accurately determined it is agreed that no further PBT-assessment is needed."

Toxicity: No data.

Risk

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

"The PECSURFACE WATER for both netarsudil and latanoprost is concluded to be less than 0.01 μg/L. No further analysis is therefore required."

Fass environmental information

Environmental information is missing for netarsudil on fass.se (2023-12-15). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Author: Health and Medical Care Administration, Region Stockholm