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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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In accordance with Column 2 adaptation statement of REACH Annex IX, sediment simulation testing, information requirement 9.2.1.4 does not need to be conducted as direct and indirect exposure to sediment is unlikely.  The sole substance use is as an intermediate and therefore the substance has a short-life cycle.  Additionally, the facility operates with a focus to prevent loss of product and there is no releases to the environment. Losartan free acid will not enter the aquatic environment . See supporting sorption data (CSR section 4.2.1 Adsorption/desorption) and exposure assessment information (CSR Chapter 9).
In accordance with Section 3 of REACH Annex XI, Substance-tailored exposure driven testing; simulation testing on ultimate degradation in surface water, information requirement 9.2.1.2 in Annex IX, may be omitted based on the exposure scenarios developed in the Chemical Safety Report. Justification and documentation are provided in Chapter 9 based on a thorough and rigorous exposure assessment in accordance with section 5 of Annex I.

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