Registration Dossier

Environmental fate & pathways

Biodegradation in soil

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In accordance with column 2 of REACH annex IX, information requirement 9.2, further degradation testing does not need to be conducted as the chemical safety assessment does not indicate a need for further investigation.
In accordance with Column 2 adaptation statement of REACH Annex IX, information requirement 9.2.1.3, soil simulation testing does not need to be conducted as there is no direct or indirect exposure to soil for this test substance. 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 environment. See supporting exposure assessment information (CSR Chapter 9).
In accordance with Section 3 of REACH Annex XI, Substance-tailored exposure driven testing, Confirmatory testing on biodegradation rates (aerobic and/or anaerobic), information requirement 9.2.1 in Annex X, may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. Justification and documentation are provided in CSR Chapter 9 based on a thorough and rigorous exposure assessment in accordance with section 5 of Annex I.

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