Registration Dossier
Registration Dossier
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EC number: 601-329-8 | CAS number: 114798-26-4
Biodegradation in soil
Administrative data
Link to relevant study record(s)
Description of key information
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.
Key value for chemical safety assessment
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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