Registration Dossier
Registration Dossier
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EC number: 208-993-4 | CAS number: 551-16-6
Endpoint summary
Administrative data
Description of key information
Additional information
The potential for biodegradation of the test material was investigated in the study by Flanders 2010 using the EU method C19, ECD guideline 301B and the EPA OPPTS 835.3110. The test material attained 81% degradation after 28 days. Under the strict terms and conditions of OECD Guideline No 301B the test material cannot be considered to be readily biodegradable as the test material failed to satisfy the 10-Day window validation criterion, whereby 60% degradation must be attained within 10 days of the degradation exceeding 10%. However, the test material has exhibited the potential for rapid degradation.
Section 9.2.1.2 Annex IX Column 2.The study need not be conducted if:
- the substance is readily biodegradable. From the results from section 9.2.1.1 the test material attained 81% degradation after 28 days. Under the strict terms and conditions of OECD Guideline No 301B the test material cannot be considered to be readily biodegradable as the test material failed to satisfy the 10-Day window validation criterion, whereby 60% degradation must be attained within 10 days of the degradation exceeding 10%. However, the test material has exhibited the potential for rapid degradation.
According to Annex IX Section 9.2.1.3 Column 2 The study need not be conducted:
- if the substance is readily biodegradable
- if direct and indirect of the soil is unlikely Although the results from section 9.2.1.1 demonstrated the test material was found not to be readily biodegradable, the nature of the test material demonstrated the potential for rapid degradation. Exposure to soil is also considered unlikely as the substance is an intermediate and undergoes further manufacturing processes before the end product is released. Any waste is treated in a treatment plant on site, therefore levels released to the environment would be minimal.
Beta-lactams naturally occur in the environment as they are produced by penicillium fungi (moulds) which are present in typically cool, damp environments rich in organic matter.
Annex IX Column 2, Section 9.2.3
The study need not be conducted if:
- based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient). The partition coefficient of the test material was determined to be 1.34 x 10-4 at 22.5 ± 0.5°C, log10 Pow, -3.87.
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