Registration Dossier
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EC number: 212-133-3 | CAS number: 764-99-8
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
The substance is considered to be not readily biodegradable.
Key value for chemical safety assessment
Additional information
QSAR-disclaimer:
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of the substance, (Q)SAR results were used for the estimation of the biodegradability and the formation of metabolites. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Assessment
The ready biodegradability of the substance was investigated following OECD TG 301B and OECD TG 301D. In the CO2-evaluation test conducted with German domestic sewage sludge, the test substance degraded to 11 % after 28 days (BASF, 2021). The closed bottle test was performed using secondary effluent from a domestic wastewater treatment plant. The substance was degraded to 85.2% after 28 days (Rohm & Hass, 2007). The pass level for ready biodegradability was met; however, it failed the 10-d window. Therefore, the substance is assessed to be not readily biodegradable according to OECD criteria. The validity criteria were fulfilled in both tests.
The ready biodegradability is supported by the valid QSAR model BOD 28 days MITI (OECD 301C) v11.16 by OASIS CATALOGIC v5.14.1.5. The substance was completely within the applicability domain of the model. The degradability was predicted to be 91% (O2 consumption) after 28 d (BASF SE, 2020). As the substance was not readily biodegradable according to OECD criteria the Catalogic model was used to predict potentially forming metabolites.
Metabolite predition: The model Catalogic 301 C v11.16 (OASIS Catalogic v5.14.1.5) calculated 16 metabolites identifying 1 metabolite as a relevant degradation product with an estimated quantity of ≥ 0.1%. All metabolites identified were calculated to be readily biodegradable. Individual biodegradation of this metabolite was estimated to be 86 to 100% after 28 days (based on BOD).
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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