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EC number: 212-133-3
CAS number: 764-99-8
The substance is considered to be not readily biodegradable.
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.
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 v184.108.40.206. 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 v220.127.116.11) 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).
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