Registration Dossier
Registration Dossier
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EC number: 216-125-0 | CAS number: 1503-48-6
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
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. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
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 test substance (Q)SAR results were used for Biodegradation in water. 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.
Therefore, further experimental studies on Biodegradation in water are not provided.
Three QSARS have been conducted to assess the Ready Biodegradability of the test substance. Both VEGA and EPISuite gave the result that the test item is not readily biodegrdable. For both QSARs the test substance was within the applicability domain.
Additionally, CATALOGIC has been conducted and resulted in 2 % biodegradation. However, the applicability domain was correct with only 7.69% (unknown 92.31%). Even though the substance was out of the applicability domain, the result supports the first two QSAR calculations.
In overall conclusion, the test substance is regarded as not readily biodegradable.
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