Registration Dossier
Registration Dossier
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EC number: 239-763-1 | CAS number: 15680-42-9
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
The test item is not readily biodegradable (by OECD criteria). It is poorly biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
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 aerobic biodegradability 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 aerobic biodegradability in water are not provided.
Two QSAR calculations have been conducted (BASF SE 2013 and 2015). Both EPISuite BIOWIN v4.10 and CATALOGIC v5.11.16 (BOD 28 days MITI (OECD 301C) v06.07) showed that the test substance is not readily biodegradable according OECD criteria. The test substance is within the applicability domain of both QSAR models. Even though for CATALOGIC the structural domain was correct with only 10 % (unknown 90 %) the results support the overall conclusion in the weight-of-evidence.
Therefore, in conclusion, it can be stated that the test substance in not readily biodegradable according OECD criteria.
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