Registration Dossier
Registration Dossier
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EC number: 241-793-5 | CAS number: 17832-28-9
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
The substance is readily biodegradable without fulfilling the 10-day window criterion.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable but failing 10-day window
Additional information
To assess the ready biodegradability of 4 -(vinyloxy)butan-1 -ol, read-across is performed to the close structural analogue 2-methyl-1-(vinyloxy)propane (CAS 109 -53 -5).
For 2-methyl-1-(vinyloxy)propane a study according to OECD TG 310 and in compliance with GLP criteria is available (BASF, 2004). In this study, Activated sludge from a laboratory wastewater plant treating municipal sewage was inoculated with 27.7 mg test substance (20 mg/L based on DOC) for 28 -days. The percentage biodegradation was monitored by assessment of the ratio of eliminated DOC to initial DOC. After the 28 -day incubation period 60 -70% of the test substance was biodegraded. The 10 -day window criterion for this test was not met. Therefore the substance was assessed as 'readily biodegradable but failing 10 -day window'.
For the substance itself, two older studies are available that justify the use of data from read-across. First, a (BOD5*100)/COD of 50% was determined for the substance in a study according to national guidelines (DIN38409) (BASF, 1988). Although such data is not accepted as stand alone data, it may be considered evidence for rapid biodegradation. Second, an inherent biodegradation study according to OECD TG 302B was performed in which 100% biodegradation was seen within 27 days when exposed to adapted activated sludge (BASF, 1988). This also is no direct proof for 'ready' biodegradation but shows at least that the substance is rapidly eliminated under conditions of sewage treatment in a municipal/industrial STP.
Finally, to add further weight to the use of read-across data, the potential for ready biodegradability of the substance itself was estimated using two different QSARs: the BIOWIN model (v4.10) within EPISuite (v4.11) and the Catalogic 301C model (v9.13) within OASIS (v5.11.19). Both models predict that the substance is readily biodegradable.
Therefore the overall assessment is that 4-(vinyloxy)butan-1 -ol is readily biodegradable without fulfilling the 10-day window criterion, is considered justified as a reasonable worst case.
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.
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 4 -(vinyloxy)butan-1 -ol (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.
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