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Environmental fate & pathways

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For the assessment of the biodegradability of "Reaction products of 3-methylbutanal and 3-methylbut-3-en-1-ol after acidic treatment", both main components with highest potential for aquatic toxicity (5,6-dihydro-4-methyl-2-(2-methylpropyl)-2h-pyran (CAS 59848-65-6) and 3,6-dihydro-4-methyl-2-(2-methylpropyl)-2h-pyran (CAS 59848-69-0) have been assessed. Together, both components make up to 80 % fraction of the substance and are considered to be the most relevant for the environmental hazard assessment based on a QSAR-toxicity-screening of all components (ECOSAR).

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 both main components with highest potential for aquatic toxicity (5,6-dihydro-4-methyl-2-(2-methylpropyl)-2h-pyran (CAS 59848-65-6) and 3,6-dihydro-4-methyl-2-(2-methylpropyl)-2h-pyran (CAS 59848-69-0)) (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. Based on the outcome of the biodegradation potential of these two main components, "Reaction products of 3-methylbutanal and 3-methylbut-3-en-1-ol after acidic treatment" is considered as not readily biodegradable.