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EC number: 307-037-4 | CAS number: 97488-98-7
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Weight of evidence comparison of predicted BCFs and BAFs to B Criterion: BCF>2000 L/kg and vB Criterion: BCF>5000 L/kg indicates that the fish oil derivative is "not B" and "not vB" according to REACH and applicable guidance.
Key value for chemical safety assessment
Additional information
1. Evaluation of log Kow
Each of the QSAR-predicted log Kowvalues for the molecule exceeded the screening criterion, indicating a potential for bioaccumulation. Based on this comparison, it was not possible to classify the molecule as “not B” according to the log Kowcriterion alone. As a screening criterion, the log Kowthreshold represents bioaccumulation potential based on partitioning and uptake behavior but does not account for mitigating factors such as molecular size and biotransformation and, therefore, the BCF and BAF predictions provide a better representation of overall bioaccumulation potential. Thus, the bioaccumulation assessment relied primarily on comparison of the QSAR estimates of BCF and BAF to the definitive criteria from Annex XIII.
2. Evaluation of BCF and BAF
Using the KOWWIN estimates for log Kow, the ranges of BAF and BCF predictions are as follows:
Fish Oil Derivative:0.3 to 79.4 L/kg; and
All of these values were far below the BCF and BAF criterion of 2000 providing support for a “not B” conclusion for the fish oil derivative.
Using the ALOGPS estimates for log Kow, the ranges of BAF and BCF predictions are as follows:
Fish Oil Derivative:0.56 to 1000 L/kg; and
The large ranges in predictions are due to wide ranges in log Kowestimates using KOWWIN and the lowest value from ALOGPS.
All of these values were below the BCF and BAF criterion of 2000 providing support for a “not B” conclusion for the fish oil derivative.
3. Weight of Evidence Conclusion
At the higher log Kowvalues predicted by KOWWIN that are considered more realistic because of the observed/predicted extreme low water solubility and expected lipophilicity of the substances, the BAF and BCF predictions are far below the 2000 criterion.
These findings provide a weight of evidence that the molecule does not have significant bioaccumulation potential. By read-across, none of the substances in the group of sulfonated oils are expected to be bioaccumulative.
Thus,classifications of “not B” and “not vB” are considered appropriate for the substance group according to the REACH B Criteria and applicable guidance.
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