Registration Dossier
Registration Dossier
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EC number: 942-993-1 | CAS number: -
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
BCF QSAR Fish (range; all constituents): 10.0 – 34.7 ± 0.057-0.279 L/Kg ww, BCF base-line model v.02.09; OASIS Catalogic v5.11.17, Firmenich SA 2015
Key value for chemical safety assessment
Additional information
In accordance with REACH Regulation (EC) No. 1907/2006 Annex XI, section 1.2 justification for not performing a bioaccumulation study includes expert assessment: The components of the substance are not bioaccumulative despite having Log Kow > 4.0 since aliphatic esters are present in mammals via a food and are known to be metabolised. Specifically, aliphatic esters are metabolized by the same metabolic processes to that of dietary fats and are extensively metabolized by carboxylesterase enzymes that are ubiquitous across vertebrate and invertebrate species. Specific enzymatic activity explains the discrepancy between model predictions and actual bioconcentration potential is the rapid metabolism of this class of chemistry by fish. Models that do not account for metabolism over predict bioaccumulation potential in fish. The applicant adapts the information requirement through (i) (Q)SAR assessment and (ii) providing evidence of substance metabolism and elimination within the literature, for a weight-of-evidence approach to the endpoint which indicates no reasonable foreseen bioaccumulation potential.
BCF QSAR Fish (range; all constituents): 10.0 – 34.7 ± 0.057-0.279 L/Kg ww, BCF base-line model v.02.09; OASIS Catalogic v5.11.17, Firmenich SA 2015
Estimated Log BCF = 1.00 – 1.54 (all constituents)
BCF = 10.0 – 34.7 ± 0.057-0.279 (all constituents) L/kg wet-wt
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