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EC number: 251-110-2 | CAS number: 32582-32-4
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
There are no reliable toxicity data for terrestrial organisms relating to 2 -tetradecyloctadecan-1 -ol. A waiver is applied for this endpoint as the substance is highly insoluble, readily biodegradable, has no short-term toxicity and exposure is unlikely.
Key value for chemical safety assessment
Additional information
There are no toxicity data for soil organisms relating to reaction mass of 2-hexyldodecan-1-ol and 2-octyldecan-1-ol or other long chain alcohols.
In Annex X of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity to terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on terrestrial organisms. Column 2 of Annex X states that studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
The test substance is not supposed to be applied directly to soil. Indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable.
Read-across from Guerbet Alcohols and LCA categories has been used to meet the data gap for the reaction mass of 2-hexyldodecan-1-ol and 2-octyldecan-1-ol biodegradation endpoint, as described in the ‘Read Across Justification Document’ section 13.
A ready biodegradation study by Federle (2009) tested 10 linear primary alcohols from butanol (C4) to docosanol (C22) and concluded that all 10 LCAs are readily biodegradable and satisfy the 10-day criterion. When the biodegradation data are considered in more detail, it is clear that longer chain LCAs degrade more rapidly than the intermediate chain lengths; docosanol achieved a mineralisation level of 88% at the end of the 28-day study and 83% mineralisation within the 10-day window. Other studies by Richterich (1998a and b), Belangeret al(2009) and Federle and Itrich (2006) all reported rapid biodegradation in LCAs from C16 to C22 linear and Guerbet alcohols.
It is concluded that given the very close similarity between C6-C22 LCAs and C16 LCAs (both linear and Guerbet) as well as similar physico-chemical properties and structure, it is fully expected that reaction mass of 2-hexyldodecan-1-ol and 2-octyldecan-1-ol will be readily biodegradable. Indirect exposure is not expected as rapid biodegradability means the substance will be biodegraded within the STP process and as a consequence a transfer to the soil compartment via STP effluent is not expected. reaction mass of 2-hexyldodecan-1-ol and 2-octyldecan-1-ol will not be directly applied to soils and as such, direct exposure to soil organisms is not expected. Therefore, no tests on terrestrial organisms are provided.
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