Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol. As defined in the Read-Across Justification Document in section 13, data provided for these constituents when considered together is representative of Alchisor TAL 123 and suitable for assessment purposes. The approach taken has been to evaluate together the study data for each constituent, where available. In a conservative approach the most sensitive study result from across the three constituents would be identified and used to address the endpoint in question. However, no reliable measured data were available for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol or dodecan-1-ol. In accordance with Column 2 of REACH Annexes IX and X, the toxicity testing of soil organisms does not need to be conducted for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol or dodecan-1-ol where exposure is unlikely to occur. Presented below are argumentations supported by evidence for waiving data requirements for terrestrial endpoints. For completeness, supporting information is provided for undecan-1-ol and dodecan-1-olwhere equilibrium partitioning method has been used to derive a PNECsoil from the respective PNECfreshwater. In summary, the requirement for toxicity testing of Alchisor TAL 123 to soil organisms is waived.

Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) substance is a hydrocarbon UVCB. Standard tests for this endpoint are intended for single substances and are not appropriate for this complex substance due to the substances complex nature and solubility. In addition, the substance is readily biodegradable (the test substance was 74.7% degraded by day 28 and met the 10-day window requirement) and the direct or indirect exposure of the soil compartment is unlikely. Therefore, the requirement for terrestrial toxicity testing of Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) is waived.

Undecan-1-ol and Dodecan-1-ol

In accordance with Annex X, section 2, the long-term toxicity effects studies to soil organisms do not need to be conducted as these long chain alcohols are readily biodegradable and the direct or indirect exposure of the soil compartment is unlikely. Evidence for the ready biodegradability of the substances is provided in the dossier. Experimental studies for dodecan-1-ol demonstrate its ready biodegradability. A weight of evidence approach was taken with undecan-1-ol where data have been reported for a number of analogous substances with the closest chain lengths to C11 being taken into consideration. These data show that alcohols with chain lengths up to C22 are readily biodegradable. This is confirmed in the SIDS SIAR for Long Chain Alcohols (2006) report where decanol, dodecanol, and alcohols with chain lengths of <= C20 are readily biodegradable.

In summary, there was not adequate reliable measured data for the toxicity to soil organisms from components of Alchisor TAL 123 (namely, Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol). However, testing with Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol or dodecan-1ol is deemed not necessary due to the ready biodegradability and unlikely direct or indirect exposure to soil of the components and the Alchisor TAL 123 substance. PNEC values were calculated for undecan-1-ol and dodecan-1-ol by the Long Chain Alcohols Consortium using the equilibrium partitioning method and these are presented here for consistency with the individual alcohol dossiers:

• An equilibrium partitioning has been used to determine a PNECsoil for undecan-1-ol of 1.606 mg/kg wwt; and

• An equilibrium partitioning has been used to determine a PNECsoil for dodecan-1-ol of 0.888 mg/kg wwt.

However, PNECsediments were derived in this assessment for Alchisor TAL 123 using EUSES for the purposes of the CSA.