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Ecotoxicological information

Toxicity to soil microorganisms

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Description of key information

The toxicity in soil organisms of components of Alchisor TAL 123 has been documented within this dossier. There was not adequate reliable measured data for the toxicity to soil organisms to components of Alchisor TAL 123 (namely, Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%), undecan-1-ol and dodecan-1-ol).  Testing with Hydrocarbons C11 -C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%), undecan-1-ol or dodecan-1-ol was deemed not necessary and is waived. The waiver for this endpoint is based on the substance being readily biodegradable and the direct or indirect exposure of the soil compartment is unlikely.

Key value for chemical safety assessment

Additional information

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11 -C14, n-alkanes, isoalkanes, 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. Study data for each constituent has been evaluated, where available and considered together. In a protective approach the most sensitive study result from across the three constituents has been identified and used to address the endpoint in question. However, measured toxicity data were not available for terrestrial organisms for Alchisor TAL 123 constituents.

 

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that toxicity to terrestrial microorganisms 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 IX states that studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely. These criteria have been met for this substance and the requirement for further testing is waived.

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

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

 

Undecan-1-ol and Dodecan-1-ol

In accordance with Annex IX, Column 2, the toxicity effects studies to soil microorganisms do not need to be conducted as reliable data demonstrates decanol, dodecanol, and alcohols with chain lengths of < C20 are readily biodegradable, according to the SIDS SIAR for Long Chain Alcohols (2006). In the environment, ready biodegradability means it can be assumed that Alchisor TAL 123 will be biodegraded within the STP process and as a consequence a transfer to the soil compartment via sewage sludge is not expected. Therefore, the requirement for further testing on terrestrial organisms is waived.

 

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 of Alchisor TAL 123 and the Alchisor TAL123 substance itself. For completeness, PNEC values were calculated using the equilibrium partitioning method and are presented in the terrestrial endpoint summary.