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Diss Factsheets

Ecotoxicological information

Toxicity to terrestrial plants

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Description of key information

In accordance with Column 2 of REACH Annexes IX and X, toxicity testing with terrestrial plants (required in Section 9.4.3 and 5) is not needed as the chemical safety assessment according to Annex I indicates this is not necessary. Moreover, considerable technical difficulties would be expected in the conduct of such a test, due to the very rapid biotic removal of the substance from the test system (based on experience in the long-term aquatic invertebrate study; tetradecanol) and the ready biodegradability of all the Alchisor TAL 145 constituents. 
The toxicity in soil organisms of components of Alchisor TAL145 has been documented within this dossier. Further testing with Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-1-ol is deemed not necessary and is waived.

Key value for chemical safety assessment

Additional information

Alchisor TAL 145 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1-ol and tetradecan-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 145 and suitable for assessment purposes. The testing of terrestrial plants is waived as it is not deemed necessary according to the chemical safety assessment. Direct and indirect exposure of the soil compartment is unlikely and the constituent substances are readily biodegradable ensuring that exposure of terrestrial plants to Alchisor TAL 145 is unlikely to occur. Therefore the need for terrestrial plant tests 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, three constituent substances are readily biodegradable and the direct or indirect exposure of the soil compartment is unlikely. Therefore, the requirement for terrestrial toxicity testing of C9-C12 aliphatics is waived.

 

Dodecan-1-ol and Tetradecan-1-ol

In accordance with Annexes IX and X, Column 2, toxicity studies using terrestrial plants do not need to be conducted as reliable measured data demonstrates the dodecan-1-ol and tetradecan-1-ol constituents are readily biodegradable and this is supported by the SIDS SIAR for Long Chain Alcohols (2006). In the environment, ready biodegradability means it can be assumed that Alchisor TAL 145 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.

 

The toxicity in soil organisms of components of Alchisor TAL has been documented within this dossier. There was adequate reliable measured data for the toxicity to other soil organisms to components of Alchisor TAL (namely, tetradecan-1-ol) and for completeness, a no-effect concentration was predicted using the assessment factor and equilibrium partitioning approaches (as presented in the CSR). Further testing with Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), dodecan-1ol or tetradecan-1-ol was deemed not necessary and is waived.