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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Description of key information

In accordance with Column 2 of REACH Annexes IX and X, the toxicity testing of terrestrial invertebrates (required in Section 9.4.1 and 4) does not need to be conducted as direct and indirect exposure of the soil compartment is unlikely. 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; dodecan-1-ol) 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. Study data for each constituent has been evaluated 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. Measured short-term toxicity data are available for terrestrial organism exposure to tetradecan-1-ol, although no short-term data are available for dodecan-1-ol or Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%).

 

In Annex I 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 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, 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

In accordance with Annexes IX and X, Column 2, the toxicity effects studies on soil organisms do not need to be conducted as reliable data demonstrates dodecanol, tetradecan-1-ol 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 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 toxicity testing on terrestrial organisms is waived.

 

Tetradecan-1-ol

The key study by Shell (2004) is a short-term test of 72-hr where the nematodeC. eleganswas exposed to tetradecan-1-ol with a population decrease and EC50 of >1,000 mg/kg (d.w. and 1.3% organic carbon). The study reflects the lowest reliable value that is available for this endpoint. A supporting study (Shell, 2004) presents an EC50 value from a 7-day exposure of tetradecan-1-ol to the earthwormE. fetidaof >1,000 mg/kg (d.w. and 1.3% organic carbon). The data are used in the assessment factor approach to the derivation of the PNECsoil.

 

In accordance with Annexes IX and X, Column 2, toxicity studies to soil organisms do not need to be conducted as reliable data demonstrates dodecan-1-ol, tetradecan-1-ol 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 145 will be biodegraded within the STP process and as a consequence a transfer to the soil compartment via sewage sludge is not expected. In addition, considerable technical difficulties would be expected in the conduct of the test, due to very rapid biotic removal of the substance from the test system (based on experience in the long-term aquatic invertebrate study). Therefore, the requirement for further long-term toxicity testing on terrestrial organisms is waived.

 

The toxicity in soil organisms of components of Alchisor TAL 145 has been documented within this dossier. There was adequate reliable measured data for the toxicity to 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 this 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.