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Alchisor TAL 111 is decene, hydroformylation product, low boiling and can be characterised as a UVCB substance. As defined in the ‘Read-Across Justification Document’ section 13, data provided for the analogue substance Alchisor TAL 123 and the Alchisor TAL 111 consitutent category substances, Category 3 hydrocarbon solvents, are representative of Alchisor TAL 111 and suitable for assessment purposes. Study data for each analogue/constituent category has been evaluated and considered together. The most relevant and reliable study result from across the analogue/constituent categories has been identified and used to address the endpoint in question.However, no reliable measured data were available for the analogue substance or the constituent categories (C9-C14 aliphatics (2-25% aromatics)). In accordance with Column 2 of REACH Annexes IX and X, the toxicity testing of soil organisms does not need to be conducted for C9-C14 aliphatics (2-25% aromatics) where exposure is unlikely to occur. Presented below are argumentations supported by evidence for waiving data requirements for terrestrial endpoints. In summary, the requirement for toxicity testing of Alchisor TAL 111 to soil organisms is waived.

 

C9-C14 Aliphatics (2-25% Aromatics)

C9-C14 Aliphatics 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 Category 3 hydrocarbon solvent substances were 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, therequirement for terrestrial toxicity testing of C9-C12 aliphatics is waived.

Biodegradation

In accordance with the technically robust approach defined in the 'Read-Across Justification' report in section 13, the most reliable and relevant study result from the analogue/constituent categories is applied to the Alchisor TAL 111 biodegradation endpoint. The analogue substance, Alchisor TAL 123 is determined to be readily biodegradablein a reliable (Klimisch 1), GLP compliant OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test) study. In this test Alchisor TAL 123 biodegraded to an extent of 78.38% after 28 days with an unacclimated sewage sludge inoculum. It was concluded that Alchisor TAL 123 is readily biodegradable, although failed the 10 -day window. In addition, the representative constituent categories of Alchisor TAL 111 (i.e., C9 -C14 aliphatics (2 -25% aromatics)) are reported to be readily biodegradable. In a GLP-compliant OECD 301F study, the test substance Shellsol H biodegraded to an extent of 74.7% after 28 days with a sewage sludge inoculum. The test substance was determined to be readily biodegradable.

Reliable studies indicate that both the analogue substance, Alchisor TAL 123, and the constituent categories, C9 -C14 aliphatics (2 -25% aromatics), of Alchisor TAL 111 are readily biodegradable.In the environment, ready biodegradability means that it is unlikely that aquatic or sediment life will be exposed to Alchisor TAL 111 over extended periods, with low potential to exert long-term toxic effects. In addition, ready biodegradability means it can be assumed that Alchisor TAL 111 and its constituents will be biodegraded within the STP processs and as a consequence a transfer to the sediment compartment via STP effluent is not expected.Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biological degraded in the surface water within a short time.

 

The toxicity in soil organisms of components of Alchisor TAL111 has been considered within this dossier. However, there was not adequate reliable measured data for the toxicity to soil organisms to components of Alchisor TAL 111 (namely, C9 -C14 aliphatics (2 -25% aromatics)) or the analogue substance Alchisor TAL 123. Testing with C9 -C14 aliphatics (2 -25% aromatics) was deemed not necessary and is waived. The waiver is applied for this endpoint as the substance is readily biodegradable in the environment.

In summary, there was not adequate reliable measured data for the toxicity to soil organisms from components of Alchisor TAL (namely, C9 -C14 aliphatics (2 -25% aromatics)). However, testing with C9 -C14 aliphatics (2 -25% aromatics) is deemed not necessary due to the ready biodegradability and unlikely direct or indirect exposure to soil of the components and the Alchisor TAL 111 substance. 

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