Registration Dossier
Registration Dossier
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EC number: 938-875-4 | CAS number: -
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
The toxicity in soil organisms of components of Alchisor TAL 111 has been documented within this dossier. There was not adequate reliable measured data for the toxicity to soil organisms to components of Alchisor TAL (namely, C9 -C14 aliphatics (2 -25% aromatics)). Testing with C9 -C14 aliphatics (2 -25% aromatics) 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 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 Annex X 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 Annexes IX and X 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.
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.
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 of TAL and the Alchisor TAL111 substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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