Registration Dossier
Registration Dossier
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EC number: 947-849-1 | CAS number: -
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to terrestrial plants: long-term
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the toxicity to terrestrial plants.
Key value for chemical safety assessment
Additional information
No experimental data for the toxicity of the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters to terrestrial plants are available.
However, according to Regulation (EC) No. 1907/2006, Annex IX, 9.4, column 2, further studies on the effects on terrestrial organisms are not necessary because the chemical safety assessment does not indicate the need for further investigations.
The substance is characterized by a high log Koc (log Koc > 5), indicating a potential for adsorption to the soil particles. Due to the low water solubility (< 1 mg/L), only low concentrations of the substance are expected in pore water, which is the main exposure route for terrestrial plants. Therefore, tests with soil-dwelling organisms such as earthworms, for which uptake via surface contact, soil particle ingestion and pore water are potential exposure routes (ECHA, 2017), are most relevant for the evaluation of soil toxicity. In addition, in the absence of a clear indication of selective toxicity, an invertebrate (earthworm or collembolan) test is preferred, as outlined in ECHA Guidance (Chapter R.7c, 2017).
In the available earthworm study with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), no significant effects on mortality/growth and reproduction of E. fetida were found, resulting in a NOEC (56 d) ≥ 1000 mg/kg soil dw (OECD 222).
Furthermore, no acute and chronic effects were observed in the available aquatic studies. Moreover, exposure of the soil compartment is generally expected to be low because the substance will not persist in the environment due to ready biodegradability. Indirect exposure via irrigation or atmospheric transport is considered negligible based on the physico-chemical properties of the substance (water solubility: < 1 mg/L; vapour pressure: < 0.00001 Pa).
Thus, no higher toxicity of the test substance is expected for terrestrial plants in comparison to soil macroorganisms and toxicity to terrestrial plants is not expected to be of concern. Therefore, in accordance with Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.4, further studies on the effects on plants are not necessary because the chemical safety assessment indicates absence of toxicity to terrestrial plants.
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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