Registration Dossier
Registration Dossier
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EC number: 613-333-7 | CAS number: 63705-03-3
Endpoint summary
Administrative data
Description of key information
Additional information
One experimental study investigating the toxicity of 1,2,3-propanetriol, homopolymer, diisooctadecanoate to soil macroorganism was conducted according to OECD 222 under GLP conditions (Moser &Scheffczyk, 2013) is available. Eisenia fetida was exposed to five nominal concentrations between 62.5 and 1000 mg test item/ kg soil dw for 56 d. Significant effects on reproduction were observed at the two highest test concentrations resulting in a NOEC (56 d) of 250 mg/kg soil dw.
In accordance with Regulation (EC) No. 1907/2006, Annex IX, 9.4.column 2 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that there is no need. The test substance is characterised by a high log Koc (log Koc >= 2.95) indicating a considerable potential for adsorption to the soil particles. Due to the low water solubility (< 0.15 mg/L), only low concentrations are expected in the pore water, which is the main exposure route for terrestrial plants. Therefore, tests soil-dwelling organisms like earthworm which allows potential uptake via surface contact, soil particle ingestion and porewater (ECHA, 2012), are most relevant for the evaluation of soil toxicity of 1,2,3-propanetriol, homopolymer, diisooctadecanoate. 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 section R.7.11.5.3, page 122 (ECHA, 2012). Thus, it can be assumed that earthworms would be highly exposed to toxicants in soil and hence are most sensitive to the potential adverse effects of the substance.
Moreover, 1,2,3-propanetriol, homopolymer, diisooctadecanoate is readily biodegradable and no inhibition of the respiration rate was observed after 3 h for activated sludge microorganisms in a test according to OECD 209 (EC10/EC50 (3 h) > 1000 mg/L). The applied test concentration is higher than concentrations that can be expected in the influent of a sewage treatment plant, as the substance has low water solubility (< 0.15 mg/L). The ECHA Guidance Document R.7c (ECHA, 2012) states that a test on soil microbial activity will only be additionally necessary for a valid PNEC derivation if inhibition of sewage sludge microbial activity has occurred.
In accordance with Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that toxicity to other terrestrial organisms other than to soil macroorganisms is not expected to be of concern.
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