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Experimental data investigating the aquatic toxicity of 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) are not available. Therefore in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, a read across to the source substances pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS 68424-31-7), fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2), decanoic acid, mixed esters, with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9), fatty acids, C8-10 mixed esters with dipentaerythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) and fatty acids, C16-18 (even numbered), esters with pentaerythritol (CAS-No. 85116-93-4) was conducted to cover the aquatic toxicity endpoints.

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the source and target substances are not considered to be harmful to aquatic organisms based on the results from short-term toxicity studies with fish, aquatic invertebrates and algae and chronic toxicity studies conducted with aquatic invertebrates.
Experimental data on the toxicity of the source substances is available for all three trophic levels. All available studies were performed according to internationally accepted guidelines. Acute or chronic toxicity was not observed up to the limit of water solubility of the target and the source substances (WS < 1 mg/L). The evaluation of the short-term toxicity to fish is based on two guideline studies conducted with the source substance pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS 68424-31-7). The determined LC50 (96 h) values was > 1000 mg/L and thus above the limit of water solubility of the target and source substances. The acute toxicity to aquatic invertebrates was determined for the source substance fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2). Immobilisation of Daphnia magna was not observed and an EL50(48 h) > 100 mg/L was determined. Similar results were obtained by toxicity testing in algae. The assessment is based on the source substances fatty acids, C8-10 mixed esters with dipentaerythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) and fatty acids, C16-18 (even numbered), esters with pentaerythritol (CAS-No. 85116-93-4). Inhibition of algal growth was not observed up to the limit of water solubility. Data on the long-term toxicity to fish are not available for any of the analogue substances. However, short-term studies available for fish, daphnia and algae indicate a low potential for aquatic toxicity. Moreover, the reliable NOELR (21 d) obtained from a daphnia reproduction study conducted with the source substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) was > 135 mg/L and thus above the limit of water solubility. Therefore, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed. Respiration inhibition of activated sludge is not anticipated due to the ready biodegradability of the substance and based on two toxicity tests performed with the source substances decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) and Fatty acids, C7, C8, C10 and 2-ethylhexanoic acid, tetraesters with pentaerythritol (CAS 68424-31-7). Overall, it can be concluded that the target substance 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) is not toxic to aquatic organisms up to the limit of water solubility, based on the results from suitable source substances.

 

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