Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are currently no data available investigating the aquatic toxicity of Pentaerythritol, mixed esters with linear and branched fatty acids. In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

The target substance and all source substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the source substances are used to predict comparable results for the target substance Pentaerythritol, mixed esters with linear and branched fatty acids.

The target substance is characterized as a tetraester of pentaerythritol and 2-ethylhexanoic acid and nonanoic acid. The four source substances are structurally very similar to the target substance. Fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2) is characterized as a tetraester of pentaerythritol with fatty acids of C5-C9. The source substance Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) is a triester of trimethylolpropane and C8-C10 fatty acids (even numbered). The source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) ischaracterized as a UVCB of tetraesters of pentaerythritolwith fatty acids valeric, heptanoic, octanoic, and decanoic acids. The source substance Tetraesters of pentaerythritol with heptanoic acid and 3,5,5trimethylhexanoic acid characterized as a UVCB of tetraesters of pentaerythritol with fatty acids, C7-C9 that are both linear and branched.  All selected source substances are representative for the target substance as they all include linear or linear and branched fatty acid esters of similar target chain lengths. They only differ slightly in their specification. However, none of the selected source substances contains any functional group which might change the overall mode of action or expected toxicity. None of the source substances contains any chemical alert structure leading to an increased toxicity.

All experimental studies available for the suitable source substance were performed according to internationally accepted guidelines. They cover all three trophic levels of an aquatic ecosystem. No toxicity was observed up to the limit of water solubility in all available experimental studies. The water solubility of the target substance is predicted to be very low with a concentration of <0.00001 µg/L at 25°C.

The short-term toxicity to fish and aquatic invertebrates was determined in standard OECD guideline studies according to OECD 203 and 202 (using source substances CAS 67762-53-2 and CAS 11138-60-6). No mortality was observed in fish after 96 h resulting in effect values > the limit test concentration (i.e. above the water solubility limit). No immobilization was observed in the treatment throughout the test period of 48 h for aquatic invertebrates below the water solubility limit resulting in effect values > the limit test concentration. The same was recorded for the toxicity to aquatic algae using CAS 1138-60-6. At the water accommodating fraction (WAF) loading rate of 100 mg/L no inhibition with respect to algal growth rate and algal cell growth (area under growth curve) compared to the untreated controls were observed. The no-observed-effect concentration for growth rates (ErL0) and biomass production (EbL0) with respect to the loading rate was ≥ 100 mg/L. The EL50 -value was conducted as EL50 (24 -72 h). But the EL50 can also be stated as EL50 (72 h) > 100 mg/L for the algal growth rate and algal cell growth. Due to the low water solubility, long-term testing to aquatic invertebrates was considered to be necessary to assess the aquatic toxicity. The available studies performed with suitable source substances resulted in a NOELR/NOEC (21 d) ≥ 100 mg/L (nominal) indicating no effects on reproduction up to the limit of water solubility. Long-term toxicity testing to fish has not previously been considered to be necessary in category group of polyol esters since there is no evidence from the available data that fish are more sensitive compared to aquatic invertebrates. No toxicity to fish was observed in the available acute tests. Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.

The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. Available studies performed with activated sludge from a sewage treatment plant did not indicate a risk since respiration of activated sludge microorganisms was not inhibited. 

Based on the results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Pentaerythritol, mixed esters with linear and branched fatty acids exhibits no toxic effects on freshwater organisms up to the limit of the water solubility.