Registration Dossier

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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

A chronic earthworm reproduction test according to OECD 222 is available for DiPE triisononanoate triethylhexanoate (CAS No. 68443-84-5). Mortality, a decrease in body weight of the adult earthworms or inhibition of reproduction was not observed. Thus a NOEC ≥ 1000 mg/kg soil based on the reproduction rate was determined. The result shows that adverse effects of the test substance to terrestrial organisms are highly unlikely. This assumption is further supported by information on the metabolism and aquatic ecotoxicity as given in more detail below.

Aquatic ecotoxicity data

Acute and chronic aquatic toxicity tests of the substance and its read across substances (CAS No. 647028-25-9, Dipentaerythritol ester of nC5/iC9 acids; CAS No. 84418-63-3, Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol) to fish, invertebrates, algae and microorganisms showed no adverse effects occurred in the range of the water solubility of the substance (< 0.05 mg/L measured in aqua dest). The absence of chronic or long-term toxicological effects in aquatic organisms up to the substance solubility limit, can, as ECHAs Guidance R.7c states, can be used as part of a Weight of Evidence argument to modify/waive the data requirements of Annex IX and X. There is a chronic test on aquatic invertebrates available for this substance resulting in a LC50 (21d) well above the limit of water solubility. This result is also supported by algal toxicity data where no toxicity was observed within the water solubility, either. Therefore, it is assumed that due to the lack of chronic aquatic toxicity, long term tests on terrestrial organisms will not result in a different outcome.

Metabolisms/Bioaccumulation

After uptake by organisms, biotransformation of the substance by carboxylesterases into 2-Ethylhexanoic acid, Isononanoic acid and the corresponding alcohol is expected. However, the molecular weight range of 1053 g/mol and the high octanol/water partition coefficient of > 10 in combination with the low water solubility, indicates a low absorption and correspondently slower hydrolysis rate for this substance. All three metabolites are not of concern for the environment. REACh registration dossiers of 2-Ethylhexanoic acid, Isononanoic acid and Dipentaerythritol are available and can be publicly viewed on the ECHA webpage (http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances). QSAR estimations using BCFBAF v3.0 support the expected low bioconcentration with BCF/BAF values of <1 L/kg for this substance.

Conclusion

After uptake by soil species, biotransformation of the substance by carboxylesterases into Dipentaerythritol, 2-ethylhexanoic acid and Isononanoic acid is expected. The supporting BCF/BAF values estimated with the BCFBAF v3.01 program, Arnot-Gobas model including biotransformation, also indicate that this substance will not be bioaccumulative (all below 1 L/kg). Furthermore, aquatic toxicity data show that no effects occur up to the limit of water solubility, even in a chronic Daphnia reproduction test (OECD 211). In addition an OECD 222 reproduction test to earthworm, revealed that no effects occur up to the highest test substance concentration (NOEC >= 1000 mg/kg). Therefore, in accordance with Regulation (EC) No. 1907/2006, Annex X, Column 2, 9.4 further studies on the effects on terrestrial organisms does not have to be conducted since the chemical safety assessment indicates that there is no need.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.