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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 19 October 2022 and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Key value for chemical safety assessment

Additional information

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 19 October 2022 and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Since no studies investigating the short-term toxicity to fish of fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS 84988-75-0) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to two structurally related category members decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and 1-methyl-1,2-ethanediyl diisooctadecanoate (CAS 68958-54-3) was conducted. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment. Both read-across substances represent the upper and the lower limit of fatty acid chain lengths distribution and allow interpolation to the target substance. Nevertheless, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results. The first study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed as a limit test according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio under semi-static conditions. A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since they were oversaturated, whereas the effect concentration was based on the nominal values. Thus, a LL50 of > 1000 mg/L was determined. The second study with the read-across substance propylene glycol diisostearate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio. Five concentrations up to 100 mg/L were tested in a semi-static exposure regime. No effects were observed after an exposure of 96 h resulting in a LC50 > 100 mg/L. Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol will not exhibit acute effects to fish up to the limit of water solubility.