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Long-term toxicity to aquatic invertebrates

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The hazard assessment is based on the current data available. Based on the ECHA decision on a compliance check (decision number CCH-D-2114546485-42-01/F) from 14 April 2021 a long-term toxicity study on aquatic invertebrates (OECD 211) is requested. The finalised study will be included into the dossier and the aquatic toxicity will be re-evaluated in the update of this dossier latest by 19 October 2022.

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The hazard assessment is based on the current data available. Based on the ECHA decision on a compliance check (decision number CCH-D-2114546485-42-01/F) from 14 April 2021 a long-term toxicity study on aquatic invertebrates (OECD 211) is requested. The finalised study will be included into the dossier and the aquatic toxicity will be re-evaluated in the update of this dossier latest by 19 October 2022.

Since no studies investigating the long-term toxicity to aquatic invertebrates 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 another structurally related category member butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. Nevertheless, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results. The study was performed according to the OECD Guideline 211 under GLP conditions. Daphnia magna was exposed to individually prepared Water Accommodated Fractions (WAF’s) of nominal 6.25, 12.5, 25, 50 and 100 mg/L under semi-static conditions. Analytical determination of test solution concentration resulted in very low concentrations of 0.03 mg/L in freshly prepared medium and concentrations below the detection limit of 0.01 mg/L before test medium renewal periods after every 48 or 72 h, respectively. After 21 d, no particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test resulting in an EL50 of > 0.02 mg/L (measured, arithm. mean) and a NOELR of ≥ 0.02 mg/L (measured, arithm. mean). Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is 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 chronic effects to aquatic invertebrates up to the limit of water solubility.