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EC number: 210-826-5 | CAS number: 624-03-3
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
The hazard assessment is based on the current data available. Based on the ECHA decision on a compliance check (decision number CCH-D-2114546559-35-01/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 22 July 2024.Key value for chemical safety assessment
Additional information
The hazard assessment is based on the current data available. Based on the ECHA decision on a compliance check (decision number CCH-D-2114546559-35-01/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 22 July 2024.
Since no studies investigating the long-term toxicity to aquatic invertebrates of ethane-1,2-diyl palmitate (CAS 624-03-3) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related category member butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category justification in IUCLID Section 13. 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, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, 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 (Hertl, 2001). 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 ethane-1,2-diyl palmitate will not exhibit chronic effects to aquatic invertebrates up to the limit of water solubility.
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