Registration Dossier
Registration Dossier
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EC number: 210-826-5 | CAS number: 624-03-3
Toxicity to aquatic algae and cyanobacteria
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 growth inhibition study aquatic plants (OECD 201) 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.See also the attached category concept document in chapter 13 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 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 growth inhibition study aquatic plants (OECD 201) 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 toxicity of ethane-1,2-diyl palmitate (CAS 624-03-3) to aquatic algae are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the two structurally related category members butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) was conducted.
The first study with butylene glycol dicaprylate / dicaprate was performed as a limit test according to EU Method C.3 using the freshwater algae Scenedesmus subspicatus (Scholz, 1997). A test substance concentration of 1000 mg/L (nominal) and 3 mg/L (measured, based on TOC content) respectively, did not result in any effects on the growth rate and biomass after 72 h resulting in an EL10/50 > 3 mg/L (measured, initial). The recovery rate in the stability test was > 80% and the concentration after 48 and 72 h did not differ more than 20%. Therefore, the test substance was bioavailable throughout the test. The second study with the read-across substance fatty acids, C16-18, esters with ethylene glycol was performed according to the DIN 38412-9 under GLP conditions (Stelter, 1994). The green algae Scenedesmus subspicatus was exposed to nominal concentrations of 10 and 100 mg/L without a further filtration step. No inhibition of growth of S. subspicatus up to the limit of water solubility was observed resulting in an EC50 > 100 mg/L. An EC10 of 34 mg/L was determined since growth stimulation was observed in both concentrations used in this study. 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 ethane-1,2-diyl palmitate will not exhibit toxic effects to aquatic algae up to the limit of water solubility.
The assessment is based on the current data available. Based on the decision on a compliance check (decision number XXX) from 14 April 2021 a growth inhibition study for aquatic plants (OECD 201) 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.
See also the attached category concept document in chapter 13 showing an overview of the strategy for all substances within the glycol esters category.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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