Registration Dossier
Registration Dossier
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EC number: 284-864-6 | CAS number: 84988-75-0
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 data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, 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 are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, 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 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.
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