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Short-term toxicity to aquatic invertebrates

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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.

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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 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 two structurally related category members decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and 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 substances were used for the assessment. The first study with decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed according to the EU Method C.2 under GLP conditions (Scholz, 1995). Daphnia magna was exposed to a measured concentration (geometric mean) of 2.4 mg/L in a static limit test for 48 h. Since the test solution was prepared by adding 1 g/L with subsequent filtration (WAF), the measured concentration of 2.4 mg/L represents the highest concentration which is soluble in water. No effects were observed resulting in an EL50 of > 2.4 mg/L. The second study using butylene glycol dicaprylate / dicaprate supports this result (Scholz, 1997). It was conducted under the same conditions like the first study. Daphnia magna was exposed to a measured concentration (initial) of 2 mg/L in a static limit test for 48 h. The test concentration of 2 mg/L represents the highest soluble concentration, since 1 g/L was added to the test medium, stirred and subsequently filtered (WAF). No effects were observed, resulting in an EL50 of > 2 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 toxic effects to aquatic invertebrates up to the limit of water solubility.