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Short-term toxicity to aquatic invertebrates

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Description of key information

No toxic effects to aquatic invertebrates up to the limit of water solubility.

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity to aquatic invertebrates of ethylene distearate (CAS 627-83-8) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar 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. 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 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 two 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 ethylene distearate will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.