2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate

Short-term toxicity to aquatic invertebrates

Description of key information

No effects up to the limit of water solubility (OECD 202), read across.

Additional information

Since no studies investigating the short-term toxicity of 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2) and Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) was conducted.

The target substance is characterized by C18 unsaturated fatty acid esterified trimethylolpropane (TMP) (mainly di- and triester). The selected source substances are structurally very similar to the target substance and are thus adequate for the assessment of short-term toxicity to aquatic invertebrates. Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2) is characterized by C18, C18 unsatd fatty acids triesterified with TMP. Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6) mainly consists of C18:1 FA triesterified with TMP. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue 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.

Two studies, investigating the short-term toxicity to aquatic invertebrates of the source substance Fatty acids, C16-18 even numbered and C18-unsatd. triesters with propylidynetrimethanol (former CAS 57675-44-2) are available. The available studies were performed under static conditions according to OECD 202. Daphnia magna was used as test organism. The test solution was prepared by Water Accommodated Fraction (WAF). The first study determined an EL0 (48 h) ≥ 100 mg/L and EL50 (48 h) > 100 mg/L (Häner, 2006). This is supported by the second study which resulted in an EL50 (48 h) > 1000 mg/L (Craig, 2005).

Two short-term studies with Daphnia magna, freshwater invertebrates, and one short-term test with Acartia tonsa, a marine invertebrate, are available for the source substance Fatty acids, C8-10 (even), C14-18 (even) and C16-18 (even)-unsatd., triesters with trimethylolpropane (former CAS 85186-89-6). In both static GLP-freshwater studies equivalent or similar to OECD 202 no immobilised daphnids or other adverse reactions were observed within 48 h (first study: EL0 ≥ 100 mg/L, EL50 > 100 mg/L; second study: NOELR ≥ 1000 mg/L, EL50 > 1000 mg/L). Because of the serial dilution in the supporting study from the highest concentration (1000 mg/L), only the highest test concentration of 1000 mg/L was valid and could be used for evaluation of toxicity of the test substance. In the static GLP-saltwater study (Hudson, 2005) according to ISO 14669 no immobilisation was determined within 48 h of exposure (NOELR ≥ 10000 mg/L, EL50 > 10000 mg/L).

Based on the available result from several structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that 2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate will not exhibit short-term effects to aquatic invertebrates up to the limit of water solubility.