Registration Dossier
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EC number: 306-657-2 | CAS number: 97358-80-0
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility (WS 0.1 mg/L)
Key value for chemical safety assessment
Additional information
No experimental data evaluating the chronic toxicity of isooctadecanoic acid, mono- and diester with glycerol (CAS No. 97358-80-0) to aquatic invertebrates are available.Therefore, toxicity data from a structurally related category member (Glycerides, C14-18 and C16-18 unsatd. mono-, di- and tri-, CAS No. 91052-28-7) are used as read-across in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Both are UVCB substances, formed from the esterification of long-chain fatty acids (C14-18 and C16-18 unsaturated and C18 iso for CAS No. 91052-28-7 and CAS No. 97358-80-0, respectively) and glycerol.They are predominantly monoesters. Furthermore, both substances are insoluble in water (water solubility 0.1 mg/L and < 0.05 mg/L for target and source substance, respectively) and have log Kow values > 4. They are expected thus to show similar behaviour in the water phase. The acute tests conducted with these two substances on Daphnia magna (Schlechtriem (2012); Salinas (2013)) showed no immobilization up to a nominal loading rate of 100 mg/L (WAF). Therefore, the EL50 (48 h) values were determined to be > 100 mg/L (nominal, loading rate). There results indicate that indeed, due to their structural and physico-chemical similarities, isooctadecanoic acid, mono- and diester with glycerol and Glycerides, C14-18 and C16-18 unsatd. mono-, di- and tri- are expected to exhibit a comparable toxicity profile. Based on the above information, the use of Glycerides, C14-18 and C16-18 unsatd. mono-, di- and tri- as read-across substance is considered justified.
The chronic toxicity of Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7)to aquatic invertebrates has been evaluated by Salinas (2013). This test was conducted according to OECD 211, under GLP conditions. Daphnia magna was exposed to the substance at a single loading rate of 10 mg/L (limit test) for 21 days within a semi-static water regime. At the end of the exposure period, no effects on survival, reproduction or any other adverse effects were reported. Therefore the NOELR was determined to be ≥ 10 mg/L (nominal, loading rate).
Based on the results obtained for the structurally related analogue substance (in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5), no chronic toxicity of isooctadecanoic acid, mono- and diester with glycerol to aquatic invertebrates up to the limit of its water solubility (0.1 mg/L) is expected.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within the CSR.
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