Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
A valid OECD 211 study performed as a limit test according to GLP is available for a substance in the same subgroup of the category ( Fatty acids, C16-18 and C18-unsatd., Me esters, epoxidized, reaction products with ethylene glycol (CAS 211450 -54 -3). The No Observed Effect (NOEC) concentration was > 10 mg/l.
This substance is part of the Dossier Improvement Pilot Project (DIP) as a member of the category “Epoxidized fatty acid esters (EFAE)”, as agreed upon by the European Chemicals Agency (ECHA) and the European Chemical Industry Council (CEFIC).
To confirm the hypothesis a testing proposal for long-term toxicity to aquatic invertebrates for Fatty acids, C16-18 and C18-unsatd., Me esters, polymers with trimethylopropane (CAS 188831 -96 -1) is submitted.
Key value for chemical safety assessment
Additional information
In a 21-day chronic toxicity study, Daphnia magna were exposed to water accommodated fractions of an analogous substance fatty acids, C16 -18 and C18 -unsatd., epoxidized, Me esters, reaction products with ethylene glycol (CAS 211450 -54 -3) prepared at loading rates of 0 (control), 10 mg/L under semistatic daily renewal conditions in accordance with the OECD 211 guideline. The water pH, temperature and dissolved oxygen were within acceptable guideline specifications. Mortality, reproduction and sublethal effects were observed daily.
The following overall effect concentrations (mg/L) were obtained based on nominal
concentrations (loading rate):
LOEC/LOELR > 10 mg/L
NOEC/NOELR ≥ 10 mg/L
No significant mortality or any other additional significant adverse effects or abnormal behavior were observed in any of the test treatments. The data were not sufficient to calculate ECx values for reproduction or mortality. However based on best professional judgment, a 21-day EC0 ≥ 10 mg/L is estimated.
The study was tested with a similar molecule, which has the same structural body, only the reaction products of the functional groups are different. Both substances show similar structural, physico-chemical, environmental and toxicological properties.
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