Registration Dossier
Registration Dossier
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EC number: 241-640-2 | CAS number: 17661-50-6
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 (OECD 211); read-across
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity to aquatic invertebrates of tetradecyl stearate are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances dodecyl oleate (CAS 36078-10-1) and (Z)-octadec-9-enyl oleate (CAS 3687-45-4) was conducted. The source substance dodecyl oleate is characterized by a linear C18 unsaturated fatty acid esterified with a linear C12 alcohol. The second source substance (Z)-octadec-9-enyl oleate is a mono-constituent substance characterized by a linear C18 unsaturated fatty acid esterified with a linear C18 unsaturated alcohol. Both substances allow for interpolation to the target substance based on their chemical structure since they cover the upper and lower end of C-chains. This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13.
The study with the source substance dodecyl oleate was performed according to OECD 211 under GLP conditions with the water flea Daphnia magna (Brunswik-Titze, 2013). Five nominal concentrations up to 100 mg/L were tested in a semi-static exposure system as Water Accommodated Fractions (WAF). No effects on the reproduction of D. magna were observed after 21 d. One dead animal was recorded at 50 mg/L but it was reported that it was no substance specific effect (accident during medium change). Therefore, a NOELR (21 d) of ≥ 100 mg/L (nominal) was derived. The chemical analysis resulted in concentrations below the analytical detection limit of 0.005 mg/L reflecting the very low water solubility of the test item.
The second study with the source substance (Z)-octadec-9-enyl oleate was performed according to OECD 211 (GLP) with the water flea Daphnia magna under semi-static conditions (Höger, 2013). Due to the very low water solubility (< 0.05 mg/L) a limit test with a Water Accommodated Fraction (WAF) of nominal 100 mg/L was performed. No effects on reproduction and mortality were recorded after 21 d resulting in a NOELR (21 d) of ≥ 100 mg/L. 0% mortality was recorded in the control whereas 5% mortality was observed in the treatment. This mortality is regarded as natural and tolerated by the test guideline. The chemical analysis resulted in concentrations below the analytical detection limit of 0.0423 mg/L reflecting the very low water solubility of the test item.
Based on the available result 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 and comparable structure, it can be concluded that tetradecyl stearate will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.
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