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EC number: 947-919-1
CAS number: -
No immobile daphnids were observed after 48 h exposure to a test
concentration of 0.104 g/1000 g (loading ratio while operating the
'WAF'). This test concentration is stated as 0.104 g/L.
Table 1: Validity criteria for OECD 202.
Criterion from the guideline
Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.
The inhibition of mobility level in the control cohort is not above 10%.
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.
The dissolved oxygen concentration in dilution water is higher than 7 mg/L.
The highest nominal test concentration (3000 mg/L) was not used for the
assessment since the measured concentrations were lower compared to the
nominal test concentration of 1000 mg/L. Even the nominal concentration
of 1000 mg/L is high above the water solubility and represents the
highest amount of test substance soluble in test medium.
Table 1: Immobilised test species after 24
and 48 h.
immobilised test species [%]
No effects up to the limit of water solubility (EU Method C.2, D. magna,
No effects up to the limit of water solubility (OECD 202, D. magna)
Two studies are available, in which the short-term toxicity of the
target substance Fatty acids, C18-unsaturated, 2-hexyldecyl ester to
aquatic invertebrates was investigated according to internationally
accepted testing guidelines. The key study was conducted with the target
substance and the supporting study was conducted with the structurally
related source substance fatty acids, C16-18, 2-hexyldecyl esters (CAS
101227-09-2). The source substance is characterized by similar fatty
acid and alcohol components and is therefore considered a suitable
representative for the assessment of the short-term toxicity of the
target substance to aquatic invertebrates. Read-across was conducted in
accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 and a
detailed justification of the analogue approach is provided in IUCLID
In the key study, Daphnia magna was exposed to a water
accommodated fraction (WAF) with a nominal test item loading rate of
0.104 g/L for 48 h in a static limit test according to OECD guideline
202. After 48 h no immobilization was observed, resulting in an EL50 (48
h) of > 0.104 g/L (nominal).
In the supporting GLP-study, D. magna was exposed to two WAFs with
nominal test item loading rates of 1000 and 3000 mg/L, respectively, for
48 h in a static test according to EU Method C.2. Test item
concentrations were analytically verified by GC after 0, 24 and 48 h.
The measured test item concentrations in the 1000 mg/L WAF were
1.07 mg/L (0 h), 0.97 mg/L (24 h), and 1.00 mg/L (48 h). The measured
concentrations in the 3000 mg/L WAF were 0.17 mg/L (0 h), 0.12 mg/L (24
h), and < 0.10 mg/L (48 h). After 48 h, no immobilization was observed
resulting in an EL50 (48 h) > 1000 mg/L (nominal) and > 1.034 mg/L
(measured). The highest test concentration was omitted from assessment
due to the poor solubilisation of the test item (floating particles),
which was considered justifiable since both concentrations exceeded the
water solubility by a factor of > 1000.
In summary, the available key study showed that the target
substance Fatty acids, C18-unsaturated, 2-hexyldecyl ester does not
cause any short-term effects on aquatic invertebrates up to the limit of
water solubility(< 0.56 mg/L). This finding is confirmed by the
supporting study with the source substancefatty acids, C16-18,
2-hexyldecyl esters (CAS 101227-09-2).Based on the structural and
chemical similarity of the target and source substances, the target
substance is expected to exhibit a similar ecotoxicological profile as
the source substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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