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EC number: -
CAS number: -
No long-term toxic or adverse effects to aquatic invertebrates (e.g., Daphna magna) in terms of reproduction or survival is expected up to the limit of water solubility (<1mg/L); based on read-across studies.
There is no long-term test on aquatic invertebrates available for
the registered substance, CAS 68424-31-7. Since all substances within
this polyol esters category are readily biodegradable, it is not
foreseen that they will pose a risk to aquatic invertebrates on the
long-term. Reliable read-across data on the long-term toxicity in
aquatic invertebrates are available which indicate that the polyol
esters will not exhibit long-term effects to aquatic invertebrates up to
the limit of water solubility.
The first study with the read-across substance decanoic acid,
mixed esters with heptanoic acid, octanoic acid, pentaerythritol and
valeric acid (CAS No. 71010-76-9) was conducted under semi-static
conditions according to OECD 211 using Daphnia magna as test organism
(Letinski & Bragin, 2011). The test solution was prepared by adding the
appropriate amount of test substance with subsequent stirring and
sampling of the aqueous portions (WAFs) through the outlet at the bottom
of the vessels. A loading rate WAF of 135 mg/L (nominal) was applied in
a limit test. No significant effect on reproduction was observed in the
treatment throughout the test period of 21 d. Hence, the 21 d-NOELR is
determined to be > 135 mg/L on the basis of the nominal test
The second study investigating the long term toxicity to aquatic
invertebrates was performed with the read-across substance decanoic
acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
(CAS 11138-60-6) according to OECD guideline 202 "Daphnia sp. Acute
Immobilization Test and Reproduction Test", Part 2 (1993) under
semi-static conditions (Low, 1996). This test guideline is similar to
OECD 211 which was adopted in 1998. The study period of 15 days does not
meet the criteria of today standard methods recommending 21 days study
duration. However, according to the Guidance on information requirements
and chemical safety assessment, Chapter R7.b (ECHA, 2012) the study can
be regarded as valid for a long-term evaluation as corresponding
criteria were fulfilled (e.g. 80% survival in the control, surviving
females produce three broods in 21 days or less, > 60 brood neonates per
female in the control on average). In addition, all requested endpoints
could be determined (time to first brood, number of offspring produced
per female, growth and survival) and NOELR values for survival or
reproductive endpoints could be calculated. In this study Daphnia magna
were exposed to nominal concentrations of 0, 24, 97, 242, 1018 and 2570
mg/L (prepared as water accommodated fraction, WAF). No effects were
observed up to the highest test concentration resulting in a NOELR of ≥
2570 mg/L based on reproduction and immobilization.
As it can be seen in the data matrix of the category justification
in section 13 and the overall endpoint summary IUCLID 6.1, all reliable
data in the category support the hazard assessment of each category
member by showing a consistent pattern of results, i.e. no toxic effects
to aquatic organisms were observed up to the limit of water solubility.
In summary, owing to the low water solubility of the registered
substance, long-term chronic toxicity to aquatic invertebrates (e.g.,
reproduction, survival) is not expected for the registered substance up
to the limit of its solubility in water (<1 mg/L). No additional
chronic toxicity testing is proposed.
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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