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EC number: -
CAS number: -
An experimental study is planned for this substance, however based on available data no chronic toxic effects up to the limit of water solubility (<1mg/L) were observed in any of the read across studies.
There is no long-term test on aquatic invertebrates available for
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. However, due to the poor
water solubility of the test substance and as long term toxicity to
aquatic organisms is a mandatory endpoint in accordance to Regulation
(EC) No 1907/2006, Annex IX 9.1 Aquatic toxicity, we propose to test the
long term toxicity on invertebrates in order to confirm that no chronic
toxicity to aquatic organisms occurs for the polyol esters with shorter
chain lengths (C5 C10). CAS 68424-31-7 (C5, C7, C8 and C10) is a highly
complex UVCB, with varying chain lengths and combinations of structures,
hence this substance is representative for all C5-C10 PEpolyol esters in
addition to the further testing proposal submitted for CAS 15834-04-5,
which has the shortest chain length (C5) of PE esters, it is a
mono-constituent and often is a constituent with many of the other
polyol esters. For further justification on the choice of of this
representative testing substance within the poylol esters category
please see the attached document.
Reliable tests on the long-term toxicity to aquatic invertebrates
are also provided which indicate that the polyol esters will not exhibit
long-term effects to aquatic invertebrates up to the limit of water
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.
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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