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EC number: 701-023-5
CAS number: 85408-61-3
An experimental study is planned according to OECD 211.
There is no long-term test on aquatic invertebrates available for
Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and
linear, di- and triesters with trimethylolpropane (former CAS
85005-23-8). 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 longer,
unsaturated chain lengths. In particular, Fatty acids, C16-18 (even
numbered) and C18-unsatd., branched and linear, di- and triesters with
trimethylolpropane (former CAS 85005-23-8) was selected as a
representative test substance for this chain length, but it was also
selected in order to cover saturated and branched C16/C18 chain lengths
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 read-across study investigated the chronic toxicity of
Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane
(CAS 68002-78-8) to aquatic invertebrates according to OECD 211 (Grell,
2013). Daphnia magna were exposed to the test substance in a semi-static
test system. The water accommodated fraction (WAF) was used for the
preparation of the test solutions. During the exposure period of 21 days
the mortality and reproduction rate of the test animals was recorded.
The substance affected neither the survival rate nor the reproduction
rate of D. magna. Based on the loading rate a NOELR ≥ 0.11 g/L was
determined. Thus toxic effects C16-18 and C18-unsatd., triesters with
trimethylolpropane (CAS 68002-78-8) were not observed within the limit
of water solubility (WS<0.05 mg/L).
The second read across study was chosen as it should have a
theoretically higher bioavailability (even though all are insoluble)
than the target substance due to the lower chain lengths (C8-C10) This
test can therefore confirm that no chronic toxicity to aquatic organisms
occurs for the polyol triesters with shorter chain lengths (C8-10 ) with
propylidynetrimethanol. In this GLP study on the long-term toxicity of
fatty acids, C8-10 (even numbered), di-and triesters with
propylidynetrimethanol (CAS No. 11138-60-6) was performed according to
the OECD guideline 202 part 2 (Low, 1996). The test organism Daphnia
magna was exposed to the test substance in a semi-static system for 15
days. Though the exposure time does not meet the recommended 21 days
test duration for long-term tests the study is considered as valid.
According to the ECHAs 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). Thus 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. Effects on the reproduction or mobility of Daphnia
magna were not observed at the tested concentrations. A NOELR of 2570
mg/L is reported. The concentration is based on the water accommodated
fraction (WAF) of the substance.
As soon as further chronic toxicity data for Fatty acids, C16-18
(even numbered) and C18-unsatd., branched and linear, di and triesters
with trimethylolpropane becomes available the chemical safety assessment
will be updated accordingly.
Based on these already available results from 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, it can be concluded that Fatty acids, C16-18 (even numbered)
and C18-unsatd., branched and linear, di- and triesters with
trimethylolpropane (former CAS 85005-23-8) will not exhibit long-term
toxic effects to aquatic invertebrates up to the limit of water
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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