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CAS number: -
No toxic effects to aquatic invertebrates up to the limit of water solubility (<1mg/L); read-across
In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a
read across to two structurally related category members decanoic
acid, mixed esters with heptanoic acid, octanoic acid,
pentaerythritol and valeric acid (CAS No. 71010-76-9) and fatty
acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2) in
order to fulfil the data requirements according to Annex VII-IX.
This read-across is justified in detail in the overall summary
(IUCLID chapter 6.1) and within the category justification in IUCLID
Section 13. In this case of read-across, the best suited (highest
degree of structural similarity, nearest physico-chemical
properties) read-across substances were used for the assessment. All
read-across substances have the same alcohol component, i.e.
pentaerythritol, and are tetra-esters with a fatty acid chain length
within the range of C5 – C10 are comparable to the target substance
with chain length of C5.
The short-term toxicity of decanoic acid, mixed esters with
heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS
No. 71010-76-9) to aquatic invertebrates was investigated according
to OECD 202 using Daphnia magna as test organism under static
condition (Blattenberger, 2006). The test solutions were 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. Loading rate WAFs of 62, 132,
251, 503 and 1072 mg/L were tested. No immobilisation was observed
in any treatment and the control throughout the test period of 48 h.
Hence, the 48 h-EL50 is determined to be > 1072 mg/L based on the
nominal test concentration.
The short-term toxicity of fatty acids, C5-9 tetraesters with
pentaerythritol (CAS 67762-35-2) to aquatic invertebrates was
investigated in a study according to OECD 202 using Daphnia magna as
test organism under static conditions (Migchielsen, 2012). The WAFs
were prepared by adding the appropriate amount of test substance
with subsequent stirring and sampling of the aqueous portions A
nominal test concentration of 100 mg/L, corresponding to a measured
concentration of 1.3 mg/L, was tested. No immobilisation was
observed in the treatment throughout the test period of 48 h. Hence,
the 48 h-EL50 is determined to be > 100 mg/L based on the nominal
test concentration and > 1.3 mg/L based on the measured
concentration. It can therefore be concluded that the test substance
will not exhibit short-term effects to aquatic invertebrates up to
the limit of water solubility.
These findings are supported by two further read-across
studies to the TMP group where the short term toxicity of Decanoic
acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
(CAS-No. 11138-60-6), and Fatty acids, C8-10 mixed esters with
dipenaterythritol, isooctanoic acid, pentaerythritol and
tripentaerythritol (CAS 189200-48-8) was investigated according to
OECD 202. All measured results from 48 -hour toxicity studies
indicate the test substance is of low toxicity toDaphnia magna. The
11138-60-6 study (Häner, 2007) determined EL 50 (48h) > 100 mg/L
(WAF loading rate) and Febbo (1995) observed an EL50 > 1000 mg/L,
WAF loading rate.
Based on these 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 Tetra-esterification products of C5, C7,
C8, C10 fatty acids with pentraerythritol (CAS 68424-31-7) will not
exhibit short-term toxic effects to aquatic invertebrates up to the
limit of water solubility.
In addition a long term toxicty test to aquatic invertebrates has
been proposed for CAS 68424 -31 -7, hence the chemical safety
assessment will be updated accordingly. As it can
be seen in the data matrix of the category justification in section
13 and the overall summary, all reliable data in the category
support the hazard assessment of each category member by showing a
consistent pattern of results.
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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