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EC number: 239-937-7
CAS number: 15834-04-5
No toxic effects to aquatic algae up to the limit of water solubility.
In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read
across to two key structurally related category members fatty acids,
C8-10 mixed esters with dipentaerythritol, isooctanoic acid,
pentaerythritol and tripentaerythritol (CAS 189200-42-8), fatty acids,
C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS
11138-60-6) and one supporting study with fatty acids, C16-18 (even
numbered), esters with pentaerythritol (CAS-No. 85116-93-4) was
conducted. 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. The fatty acid
chain length of C8 – C10 of the key read-across substances are similar
to those of the target substance. In addition, the first read-across
substance fatty acids, C8-10 mixed esters with dipentaerythritol,
isooctanoic acid, pentaerythritol and tripentaerythritol contains the
same alcohol component, i.e. pentaerythritol, and is a tetra-ester. The
third read across substance is a mono-tetraester containing a fatty acid
chain length of C16 –C18, nevertheless it is relevant as it pins the
longer chain length end of the polyol esters category and shows that at
this chain length no toxicity to algae is expected up to the limit of
The first study with the read-across substance fatty acids, C8-10 mixed
esters with dipentaerythritol, isooctanoic acid, pentaerythritol and
tripentaerythritol (CAS 189200-42-8) was performed according to OECD 201
under GLP conditions (Febbo, 1995). The green algae Scenedesmus
capricornutum was exposed to nominal concentrations of 62.5 mg/L, 125
mg/L, 250 mg/L, 500 mg/L and 1000 mg/L. 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. No inhibition of growth of Scenedesmus
capricornutum up to the limit of water solubility was observed resulting
in an EL50 > 1000 mg/L (nominal). A NOELR of ≥ 1000 mg/L was determined
based on effects on growth rate.
For the second read across substance fatty acids, C8-10 (even numbered),
di-and triesters with propylidynetrimethanol (CAS 11138-60-6) one study
was conducted according to OECD 201 and GLP (Häner. 2007) as limit test.
The green algae Desmodesmus subspicatus was exposed to a limit
concentration of 100 mg/L (nominal). A water accommodated fraction (WAF)
was prepared by stirring the test substance in algal medium for 24 h and
removing undissolved materials by filtration. No inhibition of growth
rate and effects on biomass were observed resulting in an EL50 > 100
The third read across study investigated the toxicity of fatty acids,
C16-18 (even numbered), esters with pentaerythritol (CAS-No. 85116-93-4)
to algae. This static algal growth inhibition test with
Pseudokirchnerella subcapitata was conducted according to GLP and EPA
OPPTS 850.5400 (Algal Toxicity, Tiers I and II) and determined an ErL50
and ErL10 (72h) of > 100 mg/L (WAF loading rate) (Scheerbaum, 2007). It
can be concluded that no toxicological effects on algae are expected up
to the water solubility for fatty acids, C16-18 (even numbered), esters
with pentaerythritol (CAS-No.85116-93-4).
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 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate
(CAS-No.15834-04-5) will not exhibit effects to aquatic algae up to the
limit of water solubility. 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 polyol esters category support this
hazard assessment by showing a consistent pattern of results, i.e. no
toxic effects were observed to aquatic algae or other aquatic organisms
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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