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EC number: -
CAS number: -
No toxic effects to aquatic algae 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 three structurally related category members; fatty acids
C8-10, mixed esters with DiPE, isooctanoic acid, PE and TriPE (CAS
189200-42-8), decanoic acid, ester with
2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6)
and Fatty acids, C16-18, 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 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 final read across substanceis
a Mono-Tetraester containing a fatty acid chain length of C16 –C18,
nevertheless it is significant 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 water solubility.
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 decanoic acid, ester with
2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) two
studies (one key and one supporting study) are available. The most
recent and reliable 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 mg/L. The second study conducted
according to OECD 203 supports the results revealing in an EL50 of >
1000 mg/L (Craig, 2005).
The third read across study investigated the toxicity of Fatty
acids, C16-18, 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) determined an ErL50 and ErL10 (72h) of
> 100 mg/L (WAF loading rate). It can be concluded that no toxicological
effects on algae are expected up to the water solubility for Fatty
acids, C16-18, 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 the registered substance with CAS 68424-31-7 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
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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