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EC number: - | CAS number: -
No toxic effects to aquatic invertebrates up to the limit of water solubility.
In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to four structurally related category members decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9), fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2), fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) and fatty acids, C8-10 mixed esters with dipentaerythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8) 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. The first two 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 comparable to the target substance.
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.
In addition, two further read-across studies were available where the short term toxicity of fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS-No. 11138-60-6), and fatty acids, C8-10 mixed esters with dipentaerythritol, 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 to Daphnia magna. The study conducted with CAS 11138-60-6 (Häner, 2007) determined EL 50 (48h) > 100 mg/L (WAF loading rate) and Febbo (1995) observed an EL50 > 1000 mg/L, WAF loading rate, for CAS 189200-42-8.
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 fatty acids, C5-10 (linear and branched), tetraesters with pentaerythritol (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 toxicity 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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