Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No toxic effects to fish up to the limit of water solubility (WS: < 0.05 mg/L; OECD 203).
Key value for chemical safety assessment
Additional information
In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the two structurally most similar analogue substances dipentaerythritol with fatty acids, C5 and C9iso (CAS 647028-25-9) and isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 844-63-3) was conductedtofulfill the data requirements according to Annex VII-IX offatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) in regard to toxicity to fish.
This read across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the analogue 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. Both substances consist of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths (C5-9 for the target substance compared to C9iso and C5-9iso for the source substances, respectively).
The first study with the read across substance dipentaerythritol with fatty acids, C5 and C9iso was conducted under semi-static conditions according to OECD 203 using rainbow trout as test organism (Wetton and Mullee, 2000). A nominal test concentration of 100 mg/L (prepared as WAF) was applied. The test substance concentration was analysed using GC-analysis and resulted in a concentration of < 0.00613 mg/L (limit of quantification). No mortality and no signs of intoxication were observed resulting in a 96 h LL50 of > 100 mg/L (nomimal).
The second read-across substance isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol was conducted under semi-static conditions according to OECD 203 using rainbow trout as test organism (Comber, 1993). A nominal concentration of 1000 mg/L was applied. No analytical monitoring was performed. No mortality and no signs of intoxication were observed. Therefore, this study resulted in a 96 h LC50 of > 1000 mg/L (nominal). The NOEC was derived to be >= 1000 mg/L (nominal).
Based on the 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 esters with dipentaerythritol will not exhibit toxic effects to fish up to the limit of water solubility. As it can be seen in the data matrix of the analogue justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data support the hazard assessment of each analogue member by showing a consistent pattern of results, i.e. no toxic effects to aquatic organisms were observed 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.
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