Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-495-0 | CAS number: 68258-72-0
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the water solubility limit.
Key value for chemical safety assessment
Additional information
Since no studies investigating the long-term toxicity of 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) to aquatic invertebrates are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) was conducted. The source substance is representative to evaluate the long-term toxicity of the target substance to aquatic invertebrates.
The target substance 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) is characterized di-, tri-, tetraester of pentaerythritol an fatty acids with a chain lengths of C22. The degree of esterification is variable. However, mainly tri- and tetraesters are the result of the esterification process. Source substance Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1) is a mono-, di-, tri- and/or tetraester (in a variable composition) of mainly C16 and C18 (saturated and unsaturated) up to C22 fatty acids. This read-across is justified in detail in the overall summary (IUCLID Section 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 substance was used for the assessment.
One study investigating the long-term toxicity of the source substance fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) to aquatic invertebrates is available (Schlechtriem, 2013). The GLP study was conducted under semi-static conditions according to OECD 211 using Daphnia magna as test organism. A loading rate of 1 mg/L (nominal) was applied in the limit test. No significant effects on reproduction, mean age of first brood and immobilisation were observed in the treatment throughout the test period of 21 d. A difference between the mean length of the control and treatment group was < 10% (i.e. 6.04%) and is therefore be considered as biologically not relevant. Hence, the NOELR (21 d) is determined to be ≥ 1 mg/L on the basis of the nominal loading rate.
Based on the available result from a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate will not exhibit long-term effects to aquatic invertebrates 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.
