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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 284-864-6 | CAS number: 84988-75-0
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Key value for chemical safety assessment
Additional information
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546485-42-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Since no studies investigating the toxicity to aquatic algae and cyanobacteria of fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (CAS 84988-75-0) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to two structurally related category members butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) was conducted. 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. The first study with butylene glycol dicaprylate / dicaprate was performed as a limit test according to EU Method C.3 using the freshwater algae Scenedesmus subspicatus (Scholz, 1997). A test substance concentration of 1000 mg/L (nominal) and 3 mg/L (measured, based on TOC content) respectively, did not result in any effects on the growth rate and biomass after 72 h resulting in an EL10/50 > 3 mg/L (measured, initial). The recovery rate in the stability test was > 80% and the concentration after 48 and 72 h did not differ more than 20%. Therefore, the test substance was bioavailable throughout the test. The second study with the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene was performed according to the EU Method C.3 under GLP conditions (Scholz, 1995). The green algae Scenedesmus subspicatus was exposed to a Water Accommodated Fraction (WAF) of nominal 5.3 mg/L and subsequent dilutions for 72 h. No effects on the growth rate of S. subspicatus up to the limit of water solubility were observed resulting in an ELr50 > 5.3 mg/L and a NOELR of ≥ 5.3 mg/L. 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, C14-18 and C16-18-unsatd., esters with propylene glycol will not exhibit toxic effects to aquatic algae 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.
