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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-027-5 | CAS number: 68171-38-0
Endpoint summary
Administrative data
Description of key information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical 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.
Additional information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical 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.
The dataset for the aquatic toxicity of isooctadecanoic acid, monoester with propane-1,2-diol (CAS 68171-38-0) is not complete. Therefore, the short-term toxicity of the target substance to fish was assessed by means of a read-across approach with experimental data from three structurally and chemically closely related source substances in order to fulfill the standard information requirements laid down in Annex VIII of the REACh Regulation (EC) No 1907/2006. The selected source substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7), 1-methyl-1,2-ethanediyl diisooctadecanoate (CAS 68958-54-3), butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) are characterized by similar fatty acid and alcohol components as the target substance.
According to Article 13(1) of this regulation, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” For aquatic toxicity in particular, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). In regard to the general rules for grouping of substances and the read-across approach, the regulation specifies (Annex XI, Item 1.5) that substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Based on the high degree of structural similarity as well as similar physico-chemical properties of the target and selected source substances, the target substance is expected to have a similar ecotoxicological profile as the selected source substances.
All available studies were performed according to internationally accepted guidelines and GLP. No short-term effects were observed for any of the trophic levels up to the limit of water solubility. Furthermore one long-term toxicity result is available for aquatic algae, which identifies that no long-term hazard is expected for this trophic level.
No toxicity of the substance to freshwater microorganisms was identified in the toxicity control performed within the purposes of a biodegradability study with isooctadecanoic acid, monoester with propane-1,2-diol. The same study showed that microorganisms degrade rapidly the substance and therefore no hazard to aquatic microorganisms is expected.
Based on these data, it is concluded that isooctadecanoic acid, monoester with propane-1,2-diol does not cause adverse effects to aquatic organisms up to the limit of water solubility and is not expected to affect the degradation process in sewage treatment plants.
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.
