Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
Toxicity to microorganisms
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-2114546451-53-01/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-2114546451-53-01/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 microorganisms of Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across conducted to the two structurally related substances propylene glycol diisostearate (CAS 68958-54-3) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8).
The study with propylene glycol diisostearate was performed according to ISO 10712 under GLP conditions with Pseudomonas putida. A filtered test substance concentration of nominal 10000 mg/L was tested in this study. No inhibition of growth was observed after an incubation of 16 h resulting in an EL10 of > 10000 mg/L. The influence of the read-across substance butylene glycol dicaprylate / dicaprate to activated sludge microorganisms was investigated in a GLP study according to EU Method C.11. A test concentration of nominal 1099 mg/L did not result in an inhibition of the respiration rate after 3 hours. Thus, an EC10 of > 1099 mg/L (nominal) was derived.
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 an equal ecotoxicological profile, it can be concluded that Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) will not exhibit toxic effects to microorganisms.
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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