Registration Dossier
Registration Dossier
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EC number: 211-014-3 | CAS number: 627-83-8
Endpoint summary
Administrative data
Description of key information
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546474 -45 -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.
Additional information
The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546474 -45 -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.
In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the Glycol Esters Category members are not considered to be harmful to aquatic organisms based on the results from short-term studies with fish, aquatic invertebrates and algae and long-term results on toxicity to aquatic invertebrates. All category members are structurally similar and read-across was performed to the structurally most similar category member(s). The available studies cover the variability of the category with different alcohol and fatty acid chain lengths. The data gaps within the category were filled by interpolation and if necessary by extrapolation since the category members are characterized by a similar pattern in the ecotoxicological toxicity profile. No trend in toxicity was observed since no effects were recorded up to the limit of water solubility. There is no convincing evidence that any one of the category members might lie out of the overall profile of this category.
In particular, short-term studies with freshwater species from all three trophic levels (algae, aquatic invertebrates and fish) are available. Four acute toxicity studies to fish according to internationally accepted guidelines are available for the category members ethylene distearate (CAS 627-83-8), decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7), Butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and propylene glycol diisostearate (CAS 68958-54-3). No effects were observed up to the limit of water solubility. The available studies are covering the variability of the category with different alcohol components and representative fatty acid chain lengths. Thus, the data gaps can be covered by interpolation.
The same result was found in short-term toxicity studies with aquatic invertebrates for the category members decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8). No toxicity was observed up to the limit of water solubility in the available studies. Based on the results from these studies in combination with an available chronic result with Daphnia magna, there is no convincing evidence that the other category members lie out of the overall toxicity profile. Despite the overall low water solubility of the category members (< 0.05 mg/L) the results from decanoic acid, mixed diesters with octanoic acid and propylene glycol and butylene glycol dicaprylate / dicaprate are considered to exhibit a higher bioavailability through the water phase which is the most common route of uptake in standard aquatic tests. The water solubility directly correlates with the hydrocarbon chain lengths of the fatty acid (Lide, 2005). Thus, this read-across can be seen as a worst case.
Three standard guideline studies investigating the toxicity to aquatic algae are available for the following substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7), Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8). No toxicity was observed up to the limit of water solubility in the available studies. The available studies are covering the variability of the category with different alcohol components and fatty acid chain lengths at the lower and upper end of the category.Thus, the data gaps can be covered by interpolation.
One long-term study with Daphnia magna is available for the category member butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) resulting in a NOEC (21 d) > water solubility. This study was used as read-across for the other category members based on structural similarities. Moreover, it can be concluded that this substance can be seen as a worst case read-across approach based on the smaller fatty acid chain lengths which probably exhibits a higher water solubility since the hydrocarbon chain lengths of the fatty acid is directly correlated with the water solubility (Lide, 2005).
Toxicity to microorganisms was investigated in two studies for decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8), respectively. The first study with decanoic acid, mixed diesters with octanoic acid and propylene glycol was not considered to be reliable since only one single species (Pseudomonas putida) was tested. Nevertheless, no effects on O2-consumption were observed. The result from the second study with butylene glycol dicaprylate / dicaprate according to an accepted guideline was considered valid. No effects on respiration of activated sludge microorganisms were observed. Based on structural similarities this study was used for read-across throughout the category. In combination with results from the available biodegradation studies it can be concluded that no effects on the STP microorganism community and the subsequent degradation process in sewage treatment plants is anticipated.
In conclusion, no effects on aquatic organisms were observed in the available studies for the Glycol Esters category members in any of the three trophic levels (fish, daphnia, algae) for substances within the category up to the limit of water solubility, neither in the short-term toxicity tests nor in a long-term test with daphnia. The Glycol Esters category is a robust category with a large amount of reliable data which allows a conclusive overview about the overall ecotoxicity profile of all category members. In each case of read-across, the best suited read-across was chosen. Nevertheless, as it can be seen in the data matrix of the category justification in IUCLID Section 13, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.
For a detailed reference list please refer to the CSR.
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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