Registration Dossier
Registration Dossier
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EC number: 209-097-6 | CAS number: 555-43-1
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
Testing according to OECD 211 is ongoing
Key value for chemical safety assessment
Additional information
No experimental data evaluating the long-term toxicity of glycerol tristearate (CAS No. 555-43-1) to aquatic invertebrates are available.Therefore, toxicity data from a structurally related analogue substance, propane-1,2,3-triyl trisheptanoate (CAS No. 620-67-7) are used as read-across in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Both substances are esters formed from the combination between fatty acids and glycerol as alcohol component. Propane-1,2,3-triyl trisheptanoate and glycerol tristearate are triglycerides (the three hydroxyl functional groups of the glycerol molecule are esterified with fatty acids), differing only in the length of the C-chain of their fatty acid components (C7 and C18 respectively).The behaviour of these substances in the water phase is expected to be very similar based on very low water solubility values (<1 mg/L) and log Pow (>8). Nevertheless, the bioavailability of glycerol tristearate to aquatic organisms is expected to be lower than that of propane-1,2,3-triyl trisheptanoate due to its high molecular weight (> 700 g/Mol) which can difficult the crossing of biological membranes (Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2008)). Based on this information, reading-across from
Based on this information, reading-across propane-1,2,3-triyl trisheptanoate is justified and can be considered as a worst-case approach for glycerol tristearate.
The chronic toxicity of propane-1,2,3-triyl trisheptanoate (CAS No. 620-67-7) to aquatic invertebrates has been evaluated by Schlechtriem (2012). This test was conducted according to OECD 211, under GLP conditions. Daphnia magna was exposed to the substance at a single test concentration (100 mg/L, limit test) for 21 days within a semi-static water regime. At the end of the exposure period, no effects on mobility, timing for reproduction (1st brood) or body length were reported. On the other hand, statistically significant differences between control and treatment group were observed regarding the number of offspring (inhibition effect of 15.5%). Therefore, the overall NOELR could not be determined. Due to this fact,a new test according to OECD 211 is ongoing. The dossier will be updated as soon as possible and the Chemical Safety Assessment according to Annex I of Regulation (EC) No 1907/2006 will be re-evaluated based on the outcome of this new study.
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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