Registration Dossier
Registration Dossier
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EC number: 209-097-6 | CAS number: 555-43-1
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. Glycerol tristearate (CAS No. 555-43-1) is a readily biodegradable and poorly soluble substance (water solubility < 1 mg/L). Due to these characteristics, extensive biodegradation and adsorption to activated sludge within conventional STPs can be expected and therefore, only low concentrations, if any, are likely to be released into the water phase. Fish exposure to this substance is thus expected to be low. The available acute fish tests showed no adverse effects up to the limit of the water solubility of the substance (LC50 (96 h) > 10000 mg/L (nominal, read-across data); LC50 (96 h) > 95 mg/L (nominal, read-across data)). The two other acute studies available for aquatic invertebrates and algae also showed no toxicity (EC50 (48 h) > 3.94 mg/L (nominal) and EC50 (72 h) > 1.8 mg/L (nominal), respectively (read-across data)). A new long-term toxicity test on aquatic invertebrates according to OECD 211 is ongoing performed with a read-across substance (in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5), since the available data do not allow for the determination of a NOEC value. 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.
Based on the short term values, fish cannot be identified as the most sensitive organism. According to the Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2008), long-term toxicity testing on fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish. Considering this information, long-term toxicity testing on fish species is not deemed necessary.
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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