Registration Dossier
Registration Dossier
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EC number: 269-130-5 | CAS number: 68187-85-9
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.
One study on the toxicity to aquatic invertebrates is available for Fatty acids, tall-oil, esters with ethylene glycol (CAS 68187-85-9). The assessment of the toxicity to microorganisms is based on the toxicity control from the biodegradation study of the target substance. Read-across to the structurally related source substances ethane-1,2-diyl dioctadecanoate (CAS 627-83-8) was conducted for short-term toxicity to fish. Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) was used as source substance for toxicity to algae. This read-across approach was applied in order to fulfil the standard information requirements according to Annex IX of Regulation (EC) No 1907/2006 and is in compliance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are considered suitable representatives for the assessment of the aquatic toxicity of the target substance.
The short-term toxicity to freshwater fish was assessed using data available for ethane-1,2-diyl dioctadecanoate (CAS 627-83-8) as read-across. The study on the source substance was carried out according to OECD guideline 203 and GLP. The LC50 (96 h) was > 0.3 mg/L (nominal).
The short-term toxicity to aquatic invertebrates was determined in a study with the target substance Fatty acids, tall-oil, esters with ethylene glycol (CAS 68187-85-9). The study was carried out according to OECD guideline 202 and GLP resulting in an EL50 (48h) > 100 mg/L (nominal).
The toxicity to aquatic algae conducted with the source substance Fatty acids, C16-18, esters with ethylene glycol (CAS 91031-31-1) was tested in one study according to DIN 38412 resulting in an EC50 (72 h) > 100 mg/L (nominal) and an EC10 (72 h) of 34 mg/L (nominal).
The toxicity to microorganisms was assessed with the toxicity control of the biodegradation study (OECD 301F) for the target substance. The toxicity control attained 61% degradation after 14 days of incubation. Hence, the substance is considered not toxic to aquatic microorganisms and the test item concentration of 102.87 mg/L can be used as NOEC.
Based on the available results from the target substance and structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5), which are characterized by a comparable structure and chemistry, it can be concluded that the target substance Fatty acids, tall-oil, esters with ethylene glycol (CAS 68187-85-9) will exhibit no aquatic effects in the limit of water solubility.
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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