Registration Dossier
Registration Dossier
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EC number: 813-120-0 | CAS number: 1262967-45-2
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- the study does not need to be conducted because the substance is highly insoluble in water
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Section 9.2.2.1, Column 2; of Regulation (EC) 1907/2006 states that the study does not need to be conducted if:
— the substance is readily biodegradable, or
— the substance is highly insoluble in water.
In this instance the water solubility was determined to be approximately 2.5 mg/L for the lowest molecular weight component, but less than 1 mg/L for the predominant components (Huntingdon Life Sciences Study Number OWH0007). Computer modelling (WSKOWWIN, Version 1.41, U.S. Environmental Protection Agency) indicated that the values for these components would fall significantly below this order of magnitude. The lack of a sufficiently sensitive, specific method of analysis meant that performing a hydrolysis test with Tetraesters of pentaerythritol with 2- methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid was technically unfeasible.
Reference
Description of key information
Hydrolysis: The study does not need to be conducted as the substance is highly insoluble; Regulation (EC) 1907/2006, Annex VII, Part 9.2.2.1., Column 2.
Key value for chemical safety assessment
Additional information
Waiver – In accordance with the specific rules for adaptation listed in Part 9.2.2.1, Column 2, Annex VIII, Regulation (EC) 1907/2006 of 18 December 2006, a hydrolysis study “does not need to be conducted if the substance is readily biodegradable, or the substance is highly insoluble in water”. The test item is highly insoluble.
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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