Registration Dossier
Registration Dossier
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EC number: 247-955-1 | CAS number: 26748-41-4
Endpoint summary
Administrative data
Description of key information
The hydrolysis of tert-butylperoxyneodecanoate (TBPND) in different aqueous buffer solutions (pH = 4, 7 and 9) at 15, 37 and 50 °C was investigated using HPLC-UV. Measurements revealed a fast hydrolysis of TBPND (half-live: 0.9 hours) at pH = 4 and 50 °C.
The test item was biodegradable 63 % at day 28 in the closed bottle test according to OECD guideline 301D (2018). Therefore, it can be concluded that the test item is readily biodegradable.
The performance of simulation tests for biodegradation in water and sediment is scientifically not justified.
The performance of tests for biodegradation in soil is scientifically not justified.
The performance of a test for bioaccumulation in aquatic species, preferably fish, is scientifically unjustified.
The Koc was mesured using HPLC method. This method is applicable for substances which have log Koc value ranging from 1.5 to 5.0. The adorption coefficient was estimated to be 4424 and the log Koc was 3.64.
Additional information
The hydrolysis of tert-butylperoxyneodecanoate (TBPND) in different aqueous buffer solutions (pH = 4, 7 and 9) at 15, 37 and 50 °C was investigated using HPLC-UV. Measurements revealed a fast hydrolysis of TBPND (half-live: 0.9 hours) at pH = 4 and 50 °C. The degradation products of the hydrolysis of tert-butylperoxyneodecanoate (TBPND) (7,7-dimethyloctanoic acid andtert-butanol) were identified qualitatively using HPLC-MS and GC-FID, respectively.
The ready biodegradability of the test item was assessed according to OECD guideline 301D (2018). The test item was biodegraded 63 % at day 28 in the Closed Bottle test. Therefore, it can be concluded that the test item is readily biodegradable.
The performance of simulation tests for biodegradation in water and sediment is scientifically unjustified.
REACH Regulation No. 1907/2006, Annex IX, Sect. 9.2.1.2, Col. 2, states as follows:
“9.2.1.2: The study need not to be conducted:
-if the substance is readily biodegradable, or
-if direct and indirect exposure of sediment is unlikely. ”
Direct and indirect exposure of the test item to water and sediment is highly unlikely. Furthermore, the test item is readily biodegradable, therefore simulation testing for biodegradation in water and/or sediment was considered not scientifically justified.
The performance of tests for biodegradation in soil is scientifically unjustified.
REACH Regulation No. 1907/2006, Annex IX, Sect. 9.2.1.3, Col. 2, states as follows:
“9.2.1.3: The study need not to be conducted:
-if the substance is readily biodegradable, or
-if direct and indirect exposure of soil is unlikely. ”
Direct and indirect exposure of the test item to soil is highly unlikely. Furthermore, the test item is readily biodegradable. Therefore, simulation testing for biodegradation in soil was considered not scientifically justified.
The performance of a test for bioaccumulation in aquatic species, preferably fish, is scientifically unjustified.
REACH Regulation No. 1907/2006, Annex IX, Sect. 9.3.2, Col. 2, states as follows:
“9.3.2Thestudy need not be conducted if:
-the substance has a low potential for bioaccumulation (for instance a logKow<= 3) and/or a low potential to cross biological membranes, or
-direct and indirect exposure of the aquatic environment is unlikely. ”
Direct and indirect exposure of the test item to water is highly unlikely. Due to the unstable nature of organic peroxides, it can be assumed that upon contact with water or at temperatures above the SADT of the test item, i. e. 15 °C, the test item undergoes degradation.
Furthermore, the test item is readily biodegradable. Therefore, the test item was considered to have no bioaccumulation potential. Using EPIWIN 4.1 a BCF of 925 L/Kgwwt was calculated indicating no potential for bioaccumulation.
The Koc was measured using the HPLC method. This method is applicable for substances which have logKoc value ranging from 1.5 to 5.0. The adorption coefficient was estimated to be 4424 and the logKoc was 3.64.
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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