Registration Dossier
Registration Dossier
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EC number: 942-066-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Since no study assessing the toxicity of Reaction mass of bis(2-propylheptyl) hexanedioate and O6-[2,2-bis[[6-oxo-6-(2-propylheptoxy)hexanoyl]oxymethyl]butyl] O1-(2-propylheptyl) hexanedioate to terrestrial organisms is available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the source substance Bis(2-propylheptyl) adipate (940-510-9, DPHA) was conducted. The read across is justified since DPHA is the main constituent (80%) of the target substance. The high molecular weight (> 900 g/mole) and log Pow (> 10) of the TMP ester constituent indicate a much lower toxicity of this constituent compared to DPHA. Thus, the study result for the source substance is considered to adequately cover the terrestrial toxicity of the whole multi-constituent substance.
One study investigating the toxicity to terrestrial organisms is available for the main constituent Bis(2-propylheptyl) hexanedioate (DPHA). The study was performed according to GLP and OECD guideline 207 using Eisenia foetida as test organism (Xiaoqian 2015). A test substance concentration of 1000 mg/kg was tested in a limit test. No mortality in the treatment as well as no significant difference in body weight between treatment and control were observed during an exposure time of 14 days. Thus, the 14d-LC50 value is determined to be > 1000 mg/kg. Based on this result it can be concluded that Reaction mass of bis(2-propylheptyl) hexanedioate and O6-[2,2-bis[[6-oxo-6-(2-propylheptoxy)hexanoyl]oxymethyl]butyl] O1-(2-propylheptyl) hexanedioate is not toxic to terrestrial organisms at relevant environmental concentrations.
In accordance with Regulation (EC) No. 1907/2006, Annex X, Column 2, 9.4 further studies on the effects on terrestrial organisms does not have to be conducted since the chemical safety assessment indicates that there is no need. The test substance is readily biodegradable and will therefore not persist in soil for an extended period of time. Furthermore, the substance is not toxic to aquatic organisms up to the limit of water solubility and available data indicate that the substance is not bioaccumulative. Due to its high adsorption potential the substance is considered to be immobile in soil and uptake by roots via pore-water is not expected. Studies with aquatic microorganisms showed that the substance is rapidly degraded and show no inhibitory effect. Hence, the risk the test substance poses to terrestrial plants and microorganisms is considered to be low and a study is not considered to be necessary.
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