Registration Dossier
Registration Dossier
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EC number: 926-000-9 | CAS number: 1180524-77-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The remarks on the toxicokinetics of 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylated are based on physicochemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.
The substance is a slightly yellowish, viscous liquid. (Neuland, 2012) with a low vapour pressure under normal ambient conditions (0.011 Pa at 20 °C, Fonseca, 2012). Inhalation exposure via vapour is therefore not to be expected. Absorption of the substance via skin or mucosa could not be ruled out due to a log Pow of 1.4 at 25 °C (Garcia-Sanchez, 2012), whereas water solubility (0.063 and 0.566 g/L at 20 °C, Neuland, 2012) and the quite high average molecular weight of the substance (see IUCLID chapter 1.1) seem to point to a low ability to be absorbed. In fact, no indications for systemic availability could be observed after acute oral or dermal exposure to the substance as there were no toxicological effects at all reported (OECD TG 423 and 402, both Gillissen, 2012). Some indications for systemic availability give the oral repeated dose toxicity study where only for male rats of the high dose group (1000 mg/kg bw) slight effects on thyroids were observed (OECD TG 407, Popp, 2012).
4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylated proved as skin sensitizer in a Local Lymph Node Assay (Vohr, 2012), therefore at least some dermal bioavailability after skin contact is expected.
There are indications from the in vitro assays for irritating/corrosive properties of the substance which might influence skin or mucosa barrier function and thus systemic availability.
Deducing from the repeated dose toxicity study where no distinct substance-related adverse effects except thyroid findings were reported and from the above specified log Pow, no potential for accumulation is to be expected for the substance.
Based on the results of in vitro genotoxicity tests (negative with and without metabolic activation in Ames test, Nern, 2012; HPRT test, Wollny, 2012; Micronucleus test, Nern, 2012) it is concluded that DNA-reactive metabolites of4-[2-(4-hydroxyphenyl)propan-2-yl]phenol, 2-(2-hydroxyethylamino)ethanol and formaldehyde), propoxylatedwill most probably not be generated in mammals in the course of hepatic biotransformation.
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