Registration Dossier
Registration Dossier
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EC number: 295-714-4 | CAS number: 92128-22-8
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
The following remarks on the toxicokinetics of Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl] tall-oil amides are based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.
The substance is a brown clear liquid with a very low vapour pressure under normal ambient conditions (3.92 x 10-6 hPa at 25 °C), therefore inhalation exposure to the vapour is expected to be negligible.
The physico-chemical characteristics of the substance (limited water solubility of 10.3 mg/L at 20 °C, log Pow of 4.3 - 5.6 at 25 °C and a molecular mass of ca. 309 g/mol) suggest a low intestinal absorption after oral intake. This assumption is confirmed by the data on acute oral toxicity in rats (LD50 > 4600 mg/kg bw). In this study a dose of 5 ml/kg bw (= 4600 mg/kg bw) was tolerated without mortalities, clinical signs or effects on body weight development (Beyer, 2008).
Because of the lipophilicity of the substance accumulation of the unchanged compound in fatty tissues might be possible depending on the efficiency of metabolic and excretory processes. The results of a subacute oral study in rats (Eiben, 2010), in which doses up to 800 mg/kg bw were applied, do not reveal indications of a significant accumulation potential of the substance. In this study a daily oral administration of 200 mg/kg bw over 29 days provided no evidence of non-physiological systemic effects, whereas the highest dose of 800 mg/kg bw resulted in clinical signs, decreased body weights and histopathological changes of the liver.
Due to the limited water solubility, a log Pow of 4.3 - 5.6 at 25 °C and a molecular mass of ca. 309 g/mol no appreciable dermal or mucosal absorption is anticipated. This is confirmed by the studies on acute dermal toxicity (rat, LD50 > 2000 mg/kg bw; Gillissen, 2009) and on skin sensitization (GPMT; Dreist and Kolb, 1993) in which no signs of systemic toxicity were observed. As the skin sensitization study revealed a skin sensitizing potential after dermal contact of the substance formulated in propylene glycol, at least for a solution of the substance in propylene glycol some dermal absorption has to be assumed.
Based on the results of the in vitro genotoxicity tests (negative with and without metabolic activation in an Ames test (Herbold, 1995) as well as in a chromosome aberration test (Thum, 2009) it is concluded that DNA-reactive metabolites of the substance will most probably not be generated in mammals in the course of hepatic biotransformation.
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