Registration Dossier
Registration Dossier
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EC number: 204-614-1 | CAS number: 123-28-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Absorption rate - dermal (%):
- 10
Additional information
The test substance (molecular weight of 514.84 g/mol) is a white solid assumed to be poorly water soluble (water solubility of < 1mg/L at 20°C). The calculated log Po/w of this diester of a fatty acid with 3,3`-dithiopropionic acid, is 11.
Absorption
In an acute oral toxicity study, Tif: RAIf (SPF)-rats were administered 5000 mg/kg bw/day of the test substance per gavage (CIBA 820894). These results indicate a low acute toxicity of the test substance after oral administration ( LD 50 > 5000 mg/ kg). Additionally, in a subchronic study, the test substance was administered to Sprague-Dawley rats at doses of 125, 350 and 1000 mg/kg bw/day (Pharmakon 380/573). Cardiac toxicity was observed at 1000 mg/kg bw and accordingly, systemic availability upon ingestion is likely. This assumption is supported by the study results of Reynolds (1974). This study investigated the fate of the test substance, radiolabelled with carboxy 14C-, after oral (gavage and in feed) administration to Sprague-Dawley rats and showed an almost entire absorption from the gastrointestinal tract at dose levels up to 208 mg/kg bw/day, respectively. The fatty acid part is degraded via β-oxidation whereas the dithiopropionic acid part is expected to be sufficiently soluble to become eliminated without further metabolism.
In an acute dermal toxicity study, the LD50 was higher than 2000 mg/kg bw and the test substance did not cause sensitization to guinea pigs (CIBA Siss4733). In view of the absence of effects, the low water solubility (<1 mg/L), the high molecular weight (above 500 g/mol) and the log Po/w of 11 dermal absorption of the test substance might be low. According to the current guidance documents, a dermal absorption rate of 10% can be estimated based on the physical-chemical properties of the substance and the lack of toxicity observed following dermal exposure.
No inhalation study was performed, but the test substance is a solid that is produced in the form of granula and its vapour pressure is estimated to be 6.5E-10 Pa, so that absorption via inhalation is unlikely.
Distribution, Metabolism and Excretion
Reynolds (1974) showed an accumulation of the test substance in the fat tissue of Sprague-Dawley rats after oral administration: low amounts of the test substance were found in fat tissue at the last sacrifice on day 34. The test substance was predominantly excreted via urine (85 - 88%), as well as via faeces (1.8 - 3.5%) and as carbon dioxide (3 - 4%). Free substance or an acid-labile conjugate of the compound was detected in urine .
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