Dipropylene glycol (SIDS)
Dipropylene glycol (SIDS)
Dipropylene glycol (SIDS)
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OECD <strong>SIDS</strong> PROPYLENE GLYCOL<br />
5. Toxicity<br />
Id 25265-71-8<br />
Date 30.05.2001<br />
Method : Species: rat<br />
Sex: male<br />
Strain: F344<br />
Number of a nimals: 10<br />
Route of admin.: gavage<br />
Exposure period: one dose<br />
Frequency of treatment: once<br />
Duration of test: 24 hrs<br />
Doses: 40 mg/kg/day TPG in water at dosing volume of 4 ml/kg.<br />
Control group: No<br />
Year: 1995<br />
GLP: yes<br />
Animals and treatment<br />
Male F344 rats weighing between 187 and 197 g were obtained from<br />
Charles River and allowed 2 days for acclimation in metabolism cages<br />
before dosing. After dosing, the animals were held in the metabolism<br />
cages for 24 hours.<br />
Sample collections<br />
Air drawn through the metabolism chambers was passed through a trap for<br />
collection of radioactive CO2. All voided urine was collected and frozen for<br />
analysis. Feces were collected in dry-ice chilled containers for analysis.<br />
After 24 hours the animals were sacrificed for collection of blood, liver,<br />
kidney, fat, brain, muscle, and the remaining carcass.<br />
Sample analysis<br />
Radioactivity in all collected samples was determined using a liquid<br />
scintillation counter. Urine samples were analyzed by gas chromatography<br />
for tripropylene <strong>glycol</strong>, dipropylene <strong>glycol</strong> and propylene <strong>glycol</strong> following<br />
derivatization to pentafluorobenzoyl esters.<br />
Source : Lyondell Chemical Co. Houston, Texas<br />
Test substance : Analytical data verified identity: 99.8% tripropylene <strong>glycol</strong>., 0.08%<br />
dipropylene <strong>glycol</strong> pure. 14C-labelled test material TM = 14C-labelled<br />
TPG.<br />
Conclusion : Result: 91.4±2.1% of the administered dose was recovered from CO2,<br />
urine, feces, tissues and carcass. 20.7±0.6% was recovered as CO2;<br />
52.3±3.5% was recovered in urine. Approximately 10% of the administered<br />
radioactivity remained in the carcass after 24 hours.<br />
Urine analysis<br />
13% of the administered dose of tripropylene <strong>glycol</strong> was recovered in the<br />
urine as free or conjugated tripropylene <strong>glycol</strong>, 8.4% as free or conjugated<br />
dipropylene <strong>glycol</strong>, and 3.9% as free or conjugated propylene <strong>glycol</strong>.<br />
Administration of propylene <strong>glycol</strong> resulted in 12% recovered as propylene<br />
<strong>glycol</strong> in the urine.<br />
Conclusion: Tripropylene <strong>glycol</strong> is rapidly and extensively metabolized to<br />
dipropylene <strong>glycol</strong> which is further metabolized to propylene <strong>glycol</strong> and<br />
subsequently to lactic or pyruvic acids followed by oxidation through the<br />
citric acid cycle (21% to CO2) or production of glycogen. Much of the<br />
radioactivity remaining in the carcass probably represented metabolically<br />
incorporated carbons atoms derived from propylene <strong>glycol</strong>. (author<br />
conclusion)<br />
Reliability : (1) valid without restriction<br />
meets guidelines and GLP.<br />
Flag : Critical study for <strong>SIDS</strong> endpoint<br />
29.05.2001 (18)<br />
76<br />
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