28.01.2014 Views

Dipropylene glycol (SIDS)

Dipropylene glycol (SIDS)

Dipropylene glycol (SIDS)

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

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 />

UNEP PUBLICATIONS

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!