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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 />

5.1.1 ACUTE ORAL TOXICITY<br />

Type : LD50<br />

Species : rat<br />

Strain : Wistar<br />

Sex : male/female<br />

Number of animals : 50<br />

Vehicle : other: none<br />

Value : = 16000 mg/kg bw<br />

Method :<br />

Year : 1980<br />

GLP : no<br />

Test substance : no data<br />

Method : Guideline not specified.<br />

Animals and treatments<br />

Rats were selected with a body weight range of 182 to 283 g for males and<br />

110 to 150 g for females. <strong>Dipropylene</strong> <strong>glycol</strong> was administered by stomach<br />

tube following an overnight fast to 5 males and 5 females per dose at<br />

doses of 8.6, 10.4, 12.4, 14.0 or 17.9 ml per kg of body weight. The<br />

animals were observed for signs of intoxication for 14 days following<br />

dosing.<br />

Postmortem examination<br />

All animals were necropsied after death or 14 days after dosing. There was<br />

no indication of histopathologic examination of any tissues.<br />

Calculation of LD50<br />

Based on method of Weil et al, Biometrics (195X)=missing year; 3: 247-<br />

263.<br />

General signs of toxicity were not reported. Examination of the internal<br />

organs revealed no gross alterations.<br />

The LD50 in the rat was determined to be 15.8 ml/kg, with standard errors<br />

of 19.2 - 23.0 ml/kg (equivalent to 16000 mg/kg, standard error 15000 -<br />

17500 mg/kg).(Reviewer)<br />

Remarks: Because this study was conducted before any standardized<br />

guidelines were established, the question of guideline methodology and<br />

GLP conduct is not applicable.<br />

Source : Lyondell Chemical Co. Houston, Texas<br />

Conclusion : Based on the results of this study, an LD50 of 16000 mg/kg was<br />

determined for dipropylene <strong>glycol</strong> in the rat.<br />

Reliability : (2) valid with restrictions<br />

Test material characterization not documented; GLP compliance not<br />

indicated.<br />

Flag : Critical study for <strong>SIDS</strong> endpoint<br />

29.05.2001 (33)<br />

Type : LD50<br />

Species : mouse<br />

Strain : CD-1<br />

Sex : male<br />

Number of animals : 24<br />

Vehicle : water<br />

Value : > 2000 mg/kg bw<br />

Method :<br />

Year : 1999<br />

64<br />

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