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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 />

70<br />

GLP conduct is not applicable.<br />

Result : Seven of 25 rats exposed to 10% dipropylene <strong>glycol</strong> in the drinking water<br />

died between days 10 and 30. Five had kidney lesions. Four of the 18<br />

survivors had kidney lesions. The<br />

kidney lesions were described as hydropic degeneration of the tubular<br />

epithelium. No effects on mortality or the kidney and liver were seen in rats<br />

exposed to 5% dipropylene <strong>glycol</strong> in their drinking water.<br />

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

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

Not guideline, pre-GLP, methods and results only briefly described but<br />

generally acceptable.<br />

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

29.05.2001 (24)<br />

Species : dog<br />

Sex : no data<br />

Strain : no data<br />

Route of admin. : gavage<br />

Exposure period : not specified<br />

Frequency of<br />

treatment<br />

: Not specified, the doses for another compound were administered 3 times<br />

daily.<br />

Post obs. period : None<br />

Doses : 9 cc/kg as 1.5 cc/kg administered for 6 doses, 12 cc/kg as 2.0 cc/kg<br />

administered for 6 doses, or 20 cc/kg as 5.0 cc/kg administered for 4 doses<br />

Control group : no<br />

NOAEL : = 20 ml/kg bw<br />

Method :<br />

Year : 1939<br />

GLP : no<br />

Test substance : no data<br />

Method : Animals<br />

4 dogs; age, weight, sex and strain not specified<br />

General<br />

Divided gavage doses given as follows: 9 cc/kg as 1.5 cc/kg administered<br />

for 6 doses, 12 cc/kg as 2.0 cc/kg administered for 6 doses, or 20 cc/kg as<br />

5.0 cc/kg administered for 4 doses.<br />

Details on evaluations conducted were not provided in the report.<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 />

Result : 1 dog dosed at 9 cc/kg - no evidence of toxicity<br />

1 dog dosed at 12 cc/kg - no evidence of toxicity<br />

1 dog dosed at 12 cc/kg - emesis; recovery<br />

1 dog dosed at 20 cc/kg - no evidence of toxicity<br />

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

Conclusion : No evidence of systemic toxicity was detected under the conditions of this<br />

study.<br />

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

Not guideline, pre-GLP, methods and results only briefly described but<br />

generally acceptable.<br />

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

29.05.2001 (22)<br />

Species : rat<br />

Sex : no data<br />

Strain : no data<br />

Route of admin. : oral feed<br />

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