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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 />

500 mg undiluted dipropylene <strong>glycol</strong> was applied to intact and abraded skin<br />

of rabbits and left occluded for 24 hours. Reactions were recorded at 24,<br />

48, and 72 hr after application, using the scoring system of Draize et al<br />

(1944, J Pharmac. Exp Ther, 82, 377 - 390).<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 />

Remark : Original reference not available for review, so methods and results were<br />

described based on a reputable secondary source.<br />

Result : Detailed results not available; listed as mildly irritating.<br />

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

Conclusion : The results from this study demonstrate that undiluted dipropylene <strong>glycol</strong><br />

causes mild irritation of the rabbit skin. The response is insufficient to<br />

trigger classification of dipropylene <strong>glycol</strong> as an skin irritant. (Reviewer)<br />

Reliability : (4) not assignable<br />

PreGLP/Guidline study with brief description of methods and results; from<br />

secondary source.<br />

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

29.05.2001 (6) (29)<br />

Species : human<br />

Concentration : 25 %<br />

Exposure :<br />

Exposure time : 24 hour(s)<br />

Number of animals : 33<br />

PDII :<br />

Result :<br />

EC classification :<br />

Method :<br />

Year : 1995<br />

GLP : no data<br />

Test substance : no data<br />

Method : Limited experimental details are available for this study.<br />

0.2 ml of a 25% solution of dipropylene <strong>glycol</strong> in distilled water for 24 hours<br />

via semi-occluded patches. Reactions were recorded at 4 and 24 hr after<br />

application.<br />

Result : 2 subjects demonstrated no effects at 30 min. but mild erythema at 24 hrs.<br />

2 subjects demonstrated mild to moderate erythema at 30 min. and mild<br />

erythema at 24 hrs. 7 subjects demonstrated mild to moderate erythema at<br />

30 min. but no effects at 24 hrs.<br />

22 subjects no reaction at 30 min or 24 hr.<br />

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

Conclusion : The results from this study demonstrated that 25% dipropylene <strong>glycol</strong><br />

causes none to mild irritation of human skin.<br />

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

Study details limited.<br />

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

29.05.2001 (1)<br />

5.2.2 EYE IRRITATION<br />

Species : rabbit<br />

Concentration : undiluted<br />

Dose : .1 ml<br />

Exposure Time : 4 hour(s)<br />

Comment : other: Tested as 100% and formulation containing 7.2% dipropylene <strong>glycol</strong><br />

UNEP PUBLICATIONS 67

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