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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 />

challenge : -, TR, ?+, +<br />

(Definition of -, TR, ?+, and + were not given in the report)<br />

Statistics<br />

No statistical methods were applied to the data.<br />

Result : One patient was sensitized to dipropylene <strong>glycol</strong><br />

Score Number of responses<br />

- cosmetic DPG = 488 patients; synthesis DPG = 480 patients<br />

TR cosmetic DPG = 2 patients; synthesis DPG = 5 patients<br />

?+ cosmetic DPG = 13 patients, synthesis DPG = 17 patients<br />

+ cosmetic DPG = 0 patients; synthesis DPG = 1 patient<br />

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

Test substance : >97% pure from E.Merck (synthesis grade) and cosmetic grade (>96%)<br />

Conclusion : The authors concluded that sensitization to dipropylene <strong>glycol</strong> was rare.<br />

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

not standard guideline test<br />

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

22.05.2001 (23)<br />

5.4 REPEATED DOSE TOXICITY<br />

Species : rat<br />

Sex : no data<br />

Strain : no data<br />

Route of admin. : drinking water<br />

Exposure period : 9 to 77 days<br />

Frequency of<br />

: continuous<br />

treatment<br />

Post obs. period : none<br />

Doses : 1 to 10% dipropylene <strong>glycol</strong> in drinking water<br />

Control group : no<br />

NOAEL : = 5 %<br />

LOAEL : = 10 %<br />

Method :<br />

Year : 1939<br />

GLP : no<br />

Test substance : no data<br />

Method : Animals<br />

32 rats; age, weight, sex and strain not specified.<br />

Exposure<br />

<strong>Dipropylene</strong> <strong>glycol</strong> was mixed in the drinking water of 7 rats at<br />

concentrations from 1 to 5% for 33 to 77 days. <strong>Dipropylene</strong> <strong>glycol</strong> was<br />

mixed in the drinking water of 25 rats at a concentration of 10% for 9 to 68<br />

days. Further details of exact doses, number of animals at each dose<br />

leve l, or duration for individual animals not provided.<br />

Terminal observations<br />

Kidneys were examined microscopically for pathology. Report indicated<br />

that the liver and kidney were examined. No indication that other tissues<br />

were examined.<br />

Statistical methods<br />

None<br />

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

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

UNEP PUBLICATIONS 69

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