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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 />

Treatment<br />

The rats were exposed during a 14-day premating period, after which they<br />

were randomly assigned to mati ng pairs and cohabited until evidence of<br />

mating.<br />

Parental observations<br />

Clinicial signs, body weight, food consumption, hematology, and clinical<br />

chemistry were assessed during the study. At termination, the rats were<br />

necropsied, organs were weighed and examined histopathologically.<br />

Pup observations<br />

Litter size, sex and viability on day 0 and 4 of lactation. Visual external<br />

examination on day 4.<br />

Statistical analysis<br />

not described<br />

OECD Combined repeat dose and reproductive/developmental toxicity<br />

screening test<br />

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

Test substance : Tripropylene <strong>glycol</strong> CAS #24800-44-0<br />

Conclusion : Result: The report is in Japanese; summary results and tables are<br />

available in English.<br />

Parental animals<br />

There was no effect on parental body weight, food consumption,<br />

hematology, clinical chemistry, necropsy or histopathology. Increased<br />

salivation was noted in males treated at 1000 mg/kg/day. Males and<br />

females at 1000 mg/kg/day had increasd liver weights and males also had<br />

increased kidney weights. There was no effect on estrus cycle, mating,<br />

pregnancy index, length of gestation, or gestation index.<br />

Pups<br />

There was no difference in mean litter size, mean live pups born/litter,<br />

survival to day 4, sex ratio, or frequency of external abnormalities.<br />

NOAEL<br />

Parental: 200 mg/kg/day<br />

Reproductive: 1000 mg/kg/day<br />

Developmental: 1000 mg/kg/day<br />

Conclusion: Under the conditions of the study, tripropylene <strong>glycol</strong> had no<br />

effect on fertility or reproduction. Based on metabolism of tripropylene to<br />

dipropylene <strong>glycol</strong> to propylene <strong>glycol</strong>, these data on tripropylene <strong>glycol</strong> are<br />

relevant to dipropylene <strong>glycol</strong> toxicity characterization.<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 (35)<br />

5.11 EXPERIENCE WITH HUMAN EXPOSURE<br />

80<br />

UNEP PUBLICATIONS

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