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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 />

Exposure period : 15 weeks<br />

Frequency of<br />

: daily<br />

treatment<br />

Post obs. period : none<br />

Doses : 0, 12% of diet<br />

Control group : yes, concurrent vehicle<br />

NOAEL : = 12 %<br />

Method : other: investigative study<br />

Year : 1940<br />

GLP : no<br />

Test substance : no data<br />

Method : Limited study details ava ilable<br />

<strong>Dipropylene</strong> <strong>glycol</strong> mixed in diet at 12% and fed ad libitum.<br />

Observations<br />

The rats were observed for running activity after 15 weeks. Details on<br />

assessment of running activity not provided.<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 : Running activity was decreased in rats fed 12% dipropylene <strong>glycol</strong><br />

compared to control rats. The magnitude of the changes in running activity<br />

were not given in the report.<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 (10) (36)<br />

5.5 GENETIC TOXICITY ‘IN VITRO‘<br />

Type : Ames test<br />

System of testing : Salmonella typhimurium TA98, TA100, TA1535, TA1537<br />

Concentration : up to 10 mg/plate (lower concentrations not specified)<br />

Cycotoxic conc. : >10 mg/plate<br />

Metabolic activation : with and without<br />

Result : negative<br />

Method : other: Ame's standard plate assay<br />

Year : 1984<br />

GLP : no data<br />

Test substance : no data<br />

Method : Study details not available.<br />

Result : No increase in revertants was recorded for any of the strains exposed to<br />

dipropylene <strong>glycol</strong> with or without metabolic activation.<br />

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

Conclusion : <strong>Dipropylene</strong> <strong>glycol</strong> was not mutagenic in Salmonella typhimurium TA98,<br />

TA100, TA1535 and TA 1537, in the presence or absence of an S-9<br />

fraction, under the conditions of this test.<br />

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

summary data only available from NCI program.<br />

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

29.05.2001 (11)<br />

Type : Mouse lymphoma assay<br />

System of testing : L5178Y (TK+/TK -)<br />

UNEP PUBLICATIONS 71

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