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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 />

Concentration : 29-60 ul/ml without activation; 30 - 50 ul/ ml with activation<br />

Cycotoxic conc. : not reported<br />

Metabolic activation : with and without<br />

Result : negative<br />

Method : other: Suspension/plate<br />

Year : 1987<br />

GLP : no data<br />

Test substance : no data<br />

Method : Limited details reported.<br />

Result : No increase in revertants was recorded for dipropylene <strong>glycol</strong> with or<br />

without activation.<br />

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

5.6 GENETIC TOXICITY ‘IN VIVO‘<br />

Type : Micronucleus assay<br />

Species : mouse<br />

Sex : male<br />

Strain : other: CD-1(ICR)BR<br />

Route of admin. : gavage<br />

Exposure period : 2 days<br />

Doses : 500, 1000 and 2000 mg/kg<br />

Result : negative<br />

Method : other: US EPA OPPTS 870.5395 and OECD 474<br />

Year : 1999<br />

GLP : yes<br />

Test substance : as prescribed by 1.1 - 1.4<br />

Method : Animals and treatments<br />

Eight week old male CD-1 mice from Charles River Labs were used in<br />

these investigations. Six mice were used per treatment group (control,<br />

positive control, 3 levels of dipropylene <strong>glycol</strong>). The dose levels were based<br />

on a preliminary study. <strong>Dipropylene</strong> <strong>glycol</strong> was administered for two<br />

consecutive days by gavage at 500, 1000 or 2000 mg/kg/day in water at a<br />

dose volume of 10 ml/kg. 120 mg/kg/day cyclophophamide was<br />

administered on two consecutive days by gavage at a dose volume of 10<br />

ml/kg.<br />

Preparation and examination of bone marrow smears<br />

Mice were killed by carbon dioxide inhalation 24 hr after second gavage<br />

dose of dipropylene <strong>glycol</strong>. Femoral marrow cells were isolated, smeared<br />

onto clean glass slides, fixed with methanol and stained with Wright-<br />

Giemsa. The preparations were coded and analyzed without identification<br />

of animal number or treatment. Two thousand polychromatic erythrocytes<br />

(PCEs) per mouse were examined using light microscopy (x100), and the<br />

number of micronucleated polychromatic erythrocytes (MNPCEs) was<br />

recorded. The proportion of PCEs among the total erythrocytes was also<br />

evaluated by observation of 200 erythrocytes on the same slide.<br />

Positive control substance<br />

120 mg/kg/day cyclophosphamide administered two consecutive days by<br />

gavage.<br />

Statistical analysis<br />

The frequency of MNPCEs in each treatment was analyzed by one-way<br />

72<br />

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