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EC number: 252-104-2
CAS number: 34590-94-8
This study was performed to assess the
systemic toxicity of dipropylene glycol methyl ether (DPGME) to the rat
by oral administration, once daily for 28 days, to 3 groups of 5 male
and 5 female rats at dosage levels of 40, 200 and 1000 mg/kg/day. A
negative control group was provided. A recovery group of 5 males and 5
females were additionally assigned to the control group and high dose
All animals survived during the treatment
period of 28 days and the 2 weeks recovery period. There were no
significant differences between control group and treatment groups for
body weights and food consumption. Macroscopic examination performed at
the end of the 28 days treatment and the recovery period revealed no
Tentative salivation was recorded in the
male and female animals treated with the 1000 mg/kg from the day 11
onward, which appeared immediately after oral administration of test
substance. Relative liver weight of male and female animals treated with
the 1000 mg/kg at 28 days treatment increased with statistical
significance, while the male animals treated with 1000 mg/kg at recovery
group showed also a statistical significant increases in absolute and
relative livery weight. Upon histopathological examination centrilobular
hypertrophy of the liver was observed in the animals treated with 1000
There were no other changes that were
considered to be related to treatment of this test substance.
It is concluded that 200 mg/kg/day
represents the no-observed-effect level (NOEL) and that 1000 mg/kg/day
represents no-observed-adverse-effect level (NOAEL)for DPGME in the
rat. The only effects observed at 1000 mg/day were transient salivation
immediately after administration of the test material, increased liver
weight and centrilobular hypertrophy of the liver. The liver weight
increase (which was very minor, <10 %) and hypertrophy in the liver
observed at 1000 mg/kg/day was likely due to increased metabolism and
was not accompanied by an increase in liver enzymes.
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