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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 group.
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 treatment-related changes.
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 mg/kg.
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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