Toxicological Evaluation and Limit Values for ... - Miljøstyrelsen

NPE with 9 ethoxylene oxide units was administered to 3 dose groupsplus a control group of 36 male and 36 female Carworth-Elias rats for 2years. Sixteen rats of each sex were interim sacrificed, at 6 and 12months. At sacrifice livers and kidneys were weighed, and 11 tissueswere histopathologically examined. There was no difference betweencontrol and treated rats in any observation made.No increased frequency of tumours was reported in either rat study.dogsNPE with 4 ethoxylene oxide units was administered for 2 years togroups of 3 male and 3 female Beagle dogs in gelatine capsules in dosages40, 200, and 1000 mg/kg/day. An untreated control group was present..Haematology and blood and urinary clinical-chemical parameterswere measured repeatedly during the study. At sacrifice, liver, kidneys,spleen, heart, brain and testes were recorded, and 28 tissues were examinedmicroscopically. At 200 mg/kg/day, and more pronounced at 1000mg/kg/day, there was a moderate elevation in serum alkaline phosphataseand relative liver weight, without histopathological changes.NPE with 9 ethoxylene oxide units was administered in the diet in concentrationsof 0, 0.03, 0.09, and 0.27%, corresponding to 0, 8.5, 28, and88 mg/kg/day (author’s calculation), to groups of 3 male and 3 femaleBeagle dogs for 2 years. Haematology and blood and urinary clinicalchemicalparameters were measured repeatedly. At sacrifice liver, kidneys,and heart was weighed, and 21 tissues were examined histopathologically.NPE with 9 ethoxylene oxide units caused an increased relativeliver weight at 0.27% in the diet (88 mg/kg/day) without accompanyinghistopathological findings.Table 8 Results of 2-year oral studies with nonyl phenol ethoxylates ofvarious ethylene oxide (EO) chain lengths (compiled from Smyth &Calandra 1969) .No. of EOunits,speciesDose levels(mg/kgb.w./day)GrowthretardationIncreasedrelative liverweightOther effects4rat402001000xx9rat00.030.090.27% in diet4dog402001000xxincrease in ALPincrease in ALP9dog8.52888 xALP: alkaline phosphatase24