Toxicological Evaluation and Limit Values for ... - MiljÃ¸styrelsen

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Table 5. Results of 90-day feeding studies in rats with nonyl phenol ethoxylatesof various ethylene oxide (EO) chain lengths (compiled fromSmyth & Calandra 1969)Laboratory andyear(EO)Dose levels(mg/kgb.w./day)IncreasedabsoluteliverweightIncreasedrelativeliverweightGrowthretardationHistopathologyofliverOther effectsInd. Bio-TestLab. 1963-65(4)402001000 x xxxn.d.noInd. Bio-TestLab. 1963-65(6)402001000 xxxxxxn.d.n.d.noMellon Inst.1959-65(9)10502501250xxxxx 1)x 2)x 3)Shelanski 1960(9)*)4 (0.01%)20 (0.04%)60 (0.16%)300 (0.64%)1300 (2.5%)5% in dietxxxx, mortalityDow 1961(9)*)100 (0.1%)200 (0.3%)900 (1.0%) xxxx 4)x 4) x 5)Ind. Bio-TestLab. 1963-65(15)402001000xxn.d.noInd. Bio-TestLab 1963-65(20)Ind. Bio-TestLab 1963-65(30)Dow 1961(40)*)20010005000 x2001000500020 (0.03%)70 (0.1%)200 (0.3%)700 (1.0%)2000 (3.0%)x 6)1) Low kidney weight in females.2) Cloudy swelling of central hepatic cords, intracellular lipoid, reducedpolysaccharide.3) Focal hepatic-cell necrosis, intracellular lipoid, reduced polysaccharide.4) Slight petecchial areas of central lobular granular degeneration andnecrosis.5) Increased relative spleen weight in females & increased relativekidney weight in males.6) Slight central lobular granular degeneration and necrosis with generalcloudy swelling.n.d.)not done (only the highest dose group was examined histopathologically)20
*) In the original report, dose was given as % in diet, and was subsequentlycalculated in mg/kg/day, based on food consumption data,by the rapporteur.NPE toxicity in dogsIn the same report (Smyth & Calandra 1969), investigations of NPEtoxicity in dogs was described (Table 6). Each dosage of NPE with 4, 6,15, 20 and 30 ethylene oxide units was administered orally in gelatinecapsules to 2 male and 2 female dogs. NPE with 9 ethylene oxide unitswas administered in the diet, a single dog per dose, and 3 dogs in thecontrol group.Table 6 Results of 90-day feeding studies in dogs with nonyl phenolethoxylates of various ethylene oxide (EO) chain lengths . Datafor EO=4, 6, 15, 20, 30 from Industrial Bio-Test Labs. (1963-65).Data for EO= 9 from Shelanski (1960). (Both sources quoted fromSmyth & Calandra 1969).No. of EOunitsDose levels(mg/kgb.w./day)GrowthretardationIncreasedrelativeliverweightEmesisOthereffects4 402001000 xxxxx6 402001000 xxx9 4064050000xx15 402001000xx20 4020010005000xxxxxxxxx 1)x 2)x 2)30 20010001) Focal myocardial necrosis or degeneration (microscopically).2) Death, grossly detectable focal myocardial necrosis, lung hyperaemia.21
Page 1 and 2: Environmental Project No. 512 2000M
Page 3 and 4: 1 General description1.1 IdentityNo
Page 5 and 6: with varying average lengths of the
Page 7 and 8: 1.4 Environmental occurrenceNP and
Page 9 and 10: 2 Toxicokinetics2.1 Absorption, dis
Page 11 and 12: 3 Human toxicity3.1 Short term toxi
Page 13 and 14: 9 concentrated vapour atambient tem
Page 15 and 16: Table 3. Dermal LD 50 -values in ra
Page 17 and 18: Table 4a Number of animals with his
Page 19: with 40 ethylene oxide units, no ef
Page 23 and 24: Table 7 Results of studies in dogs
Page 25 and 26: Dermal contactNo data have been fou
Page 27 and 28: generation reproduction toxicity st
Page 30 and 31: 5 Regulations, limit valuesAmbient
Page 32 and 33: units is low, as LD 50 values varyi
Page 34 and 35: 7 EvaluationA study in humans invol
Page 36 and 37: mg/kg/day were found in rats. In do
Page 38 and 39: = 25 mg/kg soilNPEBased on the TDI
Page 40 and 41: is set at the limit value. A C-valu
Page 42 and 43: Odum J, Lefevre PA, Tittensor S, Pa

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