N-(1,3-Dimethylbutyl)-N

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OECD SIDS N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE 5. TOXICITY ID: 793-24-8 DATE: 11.05.2005 -Weight: brain, kidney, liver, spleen, testes with epidymides -Macroscopic: extensive -Microscopic: extensive STATISTICAL METHODS: Dunnett's test: body weight, food consumption, pathology, absolute organ weight Mann-Whitney test: relative organ weight Fisher's exact test: incidence of microscopic lesions Conclusion : The absence of histological lesions in bone marrow suggests that the observed anemia from the middle dose was not caused by decreased red blood cell production but rather by an increased rate of red blood cell destruction. Changes in organ weights were not accompanied by macroscopic or microspcopic lesions. Female rats at 250 ppm had mild anemia that was reversible within the end of study. Lymphocytopenia was observed in females from all dose groups at the terminal sampling. The toxicologic significance and relationship to treatment of thrombocytosis and lymphocytopenia in this study are unknown. So 250 ppm was considered to be the NOAEL. Reliability : (2) valid with restrictions Study well documented, meets generally accepted scientific principles, acceptable for assessment Flag : Critical study for SIDS endpoint 03.06.2004 (76) Type : Chronic Species : rat Sex : male/female Strain : other: Charles River CD Route of admin. : oral feed Exposure period : 24 months Frequency of treatm. : continuously in diet Post exposure period : no Doses : 0, 100, 300 or 1000 ppm Control group : yes, concurrent no treatment NOAEL : = 1000 ppm LOAEL : > 1000 ppm Method : other Year : GLP : no data Test substance : no data Remark : 0, 100, 300 or 1000 ppm = ca. 0, 8, 23 or 75 mg/kg bw/d Result : Survival rate (in %) was comparable with controls: 0 100 300 1000 ppm males 24 28 26 28 females 56 52 46 52 >= 100 ppm: no changes in organ weights, no gross or microscopic tissue changes; 1000 ppm: reduced body weight gain (with decreased food consumption during the first week of the study); decrease in erythrocyte counts, hemoglobin concentration and hematocrit values at some interim intervals, but not at the end of the study. Increased kidney and spleen weights at terminal sacrifice only in females. 108 UNEP PUBLICATIONS
OECD SIDS N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE 5. TOXICITY ID: 793-24-8 DATE: 11.05.2005 Histopathologic Observations: Average number of lesions per animal Control / 100 ppm / 300 ppm / 1000 ppm Males: Number examined / 19 / 15 / 18 / 25 Non-neoplasic / 8.8 / nd / nd / 8.5 Females: Number examined / 37 / 28 / 38 / 37 Non-neoplasic /12.1/ nd / nd / 9.7 nd = not determined The incidence of non-neoplastic lesions was comparable between control and high dose groups for male animals; for females the incidence of nonneoplastic lesions was reduced in treated animals versus controls. In summary, the histopathological examination of tissues from high dose and control animals sacrificed at termination of the study and selected gross lesions or tissue masses from all study groups gave no indication for histopathological alterations caused by the TS. Test condition : TEST ORGANISMS: -Age: no data -Weight at study initiation: no data -Number of animals: 50 males and 50 females per group CLINICAL OBSERVATIONS AND FREQUENCY: -Clinical signs: daily -Mortality: daily -Body weight: weekly for 13 weeks and monthly thereafter -Food consumption: for 5 rats per sex from each dietary level weekly for the first 13 weeks and for one week in each month thereafter -Haematology: ten rats per sex from control and high dose groups at 3, 6 and 18 months; ten rats per sex from all groups at 12 and 24 months (individual parameters not specified) -Biochemistry: ten rats per sex from control and high dose groups at 3, 6 and 18 months; ten rats per sex from all groups at 12 and 24 months (individual parameters not specified) -Urinalysis: ten rats per sex from control and high dose groups at 3, 6 and 18 months; ten rats per sex from all groups at 12 and 24 months (individual parameters not specified) ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): -Microscopic: selected tissues from the chest and abdominal regions and from the CNS of all high dose and control rats; also on tissue masses or lesions observed at post-mortem examinations of all sacrificed animals and all animals which died during the study Reliability : (2) valid with restrictions Study meets generally accepted scientific principles, data from summary without detailed documentation, acceptable for assessment Flag : Critical study for SIDS endpoint 04.06.2004 (77) (78) UNEP PUBLICATIONS 109
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N-(1,3-Dimethylbutyl)-N

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