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 Neoplastic / 0.94 / 0.80 / 1.11 / 1.12 Females: Number examined / 37 / 28 / 38 / 37 Neoplastic / 1.51 / 1.14 / 1.29 / 1.32 For male animals of the high dose group the incidence of neoplastic lesions was slightly but not significantly elevated versus the control. The greatest differences between males of control and treated groups were noted in lymph nodes and in the pituitary and parathyroids. However, the number of tumors noted was considered to be within the historical range for this strain of animal. For females the incidence of neoplastic lesions was reduced for treated groups versus controls. Individual types of neoplastic lesions were comparable to controls or within the historical range for animals of this strain and age. In summary, the histopathological examination of tissues from high dose and control animals sacrificed at termination ot the study and selected gross lesions or tissue masses from all study groups gave no indication for histopathological or neoplastic 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 -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 -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 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, without detailed documentation, acceptable for assessment Flag : Critical study for SIDS endpoint 04.06.2004 (77) Species : rat Sex : no data Strain : no data Route of admin. : oral feed Exposure period : 24 months (interim necropsy after 12 months [20 animals/group]) Frequency of treatm. : continuously in diet 128 UNEP PUBLICATIONS
OECD SIDS N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE 5. TOXICITY ID: 793-24-8 DATE: 11.05.2005 Post exposure period : no data Doses : 0, 50, 250 or 1500 ppm Result : negative Control group : yes Method : other Year : 1993 GLP : no data Test substance : other TS: Santoflex 13 Remark : 0, 50, 250 or 1500 ppm = ca. 0, 4, 20 or 120 mg/kg bw/d see also chapter 5.4 Result : The histopathological examination of all relevant organs revealed a number of benign and malign neoplasias in the liver and thyroid glands of rats in all experimental groups. The number of primary benign and malign neoplasms in control and dose groups was often similar. According to the authors of the study these neoplasias are not unusual in laboratory rats, and their occurrence in this study was not considered to be treatment-related. All findings on non-neoplastic changes were assessed as spontaneous or agonal ones, which are not unusual for rats of this strain and age. Reliability : (4) not assignable Cited from BUA report no 208 (1996) No further information available Flag : Critical study for SIDS endpoint 30.08.2001 (79) Species : other: in vitro cell transformation assay with BALB/3T3 cells Sex : Strain : Route of admin. : Exposure period : Frequency of treatm. : Post exposure period : Doses : Result : negative Control group : Method : other: see TC Year : 1982 GLP : yes Test substance : no data Remark : The positive control chemical (methylcholanthrene) led to the expected increase in transformed foci. Result : DOSE FINDING: Concentration (ug/ml) % relative survival 0.061 93.1 0.122 79.9 0.244 88.7 0.488 32.3 0.977 0.9 0.195-1000 0.0 CELL TRANSFORMATION ASSAY: Concentration (ug/ml) foci/dish 0.165 0.187 0.33 0.161 0.495 0.281 0.66 0.349 UNEP PUBLICATIONS 129
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N-(1,3-Dimethylbutyl)-N

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