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 Year : GLP : no data Test substance : other TS: Santoflex 13 and Santoflex 77 Remark : 0, 100, 300 or 1000 ppm = ca. 0, 8, 23 or 75 mg/kg bw/d Result : F0-generation: no effect on fertility, no effect on behaviour, reduced body weight gain at the mid and high dose levels, no substance-related histopathological effects F1- to F3-generation: no effect on fertility, no effect on behaviour, no substance-related histopathological effects. Pup survival was lower in those treatment groups most severely affected by the body weight reduction. However, the number of live offspring produced were similar at all treatment levels for all generations. Test condition : Groups of 8 male and 16 female F0 rats received the TS during an 11 week growth period. The administration continued through mating and during mating, gestation and lactation for two successive litters (F1a, F1b). Groups of 8 males and 16 females were retained at weaning from the 2nd litters of each dose level as parenteral animals for the succeding generation. Observations: -Mortality: daily -Clinical signs: daily -Body weights: weekly during growth periods; pups were counted and weighed during lactation Post-mortem examinations: -All animals were subject to gross examinations; tissues were preserved from randomly selected pups from the F3b litter. -Histopathologic evaluations were conducted on tissues fromt the chest and abdominal regions and CNS of 5 male/5 female adults from the three parenteral groups and of 10 male/10 female F3b pups from the control and high-dose group. Reliability : (2) valid with restrictions Study meets generally accepted scientific principles, without detailed documentation, acceptable for assessment Flag : Critical study for SIDS endpoint 28.08.2001 (77) (78) 5.8.2 DEVELOPMENTAL TOXICITY/TERATOGENICITY Species : rat Sex : female Strain : Sprague-Dawley Route of admin. : gavage Exposure period : GD 6 - 15 Frequency of treatm. : once daily Duration of test : sacrifice on GD 20 Doses : 0, 50, 100 or 250 mg/kg bw/d Control group : yes, concurrent vehicle NOAEL maternal tox. : = 50 mg/kg bw NOAEL teratogen. : = 250 mg/kg bw Method : other Year : 1987 GLP : no data Test substance : other TS: Santoflex 13 132 UNEP PUBLICATIONS
OECD SIDS N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE 5. TOXICITY ID: 793-24-8 DATE: 11.05.2005 Result : The maternal survival was 100 % in all groups and the gestation rate was 80 % in controls and 92 % in treated groups. In mid- and high-dosed dams increased salivation, soft stools, diarrhea, reduced defecation, and greenish stools were observed. At any treatment level no teratogenic or embryo/fetotoxic effects were observed. Test condition : 25 rats/group administration of TS in 5 ml cooking oil Reliability : (4) not assignable No further information available 11.08.2003 (102) Species : rat Sex : male/female Strain : Crj: CD(SD) Route of admin. : gavage Exposure period : males: 48 d; females: 14 d before mating until day 3 of lactation Frequency of treatm. : once daily Duration of test : males: 48 d; females: 14 d before mating until day 3 of lactation Doses : 0; 6; 25; 100 mg/kg bw/d Control group : yes, concurrent vehicle NOAEL maternal tox. : = 6 mg/kg bw NOAEL teratogen. : = 100 mg/kg bw Result : With regard to developmental toxicity, no abnormal findings related to the test substance were noted on external examination, or for clinical signs, growth or necropsy findings for the offspring. Method : other: see ME Year : 2001 GLP : yes Test substance : other TS Method : Reproduction/developmental toxicity screening test according to OECD TG 421 Remark : The detailed description of this study can be found in chapter 5.4 Result : The test substance had no effect on body weight gain. Food consumption was increased in high-dosed males (only intermittendly) and in all 6PPDtreated females (only during lactation). 6PPD had no adverse effects on the reproductive organs (histologic examination) in any treatment group. No abnormal findings related to the test substance were noted for external examination, clinical signs, growth or necropsy of the offspring. The NOAEL for developmental toxicity is considered to be 100 mg/kg bw/day. Control / 6 mg/kg / 25 mg/kg / 100 mg/kg Total pups born / 184 / 160 / 149* / 131 Total live pups born / 183 / 158 / 148* / 131 Male / 91 / 76 / 75 / 73 Female / 92 / 82 / 73 / 58 Live pups on day 4 Male / 81 / 74 / 74 / 72 Female / 78 / 80 / 71 / 57 Viability index (%) on day 4 Male / 88.2 / 98.2 / 98.3 / 98.3 Female / 88.7 / 97.9 / 95.8 / 98.6 Pup body weight (g) at birth Male / 5.9 / 6.1 / 6.6** / 6.6** Female / 5.6 / 5.8 / 6.2* / 6.2* Pup body weight (g) at day 4 UNEP PUBLICATIONS 133
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N-(1,3-Dimethylbutyl)-N

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