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 0.99 0.181 solvent control 0.266 positive control 1.123 No significantly increased number of transformed foci for TS (t-test) Test condition : TOXICITY SCREENING: -Concentrations: 15 concentrations from 0.061 - 1000 µg/ml -Solvent: DMSO -Negative controls: only medium, 0.5 % DMSO -Exposure: 24 h -Post-exposure incubation: 5-7 days -Dose selection: highest concentration with reduction in colony forming ability of less than 90 % CELL TRANSFORMATION ASSAY: -Concentrations: 0.165, 0.33, 0.495, 0.66, 0.99 µg/ml -Solvent: DMSO -Negative controls: only medium, 0.5 % DMSO -Positive control: 3-methylcholanthrene -Replicates: 20 dishes/concentration -Exposure: 24 h -Post-exposure incubation: 4 w Reliability : (2) valid with restrictions Test procedure in accordance with generally accepted scientific principles and described in sufficient detail Flag : Critical study for SIDS endpoint 11.06.2003 (101) 5.8.1 TOXICITY TO FERTILITY Type : other: Reproduction toxicity screening test 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 Premating exposure period Male : Female : 14 d Duration of test : males: 48 d; females: until day 4 of lactation No. of generation : studies Doses : 0; 6; 25; 100 mg/kg bw/d Control group : yes, concurrent vehicle NOAEL parental : = 100 mg/kg bw NOAEL F1 offspring : = 100 mg/kg bw Result : With regard to reproductive toxicity, no adverse effects were observed in terms of the estrous cycle, copulation and fertility results or findings for delivery. 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 130 UNEP PUBLICATIONS
OECD SIDS N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE 5. TOXICITY ID: 793-24-8 DATE: 11.05.2005 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 adverse effects were observed in terms of the estrus cycle, copulation and fertility results or findings for delivery. The NOAELs for reproductive toxicity are considered to be 100 mg/kg bw/day for both parental animals and offspring. Test condition : APPLICATION: -Gavage -Vehicle: corn oil TEST ORGANISMS: -Age: 10 weeks -Body weight at study initiation: 354-397 g (males); 217-244 g (females) -Number of animals: 12 per sex and dose group -Terminal kill: on day 48 (males) and on day 4 of lactation (females), respectively CLINICAL OBSERVATIONS AND FREQUENCY: -Clinical signs: yes, not specified in summary -Mortality: yes, not specified in summary -Body weight: on day 1,8,15,22,29,36,43,49 of administration (males), on day 15,8, and 1 before mating, day 0,7,14, and 21 of gestation and day 0 and 4 of lactation. -Food consumption: measured weekly except during mating ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): -Organ weight: liver, adrenals, testes, epididymides -Macroscopical examination: liver and reproductive organs -Microscopical examination: liver, kidney, skin, and reproductive organs OTHER EXAMINATIONS: -Reproductive performance: copulation index, fertility index, estrus cycle length, duration of gestation, number of corpora lutea, of implantations, of pups born, of live pups born, and of live pups on day 4; sex ratio, gestation index, implantation index, delivery index, live birth index, viability index on day 4, body weight change of pups EXAMINATIONS OF OFFSPRINGS: External examination, clinical signs, growth, necropsy findings. Test substance : 99.4 % (wt) purity Reliability : (1) valid without restriction Guideline study performed according to OECD Guideline 421; original reference published in Japanese, compilation of data from English summary and from tables and figures. Flag : Critical study for SIDS endpoint 10.06.2003 (81) Type : other: Three generation study Species : rat Sex : male/female Strain : other: Charles River CD Route of admin. : oral feed Exposure period : for three successive generations Frequency of treatm. : continuously in diet Premating exposure period Male : F0-generation received the test compound for 11 weeks before mating Female : F0-generation received the test compound for 11 weeks before mating Duration of test : No. of generation : studies Doses : 0, 100, 300 or 1000 ppm Control group : yes, concurrent no treatment Method : other UNEP PUBLICATIONS 131
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N-(1,3-Dimethylbutyl)-N

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