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 ADMINISTRATION: - Number of replicates: triplicate cultures, 3 slides/dose - Positive and negative control groups and treatment: negative controls: untreated, solvent DMSO positive control: 2AAF - Exposure: 18-20 hours CRITERIA FOR EVALUATING RESULTS: Net nuclear increase of grains for 20 cells, in total 60 cells/dose; TS is reported positive when the minimum net grain count of 5 per nucleus is consistently observed in triplicate wells; where possible a dose response profile should be observed. RESULTS: None of the treated cultures produced net nuclear grain counts that were substantially greater than the DMSO solvent control. Reliability : (1) valid without restriction Comparable to guideline study Flag : Critical study for SIDS endpoint 04.06.2004 (83) Type : Ames test System of testing : Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 Test concentration : 10, 33, 100, 333, 1000 µg/plate Cycotoxic concentr. : >= 500 µg/plate with TA 100 Metabolic activation : with and without Result : negative Method : OECD Guide-line 471 Year : 1984 GLP : yes Test substance : other TS: in study protocol adressed as "Flexzone 7F" (no data on chemical identity or purity) Remark : TS was dissolved in DMSO. S9 fractions were prepared from Aroclor 1254- induced male Sprague-Dawley rat livers. The preliminary toxicity screen was performed using strains TA 1538 and TA 100 without metabolic activation with TS doses up to 5000 µg/plate. There was no cytotoxicity in starin TA 1538; in strain TA 100 fewer revertant colonies and an abnormal background lawn were observed at >= 500 µg/plate. Based upon these findings the highest dose selected for the plate incorporation mutation assay was 1000 µg/plate. Concurrent solvent (DMSO) and positive controls were run with each trial. The positive control chemicals without metabolic activation were sodium azide (TA 1535 and TA 100), 9-aminoacridine (TA 1537) and 2- nitrofluorene (TA 98 and TA 1538). The positive control with metabolic activation was 2-aminoanthracene for all strains. The positive control chemicals led to the expected increase in revertants. Reliability : (1) valid without restriction Guideline study Flag : Critical study for SIDS endpoint 04.06.2004 (84) Type : Ames test System of testing : Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 Test concentration : 0, 0.1, 0.3, 1.0, 3.3, 10.0, 33.0, 100, 200 ug/plate Cycotoxic concentr. : only TA 100: >= 10 ug/plate (without metabolic activation) Metabolic activation : with and without Result : negative Method : other: Preincubation assay as described by Haworth et al., Environ. Mutagen. 5 (Suppl. 1), 3-142 (1983) Year : 1987 116 UNEP PUBLICATIONS
OECD SIDS N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE 5. TOXICITY ID: 793-24-8 DATE: 11.05.2005 GLP : no data Test substance : other TS: purity not given Remark : TS was dissolved in DMSO. S9 fractions were prepared from Aroclor 1254- induced male Sprague-Dawley rat and male Syrian hamster livers as described by Haworth et al., Environ. Mutagen. 5 (Suppl. 1), 3-142 (1983). The S9-mixes were prepared immediately prior to use and contained 10 % S-9. The TS, Salmonella culture, and S-9 mix or buffer were incubated at 37°C without shaking for 20 min. The top agar was added, and the contents of the tubes were mixed and poured onto the surface of petri dishes that contained Vogel-Bonner medium. The histidine-revertant (his+) colonies arising on these plates were counted following 2 days incubation at 37°C. The plates were hand-counted when a precipitate was present; otherwise automatic colony counters were used. All chemicals were tested initially in a toxicity assay with TA 100 to determine the appropriate dose range. Toxic concentrations were those at which a decrease in the number of his+ colonies was seen or at which there was a clearing in the density of the background lawn. At least 5 doses of the TS were tested in triplicate. Experiments were repeated at least 1 week following the initial trial. Each TS was tested initially at half-log doses up to a dose that elicited toxicity. A maximum of 0.05 ml solvent was added to each plate. Concurrent solvent (DMSO) and positive controls were run with each trial. The positive control chemicals without metabolic activation were sodium azide (TA 1535 and TA 100), 9-aminoacridine (TA 1537) and 4-nitro-ophenylenediamine (TA 98). The positive control with metabolic activation was 2-aminoanthracene for all strains. The positive controls led to the expected increase in revertants. The data were evaluated as described by Haworth et al., Environ. Mutagen. 5 (Suppl. 1), 3-142 (1983). Reliability : (1) valid without restriction Comparable to guideline study Flag : Critical study for SIDS endpoint 04.06.2004 (85) Type : Ames test System of testing : Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 Test concentration : no data Cycotoxic concentr. : no data Metabolic activation : with and without Result : negative Method : other Year : 1984 GLP : no data Test substance : no data Reliability : (4) not assignable Documentation insufficient for assessment Only results were given 27.08.2001 (86) Type : Ames test System of testing : Salmonella typhimurium Test concentration : no data Cycotoxic concentr. : no data Metabolic activation : no data Result : negative Method : other Year : 1983 GLP : no data Test substance : no data UNEP PUBLICATIONS 117
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N-(1,3-Dimethylbutyl)-N

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