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N-(1,3-Dimethylbutyl)-N

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OECD SIDS<br />

N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE<br />

5. TOXICITY ID: 793-24-8<br />

DATE: 11.05.2005<br />

Type : Sub-chronic<br />

Species : rat<br />

Sex : male/female<br />

Strain : Sprague-Dawley<br />

Route of admin. : oral feed<br />

Exposure period : 13 weeks<br />

Frequency of treatm. : continuously in diet<br />

Post exposure period : no<br />

Doses : 0, 250, 1000 or 2500 ppm<br />

Control group : yes<br />

NOAEL : = 250 ppm<br />

LOAEL : = 1000 ppm<br />

Method : other<br />

Year : 1987<br />

GLP : yes<br />

Test substance : other TS: Santoflex 13 (purity 97.1%)<br />

Result : ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX:<br />

-males: 15.7, 62.3, 153.8 mg/kg bw/d<br />

-females: 18.5, 75.0, 172.1 mg/kg bw/d<br />

TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:<br />

-Mortality and time to death: none<br />

-Clinical signs: no treatment related effects<br />

-Body weight gain: males from 1000 ppm and females at 2500<br />

ppm: reduced rate of weight gain from start of exposure;<br />

significantly reduced body weight from end of second study<br />

week till study end; NOAEL 250 ppm<br />

Table: Terminal Body Weights in g (% of control)<br />

Group Control 250 ppm 1000 ppm 2500 ppm<br />

Males 429.1 (100)/ 415.2 (97)/ 392.6 (92)/ 371.8 (87)<br />

Females 264.0 (100)/ 260.3 (99)/ 248.2 (94)/ 238.5 (90)<br />

-Food consumption: from 1000 ppm: greatly reduced in first<br />

study week, thereafter consistently below controls for males from 1000<br />

ppm and females at 2500 ppm<br />

Table: Food consumption in g/day (% of control)<br />

Group Control 250 ppm 1000 ppm 2500 ppm<br />

Males 25.6 (100)/ 24.6 (96)/ 23.3 (91)/ 22.0 (86)<br />

Females 19.0 (100)/ 18.9 (99)/ 18.3 (96)/ 16.2 (85)<br />

-Ophthalmoscopic examination: no treatment related effects<br />

-Clinical chemistry: from 1000 ppm: increase of total<br />

protein, albumin, globulin, calcium, cholesterol; decrease<br />

of SGOT, SGPT, creatinine, BUN; only in males: bilirubin<br />

elevated<br />

-Haematology: from 1000 ppm: mild anemia: mild decrease of<br />

RBC, Hb, MCV, HCT, MCH, MCHC; thrombocytosis (study end);<br />

females from 250 ppm: decrease of WBC and lymphocytes; slight anemia<br />

in interim sampling period only<br />

-Organ weights:<br />

Table: Absolute organ weights (g)<br />

Organ /Sex / Control/ 250 ppm/ 1000 ppm/ 2500 ppm<br />

Brain/ male/ 2.090/ 2.134/ 2.086/ 2.073<br />

Brain/ female/ 1.953/ 1.973/ 1.955/ 1.953<br />

Kidneys/ male/ 3.354/ 3.391/ 3.387/ 3.329<br />

Kidneys/ female/ 2.005/ 2.074/ 2.106/ 2.097<br />

Liver/ male/ 15.263/ 15.347/ 16.873/ 17.942**<br />

106<br />

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