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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 />

increase in micronuclei rate.<br />

Test condition : TEST ORGANISMS:<br />

-No. of animals per dose: 5<br />

ADMINISTRATION:<br />

-Vehicle: suspension in 1 % gum accacia<br />

-Duration of test: termination 24 h after second application<br />

-Frequency of treatment: two doses within 24 hours<br />

-Sampling times and number of samples: 24 h after second<br />

application<br />

-Control groups and treatment: negative control: 1 % gum<br />

accacia; positive control: 100 mg cyclophosphamide/kg bw<br />

-Criteria for selection of doses: > 200 mg/kg bw were found<br />

to be lethal<br />

Reliability : (2) valid with restrictions<br />

Study well documented, meets generally accepted scientific<br />

principles, acceptable for assessment<br />

Flag : Critical study for SIDS endpoint<br />

11.06.2003 (99)<br />

5.7 CARCINOGENICITY<br />

Species : rat<br />

Sex : male/female<br />

Strain : other: Charles River CD<br />

Route of admin. : oral feed<br />

Exposure period : 24 months<br />

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

Post exposure period : no<br />

Doses : 0, 100, 300 or 1000 ppm<br />

Result : negative<br />

Control group : yes, concurrent no treatment<br />

Method : other<br />

Year :<br />

GLP : no data<br />

Test substance : no data<br />

Remark : 0, 100, 300 or 1000 ppm = ca. 0, 8, 23 or 75 mg/kg bw/d<br />

Result : Survival rate (in %) was comparable with controls:<br />

0 100 300 1000 ppm<br />

males 24 28 26 28<br />

females 56 52 46 52<br />

>= 100 ppm: no changes in organ weights, no gross or<br />

microscopic tissue changes;<br />

1000 ppm: reduced body weight gain (with decreased food<br />

consumption during the first week of the study); decrease in<br />

erythrocyte counts, hemoglobin concentration and hematocrit<br />

values at some interim intervals, but not at the end of the<br />

study. Increased kidney and spleen weights at terminal<br />

sacrifice only in females.<br />

Histopathologic Observations:<br />

Average number of lesions per animal<br />

Control / 100 ppm / 300 ppm / 1000 ppm<br />

Males:<br />

Number examined / 19 / 15 / 18 / 25<br />

UNEP PUBLICATIONS 127

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