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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 />

Method : other<br />

Year : 1970<br />

GLP : no data<br />

Test substance : other TS: technical preparation of Santoflex 13<br />

Result : no death, body weight gain within the normal range,<br />

increased oxygen consumption, suppression of the central<br />

nervous system and of the synthezising function of the liver<br />

(content of hippuric acid in a 24 h urine sample was<br />

decreased), decreased ascorbic acid content in the liver<br />

Reliability : (3) invalid<br />

Documentation insufficient for assessment<br />

30.08.2001 (58)<br />

Type : Sub-acute<br />

Species : rat<br />

Sex : male/female<br />

Strain : Sprague-Dawley<br />

Route of admin. : gavage<br />

Exposure period : 28 days<br />

Frequency of treatm. : not specified<br />

Post exposure period : 14 days<br />

Doses : 0, 4, 20, 100 mg/kg bw/d<br />

Control group : yes, concurrent vehicle<br />

NOAEL : = 20 mg/kg bw<br />

LOAEL : = 100 mg/kg bw<br />

Method : other: see ME<br />

Year : 1999<br />

GLP : yes<br />

Test substance : other TS: 99 % purity<br />

Method : Guidelines for 28-Day Repeat Dose Toxicity Testing of<br />

Chemicals (Japan)<br />

Remark : The authors derived a NOEL of 4 mg/kg bw for this study<br />

(Ohara et al., 1999).<br />

As a sex-specific sensitivity is obvious from the study data<br />

the NOEL of 4 mg/kg bw is only valid for the female rats.<br />

The effects observed at the LOEL of 20 mg/kg bw were of a<br />

rather mild nature (reversible periportal fatty change of<br />

the liver without an increase of liver weight; increased<br />

total serum protein). In contrast, there were adverse<br />

effects on a range of different parameters observed at 100<br />

mg/kg for both sexes so that the LOAEL for both sexes is<br />

rather at the dose of 100 mg/kg bw and the NOAEL at 20 mg/kg<br />

bw.<br />

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

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

-Clinical signs: not reported<br />

-Body weight gain: no effect<br />

-Food consumption: not reported<br />

-Clinical chemistry:<br />

20 mg/kg: females: at end of administration sig. increase of<br />

total protein<br />

(p

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