N-(1,3-Dimethylbutyl)-N

OECD SIDS
N-(1,3-DIMETHYLBUTYL)-N´-PHENYL-1,4-PHENYLENEDIAMINE
5. TOXICITY ID: 793-24-8
DATE: 11.05.2005
-Weight: brain, kidney, liver, spleen, testes with
epidymides
-Macroscopic: extensive
-Microscopic: extensive
STATISTICAL METHODS:
Dunnett's test: body weight, food consumption, pathology,
absolute organ weight
Mann-Whitney test: relative organ weight
Fisher's exact test: incidence of microscopic lesions
Conclusion : The absence of histological lesions in bone marrow suggests
that the observed anemia from the middle dose was not caused by
decreased red blood cell production but rather by an increased rate of red
blood cell destruction. Changes in
organ weights were not accompanied by macroscopic or
microspcopic lesions. Female rats at 250 ppm had mild anemia that was
reversible within the end of study. Lymphocytopenia was observed in
females from all dose groups at the terminal sampling. The toxicologic
significance and relationship to treatment of thrombocytosis and
lymphocytopenia in this study are unknown. So 250 ppm was considered to
be the NOAEL.
Reliability : (2) valid with restrictions
Study well documented, meets generally accepted scientific
principles, acceptable for assessment
Flag : Critical study for SIDS endpoint
03.06.2004 (76)
Type : Chronic
Species : rat
Sex : male/female
Strain : other: Charles River CD
Route of admin. : oral feed
Exposure period : 24 months
Frequency of treatm. : continuously in diet
Post exposure period : no
Doses : 0, 100, 300 or 1000 ppm
Control group : yes, concurrent no treatment
NOAEL : = 1000 ppm
LOAEL : > 1000 ppm
Method : other
Year :
GLP : no data
Test substance : no data
Remark : 0, 100, 300 or 1000 ppm = ca. 0, 8, 23 or 75 mg/kg bw/d
Result : Survival rate (in %) was comparable with controls:
0 100 300 1000 ppm
males 24 28 26 28
females 56 52 46 52
>= 100 ppm: no changes in organ weights, no gross or
microscopic tissue changes;
1000 ppm: reduced body weight gain (with decreased food
consumption during the first week of the study); decrease in
erythrocyte counts, hemoglobin concentration and hematocrit
values at some interim intervals, but not at the end of the
study. Increased kidney and spleen weights at terminal
sacrifice only in females.
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