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
Neoplastic / 0.94 / 0.80 / 1.11 / 1.12
Females:
Number examined / 37 / 28 / 38 / 37
Neoplastic / 1.51 / 1.14 / 1.29 / 1.32
For male animals of the high dose group the incidence of neoplastic lesions
was slightly but not significantly elevated versus the control. The greatest
differences between males of control and treated groups were noted in
lymph nodes and in the pituitary and parathyroids. However, the number of
tumors noted was considered to be within the historical range for this strain
of animal.
For females the incidence of neoplastic lesions was reduced for treated
groups versus controls. Individual types of neoplastic lesions were
comparable to controls or within the historical range for animals of this
strain and age.
In summary, the histopathological examination of tissues from high dose
and control animals sacrificed at termination ot the study and selected
gross lesions or tissue masses from all study groups gave no indication for
histopathological or neoplastic alterations caused by the TS.
Test condition : TEST ORGANISMS:
-Age: no data
-Weight at study initiation: no data
-Number of animals: 50 males and 50 females per group
CLINICAL OBSERVATIONS AND FREQUENCY:
-Clinical signs: daily
-Mortality: daily
-Body weight: weekly for 13 weeks and monthly thereafter
-Food consumption: for 5 rats per sex from each dietary
level weekly for the first 13 weeks and for one week in each
month thereafter
-Haematology: ten rats per sex from control and high dose
groups at 3, 6 and 18 months; ten rats per sex from all
groups at 12 and 24 months
-Biochemistry: ten rats per sex from control and high dose
groups at 3, 6 and 18 months; ten rats per sex from all
groups at 12 and 24 months
-Urinalysis: ten rats per sex from control and high dose
groups at 3, 6 and 18 months; ten rats per sex from all
groups at 12 and 24 months
ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND
MICROSCOPIC):
-Microscopic: selected tissues from the chest and abdominal
regions and from the CNS of all high dose and control rats;
also on tissue masses or lesions observed at post-mortem
examinations of all sacrificed animals and all animals which
died during the study
Reliability : (2) valid with restrictions
Study meets generally accepted scientific principles,
without detailed documentation, acceptable for assessment
Flag : Critical study for SIDS endpoint
04.06.2004 (77)
Species : rat
Sex : no data
Strain : no data
Route of admin. : oral feed
Exposure period : 24 months (interim necropsy after 12 months [20 animals/group])
Frequency of treatm. : continuously in diet
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