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
Only short summary of study report available.
11.08.2003 (104)
Species : rabbit
Sex : female
Strain : other: New Zealand Albino
Route of admin. : other: oral in gelatin capsules
Exposure period : GD 6 - 18
Frequency of treatm. : once daily
Duration of test : sacrifice on GD 29
Doses : 0, 10 or 30 mg/kg bw/d
Control group : other: yes, empty gelatin capsules
NOAEL maternal tox. : = 30 mg/kg bw
NOAEL teratogen. : = 30 mg/kg bw
Method : other
Year : 1976
GLP : no data
Test substance : other TS: Santoflex 13
Remark : in a pilot study 100 and 300 mg/kg bw/d caused maternal
toxicity
Result : Reduced average body weights were seen in dosed animals and
also in controls. The mortality was 5/17 in controls and
3/17 or 6/23 in low- and high-dosed animals, resp.. In 10/14 animals found
dead, respiratory insufficieny was diagnosed. 5 of these 10 animals were
controls, so that this effect was not substance-related.
In the high-dose group the relative resorption rate was 38.6 % compared
with 31.4 % in controls, while the value for low-dosed animals was in the
upper range of historical
controls (30.5 %).
The relative number of live offspring (based on 100
implantation sites) was slightly decreased in both treatment groups
compared with controls (68.8, 48.3 or 38.6 %, resp.).
Control / 10 mg/kg/d / 30 mg/kg/d
Pregnant animals / 10 / 14 / 11
Implantation sites / 70 / 118 / 88
Live pups / 48 / 57 / 34
Resorptions / 22 / 36 / 34
Fetuses aborted / 0 / 25 / 0
Does with abortion / 0 / 3 / 0
There was no increase in the incidence of external, visceral or and skeletal
abnormalities.
Reliability : (2) valid with restrictions
Study well documented, meets generally accepted scientific
principles, acceptable for assessment
Flag : Critical study for SIDS endpoint
04.06.2004 (105)
Species : other: in vitro prescreening test with chicken embryos
Sex :
Strain :
Route of admin. :
Exposure period :
Frequency of treatm. :
Duration of test :
Doses :
Control group :
UNEP PUBLICATIONS 135