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EC number: 273-227-8
CAS number: 68953-84-4
A 26/38-week initiation-promotion carcinogenicity study with 1,4-benzenediamine, N,N’-mixed Ph and tolyl derivs. at 1900 ppm in the food (or ca. >100 mg/kg bw/day) did not reveal initiating activity nor clear evidence of promoting activity towards the liver and urinary bladder when compared and combined with control compounds.
In accordance to Directive 67/548/EEC (Dangerous Substances Directive)
and EU Classification, Labelling and Packaging of Substances and
Mixtures (CLP) Regulation (EC) No. 1272/2008, classification of
1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. for carcinogenicity
is not warranted based on the available test data, as the available rat
study did not display characteristics expected of carcinogenic chemicals.
There was a key study for carcinogenicity assessment, which was designed
as a 26/38-week initiation-promotion study in male Fisher 344 rats
(Iatropoulos, 1997). The study was conducted according to GLP and while
conventional testing for carcinogenicity employs a 2 year chronic
exposure design, the methodology employed in this study is was
considered to be a scientifically-sound approach to study the
carcinogenicity of chemicals for liver and urinary bladder. The test
compound 1,4-benzenediamine, N,N’-mixed Ph and tolyl derivs.
administered via the diet at 1900 ppm (corresponding to >100 mg/kg
bw/day) was tested in combination with and compared to ‘initiators’ and
‘promoters’ for liver (diethylnitrosamine and phenobarbital,
respectively) and urinary bladder (butylhydroxybutylnitrosamine and
nitrilotriacetate, respectively). Animals were sacrificed at weeks 26 &
38 with complete gross examinations. There were no adverse clinical
findings during the study, whereas body weights were slightly suppressed
in all but one test group compared to controls. Findings for organs
included increased liver and kidney weights in groups dosed with
initiator and test chemical above control values and reference groups
with initiator only. 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.
clearly lacked any evidence of initiating activity towards the liver and
bladder. Promotional activity was not evident as the various indices
were virtually unchanged from groups that were treated with known
initiators alone. This was supported by lack of PCNA findings in the
Overall, the test chemical did not display characteristics in this study
expected of carcinogenic chemicals. Similar results were seen at the 26
and 38-week sacrifice period.
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