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EC number: 248-948-6
CAS number: 28299-41-4
10 male and female rats each were administered orally daily doses of the
test substance of 0 (control), 550, 1650 or 5000 ppm (ca. 0, 45, 132 or
425 mg/kg bw/d - male rats; ca. 0, 56, 174 or 604 mg/kg bw/d - female
rats) via diet for a period of 13 weeks. Mortality, clinical signs,
food/water intake, body weights were recorded and hematological,
clinical biochemistry determinations, and gross necropsy, histopathology
Until the end of the study no difference in the appearance and the
behaviour of the treated and control animals was evident. Food and water
intake was not affected in any dose group. The body weight gain was
slightly decreased in male animals in the highest dose group (5000 ppm;
ca. 10%). The mortality was not affected in any dose group. No adverse
effects were evident from the hematological examinations at any dose
group. In the highest dose group the liver weights were increased, but
no histopathological findings of the liver or induction of cytochrom
P-450 or the N- and O-demethylases were observed. The pathological and
histopathological examinations revealed no damage on other organs or
tissues. Therefore no adverse effects up to and including 1650 ppm were
All dose groups: no changes of the hematological,
pathological-anatomic, histopathological or ophthalmologic parameters.
5000 ppm : in the males body weight gain reduced by ca. 10 %; in both
sexes liver weights were increased, but Cytochrome P-450 and N-
or O-Demethylases not induced;
Clinical-chemical investigations: indications of a
treatment-related influence on the metabolism of proteins
(increased content of albumin
and decreased content of globulin in the serum) and indications of a
slight cholestasis (increased activities of the alkaline phosphatase in
Method: 10 male and female rats each were administered orally daily
doses of the test substance of 0 (control), 550, 1650 or 5000 ppm (ca.
0, 45, 132 or 425 mg/kg bw/d - male rats; ca. 0, 56, 174 or 604 mg/kg
bw/d - female rats) via diet. Mortality, clinical signs, food/water
intake, body weights were recorded and hematological, clinical
biochemistry determinations, and gross necropsy, histogpathylogy were
Result: the NOAEL = 132 mg/kg bw/day (male rats), NOAEL = 174 mg/kg
bw/day (female rats)
Reference: Kroetlinger, Schilde (Bayer AG), 1988
Ditolyl ether was tolerated up to and including 1650 ppm when given via
the feed without adverse symptoms.
Therefore is the NOAEL = 132 mg/kg bw/day (male rats) and the NOAEL =
174 mg/kg bw/day (female rats).
No studies for dermal or inhalative repeated dose are available - by
oral application ditolyl ether is of low systemic toxicity. Furthermore,
in the toxicokinetic studies with diphenylether - as a surrogate for
ditolylether - was demonstrated to be quantitatively absorbed and eye
irritation studies showed no potential for irritation of mucous
membranes. Therefore, a repeated dose dermal or inhalative study is not
required and cannot be justified either scientifically or in terms of
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
13 w key study is used
A classification is not required as no serious or irreversible effects
in an oral subchronic study were seen up to and including 1650 ppm (132
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