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EC number: 418-220-4
CAS number: -
NOEL (28 d) = 50 mg/kg bw for male and
female rats when administered orally by gavage.
The oral route was considered to be the
most relevant way of exposure, therefore a subacute test was performed
on rats at 0, 50, 200, 1000 mg/kg bw concentrations. The study was
conducted according to internationally accepted guidelines (OECD 407).
The NOEC (28 d) value was determined to be
50 mg/kg bw. Starting from 200 mg/kg bw concentration, adverse effects
were determined. The effects evaluated are summarised below.
No deaths occurred during the course
of this study.
In 20% of the animals at 1000 mg/kg,
ruffled fur was noted in some days during the first part of the
In addition passive coloration of
the feces by the red test article was noted in all animals at 200 (group
3) and 1000 mg/kg (group 4). This finding was considered to be without
any toxicological significance.
Food consumption and body weights
Up to and including the highest dose
level of 1000 mg/kg, there were no effects on the food consumption or
body weight gain of the animals.
No test article related abnormal
changes were noted.
Slightly decreased haemoglobin
concentration in males of group 4, slightly to moderately increased
reticulocyte count in both sexes of groups 3 and 4, slightly increased
HFR and slightly decreased LFR reticulocyte fluorescence ratio in males
of group 4, and slightly to moderately increased methaemoglobin
concentration in both sexes of groups 3 and 4.
Slightly to moderately increased
total bilirubin concentration in both sexes of groups 3 and 4 at
termination of the treatment.
Urinalysis data at termination of
the treatment indicated no changes of toxicological significance. The
only changes noted were a deep yellow urine pigmentation in two females
of group 2 (50 mg/kg), in two males of group 3 and in one male and one
female of group 4.
At 1000 mg/kg, increased spleen
weight was in particular for the female animals. This finding indicate
the spleen as a target organ. In addition, at 1000 mg/kg, increased
relative liver weight was noted for the female animals. This finding was
without any histopathological correlate.
Macroscopic and microscopic
At terminal macroscopic examination
no test article related abnormal findings were noted.
The inhalation route was not evaluated
since exposure by inhalation of the test itemis very unlikely to happen
due to its negligible vapour pressure.
The dermal route was not evaluated since
exposure by dermal sorption of the test item is very unlikely to happen
due to its logKow value (-2.9) and molecular weight (ca. 1470).
A subacute 28 d test is available
for rats dosed at 0, 50, 200, 1000 mg/kg bw concentrations.
According to regulation EC 1272/2008
(CLP) section 22.214.171.124.6, the guidance range value to assist in Category
2 classification is between 10 and 100 mg/kg body weight/day
(dose/concentration) for a 90-day test, which is multiplied by a factor
of 3 in the case of data regarding a 28-day repeated toxicity test.
In the experiment performed, 50
mg/kg bw was determined to be the no observed effect level (NOEL).
A positive dose-response
relationship was evident between dose and haematological and biochemical
effects observed. The effects observed at 200 mg/kg were not
statistically significant and/or toxicologically relevant. For these
reasons, a no adverse effect level (NOAEL) of 200 mg/kg bw/day can be
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