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EC number: 211-989-5
CAS number: 732-26-3
The potential of the test material to cause repeated dose toxicity was investigated in the rat in a study conducted using methodology similar to that outlined in the standardised guideline OECD 452. Animals were fed diet containing the test material for up to 24 months. Haematological and serum biochemical examinations were conducted for all dose groups and at terminal sacrifice, the animals were subjected to histopathologic examination and assessed for neoplasms. No neoplastic response following test material administration was noted.
In accordance with the criteria for classification as defined in Annex
I, Regulation (EC) No. 1272/2008, the substance does not require
classification with respect to carcinogenicity.
The potential of the test material to cause repeated dose toxicity was
investigated in a study conducted using methodology similar to that
outlined in the standardised guideline OECD 452. The study was assigned
a reliability score of 2 in accordance with the criteria of Klimisch et
Groups of 40 Slc:Wistar rats of both sexes were fed diet containing 0,
30, 100, 300 and 1000 ppm of the test material for up to 24 months, with
interim examinations at 6, 12 and 18 months.
The general condition of the animals was observed and body weights were
recorded throughout the study. At 6, 12, 18 and 24 months after the
start of test material administration, haematological and serum
biochemical examinations were conducted for all dose groups. Haemoglobin
concentration, mean corpuscular volume, platelet count, blood urea
nitrogen, phospholipids, total cholesterol, glutamate oxaloacetate
transaminase and γ-glutamyl transpeptidase were all analysed. Also
following 6, 12, 18 and 24 months of test material administration,
histopathological examinations were performed for all groups.
Mortality in treated rats was comparable to that of controls. No
remarkable general findings were observed in the control and treated
groups throughout the experimental period. Significant reduction of body
weight gain was found in the female 1000 ppm group from 12 months
onward. No remarkable changes in food consumption were observed in the
control and treated groups throughout the experimental period.
The haematological, biochemical and histopathological examinations
revealed slight microcytic anaemia, changes in some biochemical
parameters relating to liver function and focal necrosis of liver cells
following test material administration. The changes observed in females
were more severe than those in males. No neoplastic response following
test material administration was noted.
It was concluded that the test material causes liver injury
characterised by focal necrosis with microcytic anaemia and elevations
of serum phospholipids and cholesterol levels presumably occurring as
secondary effects following the liver injury.
Under the conditions of this study, the no observed adverse effect level
(NOAEL) for carcinogenicity was 1000 ppm, the highest dose tested. The
NOAEL for toxicity was determined to be 30 ppm. The lowest observed
adverse effect level (LOAEL) for toxicity was determined to be 100 ppm.
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