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EC number: 421-950-6
CAS number: 187674-70-0
4 week repeated dose oral toxicity: NOAEL 1350 mg/kg bw/day, OECD 407, EU Method B.7 and Japanese guidelines (Notification No. 700 of the Environmental Agency, No. 1039 of the Ministry of Health and Welfare and No. 1014 of Ministry of International Trade and Industry), Fabreguettes 1996
The potential toxicity of the test material was assessed in a 4 week
repeated dose toxicity study with a 2 week reversibility period in the
rat. The study was performed under GLP conditions and in accordance with
the standardised guidelines OECD 407 and EU Method B.7, and three
Japanese guidelines (Notification No. 700 of the Environmental Agency,
No. 1039 of the Ministry of Health and Welfare and No. 1014 of Ministry
of International Trade and Industry).
Two groups of five male and five female Sprague-Dawley rats received the
test material daily by gavage at 150 and 450 mg/kg/day, and one group of
10 males and 10 females was given 1350 mg/kg/day. An additional group of
10 males and 10 females received the vehicle alone (purified water)
under the same conditions.
The animals were checked daily for clinical signs and mortality. Body
weight and food consumption were recorded once a week. Haematological
and blood biochemical investigations and urinalysis were performed at
the end of the treatment period (week 4). On completion of the 4 week
treatment period, the first five animals of each sex in the control and
high dose-level group (1350 mg/kg/day) were kept for a 2-week
At the end of the treatment or reversibility periods, the designated
animals were killed and submitted to a complete macroscopic examination.
Designated organs were weighed. A microscopic examination was performed
on selected tissues for animals of the control and high dose-level
groups killed at the end of the treatment period, macroscopic lesions
were microscopically examined for the animals of the low and
intermediate dose-level groups and for the animals of the control and
high dose-level groups killed at the end of the reversibility period.
Under the conditions of the test, there were no signs of toxicologically
relevant effects in any of the animals exposed to the test material up
to the highest dose of 1350 mg/kg/day. The only signs noted in animals
of the intermediate and high dose-level groups during the treatment
period were related to the dyeing properties of the test material. Some
findings of discolouration persisted in animals given 1350 mg/kg/day
during the reversibility period. Therefore the NOAEL was determined to
be 1350 mg/kg/day in male and female rats.
Two studies have been provided to address repeated dose oral toxicity; a
4 week repeated dose study and the preliminary 7 day range finding study.
The potential toxicity of the test material in the rat was assessed in a
preliminary 7 day study in order to define the dosing range for a
subsequent 4 week repeated dose toxicity study using the same species.
The study was performed under GLP conditions and in accordance with the
principles of the standardised guidelines OECD 407 and EU Method B.7.
Three groups of 3 male and 3 female Sprague Dawley rats received the
test material daily by oral gavage, at dose levels of 150, 450 and 1350
mg/kg/day for 7 days. An additional group of animals received the
vehicle alone (purified water) under the same conditions. The animals
were checked daily for clinical signs and mortality. Food consumption
and body weight were recorded twice a week. At the end of the treatment
period, the animals were killed and submitted to a complete macroscopic
No unscheduled deaths occurred during the study. No clinical signs of
toxicological significance were observed during the study. Yellowish or
orange-coloured faeces noted in treated animals were considered to be
related to the elimination of the test material or its metabolites. The
food consumption and the body weight gain were similar in the control
and treated animals during the study. With the exception of yellow
colouration of the hair and extremities seen in some animals which was
considered to be due to the staining properties of the test material, no
findings of toxicological significance were noted at necropsy.
Under the conditions of the test, there were no treatment related
mortalities or overt signs of toxicity. Therefore the NOAEL can be said
to be greater than the highest dose tested (> 1350 mg/kg/day).
The administration of the test material to rats was well-tolerated at
150, 450 and 1350 mg/kg/day. Consequently, the same dose-levels were
proposed for the 4-week study.
In accordance with the criteria for classification as defined in Annex
I, Regulation (EC) No 1272/2008, the test material does not require
classification for specific organ toxicity, repeated dose. The only
signs noted in animals were related to the dyeing properties of the test
material and were considered to be an indirect proof of the absorption
of the test material.
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