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EC number: -
CAS number: -
- The oral (gavage) administration of test
material to male and female rats of Wistar Han: RccHan: WIST strain at
dose levels of 100, 400 or 1000 mg/kg bw/day was well tolerated. There
were no clinical signs for any of the animals throughout the dosing or
recovery periods. Whilst there was no effect of treatment with the test
item on body weight development or food consumption in females
throughout the study, group mean body weight gains in males from all
dose groups generally remained lower than controls; there was no
dose-relationship and food intake in high dose males was unaffected.
During the treatment-free period, group mean body weight gains in males
previously given the high dose remained slightly lower than controls,
which was associated with marginally reduced food intake in these
animals. The majority of individual body weight gain values for these
animals were, however, within control ranges and any intergroup
differences were considered unlikely to be treatment-related.
- Hematological investigations did not
reveal any adverse effect of treatment with the test item in animals of
either sex. Some statistically significant intergroup differences were
evident in males at the end of the treatment and/or treatment-free
periods; however, individual values from test item-treated males were
within the historical control background data ranges. As there were no
associated histopathology findings, these differences were considered to
be of no toxicological importance.
- There was no adverse effect of treatment
with test material at any dose level on blood chemistry parameters in
male and female rats. At the end of the dosing period, plasma levels of
triglycerides in males treated with the test item at all dose levels
were statistically significant lower than controls in a dose-related
manner whilst plasma concentration of cholesterol in high dose males
also appeared to be slightly lower than controls albeit without
achieving statistical significance; the corresponding values in recovery
males remained statistically significantly lower than controls. The
majority of individual values were within the control background data
ranges and in the absence of any associated histopathology observations,
these findings were considered not toxicologically important. Other
statistically significant intergroup differences at the end of the
treatment period included lower total protein levels in males treated
with 400 or 1000 mg/kg bw/day, higher calcium and chloride concentration
in males from all dose groups, and lower gamma glutamyltranspeptidase
and bilirubin levels in high dose males and females, respectively. At
the end of the treatment free period, males previously receiving 1000
mg/kg bw/day showed higher plasma concentrations of chloride and
aspartate aminotranferase whilst
the corresponding females showed higher
calcium levels. The majority of individual values were, however, within
the background data ranges and in the absence of any histopathology
correlates, these findings were considered of no toxicological
The study was designed to investigate the
systemic toxicity of the test item and is compatible with Commission
Directive 96/54/EC (Method B7). Commission Directive 96/54/EC (Method
B7) and the OECD Guidelines for Testing of Chemicals No. 407 "Repeated
Dose 28 Day Oral Toxicity Study in Rodents" (adopted 03 October 2008).
The study was also designed to be compatible with Commission Regulation
(EC) No 440/2008 of 30 May 2008, laying down test methods pursuant to
Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction
of Chemicals (REACH).
The test item was administered by gavage
to three groups, each of five male and five female Wistar Han: RccHan:
WIST strain rats, for twenty-eight consecutive days, at dose levels of
100, 400 and 1000 mg/kg bw/day. A control group of five males and five
females was dosed with vehicle alone (Arachis oil BP). Two recovery
groups, each of five males and five females, were treated with the high
dose (1000 mg/kg bw/day) or the vehicle alone for twenty-eight
consecutive days and then maintained without treatment for a further
Clinical signs, body weight change, food
and water consumption were monitored during the study. Hematology, blood
chemistry and urinalysis were evaluated for all non-recovery group
animals towards the end of the treatment period and for all recovery
group animals towards the end of the treatment-free period.
All animals were subjected to gross
necropsy examination and histopathological examination of selected
tissues was performed.
Mortality: There were no deaths during the
Clinical observations: There were no
clinical signs for any of the animals throughout the study.
Behavioural assessment: Assessment scores
across the treated animals of either sex remained similar to the
Functional performance tests: There were
no treatment-related changes in functional performance at any dose
Sensory reactivity assessments: Sensory
reactivity scores remained unaffected by treatment with the test item.
Body weight: There was no adverse effect
of treatment with the test material on body weight development in
animals of either sex at any dose level.
Food consumption: Treatment with the test
item had no adverse impact on food consumption in male or female rats at
any dose level. Food conversion efficiency in males fluctuated
throughout the study reflecting intergroup differences in body weight
gains and/or food intake in these males.
Water consumption: Gravimetric measurement
of water consumption during Week 3 of the study did not reveal any
Hematology: Investigation did not reveal
any toxicologically significant findings.
Blood chemistry: No toxicologically
adverse effects were detected in blood chemistry investigations.
Urinalysis: No toxicologically significant
effects were detected in the urinalysis parameters examined at dose
levels up to 1000 mg/kg bw/day.
Necropsy: Macroscopic examination did not
reveal any treatment-related findings.
Organ weights: Analysis of organ weight
did not indicate any toxicologically significant findings at the end of
the treatment or treatment-free periods.
Histopathology: Examination did not reveal
any treatment-related findings.
The oral (gavage) administration of test
material to male and female Wistar Han: RccHan: WIST strain rats for
four weeks, at dose levels of 100, 400 and 1000 mg/kg bw/day, was well
tolerated. Based on the in-life results and histopathology findings, a
dose level of 1000 mg/kg bw/day is considered to be a No Observed
Adverse Effect Level (NOAEL) for systemic toxicity.
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