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EC number: 700-736-9
CAS number: 2149571-40-2
The no observed effect level (NOEL) of MTF was judged to be 4 mg/kg for males and 20 mg/kg for females. Treatment-related effects in the liver and kidneys of male rats receiving 20 mg/kg/day and in the liver of female rats receiving 100 mg/kg/day and above were observed.
A 28 -Day Repeated Dose Oral Toxicity study of MTF in Rats was performed
by the Kashima Laboratory, Mitsubishi Chemical Safety Institute Ltd.
The study was conducted according to 'Guidelines for the Chemical
Substances Control Law (1986)' and in compliance with 'GLP for the
Chemical Substances Control Law Guidelines (1984, 1988)'.
The aim of this study was to observe changes in biological functions and
morphological forms, and to examine the potential toxic effects of MTF
and their riversibility by repeated oral administration to rats daily
for 28 days.
The no observed effect level (NOEL) of MTF was judged to be 4 mg/kg for
males and 20 mg/kg for females. Treatment-related effects in the liver
and kidneys of male rats receiving 20 mg/kg/day and in the liver of
female rats receiving 100 mg/kg/day and above were observed.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Treatment-related effects were observed in the livers of male rats
receiving a daily oral dose of 20 mg/kg/day and above for 28 days. With
reference to Annex I, Section 3.9 of the CLP Regulation because
significant toxic effects in orgns were seen below 30 mg/kg
bodyweight/day in a subacute study it is considered that MTF meets the
criteria for classification for Specific Target Organ Toxicity following
Repeated Exposure, Category 1. The corresponding hazard phrase is H372:
Causes damage to organs through prolonged or repeated exposure.
It is noted that in addition to effects seen in the liver, the male rats
treated with MTF also showed signs of effects in the kidneys. Due to
the nature of the findings observed and on the basis that corresponding
effects were not seen in the kidneys of the female animals treated
concurrently, the effects in kidneys were due to alpha-2u globulin
nephropathy which is not relevant in human toxicity. For the purposes
of classification it is considered that the available data does not
indicate that kidneys should be considered a target organ.
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