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EC number: 263-503-6
CAS number: 62314-25-4
Oral (gavage) administration of Hydroxypropyl, 2-, trimethylammonium
formate to male and female Wistar rats for 28 days at dose levels of up
to 1000 mg/kg bw/day resulted in no adverse effects being noted.
As such, 1000 mg/kg bw/day is considered to be the `No Observed Adverse
Effect Level' (NOAEL) for systemic toxicity.
To determine the potential for oral toxicity using the Acute Toxic Class
Determination. This study was designed to comply with the standards set
forth in the current OECD Guidelines for the Testing of Chemicals,
Guideline 423. Guideline 423 is referred to in OPPTS 870.1000 as an
to assess lethality within a dose range. The test article was assigned
to a toxic category based on the mortality results and significant
clinical signs of toxicity up to the Category 4 value tested according
current Globally Harmonized System of Classification and Labeling of
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 30, 300 and 1000 mg/kg
bw/day. A control group of five males and five females was dosed with
vehicle alone (Polyethylene glycol 400).
Clinical signs, functional observations, body weight change, dietary
intake and water consumption were monitored during the study. Hematology
and blood chemistry were evaluated for all animals at the end of the
All animals were subjected to gross necropsy examination and
histopathological evaluation of selected tissues from high dose and
control animals was performed.
There were no unscheduled deaths during the study.
There were considered to be no adverse effects of treatment at any dose
There were no treatment-related intergroup differences at any dose level.
Functional Performance Tests:
There were no treatment-related changes in functional performance at any
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