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EC number: 911-553-0
CAS number: -
The present study has been designed to evaluate the acute
inhalation toxicity of the test item N-(hydroxymethyl) stearamide
(hereinafter the test item) in male and female Sprague Dawley rats by
the protocol described in the OECD Guideline Nº 436: Acute Inhalation
Toxicity. This method allows the classification of the test item
according to the Globally Harmonized System (GHS) of Classification and
Labelling of Chemicals.
For that purpose, a group of three male and three female Sprague
Dawley rats was exposed by nose-only, flow-past inhalation to the test
item at a mean concentration of 1.05 mg/L air during 4 hours as a
technical limit test.
All animals were observed for clinical signs and mortality during
the exposure and the subsequent 14-day observation period.Body
weight was recordedjust before starting exposure, 24 h, 72
h and one week thereafter and also before sacrifice two weeks after
At the end of the observation period, all surviving animals were
subjected to a gross necropsy and all macroscopic abnormalities were
Several tests were performed during technical trials to achieve
the concentration of 5 mg/L. Among others, the use of two different
powder aerosol generators, different pressure and flow conditions,
desiccation of the test item. A stable aerosol could not be obtained at
5 mg/L in any of the tests, thus, 1 mg/L air was considered as the
technical limit for a reproducible and stable aerosol.
The ranges of aerosol concentration, temperature, relative
humidity and air flow rate were considered satisfactory for a study of
this type. In addition, although the particle size of the aerosol was
above limit criterion, it was considered to be acceptable based on the
nature of the test item.
All animals survived the 14-day observation period. No relevant
findings were observed upon gross necropsy.
All animals, regardless of sex, presented wet fur up to 1 hour
after exposure. Chromorrhinorrhea and chromodacryorrhea was also
observed after exposure in all animals except for male ID 1.
Additionally, immediately after exposure, loud breathing was recorded in
the male animal ID 2.
From study day 2 until the end of the 14 day-observation period,
no clinical signs were observed in any of the animals and all of them
exhibited a normal behavior.
A decrease in mean body weight was
observed for both males and females between study day 1 (exposure) and
study day 2.
From study day 2 to the end of the
observation period (day 15), body weight increased gradually in all
No relevant macroscopic findings were observed in any of the
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