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EC number: 248-363-6
CAS number: 27247-96-7
The present study has been designed to evaluate the acute inhalation
toxicity of the test item 2-ethylhexyl nitrate in male and female
Sprague Dawley rats by the acute toxic class (ATC) method, OECD test
guideline: Nº 436. This method allows the classification of the test
item according to the Globally Harmonized System of Classification and
Labelling of Chemicals (GHS).
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
target concentration of 5mg/L for 4 hours.
All animals were observed for mortality and clinical signs during the
exposure and the subsequent 14-day observation period until the day of
gross necropsy. Body weights were recorded during acclimatization, on
the day of treatment just before the exposure and on days 2, 4, 8 and on
the day of necropsy.
All surviving animals were subjected to a gross necropsy and
descriptions of all macroscopic abnormalities were recorded if any.
The ranges of aerosol concentrations, temperature, relative humidity and
air flow rate were considered satisfactory for a study of this type. In
addition, the test item was considered to be respirable by the rats. The
mean analytical aerosol concentration was 5.65 mg/L. The deviation from
the target aerosol concentration was 13 percent.
One female animal died within 24 hours following the exposure, but all
other animals survived until gross necropsy at the end of the
observation period. Animals displayed a number of clinical signs,
including wet fur (abdomen, chest, back), chromorrhinorrhea,
lachrymation and chromodacryorrhea in both eyes. All these clinical
symptoms were no longer present at 48 hours post-exposure. For the rest
of the observation period, animals did not show any abnormal clinical
All animals lost weight between the exposure day and the 24 hours
post-exposure. Following 24 hrs post-exposure, animals started to gain
weight and this trend continued for the remaining observation period.
No macroscopic findings were observed in any of the animals during the
Under the present experimental conditions, it can be concluded that the
LC50 for the test item is >5.65 mg/l. However, based on the death of one
female out of the six animals exposed to the test concentration, it is
concluded that category 5 is appropriate according to GHS criteria (LC50
>5-12.5 mg/l for aerosols) and OECD Test Guideline 436, but that no
classification is required under CLP.
Animal data suggest a total absence of toxicity by oral and dermal
routes. Data from the inhalation route indicate that classification in
category 5 would be appropriate.
However, there are reports of effects in workers including dizziness,
headaches. Organic nitrates have vasodilatation properties that could
account for such effects. There is also a problem of habituation to
their effects, followed by possible effects upon cessation of exposure.
The results from oral and dermal animal studies do not indicate that
classification is required according to GHS and CLP criteria. The
results from the acute inhalation animal study indicate that category 5
would be appropriate according to GHS criteria and OECD Test Guideline
436, but that no classification would be required under CLP. However, as
a worst-case, Acute tox 4 (H302, H312, H332) is proposed for all routes
of exposure based on human data (corresponding dose-levels unknown).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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