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EC number: 700-323-3
CAS number: 908020-52-0
The substance showed moderate acute oral toxicity in female rats (LD50 = 500 mg/kg bw). Regarding dermal exposure, the LD50 is above 2000 mg/kg bw for male and female rats.
Acute oral toxicity
In a GLP compliant study according to OECD
guideline 423 and EU method B.1tris the acute oral toxicity of
EEA-NH4 following a single oral administration in the Sprague-Dawley CD
strain rat was investigated (SafePharm Laboratories, 2005).
A group of three fasted females was treated
with EEA-NH4 at a dose level of 2000 mg/kg bw. Based on the results from
this dose level further groups of fasted females were treated at a dose
level of 300 mg/kg bw. The test material was administered orally as a
solution in distilled water.
All animals treated at a dose level of 2000
mg/kg bw were found dead or killed in extremis.There were no
deaths noted in animals treated at a dose level of 300 mg/kg bw.
Signs of systemic toxicity noted in two
animals treated at a dose level of 2000 mg/kg bw were hunched posture,
ataxia, lethargy, decreased respiratory rate, noisy respiration,
dehydration and diuresis. There were no signs of systemic toxicity noted
in animals treated at a dose level of 300 mg/kg bw.
The surviving animals showed expected gains
in bodyweight over the study period.
Abnormalities noted at necropsy of the
animals that died during the study (2000 mg/kg bw) were abnormally red
lungs, dark liver, dark kidneys and clear liquid present in the stomach.
No abnormalities were noted at necropsy of the animal that was killedin
extremisor at necropsy of animals that were killed at the end of the
The acute oral median lethal dose (LD50)
of the test material in the female Sprague-Dawley CD strain rat was
approximately 500 mg/kg bw.
Acute dermal toxicity
In a GLP compliant study according to OECD
guideline 402 the acute dermal toxicity of EEA-NH4 following a single
administration in Sprague-Dawley SPF strain rats (5 males and 5 females
per group) was investigated (Gotemba Laboratory, 2008). Three dose
levels, 500, 1000 and 2000 mg/kg bw, were examined. A vehicle control
was also included.
No deaths occurred. Regarding clinical
observations, there were no abnormalities in any animal of either sex.
No changes were observed at the application site and effects of
administration were not observed.
All male and female animals in the test
substance groups showed similar body weight development compared to the
vehicle control group. At necropsy, no abnormalities were observed in
either sex of both the test substance groups and the vehicle control
The acute dermal lethal dose (LD50)
of the test material in male and female Sprague-Dawley SPF strain rats
was estimated to be higher than 2000 mg/kg bw.
A second acute dermal toxicity study which
is considered as a supporting study was also available (TNO Quality of
Life, 2008). A sample of EEA-NH4 was examined for acute dermal toxicity
in an experiment with 5 male and 5 female rats (limit testing),
according to OECD guideline 402. A dose level of 400 mg/kg bw was
examined and the dermal contact period was 24 hours. A 2000 mg/kg bw
dose level was not examined because the test substance appeared to be
corrosive to skin in an in vitro test. No mortality or clinical signs
were observed after treatment. Macroscopic examination of the animals at
the end of the observation period did not reveal any treatment-related
Acute inhalation toxicity
In accordance with column 2 of REACH Annex
VIII-X, in addition to the oral route, for substances other than gases,
an acute toxicity study for at least one other route is required. The
choice of the second route will depend on the nature of the substance
and the likely route of human exposure. As the dermal route is the most
likely route of exposure and as an acute dermal toxicity study is
available, an acute inhalation toxicity study is not needed.
on the oral LD50 value of 500 mg/kg bw, the substance has to be
classified according to Directive 67/48/EEC as Xn – R22 (Harmful if
swallowed). In accordance to EU Classification, Labeling and Packaging
of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the
substance has to be classified for Acute toxicity, Cat. 4 - H302
(Harmful if swallowed). No classification for acute dermal toxicity is
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