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EC number: 483-360-5
CAS number: 114435-02-8
Reliable acute toxicity studies via the oral and dermal routes of
exposure are available conducted in accordance with OECD guidelines and
Table 1: Weight gain in g (Dose: 2000
1 - male
2 - male
3 – male
4 - male
5 - male
1 - female
2 - female
3 – female
4 – female
5 - female
The acute dermal toxicity of
Monofluoroethylene carbonate was evaluated in male and female rats when
administered as a single topical application at level of 2000 mg/kg bw.
The test item was held in contact with the skin by a semi-occlusive
dressing throughout a 24 -hour period. Mortality, clinical signs and
bodyweight changes were monitored throughout the study.
At the end of the observation period, all
animals were sacrificed and were subjected to gross necropsy.
One male was found dead on Day 2 post-dose
in abdominal position.
Two males showed reduced spontaneous
activity, piloerection, half eyelid closure and bent back immediately
after the termination the exposure.
The formation of small wounds on the
application site were observed in all animals (except the dead animal)
as from day 8 post-dose. Eschar formation was observed on days 11 - 13
post dose. At the end of the observation period the wounds were
partially healed, although eschar formation was still observed.
After removing the dressing, the skin of the
dorsal area of the test animals showed an orange discoloration.
Weight gain of all animals was within the
Beside acute injection of blood vessels in
the abdominal region of the sacrificed animals, which is due to the
euthanasia injection, no specific gross pathological changes were found
in any animal of any step.
Considering the reported data of this dermal
toxicity test it can be stated that the test item Monofluoroethylene
carbonate has acute dermal toxic potential and may be harmful in contact
The dermal LD50 was determined to be > 2000
mg/kg bw ≤ 5000 mg/kg bw.
The LD50 cut of value in accordance with the OECD 423 guideline for the
acute oral toxicity study provides a value of 500 mg/kg based on the
mortality observed. This equates to a classification of 'Harmful if
swallowed' (H302) in accordance with the CLP Regulation (EC No.
1272/2008, as amended).
For the acute dermal study, only 1 death was observed at the limit dose
of 2000 mg/kg. As such, the LD50 cut-off value was deemed to be greater
than 2000 mg/kg based on the observed mortality. As such, no
classification is warranted for acute dermal effects in accordance with
the CLP Regulation (EC No. 1272/2008, as amended).
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