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EC number: 222-477-6
CAS number: 3486-35-9
Acute oral toxicity: key study carried out according to OECD guideline no 401 indicating for zinc oxide LD50 > 5000 mg/kg bw (read across to zinc carbonateAcute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for zinc oxide LC50 > 5.7 mg/L/4hrs (read-across to zinc carbonate
In an acute toxicity test Wistar rats (5/sex) were given a single dose
of 5 g ZnO/kg bw (in water) by gavage and observed for 14 days. No
mortality and signs of toxicity were observed. The LD50for
rats is therefore >5 g ZnO/kg bw.
In an acute inhalation toxicity study, 10 male and 10 female animals per
group were exposed to zinc oxide aerosol (head and nose only) for 4 h.
Aerosol concentration was 5.7 mg/l and the particle size distribution
had a mass median aerodynamic diameter of 4mm ± 2.9 (GSD).
Only one concentration and a control group were tested. All animals
survived up to day 14 post exposure. Apart from a dusty fur on the head
the day after the exposure, no effects were seen. Body weights developed
normally. At pathological examination all organs were normal. The LC50was
With LD50values consistently
exceeding 2,000 mg/kg bw, slightly soluble or insoluble zinc compounds
such as zinc oxide (LD50ranges between 5,000 and 15,000mg/kg
bw), zinc phosphate (LD50is >5,000mg/kg bw), zinc metal (LD50
>2,000mg/kg bw) or zinc sulphide (LD50is >15,000mg/kg bw),
show very low level of acute oral toxicity. Moreover, zinc oxide and
zinc metal were further shown to be of low acute inhalation toxicity
(i.e., LC50 values of > 5.7 and 5.41 mg/L/4hrs). Given the common
characteristics shared via their solubility characteristics, the
remaining slightly soluble zinc compounds are also considered to be of
low acute inhalation toxicity. There
are no available data on which to evaluate acute dermal toxicity for
slightly soluble or insoluble zinc compounds, however, acute dermal
toxicity can be considered to be low in view of the poor absorption by
for humans from an acute toxicity standpoint is the occurrence of
metal fume fever following exposure to ultrafine particles of special
grades of zinc oxide in context of very specific operations such as
cutting or welding of galvanised steel. Metal fume fever is exclusively
associated with freshly formed ultrafine particulate zinc oxide (<0.1
µm). As these ultrafine particles (nanoparticles) rapidly agglomerate to
bigger particles, which are normally encountered at production and
processing sites, at these sites there is no indication for metal fume
fever. According to the response from 11 zinc companies to a
questionnaire, there have been no observations of zinc metal fume fever
over the last decade and in recent occupational practice (EU RAR,
2004a-f). However in light of responsible care and since no studies are
available that allow the establishment of a NOAEL for metal fume fever
with a reasonable degree of certainty, a LOAEL (5 mg ZnO/m3)
for 2 hours (showed the typical metal fume fever symptoms beginning 4 to
8 hours after exposure and disappearing within 24 hours) can be used for
metal fume fever based on the study by Gordon et al.(1992).
The slightly soluble and insoluble zinc
compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc
carbonate, zinc metal and zinc sulphide)
are of low acute, dermal and inhalation
toxicity not requiring a classification for acute toxicity according to
the EC criteria.
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