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EC number: 215-222-5
CAS number: 1314-13-2
Acute oral toxicity: key studies carried out according to OECD guideline no 401 or 423 indicating for both micro- and nanomaterial zinc oxide LD50 > 2000 mg/kg bwAcute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for micro zinc oxide LC50 > 5.7 mg/L/4hrs. Acute dermal toxicity: key study carried out according to OECD guideline no 402 indicating for nano zinc oxide LD50 >2000 mg/kg bw.
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
study was conducted to determine
the acute dermal toxicity of nanoscaled ZnO according
to the OECD Guideline 402 in compliance with GLP.
mg/kg bw of the test substance were semiocclusively administered for 24
h as pasty formulation in corn oil to the shaved and defaffed back of 5
female and 5 male rats. After the end of the exposure period, the test
substance paste was recovered as effectively as possible using water and
the animals were observed for 14 d. During the present study no
mortality occurred and there were no indications of systemic toxicity,
no effects regarding the body weight and neither clinical signs nor
pathological findings observed.
LD50 of the test substance is therefore estimated to be > 2000 mg/kg bw.
- With LD50values
consistently exceeding 2,000 mg/kg bw, zinc oxide (LD50ranges
between 5,000 and 15,000mg/kg bw), shows very low level of acute oral
- With LC50 value > 5.7 mg/L/4hrs, zinc
oxide is shown to be of low
acute inhalation toxicity.
- There are no available data on which
to evaluate acute dermal toxicity for ZnO micromaterial. However, acute
dermal toxicity can be considered to be low in view of the poor
absorption by this route.
Zinc oxide nanomaterial:
Tests performed specifically on
nano-ZnO demonstrate alsovery
low acute oral toxicity (i.e. LD50 values consistently exceeding
mg/kg bw). The
only available inhalation data on nano-ZnO indicates an LC50 value of >
1.79 mg/L. However, only this one single dose of 1.79 mg/L was tested
which wasthe maximum
attainable exposure concentration for achieving respirable particle size.Data
on nano-ZnO confirms low acute dermal toxicity with LD50>2000 mg/kg bw.
In conclusion, for nano-ZnO no
nano-specific acute toxicity could be identified. Zn2+ion
determines the toxicity of ZnO and read across between various forms of
ZnO (micro-scale, nano, coated or not) is fully supported.
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).
(micro- and nanomaterial) isof
low acute, dermal and inhalation toxicity not requiring a classification
for acute toxicity according to the EC criteria.
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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