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EC number: 239-290-0
CAS number: 15245-44-0
Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals.
available studies indicate a very low acute oral toxicity of inorganic
lead compounds. There was also no evidence of any local or systemic
toxicity associated with the oral administration of any of seven
different lead compounds (including lead pthalate). Whether or not the
compound contained the anion of an inorganic acid or an organic acid had
no effect upon toxicity, and literature searches found no indications
that anions present in high production volume compounds not tested would
impart properties of toxicity different from those that have been
tested. Based upon these overall observations, both experimental data
and read across from other lead compounds permits the conclusion to be
drawn that lead styphnate will not be acutely toxic via oral exposure
toxicity was not observed in animals after inhalation or dermal
exposures up to the limit values of acute toxicity testing for a smaller
number of compounds. Inhalation studies were restricted to lead oxide, a
material found to have a particle size distribution that would
approximate that of other sparingly soluble lead compounds and lead
metal powder. Pulmonary deposition modelling further indicated that lead
oxide provided a good surrogate for other lead compounds in that similar
pulmonary deposition patterns, and corresponding local and systemic
exposures, would be similar to those of other compounds. Read across
from lead oxide inhalation data to other compounds was thus
scientifically justified and in the interests of animal welfare.
Similarly, a group of three compounds (lead oxide, lead pthalate and
dibasic lead phosphite) were tested for dermal toxicity and irritation
endpoints. The three compounds selected spanned the range of chemistries
(organic and inorganic anions) and solubilities found for a number of
other lead compounds. Data demonstrating lack of toxicity and irritant
properties were generated for and provide a basis for read across for
other lead compounds that is similarly scientifically justified and in
the interests of animal welfare. The uniformly negative acute toxicity
profile is mirrored by observations in humans where toxicity in humans
after true acute exposures is very limited. When human toxicity is
observed it is generally under conditions that yield sub-chronic or
chronic exposures. This finding is not unexpected given the
pharmacokinetics of lead uptake into the body. Lead uptake is generally
quite low and heavily reliant upon easily saturable active transport
mechanisms. Once saturation of these uptake mechanisms has occurred,
uptake proceeds by inefficient passive diffusion. The uptake of lead is
thus highly non-linear as a function of dose with uptake efficiency
declining with the amount of lead administered to a test animal or an
exposed human. Although toxic under chronic exposure situations, the
acute toxicity of inorganic lead metal compounds appears to be quite low
via all exposure routes.
The current classification of lead styphnate is:
R20/22 (harmful by inhalation and if swallowed)
Acute Tox. 4 * (H332)
Acute Tox. 4 * (H302)
Existing classifications for acute
toxicity of lead styphnate are not supported by the existing data. Acute
toxicity from lead pthalate is not observed in animals after oral or
dermal exposures up to the limit values of acute toxicity testing. Test
data further show a lack of irritant properties for the skin and eyes
for lead pthalate. Analogous substances show similar toxicological
profiles, further confirming a lack of acute toxic properties.
Although toxic under chronic exposure
situations, the acute toxicity of lead styphnate appears to be quite low
and does not require classification.
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