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EC number: 239-290-0
CAS number: 15245-44-0
Animal studies serve primarily to validate mechanistic inferences drawn
from studies in humans - a number of which are described in section
7.10.2. The following conclusions have been drawn from observational
studies in humans.
available data indicate that extremely high lead exposure can have a
marked adverse impact upon semen quality. Aberrant sperm morphology,
decreased sperm count and decreased sperm density have all been
demonstrated in heavily exposed individuals. However, it is difficult to
precisely define the levels of exposure at which these effects will be
exerted. The recently completed Asclepios Project (Bonde et al., 1999,
2002) was of sufficient size to model dose-effect relationships and
indicted a threshold for an effect of concurrent blood lead upon semen
quality of 45 µg/dL. Significant changes in semen quality that may
adversely impact reproductive function of the individual require
exposures in excess of 50 µg/dL. In the range of 50 – 60 µg/dL lead in
blood, alterations in semen quality are relatively mild, but could be
significant for individuals who (for other reasons) are already of
marginal fertility. Lead exposure might thus be hypothesised to increase
the difficulty such individuals experience in achieving conception, but
such as effect has not yet been documented in association with lead
exposure. Decrements in semen quality that would unambiguously impact
upon fertility have been only inconsistently reported and are associated
with exposure levels (e.g. require occupational exposures that produce
blood lead levels of 70 µg/dL or higher) associated with clinical lead
NOAEL of 45 µg/dL is indicated for effects upon male semen quality and
thus for effects upon male fertility. At exposure levels moderately in
excess of the NOAEL effects upon actual fertility will be modest.
upon female human fertility have been documented in the historical
literature but their dosimetry is uncertain. Given that other
reproductive impacts will manifest at lower doses (e.g. developmental
effects), the exposure levels that may impair female fertility will be
secondary to other reproductive endpoints in quantitative risk
assessment. Data in females are not adequate to estimate a NOAEL for
fertility, but any effects will likely manifest as secondary impacts of
systemic toxicity associated with clinicallead intoxication at blood
lead levels in excess of 70 µg/dL .
The existing data indicate that lead exposure will not lead to increased frequency of congenital abnormalities in humans. Data relating prenatal blood levels to preterm delivery, gestational age and/or birth weight are mixed and provide uncertain results. Weight of evidence evaluation indicates that effects do not occur at blood lead levels up to 30 µg/dL, but are not adequate to determine the extent of the higher exposure levels that would be required to produce effects. A NOAEL of 30 µg/dL is recommended for pregnancy outcome on a precautionary basis.
of prenatal lead exposure upon neurobehavioural performance measures
have been demonstrated in studies of experimental animals and presumably
will occur in humans. However, available data are inadequate to
establish the dose-effect relationships that characterize this endpoint.
While effects have been observed upon early measures of mental and
physical development, attenuation of effects typically occurs over time
and, in most studies, are not associated with impacts upon measures such
as IQ. However, effects of prenatal lead exposure upon IQ can be
difficult to dissociate from those of postnatal exposure. An effect of
pre-natal lead exposure has been suggested by two of nine longitudinal
studies and has only been reported to persist in one. Effects observed
are secondary in magnitude to those produced by exposures after birth,
but blood lead levels above 10 µg/dL have been suggested to exert an
effect. Although the effects under consideration would not constitute
material impairment of an individual child born to a woman with a blood
lead level in the range of 10 – 20 µg/dL, maintenance of the blood lead
levels of pregnant women at or below 10µg/dL is advised. In essence this
is designating 10 µg/dL as the NOAEL for prenatal effects of lead
exposure upon neurobehavioural development in children.
Lead compounds not otherwise specified in Annex 1 of Directive
67/548/EEC are classified as follows:
Cat. 1; R61 (may cause harm to the unborn child)
Cat. 3; R62 (possible risk of impaired fertility)
the CLP this classification is designated as:
Repro. 1A :
for reproductive toxicity is supported by the experimental data and
observational human studies. Evidence of impact upon human male
fertility indicates consideration of Repr. Cat. 3 being changed to Repr.
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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