P.1 

D-33 

perhaps, below" (CD, p. 12-95). 

3. Effects on the Cardiovascular System 

Symptoms consistent with cardiac disease, such as degenerative changes 

in heart muscle (Kline, 1960), abnormal electrocardiograms (ECG) (Silver 

and Rodriquez-Torres, 1968) and increased cerebrovascular mortality 

(Dingwall-Fordyce and Lane, 1963) have been associated with high human 

lead exposures. Cardiotoxicity has been reproduced in experimental 

animals acutely exposed to high concentrations of lead. Effects include 

depression in contractility, increased susceptibility to norepinephrine-induced 

arrhythmias (exaggerated in neonates), and decreased cardiac protein 

phosphyrlation (Kopp et al., 1980b; Williams et al., 1977 a,b). It 

appears that effects may persist in immature rats even after cessation of 

lead exposure (Williams et al., 1977b). 

Chronic administration of lead resulting in PbB levels as low as 

40 ug/dl caused structural changes in the myocardium of mice, and ECG 

abnormalities that are likely due to nerve conduction disturbances (Khan 

et al., 1977, Kopp et al., 1980 a,b). Besides affecting cardiac output, 

low levels of lead exposure have produced increased vascular responsiveness 

to contractile agents such as noradrenaline, and significant elevations 

in systolic blood pressure in rats with PbB levels around 40 ug/dl (and 

possibly lower) (Webb et al., 1981; Victery et al., 1982; Perry and 

Erlanger, 1979; Kopp, 1980a). These changes may be linked to reduced 

energy availability due to heme synthesis inhibition (Kopp, 1980a) or to 

altered nerve transmission caused by changes in calcium availability 

(Webb et al., 1981), and suggest possible mechanisms by which lead may 

contribute to hypertension in humans. 
P.2 

D-34 

Excessive amounts of mobilizable lead have been measured in patients 

with hypertension (and renal impairment of unknown cause) (Batuman et al., 

1983) and evidence of increased hypertension has been found among men 

occupationally exposed to high levels of lead (Inglis et al., 1978; 

Lilis et al., 1977), although there have been contrasting findings in 

similar populations (Richet et al., 1966; Cramer and Dahlberg, 1966;). 

Lower levels of exposure as indexed by PbB or urinary Pb levels, have been 

associated in some adult populations with hypertension prevalence (Beevers 

et al., 1976; Kromhout and Coulande, 1984) and blood pressure (Moreau 

et al., 1982; Pocock et al., 1984), but not in others (Staessen et al., 1984). 

Pocock et al. (1984) considered the weak (but statistically significant) 

correlation between lead exposure and hypertension at levels above 37 ug/dl 

to be of minor importance given the lower PbB levels typically found in 

British men. However, an unpublished EPA reanalysis of the grouped data 

reported by Pocock et al. (1984) indicates that blood lead is a significant 

predictor of blood pressure in their data, both before and after adjusting 

for covariates, when a regression of blood pressure is performed versus 

the log of blood lead for their reported group averages (U.S. EPA, 1985c). 

Furthermore, the regression coefficient indicated that the size of the 

effect was significant, suggesting a blood pressure increase of 3 mm Hg 

as blood lead increases from 5 to 15 ug/dl. 

Recent analyses of NHANES II data have demonstrated significant 

associations between blood pressure (systolic and diastolic) and PbB levels 

among males (not females) aged 12 to 74 years independent of other, potentially 

confounding variables (e.g., nutrition) (Harlan et al., 1985). Further 

analyses were conducted on white males aged 40 to 59 years to avoid the 

collinearity between blood pressure and blood lead evident at lower ages 

and because data relating cardiovascular disease to blood pressure are 
P.3 

D-35 

less extensive for non-whites (Pirkle et al., 1985). PbB levels were a 

significant predictor of blood pressure in this subgroup after including 

in the multiple regression analyses all known factors previously established 

as correlated with blood pressure and also when the relationship was tested 

against every dietary and serologic variable measured in the NHANES II 

survey (Pirkle et al., 1985). Including both curvilinear transformations 

and interaction terms had little effect on the blood lead coefficient. A 

threshold below which blood lead was not significantly related to blood 

pressure could not be found across a range of adjusted PbB levels between 

7 and 34 ug/dl. It is of interest to note that the dose-response relationships found by Pirkle et al. (1985) suggest a large initial effect, leveling 

off at higher PbB levels, which is consistent with the biphasic blood 

pressure response to PbB levels found in rats (Victery et al., 1982) and 

which may account for the inconsistent epidemiologic findings in persons 

with mild to moderate elevations of blood lead. 

Because of the complex inter-relationships among the multiple 

environmental, dietary, medical, socio-economic, and genetic factors that 

influence blood pressure, all of which may not be measurable, results 

from even the recent studies that employed thorough and extensive analyses 

and high quality data, must be interpreted cautiously. Nevertheless, the 

suggested relationships between blood lead and blood pressure among adults, 

even at PbB levels below 30 ug/dl, should continue to be carefully studied 

and be considered to have potentially important public health implications in 

terms of increased incidence of hypertension and more serious cardiovascular 

disease. Pending review of the most recent papers in the criteria document, 

their results are not reflected in the assessment of health risks associated 

with different PbB levels in determining an acceptable PbB level. 
P.4 

D-36 

4. Effects on the Kidney 

Lead at high concentrations is concentrated in the kidneys by high 

affinity binding proteins (which form intranuclear inclusion bodies) and 

causes numerous types of changes in a variety of physiological processes 

associated with the kidney. At low dosages, lead affects renal mitochondrial 

structure (e.g., swelling) and function (e.g., altered respiratory rates, 

oxidative phosphorylation and synthesis of heme, proteins, nucleic acids 

and vitamin D hormone) (Goyer, 1968; Fowler et al., 1980, 1981 a,b; 

Silbergeld et al., 1982; Rosen and Chesney, 1983). Lead's interference 

with these biochemical processes in the kidney, particularly energy 

metabolism, might account for the transient decreases in renal tubular 

reabsorptive processes, as indicated by hyperaminoaciduria, glycosuria, 

and hyperphosphaturia, at PbB levels ranging from 40 to more than 100 ug/dl, 

and possibly as low as 30 ug/dl (See CD, Sections 12.5.2 and 12.5.3; 

p. 12-170). Irreversible kidney damage (e.g., interstitial nephritis) 

appears to require prolonged high exposure, with PbB levels probably 

exceeding 70 ug/dl in adults although lead chelation is necessary to 

detect cumulative body stores that may contribute to the gradual development of this disease (Lilis et al., 1968; Cramer et al., 1974; Wedeen et 

al., 1979). It should be noted that the effects of chronic, low-level 

lead exposure on renal dysfunction in children have not been adequately 

studied. 

There is limited evidence that elevated lead absorption contributes 

to renal disease in association with gout and hypertension (Emmerson, 

1973; Batuman et al., 1981; Wedeen, 1982). The mild hypertension observed 

with chronic low-level lead exposure however, may be related to lead's 

ability to directly alter vascular reactivity (Webb et al., 1981; see Appendix D.3) and any contribution of lead-induced renal impairment to this 
P.5 

D-37 

disorder, at low exposure levels, remains to be determined. 

5. Effects on Reproduction and Development 

Lead compounds have been used as an abortifacient and lead poisoning 

has been shown to be accompanied by reduced fertility, miscarriages and 

stillbirths (Oliver, 1911). Little research has been directed however, 

at whether subtoxic levels affect fertility or cause fetal injuries in 

humans. In female animals, relatively low-level lead exposure has been 

shown to affect pubertal progression and hypothalmic-pituitary-ovarianuterine functions, as evidenced by ovarian abnormalities (Hilderbrand et 

al., 1973; Der et al., 1974), and delays in vaginal opening (Grant et 

al., 1980; Kimmel et al., 1980) and first conception (Maker et al., 

1975). In addition, the ability of the placenta to support fetuses is 

compromised in mice exposed to relatively low lead levels (Maisin et al., 

1975; Jacquet et al., 1976). 

It is of particular concern that placental transfer of lead begins 

as early as the 12th week of gestation and continues to accumulate 

in the fetus throughout pregnancy (Barltrop, 1969) resulting in comparable 

PbB levels in the mother and newborn child (Alexander and Delves, 1981; 

Rabinowitz and Needleman, 1982). Newborn rodents whose mothers were 

exposed to lead during pregnancy showed compromised growth (Reiter et 

al., 1975), congenital malformations in the spinal cord (Carpenter and 

Ferm, 1977; Jacquet and Gerber, 1979) and delayed development of the CNS 

(e.g., cortical connections) and its functions (e.g., motor function, 

size discrimination) (Klein et al., 1978; Crofton et al., 1980; Grant et 

al., 1980; Overmann et al., 1981; Winneke et al., 1977; 1982b; Schlipkoter 

and Winneke, 1980; Fox et al., 1977, 1982; McCauley et al., 1982). 
P.6 

D-38 

Pregnant women who lived in homes with excessive drinking water 

lead concentrations (>800 ppm) bore a significantly higher proportion of 

retarded infants (Beattie et al., 1975). Children of women who had worked 

and lived near a smelter during pregnancy had lower birthweights and an 

increased frequency of single and multiple malformations although the 

cause is unclear given the possible exposures both of the mothers and 

presumably, the fathers, to high concentrations of arsenic, mercury, 

cadmium, sulfur dioxide, as well as lead (Nordstrom et al., 1978; 1979a,b). 

An increased incidence in the overall number of minor congenital 

anomalies, such as benign tumors and cysts and minor skin defects, was reported 

in newborn children with mildly elevated umbilical cord lead levels (> 6.3 

ug/dl) after controlling for other covariates, although no single anatomic 

defect was individually associated with lead (Needleman et al., 1984). This 

suggested to the authors that lead may interact with other teratogenic risk 

factors to enhance the possibility of an abnormal outcome. No association was 

found between cord PbB levels and increases in major congenital anomalies. 

Further investigation of lead's possible interactions with other teratogens 

at low levels is needed before definitive conclusions can be made. 

More subtle effects on the fetus and newborn, such as inhibited heme 

synthesis, may also be important consequences of maternal lead exposure 

below 30 ug/dl and transplacental transfer (Hubermont et al., 1976; 

Hayashi , 1983a,b; Gerber and Maes, 1978). 

Several mechanisms can explain lead's teratogenic activity: a) disturbance 

of DNA synthesis and cell proliferation; (Choie and Richter, 1974a; Sirover 

and Loeb, 1976); b) chromosomal aberrations; (CD, Table 12-20); c) interference 

with embryonic nutrition through competition with calcium, iron, and zinc 

(Mahaffey and Michaelson, 1980); and d) interference with embryonic energy 
P.7 

D-39 

supply by depressing mitochondrial function and cytochrome synthesis 

(Holtzman and Shen Hsu, 1976). 

Lead also affects the male gamete. Industrial exposure of men resulting 

in PbB levels possibly as low as 40-50 ug/dl resulted in abnormal sperm 

number and vigor (Lancrajan et al., 1975; Wi1dt et al., 1983). Sperm 

abnormalities, reduced fertility, and altered testicular function have 

also been observed among male mice exposed to low doses of lead (Hilderbrand 

et al., 1973; Maker et al., 1975; Wryobeck and Bruce, 1978; Donovan et 

al., 1980). Such changes may be related to observations of compromised 

viability of progeny to mice exposed to lead before conception (Stowe and 

Goyer, 1971). 

Although the data base is limited, the available studies suggest that 

low level exposure of mothers and fathers to lead might induce post-natal 

developmental delays and increase the risk of reproductive abnormalities. 

OSHA reviewed the available literature in 1978 and concluded that men and 

women planning to have children should maintain PbB levels at or below 30 

ug/dl (OSHA, 1978). Defining a PbB at which effects on other aspects of 

reproductive function (e.g., loss of vigor, erectile dysfunction) would 

begin to be of concern must await further research. 

6. Possible Genotoxicity/Carcinogenicity 

At high concentrations (>500 ppm), dietary lead acetate induced 

renal tumors in experimental animals (Azar et al., 1973; see CD, Figure 

12.5). A dietary lead acetate level of 500 ppm produced a PbB of 80 ug/dl 

in dogs within 2 years; defining a corresponding exposure level be in 

humans is difficult to determine, however. 

Since lead is capable of transforming cells directly in culture 

(Dipaolo et al., 1978; Casto et al., 1979) and affecting DNA-to-DNA and 

DNA-to-RNA transcription (Sirover and Loeb, 1976; Robinson et al., 1984), 
P.8 

D-40 

lead may serve as an initiator of carcinogenic activity. Lead's ability to 

induce chromosomal aberrations (CD, Table 12-20) is also indicative of 

its ability to initiate carcinogenic activity. In addition, lead may be 

a promoter of carcinogenesis, as indicated by its ability to increase 

DNA, RNA, and protein synthesis (Choie and Richter, 1974 a,b) and to 

enhance the development of renal tumors in rats previously treated with a 

known carcinogenic initiator (Hiasu et al., 1983). Lead's sequestration 

in the form of "inclusion bodies" in kidney cell nuclei may be linked to 

its carcinogenic effects (CD, p. 12-225). 

Epidemiological studies of lead-exposed workers and.children suggest 

that lead may induce chromosomal aberrations that may be associated 

with certain forms of cancer (Grandjean et al., 1983; Dalpra et al., 

1983). Little can be reliably concluded from the conflicting occupational 

findings on kidney tumor incidence and excess cancer mortality (Cooper 

and Gaffey, 1975; Kang et al., 1980; Baker et al., 1980; Lilis, 1981; 

Cooper 1981; McMichael and Johnson, 1982; Selevan et al., 1984), although 

the significant elevations in respiratory and digestive tract cancer in 

workers exposed to lead and other agents warrant concern (CD, p. 12-225). 

These latter findings should not be over-interpreted given differences 

in age distributions among the populations studied and inadequate 

controls for factors such as smoking, diet, ethnicity, and geographical 

location. Furthermore, these studies provide no specific information on 

the long-term lead exposure levels or the lead compounds to which workers 

were exposed. Lead emissions from other smelters and refineries include 

lead sulfate and oxides of lead while windblown dust from stored ore 

concentrate and contaminated soil is predominantly lead sulfide (Jennett 

et al., 1977). Exposure to even relatively insoluble lead compounds (e.g. 

lead sulfide) however, could account for the observed gastrointestinal 
P.9 

D-41 

and respiratory cancers (CD, p. 12-206). 

The criteria document concludes that: 

"Since lead acetate can produce renal tumors in some experimental 

animals, it seems reasonable to conclude that at least that 

particular lead compound should be regarded and treated as a 

human carcinogen (as per recommendations of the International 

Agency for Research on Carcinogenicity). However, this statement 

is qualified by noting that lead has been seen to increase tumorigenesis rates in animals only at relatively high concentrations, 

and therefore does not seem a potent carcinogen. In vitro studies 

further support the genotoxic and carcinogenic role of lead, but 

also indicate that lead is not potent in these systems" (CD, p. 

12-268). 

It is important to note that the IARC recommendations were published 

in 1980 and do not reflect findings from several recent experimental and 

occupational studies cited in the criteria document that suggest that 

other inorganic lead compounds besides lead acetate may be carcinogenic. 

It appears, therefore, that there is some need for caution and further 

research on the carcinogenicity of lead compounds,other than lead acetate, 

that are present in the atmosphere and other exposure media. 

7. Effects on the Immune System 

Lead interferes with host immune defense mechanisms as indicated by 

increased susceptibility to infectious agents (CD, Table 12-22), endotoxins 

(Cook et al., 1974), and increased incidence of tumors (CD, Section 12.8.2.2), 

in lead-exposed animals. There is suggestive evidence that human resistance 

to infection may be lowered by elevated lead exposure (Sachs, 1978; Ewers 

et al., 1982), although no dose-response information is available. Leadinduced immunosuppression, possibly through direct interference with macrophage 

function (Lawrence, 1981) occurs at low-level exposures in animals (PbB levels of 

20-40 ug/dl) (CD. p. 12-268). Although these effects do not induce overt 

toxicity, they, nevertheless, may be detrimental to health and lead's 

immunosuppressive capabilty "should be carefully considered" (CD, p. 12-241). 
P.10 

D-42 

8. Effects on the Hepatic System 

The metabolic breakdown by the liver of some pharmacologically active 

substances (e.g., drugs, hormones, environmental toxins) depends on the 

availability of the hemoprotein, cytochrome p-450 and consequently, the 

synthesis of heme (Remmer et al., 1966). Lead exposure impairs the detoxification 

capabilities of experimental animals, while drug metabolism and liver function 

in children appear to be affected at fairly high exposures (>40 ug/dl) 

(Alvares et al., 1975; Saenger et al., 1984). As discussed in Appendix D.l(b), 

in the absence of conclusive data it must be assumed that any indication of 

significantly altered heme biosynthesis (e.g., elevated EP) may also indicate 

a possible inhibition of liver detoxification function. 

9. Effects on the Gastrointestinal System 

Typical gastrointestinal signs and symptoms caused by lead intoxication 

include constipation or diarrhea, abdominal pain, nausea, indigestion, and 

anorexia. Mild symptoms have been associated with PbB levels in the 50 

to 70 ug/dl range, and as low as 30 ug/dl (Haenninen et al., 1979; 

Fischbein et al., 1980). There is insufficient information, however, to 

establish a clear dose effect relationship for the general population at 

ambient exposure levels (CD, p. 12-247). 

10. Effects on the Endocrine System 

Relatively high level lead exposures affect various endocrine processes 

(e.g., impaired thyroid function) (Sandstead and Galloway, 1967; Sandstead 

et al., 1969, 1970). Apart from the previously discussed alterations in 

vitamin D hormone metabolism that is secondary to interference with heme 

synthesis, endocrine processes do not appear to be impaired by lead at PbB 

levels below 30 ug/dl. 
P.11 

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