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Draft Toxicological Profile for 1,3-Butadiene

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Draft Toxicological Profile for 1,3-Butadiene 1,3-BUTADIENE 19 3. HEALTH EFFECTS 3.1 INTRODUCTION The primary purpose of this chapter is to provide public health officials, physicians, toxicologists, and other interested individuals and groups with an overall perspective on the toxicology of 1,3-butadiene. It contains descriptions and evaluations of toxicological studies and epidemiological investigations and provides conclusions, where possible, on the relevance of toxicity and toxicokinetic data to public health. A glossary and list of acronyms, abbreviations, and symbols can be found at the end of this profile. 3.2 DISCUSSION OF HEALTH EFFECTS BY ROUTE OF EXPOSURE To help public health professionals and others address the needs of persons living or working near hazardous waste sites, the information in this section is organized first by route of exposure (inhalation, oral, and dermal) and then by health effect (death, systemic, immunological, neurological, reproductive, developmental, genotoxic, and carcinogenic effects). These data are discussed in terms of three exposure periods: acute (14 days or less), intermediate (15–364 days), and chronic (365 days or more). Levels of significant exposure for each route and duration are presented in tables and illustrated in figures. The points in the figures showing no-observed-adverse-effect levels (NOAELs) or lowest­ observed-adverse-effect levels (LOAELs) reflect the actual doses (levels of exposure) used in the studies. LOAELs have been classified into "less serious" or "serious" effects. "Serious" effects are those that evoke failure in a biological system and can lead to morbidity or mortality (e.g., acute respiratory distress or death). "Less serious" effects are those that are not expected to cause significant dysfunction or death, or those whose significance to the organism is not entirely clear. ATSDR acknowledges that a considerable amount of judgment may be required in establishing whether an end point should be classified as a NOAEL, "less serious" LOAEL, or "serious" LOAEL, and that in some cases, there will be insufficient data to decide whether the effect is indicative of significant dysfunction. However, the Agency has established guidelines and policies that are used to classify these end points. ATSDR believes that there is sufficient merit in this approach to warrant an attempt at distinguishing between "less serious" and "serious" effects. The distinction between "less serious" effects and "serious" effects is considered to be important because it helps the users of the profiles to identify levels of exposure at which major health effects start to appear. LOAELs or NOAELs should also help in determining whether or not 1,3-BUTADIENE 20 3. HEALTH EFFECTS the effects vary with dose and/or duration, and place into perspective the possible significance of these effects to human health. The significance of the exposure levels shown in the Levels of Significant Exposure (LSE) tables and figures may differ depending on the user's perspective. Public health officials and others concerned with appropriate actions to take at hazardous waste sites may want information on levels of exposure associated with more subtle effects in humans or animals (LOAELs) or exposure levels below which no adverse effects (NOAELs) have been observed. Estimates of levels posing minimal risk to humans (Minimal Risk Levels or MRLs) may be of interest to health professionals and citizens alike. Levels of exposure associated with carcinogenic effects (Cancer Effect Levels, CELs) of 1,3-butadiene are indicated in Table 3-1 and Figure 3-1. Because cancer effects could occur at lower exposure levels, Figure 3-1 also shows a range for the upper bound of estimated excess risks, ranging from a risk of 1 in 10,000 to 1 in 1,000,000 (10-4 to 10-6), as developed by EPA. A User's Guide has been provided at the end of this profile (see Appendix B). This guide should aid in the interpretation of the tables and figures for Levels of Significant Exposure and the MRLs. 3.2.1 Inhalation Exposure 3.2.1.1 Death Information on the lethality of 1,3-butadiene in humans is limited. A number of occupational exposure studies have examined mortality ratios in 1,3-butadiene workers, the results of these studies are discussed in subsequent sections on the primary effects. No deaths were seen in B6C3F1 mice exposed to ≤8,000 ppm 1,3-butadiene 6 hours/day, 5 days/week, for 2 weeks (NTP 1984). The majority of rabbits died when exposed to 250,000 ppm 1,3-butadiene for an average of 23 minutes (Carpenter et al. 1944). The LC50 values calculated for mice and rats exposed for 2 and 4 hours, respectively, was 122,000 and 129,000 ppm, respectively (Shugaev 1969). Intermediate-duration exposures produced no deaths in rats exposed for 6 hours/day, 5/days/week, for 13 weeks to 8,000 ppm (Crouch et al. 1979), or in rats, guinea pigs, rabbits, and dogs during 8 months of exposure to 6,700 ppm (Carpenter et al. 1944). Increased mortality was seen in mice exposed to 5,000 ppm, but not 2,500 ppm, for 6 hours/day, 5 days/week, for 14 weeks (NTP 1984). The lowest 1,3-BUTADIENE 21 3. HEALTH EFFECTS intermediate-duration exposure resulting in death was observed in mice receiving 200 ppm for 6-hours/day, 5 days/week, for 40 weeks (NTP 1993), ostensibly from the early development of neoplasms. During chronic exposure to 625 and 1,250 ppm of 1,3-butadiene for 61 weeks, significantly increased mortality, primarily due to cancer, was found in B6C3F1 mice (NTP 1984). Similar results were obtained in another study using a much lower concentration (20 ppm) (NTP 1993). Exposure of rats to 8,000 ppm 1,3-butadiene resulted in statistically significant increased mortality from cancer when compared with controls (Owen et al. 1987). The LC50 values and all reliable LOAEL values for death in each species and duration category are recorded in Table 3-1 and plotted in Figure 3-1. 3.2.1.2 Systemic Effects Respiratory Effects. Workers exposed to 1,3-butadiene gas during the manufacture of rubber complained of irritation of the eyes, nasal passages, throat, and lungs (Wilson 1944). In some, coughing, fatigue, and drowsiness developed. All symptoms disappeared on removal from the gas. The associated exposure levels were not reported. No effects in respiratory tissues were observed in rats, guinea pigs, rabbits, or dogs inhaling up to 6,700 ppm 1,3-butadiene for 7.5 hours/day, 6 days/week, for 8 months (Carpenter et al. 1944) or in rats or mice exposed to 8,000 ppm 1,3-butadiene for 6 hours/day, 5 days/week, for 13–14 weeks (Crouch et al. 1979; NTP 1984). No effects were observed in lungs of mice exposed to concentrations as high as 625 ppm for 6 hours/day, 5 days/week, for 9 months (NTP 1993). An increase in chronic inflammation of the nasal cavity, fibrosis, cartilaginous metaplasia, osseous metaplasia, atrophy of the sensory epithelium, and hyperplasia of the respiratory epithelium were observed in mice exposed to 1,250 ppm for 2 years (NTP 1984). Lungs of rats exposed chronically to 8,000 ppm 1,3-butadiene exhibited metaplasia (Owen and Glaister 1990; Owen et al. 1987). Atrophy of the nasal olfactory epithelium was observed in mice exposed to concentrations as high as 1,250 ppm 1,3-butadiene for 6 hours/day, 5 days/week, for 61 weeks (NTP 1993), while alveolar epithelial hyperplasia (a possible precancerous lesion) occurred in mice exposed to 6.25 ppm 6 hours/day, 5 days/week for 2 years (NTP 1993). Table 3-1 Levels of Significant Exposure to 1,3-butadiene - Inhalation 1,3-BUTADIENE Exposure/ LOAEL Duration/ a Frequency Key to Species NOAEL Less Serious Serious Reference (Route) Figure (Strain) System (ppm) (ppm) (ppm) Chemical Form Comments ACUTE EXPOSURE Death 1 Rat 1 d 129000 (LC50) Shugaev 1969 4 h/d 129000 97 2 Mouse 1 d 122000 (LC50) Shugaev 1969 2h/d 122000 96 3 Rabbit 1 d 250000 Carpenter et al. 1944 23 min/d 250000 67 Systemic 3. HEALTHEFFECTS 4 Rat 10 d Irvine 1981 6 hr/d Bd Wt 200 F (decreased maternal 8000 F (45% decreased Gd 6-15 body weight gain) maternal body weight gain) 200 8000 159 Neurological 5 Human 1 d 8000 Carpenter et al. 1944 6-8 hr/d 8000 71 6 Rabbit 1 d 250000 (anesthesia) Carpenter et al. 1944 23 min/d 250000 68 Reproductive 7 Mouse 5 d DOE/NTP 1988a 6 h/d 1000 M (73% increase in number (B6C3F1) of abnormal sperm heads) 1000 154 8 Mouse 6 hr/day DOE/NTP 1988b 5 days 200 M (increased intrauterine CD-1 death) 200 158 22 Table 3-1 Levels of Significant Exposure to 1,3-butadiene - Inhalation (continued) 1,3-BUTADIENE Exposure/ LOAEL Duration/ a Frequency Key to Species NOAEL Less Serious Serious Reference (Route) Figure (Strain) System (ppm) (ppm) (ppm) Chemical Form Comments Developmental 9 Rat 10 d 1000 DOE/NTP 1987a (Sprague- 6 hr/d 1000 Dawley) Gd 6-15 74 10 Rat 10 d 200 8000 (decreased fetal growth) Irvine 1981 6 hr/d 200 8000 Gd 6-15 1000 (major skeletal malformations) 1000 72 3. HEALTHEFFECTS 11 Mouse 10 d 40 M (decreased fetal BW in DOE/NTP 1987b (CD-1) 6 hr/d GD 6-15 males) 40 100 INTERMEDIATE EXPOSURE Death 12 Mouse 14 wk 5000 (increased mortality) NTP 1984 5 d/wk 5000 6 hr/d 23 13 Mouse 13-52 wk 200 (increased mortality from NTP 1993 (B6C3F1) 6 hr/d 5 d/wk 40 weeks of exposure) 200 144 23 Table 3-1 Levels of Significant Exposure to 1,3-butadiene - Inhalation (continued) 1,3-BUTADIENE Exposure/ LOAEL Duration/ a Frequency Key to Species NOAEL Less Serious Serious Reference (Route) Figure (Strain) System (ppm) (ppm) (ppm) Chemical Form Comments Systemic 14 Rat 13 wk Resp 8000 Crouch et al.
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