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Toxicological Profile for 2,4-Dichlorophenoxyacetic Acid

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Toxicological Profile for 2,4-Dichlorophenoxyacetic Acid 2,4-D A-1 APPENDIX A. ATSDR MINIMAL RISK LEVEL WORKSHEETS MRLs are derived when reliable and sufficient data exist to identify the target organ(s) of effect or the most sensitive health effect(s) for a specific duration for a given route of exposure. An MRL is an estimate of the daily human exposure to a hazardous substance that is likely to be without appreciable risk of adverse noncancer health effects over a specified route and duration of exposure. MRLs are based on noncancer health effects only; cancer effects are not considered. These substance-specific estimates, which are intended to serve as screening levels, are used by ATSDR health assessors to identify contaminants and potential health effects that may be of concern at hazardous waste sites. It is important to note that MRLs are not intended to define clean-up or action levels. MRLs are derived for hazardous substances using the NOAEL/uncertainty factor approach. They are below levels that might cause adverse health effects in the people most sensitive to such chemical- induced effects. MRLs are derived for acute (1–14 days), intermediate (15–364 days), and chronic (≥365 days) durations and for the oral and inhalation routes of exposure. Currently, MRLs for the dermal route of exposure are not derived because ATSDR has not yet identified a method suitable for this route of exposure. MRLs are generally based on the most sensitive substance-induced endpoint considered to be of relevance to humans. Serious health effects (such as irreparable damage to the liver or kidneys, or birth defects) are not used as a basis for establishing MRLs. Exposure to a level above the MRL does not mean that adverse health effects will occur. MRLs are intended only to serve as a screening tool to help public health professionals decide where to look more closely. They may also be viewed as a mechanism to identify those hazardous waste sites that are not expected to cause adverse health effects. Most MRLs contain a degree of uncertainty because of the lack of precise toxicological information on the people who might be most sensitive (e.g., infants, elderly, nutritionally or immunologically compromised) to the effects of hazardous substances. ATSDR uses a conservative (i.e., protective) approach to address this uncertainty consistent with the public health principle of prevention. Although human data are preferred, MRLs often must be based on animal studies because relevant human studies are lacking. In the absence of evidence to the contrary, ATSDR assumes that humans are more sensitive to the effects of hazardous substance than animals and that certain persons may be particularly sensitive. Thus, the resulting MRL may be as much as 100-fold below levels that have been shown to be nontoxic in laboratory animals. 2,4-D A-2 APPENDIX A Proposed MRLs undergo a rigorous review process: Health Effects/MRL Workgroup reviews within the Division of Toxicology and Human Health Sciences, expert panel peer reviews, and agency-wide MRL Workgroup reviews, with participation from other federal agencies and comments from the public. They are subject to change as new information becomes available concomitant with updating the toxicological profiles. Thus, MRLs in the most recent toxicological profiles supersede previously published MRLs. For additional information regarding MRLs, please contact the Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road NE, Mailstop S102-1, Atlanta, Georgia 30329-4027. 2,4-D A-3 APPENDIX A MINIMAL RISK LEVEL (MRL) WORKSHEET Chemical Name: 2,4-D CAS Numbers: 94-75-7 Date: July 2020 Profile Status: Final Route: Inhalation Duration: Acute MRL Summary: An acute-duration inhalation MRL was not derived for 2,4-D. Rationale for Not Deriving an MRL: No acute-duration inhalation data were available for review. Agency Contacts (Chemical Managers): Obaid Faroon 2,4-D A-4 APPENDIX A MINIMAL RISK LEVEL (MRL) WORKSHEET Chemical Name: 2,4-D CAS Numbers: 94-75-7 Date: July 2020 Profile Status: Final Route: Inhalation Duration: Intermediate MRL Summary: An intermediate-duration inhalation MRL was not derived for 2,4-D. Rationale for Not Deriving an MRL: Only one inhalation study in animals was available for review. In that study, male and female rats were exposed nose-only 6 hours/day, 5 days/week for 28 days to 2,4-D dusts in target concentrations of 0, 50, 100, 300, and 1,000 mg/m3 (EPA 2008). After termination of exposure, controls and rats from the highest exposure concentration group were kept for a 4-week recovery period to assess reversibility of the effects. A significant reduction in reticulocytes occurred in males and females at 2,4-D exposure concentrations ≥300 mg/m3 and a significant increase in serum alkaline phosphatase was reported in females at ≥300 mg/m3. Histopathologic examination of a comprehensive set of organs and tissues revealed no sign of 2,4-D exposure-related systemic effects. The most salient effect was the occurrence of squamous/squamoid epithelial metaplasia with hyperkeratosis in the larynx of all exposed groups, with increasing severity as the exposure concentration increased. The lesions persisted during the recovery period, but with reduced severity. Therefore, the exposure concentration of 50 mg/m3 represents the study LOAEL, a portal-of-entry LOAEL. Although this is a well-conducted study that examined a comprehensive number of end points, the database is insufficient for MRL derivation. It would be important to determine a NOAEL for the portal-of-entry effects. Agency Contacts (Chemical Managers): Obaid Faroon 2,4-D A-5 APPENDIX A MINIMAL RISK LEVEL (MRL) WORKSHEET Chemical Name: 2,4-D CAS Numbers: 94-75-7 Date: July 2020 Profile Status: Final Route: Inhalation Duration: Chronic MRL Summary: A chronic-duration inhalation MRL was not derived for 2,4-D Rationale for Not Deriving an MRL: No chronic-duration inhalation data were available for review. Agency Contacts (Chemical Managers): Obaid Faroon 2,4-D A-6 APPENDIX A MINIMAL RISK LEVEL (MRL) WORKSHEET Chemical Name: 2,4-D CAS Numbers: 94-75-7 Date: July 2020 Profile Status: Final Route: Oral Duration: Acute MRL Summary: An acute-duration oral MRL was not derived for 2,4-D. Rationale for Not Deriving an MRL: No adequate acute-duration human data were located. Information regarding health effects in humans following acute-duration exposure to 2,4-D is limited to case reports of intentional or accidental ingestion of herbicide formulations containing 2,4-D. Effects that have been reported following oral exposure to high amounts of 2,4-D include tachypnea, tachycardia, vomiting, leukocytosis, liver and kidney congestion in fatal cases, metabolic acidosis, and death (Dudley et al. 1972; Durakovic et al. 1992; Keller et al. 1994; Nielsen et al. 1965; Smith and Lewis 1987). While some of these studies provided estimates of amounts of 2,4-D ingested, the reported effects represent the result of exposure to a chemical mixture consisting of 2,4-D and other substances present in the commercial formulations (i.e., solvents, other herbicides), which is the exposure that most humans experience. Yet, the common exposure reported across studies was to 2,4-D. In two studies designed to evaluate the pharmacokinetics of 2,4-D in volunteers, administration of 5 mg 2,4-D/kg once in a gelatin capsule resulted in no ill effects during 144–168 hours post-dosing (Kohli et al. 1974; Sauerhoff et al. 1977). The information available in humans is inadequate for MRL derivation. Two animal studies defined LOAELs of 50 mg/kg/day. In one of these studies, doses of 50 mg/kg/day (lowest dose tested) induced significant weight loss in pregnant Wistar rats when administered by gavage in water on GDs 6–15 (Fofana et al. 2000). It is not totally clear, however, whether the investigators meant that the final weight was lower than the starting weight or whether treated rats just gained less weight than control rats. In another developmental study, administration of 2,4-D at 50 mg/kg/day by gavage in corn oil to pregnant Sprague-Dawley rats, also on GDs 6–15, did not affect maternal weight (terminal weight similar in treated and controls), but induced a statistically significant reduction in fetal weight (approximately 7%) measured on GD 20 and increased the incidence of some soft-tissue anomalies and skeletal malformations; the NOAEL was 25 mg/kg/day (Schwetz et al. 1971). Long-term oral studies suggest that the kidney is a target for 2,4-D toxicity; however, only one acute-duration study conducted microscopic examinations of the kidneys. The paucity of information regarding the effects of acute-duration oral exposure to 2,4-D in experimental animals precludes deriving an acute-duration oral MRL for 2,4-D. Agency Contacts (Chemical Managers): Obaid Faroon 2,4-D A-7 APPENDIX A MINIMAL RISK LEVEL (MRL) WORKSHEET Chemical Name: 2,4-D CAS Numbers: 94-75-7 Date: July 2020 Profile Status: Final Route: Oral Duration: Intermediate MRL: 0.2 mg/kg/day Critical Effect: Increased kidney weight, histopathologic kidney lesions Reference: Marty et al. 2013 Point of Departure: 16.6 mg/kg/day (NOAEL) Uncertainty Factor: 100 LSE Graph Key: 33 Species: Rat MRL Summary: An MRL of 0.2 mg/kg/day has been derived for intermediate-duration oral exposure to 2,4-D based on a NOAEL of 16.6 mg/kg/day and a LOAEL of 45.3 mg/kg/day for increased kidney weight and slight proximal tubule degeneration in the kidney of male Sprague-Dawley rats receiving 2,4-D from food for up to 11 weeks (Marty et al.
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