FUNDAMENTAL AND APPLIED TOXICOLOGY 20. 34 I -347 ( 1 99? ) Acute Methanol Toxicity in Minipigs1 DAVIDC. DORMAN.* JANICE A. DvE.t MARK. P NASSISE.J JETIIRO HKL r v* BRAD BOLON.* AND MICHELE A. MEDINSKY 'Chemical Imlimirv ln\iitiili'nl Ti>yiiiittn>vcincl^lli'tilili l:'lli-ti\ Kwiiri It l.,ih< ir,u,l I'cit-rniun l/n//i/ur Vnr//i i .ii<-/ni,i s/i//, ( /jni'/w/t. RiiU-iaii. \i>rili Citroltiiii .' /C I'urk. Received August :?. |iW2; javpk'd IVivmhcr : I. Acute Methanol Toxicity in Minipigs. DORMAN. D. C. DVE. J. A.. NASSISE, M. P., EKUTA. J.. BOLON. B.. AND MEDINSK\ . M. A. (1993). Fundant. Appl. Toxicol. 20. 341-3-47. :-; _The pig has been proposed as a potential animal model for methanol-induced neuro-ocular toxicosis in humans because of its low liver tetrahydrofolate levels and slower rate of formate metabolism compared to those of humans. To examine the valid- ity of this animal model. 12 4-month-old female minipigs (mini- pig YU) were given a single oral dose of water or methanol at 1.0. 2.5. or 5.0 g/kg body wt by gavage (n = 3 pigs/dose). Dose- dependent signs of acute methanol intoxication, which included mild CNS depression, tremors, ataxia. and recumbency, devel- oped within 0.5 to 2.0 hr. and resolved by 52 hr.'-Average maxi- mum methanol concentrations in plasma, of 3100 ± 700 (SD). 6200 ± 2300. and 15.200 ± 900 Mg/ml were reached within 0.5 to 4 hr following methanol administration in animals given 1.0. 2.5. or 5.0 g methanol/kg, respectively. The mean initial elimina- tion half-lives of methanol were 9.0 ± 1.6. 22.4 + 6.1. and 18.9 ± 4.3 hr, for 1, 2.5. and 5.0 g/kg doses, respectively. In 3 mini- pigs, a transient increase in plasma formate concentration (1.74-3.40 mEq/liter vs control = 0.5 ± 0.3 mEq/liter) occurred 4 to 30 hr following methanol administration. Methanol- and formate-dosed pigs did not develop optic nerve lesions, lexico- logically significant formate accumulation, or metabolic acido- sis. Based on results following a single dose, female minipigs do not appear to be overtly sensitive to methanol and thus may not be a suitable animal model for acute methanol-induced neuro- ocular tOXicOSIS.^ ic 1993 Society ofToxicolog). Methanol exposure may result in neurobehavjoral (In- furna and Weiss. 1986). teratological (Infurna and Weiss. 1986: Nelson et a/., 1985). neurodevelopmental (Nelson et a/.. 1985). reproductive (Cooper el a/.. 1992), and neuro- ocular effects. The toxicity of methanol in humans is char- acterized by central nervous system depression, weakness. headache, vomiting, severe metabolic acidosis (McMartin ' This paper has been reviewed by the Health Effects Research Labora- tory. U.S. Environmental Protection Agency, and approved for publica- tion. Approval does not signify that the contents necessarily reflect the views and policies of the Agency nor does mention of trade names or commercial products constitute endorsement or recommendation for use. ci nl.. I'M): Cljy ci a/.. 1975). optic disc edema (Hayreh ci al. 1977). and hilaieral necrosis ot'lhc putamcn (Koopmans citil.. I9S.X; LeyandGali. 1983: Sharpe cv /.. 1982). Clini- cal consequences of these lesions, which typically occur fol- louinga single accidental onmentional mgestion of metha- nol. are blindness or Parkinsoniun-like motor disease (Ley and Call. 1983). In nonhuman primates, melhanol is metabolized lo lorm- aldehyde predominantly by hepatic alcohol delndrogenase (McManin ci til.. 1975). In nonhuman primates, formalde- hyde has also been shown to be reactive with a half-life in blood on the order of minutes, and is not thought to be directly involved in the production ol methanol toxicosis (McMartin el ul.. 1979). Formaldchvde is metabolized by a glutathione-mediated pathway, involving lbrmaldch\dede- hydrogenase. to formic acid, which at physiological condi- tions dissociates to formate and hydrogen ions (Tcphly and McManin. 1984). Although methanol ma\ have direct toxic effects, formate is considered to be the toxic metabo- lite of methanol. and the accumulation of formic acid with the subsequent development of metabolic acidosis and blindness is characteristic of methanol poisoning in sensi- tive species (e.g.. humans, nonhuman primates)(McMartin etui.. 1977. 1980). Furthermore, administration of formic acid to monkeys reproduces optic disc edema with the loss of the papillary light reflex, features that are also character- istic of methanol toxicity in humans (Manin-Amai et al.. 1978). Conversely, in resistant species (e.g.. rats. mice). methanol administration does not result in formate accu- mulation, metabolic acidosis. or blindness (Tephly and McManin. 1984). The rate at which methanol-derived formate accumu- lates to toxic levels following methanol exposure is primar- ily influenced by the rate of formate metabolism. Formate metabolism is dependent upon the activities of formyltetra- hydrofolate synthetase as well as methenyltetrahydrofolate dehydrogenase and their cosubstrate. tetrahydrofolate (Black et al., 1985; Johiin ei al., 1987). Susceptible species appear to have lower liver tetrahydrofolate concentrations. slower formate metabolism, and thus increased sensitivity to methanol when compared to resistant species such as 341 0:72-0590/93 $5.00 Copyright ?: 1993 by the Socieu oC Toxicology. All rights of reproduction in am form reserved. \ NTIS is authorized lo reproduce and sell this 1 I report. Permission for lurttier reproduction ; I must be obtained from the copyright owner. ; ------- 342 DORMAN ET AL. rats. Like humans, young swine and micropigs have low hepatic tetrahydrofolate concentrations and appear to me- tabolize formate at a rate slower than that observed in rats (Makar el al.. 1990; Tephly el al, 1992). It is predicted that the proposed heavier reliance on meth- anol-based automotive fuels will result in an increased inci- dence of blindness and deaths in people resulting from acci- dental methanol ingestion (Litovitz, 1988). The animal models available to study methanol-induced neuro-ocular toxicity have been limited to nonhuman primates (Martin- Amat el al., 1977) and to monkeys and rodents made fo- late-deficient by nutritional or pharmacologic manipula- tion (McMartin el al, 1977: Eells, 1991). Pigs represent an attractive animal model for the study of methanol-induced neurotoxicity. It would be predicted that pigs would accu- mulate formate following methanol exposure based upon their reported low levels of hepatic tetrahydrofolate con- centrations and slow rate of formate metabolism (Makar el al. 1990; Tephly el al, 1992). The actual sensitivity of swine to methanol and methanol-induced neuro-ocular tox- icity is unknown. This study was, therefore, performed to evaluate the Yucatan minipig as a potential nonprimate model for methanol neuro-ocular toxicosis by exploring the toxicity and pharmacokinetics of melhanol and formate in these animals. MATERIALS AND METHODS Chemicals. Methanol (high-performance liquid chromatograpny grade) was obtained from Sigma Chemical Co. (St. Louis. MO). Sodium penlobarbital was purchased from Abbott Laboratories (North Chicago. IL). ketamine hydrochloride from Aveco (Fort Dodge. IA), halothane from Fort Dodge Laboratories (Fort Dodge. IA), and tropicamide from Alcon Laboratories (Ft. Worth. TX). Formate dehydrogenase was pur- chased from Boehringer Mannheim Corp. (Indianapolis. IN). Hog kidney acetone powder and all other chemicals were purchased from Sigma and were of the highest available purity. Animals. Fourteen. 4-month-old. 8.5 to 13.0 kg, female minipigs (Minipig YU. Charles Rivers Breeding Laboratories, Wilmington, MA) were used. Minipigs were housed individually in raised stainless-steel runs with tenderfoot flooring. They were fed a commercially available, pelleted, pig and sow diet (Wayne Feed Division, Chicago, IL) meeting National Research Council nutritional specifications for swine. Food and water were available ad IMium except for the 12 hr immediately prior to surgery or methanol administration. A 12-hr light/dark cycle was provided throughout the study. Catheter implantation. Following premedication with atropine (0.04 mg/kg. sc). ketamine (10 mgAg, im), and xylazine (5 mg/kg, im), anes- thetic induction was achieved with 1.5 to 2.0% halothane. Animals were maintained on I to 1.5% halothane in a closed circuit system. External jugular vein and carotid artery catheters were surgically implanted approxi- mately 48 hr prior to methanol or formate administration using the meth- ods described by Smith and coworkers (1989). A 75-cm long, single lumen, medical-grade silicone elastomere tube (Silastic. Dow Coming. Midland, MI) with an outside diameter of 2.2 mm and an inside diameter of 1.0 mm was used for all catheierizations. Catheters were exteriorized through a dorsal skin incision and placed into a vinyl pouch sutured to the skin (Wittry et al.. 1990). Melhanol administration. A single oral dose of melhanol (20% v/\ in sterile water) was given by gavage at 0. 1.0, 2.5. or 5.0 g/kg (n = 3 pigs per dose). Conirol animals were given a volume of water equivalent to the highest volume given to the methanol-dosed group. Formate administration. To examine whether formate accumulation alone would result in neuro-ocular toxicosis, a formate buffer (sodium formaie.formic acid. 10:1. 0.5 M, pH 7.4) was given (425 mg formate/kg) intravenously every 4 hr for 32 hr to two additional minipigs. The dose of formate gi\cn was anticipated to produce blood formaic concentrations similar to ihose seen in formate-poisoned monkeys lhai subsequently de- veloped neuro-ocular loxicity (Martm-Amal el a/.. 1978). Animal monitoring and assessment of toxicity. Before and each 24 hr after methanol dosing, funduscopic examinations were performed by indi- rect ophthalmoscopy after inducing pharmacologic mydriasis with topical tropicamide. In some pigs, retinal vascular permeability was also assessed 24 10 96 hr after melhanol administration by conventional fluoresccin angiography (Bellhom. 1973). Angiographic hndmgs were recovered on high-speed color film using a hand-held fundus camera (Kowa RC 2. Kowa. Japan). Animals were monitored continuously for the development of clinical signs during the first 8 hr after methanol or formate administra- tion. They were subsequently observed for clinical signs at least every 4 hr for the first 48 hr after dosing and then every 8 hr until completion of the study. Serial neurologic and physical examinations were performed more frequently in animals that developed clinical signs. Blood gas analysis. Routine arterial blood gas analyses were per- formed every 6 hr after melhanol administration using a commercially available blood gas analyzer (IL 1306. Instrumentation Laboratories. Lex- ington. MS). Methanol and formate pharmacokinetics. Heparinized venous blood (1 ml) was collected at 0.0.25,0.5. I, 1.5,2.4.8. 12. 16, 32. and 64 hr after administration of melhanol or formate. All samples were kept frozen until analyzed- Blood methanol concentration was determined by gas chroma- tography-flame lonizalion detection using the meihods described by Pol- lack and Kawagoe(199l). A Hewlett-Packard 5880A gas chromatograph (Kennett Square. PA) equipped with a 30 m x 0.25 mm column (J&W DB-Wax. J&W Scientific. Folsom. CA) and a I m x 0.53 mm deactivated silica precolumn were used. Temperatures were as follows: injector. 70°C: detector, 325°C; column oven, I05°C. These conditions produced reten- tion times of 1.9 and 2.1 mm for acetonitriie (external standard) and metha- nol. respectively. Blood formate concentration wasdeterminedspectropho- tometrically using the enzymatic method of Cook el al. (1991). Liver (total) folate determination. Liver samples from control pigs were prepared as described by McMartin and coworkers (1981). Folates were assayed in their monoglutamate form after hydrolysis with hog kid- ney polyglutamate hydrolase prepared from hog kidney acetone powder (Lin and Lester. 1985). Total hepatic folate was determined using a com- mercially available homogenous enzyme immunoassay (Microgenics Cor- poration, Concord. CA) described by KJianna and coworkers (1989). Pathology. Animals were euthanatized 10 days after melhanol admin- istration. Minipigs were tranquilized with chlorpromazine (0.3 mg/kg. iv) and anesthetized by the intravenous administration of pentobarbital (20.0 mg/kg). Following induction of deep anesthesia, a liver biopsy specimen was obtained from control minipigs through abdominal laparotomy. The liver wedge was frozen in liquid nitrogen and stored at -80°C until ana- lyzed for folate. The aorta was then cannulated through the left ventricle with a 13-mm o.d. plastic catheter, and 2 liters of 0.9% saline containing 2000 IU heparin/liter at a temperature of 37°C were infused through the catheter by gravity at a pressure equivalent to 120-150 mm water. Blood and saline escaped from the vascular system through a 2- to 3-cm incision in the right auricle. When the escaping saline became clear, the infusion was changed to 2.5% glutaraJdehyde in 0.1 M phosphate buffer (pH 7.4). also at 37 "C Each pig was perfused with 4.0 liters of this fixative. The total fixative perfusion time ranged from 20 to 35 min. ------- METHANOL TOXICITY IN MINIPIGS 343 A necropsy was performed immediately on each fixed animal. The fol- lowing tissues were collected for histologic examination: brain (cerebrum. cerebellum, and brain stem), spinal cord (cervical and lumbar intumes- cences), eye (optic nerve and retina), kidney, liver, lung, heart, adrenal. pancreas, and spleen. Tissues were stored overnight in 2.5ri< glularaldchyde in 0.035 M phosphate buffer (pH 7.4) at 4°C. processed by standard proce- dures, embedded in paraffin, sectioned at 5 ^m. and stained with hemato\- ylin and eosin. Data analysis. Because of the small sample size (/i = 3 per dose group). no formal statistical analysis was performed. Data are reported js means ± SD. Peak plasma concentration (Cml.) and time to peak plasma concen- tration (/„„) were determined by inspection of the methanol plasma con- centration vs time results. The half-life ((l/:) of melhanol was estimated from the slope of the terminal phase of the log plasma conccniration-ume plot tilted by the method of least squares. Following the initial intravenous dose of formate, the 1II3 of formate was estimated from the slope of i he log plasma concentration-lime plot and was also fitted by the method of least squares. RESULTS Clinical signs of acute toxicosis developed within 0.5 to 2 hr of methanol administration and resolved by 52 hr. The clinical signs of methanol toxicosis included mild to severe CNS depression (8 of 9 pigs), ataxia (8/9). recumbency (2/ 9). and tremors (1/9). Once they had recovered from the initial effects, the minipigs remained asymptomatic until they were euthanized. With each increasing methanol dose. the time until the onset of clinical signs decreased, and the duration and severity of clinical effects increased. No clini- cal signs were apparent in the control minipigs given water. Clinical signs consistent with ocular toxicity were not ob- served in any of the minipigs given methanol. Their pupil- lary light reflexes and menace responses remained normal. and the pigs appeared to maintain the ability to negotiate around objects. No significant changes in the optic nerves and retinal vessels were observed using funduscopic exami- nation or fluorescein retinal angiography. The 10-day histo- logic evaluation of one of the minipigs given the highest methanol dose (5.0 g/kg) revealed multifocal degeneration of the outer retinal layers (Fig. I). The accumulation of amorphous cellular debris in the outer nuclear layer re- sulted in the elevation of the adjacent sensory retina. How- ever, no histopathologic lesions consistent with methanol- related toxicosis were seen in the eyes of other methanol- treated or control minipigs. Putamen lesions were not observed in brain cross-sections from either methanol- treated or control minipigs. A dose-dependent increase in blood methanol concentra- tion was observed. Mean peak plasma methanol concentra- tions (±SD) of 3100 ± 700. 6200 ± 2300, and 15,200 ± 900 Mg/ml occurred 0.5 to 4 hr after administration of 1.0. 2.5, or 5.0 g methanol/kg, respectively (Fig. 2). The mean initial elimination tl/2 of methanol was 9.0 ± 1.6, 22.4 ±6.1, and 18.9 ± 4.3 hr for animals given 1.0, 2.5, or 5.0 g methanol/ kg, respectively. The terminal phase elimination ?I/2 of methanol could not be determined. Although a slight decrease in blood pH was noted in the minipigs given 5.0 g/kg methanol (Fig. 3). neither depletion of blood bicarbonate nor formic acidemia occurred. In three of the minipigs (from the I and 2.5 g/kg dose groups). a transient, dose-independent increase in plasma formate concentration (1.74-3.40 mEq/liter) developed between 4 and 30 hr after melhanol gavage (Fig. 4): endogenous blood formate concentrations in control minipigs were 0.53 ±0.3 mEq/liier. Minipigs given intravenous formate developed depres- sion, polyuria. and polydipsia between 36 and 40 hr after the initial formate dose. Neither animal given formate de- veloped metabolic acidosis or significant formate accumu- lation (data not shown). Minipigs given formate had nor- mal pupillary light reflexes and menace responses and did not develop clinical signs consistent with optic nerve or retinal involvement. No significant changes in the optic nerves and retinal vessels were observed using funduscopic examination or fluorescein retinal angiography. No histo- pathologic lesions consistent with formate-related toxicosis were seen in the eyes of minipigs given formate. The initial formate elimination /,/2 was 50 and 1 12 min for the two minipigs given formate intravenously (Fig. 5). The average total hepatic folate concentration in the con- trol minipigs was 17.5 ± 2.2 nmol/g of liver (n = 3). DISCUSSION The use of the pig as an animal model of methanol poi- soning in man has been suggested by Makar and coworkers (1990). They based their hypothesis on the known associa- tion between formate accumulation and the subsequent de- velopment of metabolic acidosis and blindness in species sensitive to methanol poisoning. Formate is converted by 10-formyltetrahydrofolate synthetase to 10-formyltetrahy- drofolate. 10-Formyltetrahydrofolate is subsequently me- tabolized by 10-formyltetrahydrofolate dehydrogenase to carbon dioxide (Johlin el al.. 1989). The rate of formate metabolism, therefore, is dependent on adequate levels of hepatic folic acid, especially its tetrahydrofolate form (Joh- lin el al., 1987). As demonstrated by Makar and coworkers (1990), some pigs have low liver tetrahydrofolate concen- trations and a decreased rate of formate metabolism, sug- gesting an increased sensitivity to methanol toxicosis. In our study, however, a single oral dose of 1.0 to 5.0 g/kg of methanol failed to result in formate accumulation suffi- cient to induce toxicity. The dose at which methanol-in- duced neuro-ocular toxicity occurs in pigs remains un- known. The doses of methanol used in this study are compa- rable to or greater than the minimal lethal oral dose (1.0 gram/kg) of methanol in humans (Roe. 1982). There are a number of cases in which adult humans have survived the ingestion of 500 to 600 ml of methanol (Naraqi el al. ------- 344 DORMAN ET AL. FIG. I. Multifocal reiinal degeneration ofihe outer retinal layers (b) in a mmipig given methanol (5.0g/kg) 10 days earlier, compared to control (a). Accumulation of amorphous cellular debris (arrow) in the outer nuclear layer resulting in the elevation of the adjacent sensory retina is also present. (HE. 40x). ------- METHANOL TOXICITY IN MINIP1GS 345 12 24 36 Time after dosing (hrs) 48 FIG. 2. Blood methanol concentration following a single oral dost of methanol (n = 3 minipigs per dose). Error bars (.v ± SD) nol visible arc within the symbol used. 1979). Even among sensitive humans, there is a tremen- dous amount of variability in the methanol dose-response. The oral absorption and total body clearance of metha- nol in these minipigs appeared similar to those observed in humans. Whether unusual methanol distribution or metab- olism occurs in minipigs is unknown. Minipigs rapidly ab- sorbed the methanol and developed maximal blood metha- nol concentrations (range, 1600 to 30,300 Mg/ml) that were comparable to those reported in humans following metha- nol ingestion. These plasma methanol concentrations ap- pear higher than what would be expected based on metha- nol kinetics in other species. Although maximal blood methanol concentrations following acute lethal methanol exposure in humans are often undetermined, blood metha- nol levels in excess of 1000 ^g/ml are commonly reported within 24 to 48 hr of methanol ingestion (Jacobsen et al., 1982: Naraqi et al.. 1979; Kane et al., 1968; Swartz el al.. 1981). The initial methanol elimination half-lives (9 to 22 hr) observed in the minipig were also comparable to those 7.7-, 7.2 24 36 48 60 Time after dosing (hrs) 12 24 36 '& 50 72 Time after melhanol administralion (nr) FIG. 4. Individual animal blood formate concentrations following a single oral dose of methanol. Only three minipigs. two from the lowest (1.0 g/kgl and one from the intermediate (2.5 g/kgl melhanol dose groups, had increased blood formate levels following methanol administration. All other minipigs did not have increased blood formate concentrations, in- cluding three minipigs given 5.0 g melhanol/kg and the remaining animal from each of the lower 11 or 2.5 g/kg) methanol dose groups. reported following methanol ingestion in humans (17 to 27 hr) without ethanol or dialysis treatment (Kane el al.. 1968). Finally, as in humans, methanol administration was associated with transient CNS depression and aiaxia that paralleled their blood methanol concentrations. Ultimately, however, no significant accumulation of for- mate occurred in any of the methanol-treated minipigs in this study. Blood formate levels in excess of 10 mEq/liter are reported in humans with neuro-ocular toxicosis follow- ing methanol ingestion (Sejersted et al., 1983: McMartin et al.. 1980). Although there was a mild decrease in the blood pH of the minipigs given the highest methanol dose (5 g/ kg), none of the methanol-treated minipigs developed a de- gree of metabolic acidosis or bicarbonate depletion consis- tent with methanol poisoning in humans. Minipigs in this study given the highest methanol dose (5 g/kg) had blood bicarbonate levels 72 hr after methanol ingestion (25.5 100, 0.1 30 60 90 120 150 190 210 240 Time (min) FIG. 3. Blood pH following a single oral dose of methanol (n minipigs per dose). FIG. 5. Initial formate elimination following an intravenous adminis- tration of buffered formate (425 mg/kg) in two minipigs. ------- 346 DORMAN ET AL. ± 1.5 mEq/liter) that were similar to those of control mini- pigs (27.8 ± 1.4 mEq/liter). For comparison, a blood pH less than 7.2 with a blood bicarbonate concentration less than 15 mmol/liter commonly occurs in methanol-poi- soned humans with blurred vision (Jacobsen el al.. 1982: Sejersted a al.. 1983). The significance of this decrease in blood pH in the highest dose group of pigs in the present study is unknown. Susceptible species have lower total liver folate concen- trations and slower formate metabolism, and thus in- creased sensitivity to methanol when compared to resistant species such as rats. For example, total liver folate concen- tration in humans (15.8 ± 0.8 nmol folate/g of liver) and monkeys (25.5 ± 1.2 nmol folate/g of liver) are lower than those observed in rats (25.3 ± 0.9 nmol folate/g of liver) and mice (60.9 - 2.1 nmol folate/g of liver) (Johlin el al.. 1987). Previously reported values (5.1 ± 1.2 nmpl/g of liver) for total liver folate concentration in young swine (Makar ei al.. 1990) and micropigs (8.2 ± 0.6 nmol/g of liver; Tephly ci al.. 1992) were lower (17.5 ± 2.2 nmol/g of liver) than those determined for control minipigs used in this study. These findings are consistent with the lack of formate accu- mulation observed in the minipigs. However, even within this strain of minipig. formate elimination was variable. In this present study, one minipig given formate directly had an initial rate of formate elimination (/,/: = 50 min) that was similar to that reported for rats (Johlin ei al.. 1987). while a second minipig had a much slower initial rate of formate elimination (/,/2 = 112 mm) similar to that re- ported for young female swine (/,/2 = 87 ± 18 min; Makar et al.. 1990) and micropigs (/,/2 = 74.1 ± 6.0 min: Tephly et al.. 1992). Humans have low (15.8 ± 0.8 nmol/g of liver) total liver folate concentrations (Johlin et al.. 1987) that result in slow formate elimination, but this elimination rate of formate in humans is also variable (tl/2 = 60 to 120 min: McMartin ct al.. 1980). These results suggest that strain differences as well as differences between individual ani- mals in formate metabolism may exist. Most importantly, none of the minipigs given methanol developed clinical signs of ocular toxicity. although one minipig given the highest methanol dose (5 g/kg) did have histopathologic evidence of multifocal retinal degenera- tion. Histopathologic evidence of retinal damage following methanol administration has been reported in nitrous ox- ide-treated methanol-exposed rats (Murray et al.. 1991). Electroretinographic alterations suggestive of retinal in- volvement have also been reported following methanol ad- ministration to mice (Carricaburu et al.. 1979). monkeys (Potts ei al.. 1955). and folate-deficient rats (Eells, 1991). Interestingly, in this study, retinal degeneration in this mini- pig developed in the absence of significant formate accu- mulation (maximal blood formate = 1.8 mEq/liter). These results, albeit limited, suggest that methanol may be acting as a direct retinal toxicant or. alternatively, that regional (ocular) methanol metabolism to formate occurs at a rate sufficient to induce retinal toxicity. Whether formate in vit- reous humor accumulated to toxic levels in this animal is unknown. However, vitreal accumulation (in excess of blood concentrations) of formate has been reported in rats (Eclls. 1991). It is possible that similar lesions may have been present al earlier times in the other methanol-treated minipigs. However, no microscopic evidence of retinal dam- age or repair was observed. Since acute methanol-induced neuro-ocular toxicosis of- ten develops in humans following a single oral ingestion of methanol (>0.4 to I g/kg). it does not appear that the Yuca- tan minipig on a normal folate diet will serve as a suffi- ciently sensitive animal model to study this syndrome or to evaluate effective means of therapeutic intervention. Simi- larly, rhesus monkeys given a single oral dose (0.5 to 6.0 g/kg) of methanol comparable to those given to the mini- pigs used in this study survived (Cooper and Felig, 1961). As with other animal models including primates (Martin- Amat et a!.. 1977). it is still possible that the administration of repealed doses of methanol to minipigs could result in sufficient formate accumulation to result in neuro-ocular toxicity. ACKNOWLEDGMENT We lhank Susan Brink for technical assistance throughout ihis project. 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Tephly, T. R., and McMartin. K. E. (1984). Methanol metabolism and loxicity. InAspartame. Physiology and Biochemistry (L. D Steginkand L. J. Filer. Jr., Eds.). Chap. 6, pp. 111-140. Marcel Dekker. New York Tephly, T. R.. Green. M. D.. and Gamble, J. (1992). Formate metabolism in micropigs. Toxicol. Appl. Pharmacol 116, 142-145. Wittry, J. P.. Blum. J. R., Rodkey, W. G.. and Hamm. T. E., Jr. (1990). The use of Velcro pocket bandages in chronic cathetenzation studies. Lab. Anim. Sci. 40, 563. ------- MS-92-219 TECHNICAL REPORT DATA fPiease read/nstructfws on the nyffse before c&npietmgj . REPORT NO. EPA/600/J-94/392 2. 3. RECIPI PB95-126520 4. TITLE AND SUBTITLE ACUTE METHANOL TOXICITY IN MINIPIGS 5. REPORT DATE 6. PERFORMING ORGANIZATION CODE 7. AUTHOR(S) J.A. Dye,1 D.C. Dormcn,2 M.P. Nassise,3 J. Ekuta,-2 B. Bolon,2 M Medinsky2 8. PERFORMING ORGANIZATION REPORT NO. 9. PERFORMING ORGANIZATION NAME AND ADDRESS 'EPA.HERL.ETD.PTB, RTP, NC 27711; 2CIIT, RTP, NC 27709; 3Coll. Vet. Med., NCSU, Raleigh, NC. 10. PROGRAM ELEMENT NO. 11. CONTRACT/GRANT NO. 12. SPONSORING AGENCY NAME AND ADDRESS OFFICE OF RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY, HEALTH EFFECTS RESEARCH LABORATORY, ENVIRONMENTAL TOXICOLOGY DIVISION, PULMONARY TOXICOLOGY BRANCH, RESEARCH TRIANGLE PARK, NC 27711. 13. TYPE OF REPORT AND PERIOD COVERED 14. SPONSORING AGENCY CODE EPA-600/10 15. SUPPLEMENTARY NOTES Fundamental and Applied Toxicology 20(3): 341-347, March 1993 16. ABSTRACT The pig has been proposed as a potential animal model for methanol-induced neuro-ocular toxicosis in humans because of its reported low liver tetrahydro folate levels and therefore, slower formate metabolism as compared to humans. To determine the validity of the animal model, rninipigs were given a single oral dose of methanol or water. Dose-dependent signs developed including mild CNS depression, tremers, and ataxia, however, these subjects failed to develop optic nerve lesions, toxicologically- significant formate accumulation or metabolic acidosis. Methanol and formate pharmocokinetics are also discussed. 17. KEY WORDS AND DOCUMENT ANALYSIS DESCRIPTORS b. IDENTIFIERS/OPEN ENDED TERMS c. COSATI Reid/Group 18. DISTRIBUTION STATEMENT RELEASE.TO THE PUBLIC 19. SECURITY CLASS (Mis Report} Unclassified 21. NO. OF PAGES 7 20. SECURITY CLASS (Thapoge} Unclassified 22. PRICE ------- 0 = G) MO> i.2 «*Ei +5 o 0 G) a1^1" ±o 0 O 0£i aa>l 0? c c - T3 (0 h Reproduced by NTIS National Technical Information Service Springfield, VA 22161 This report was printed specifically for your order from nearly 3 million titles available in our collection. For economy and efficiency, NTIS does not maintain stock of its vast collection of technical reports. Rather, most documents are printed for each order. 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