Document g2mVkLj8o0qvze8jvpjmVndQ

Metabolism and Peripheral Blood Effects in Shanghai Benzene Workers Benzene 2009 Symposium Munich, Germany September 9, 2009 A. Robert Schnatter ExxonMobil Biomedical Sciences, Inc. 0 G) c I OzmJ 0 0 0 0c.o 0c.1o Background: benzene metabolism sPMA, ttMA more sensitive, specific vs. phenolic metabolites Toluene may inhibit (Andrews 1977) or enhance (Wetmore 2008) metabolism, depending on dose Conflicting findings regarding single gene polymorphisms (SNP's) Dougherty et al. 2008 CYP2E1 *5 CT or TT I ttMA CYP2E1 *5 CT or TT I Phenol GSTT1 null I sPMA Positive 1 1 4 Negative 4 1 4 Different proportions I enhanced metabolism for lower exposures - ttMA favored at lower ambient exposures 0 G) c I - 9x increase <1 ppm when ambient exposures predicted from urinary benzene OzmJ (Kim 2006) 0 0 2 0 0c.o (j) 0 Benzene metabolism: expected influence of SNP's 0 "'s I 0 CH2 II I C- N- CH2 II CH3 COOH S-Phenylmercapturic acid 0 Benzene wild type: increased metabolites HH II OHC-CC-CC-CHO II HH Trans, Trans- Muconaldehyde INonenzymatic \aHrearrangement O c1( l PBenzene Benzene HEypdoroxrladese -;:7 ----+ " OH H Benzene OH dihydrodiol Oxide Oxepin Nonenzymatic rearrangement 1Drhydrodiol Dehydrogenase CYP ~H-:?' OH '- H 0 OH Diol Epoxide 0 0OH OH OH CYP CYP AoH lJ I OH Hydroquinone ~0~wild type: mutant: Phenol Catechol ~~~ lL)wild type: ~)....0 mutant: reduced CAT reduced CAT reduced HQ 1 1 reduced HQ 0 a-Benzoquinone G) c I 0 zOmJ p-Benzoquinone 0 0 0 0c.o (j) 3 Background: benzene and peripheral blood effects Well established effects for anemia (low RBC), leukopenia (low WBC), and thrombocytopenia (low PLT) early data suggested more I II prevalent effects on RBC (Greenberg 1939), or WBC (Aksoy 1971; Kipen 1988) No consensus on most sensitive effect candidates mentioned: I II - MCV (Yardley-Jones 1988; Collins 1991) - Lymphocytes (Goldstein 1988; Rothman 1996) - Neutrophils (Qu 2002) - Early progenitor cells (Lan 2004) Early studies showed clear effects >1 0 ppm more recent studies II I show effects at lower levels 0 G) c I OzmJ 0 0 4 0 0c.o (j) 1\J Study design I overview Cross-sectional study in five factories in and around Shanghai, China Approved by IRS's at University of Colorado and Fudan University Consent form, questionnaire, blood sample Post-shift urine sample in 2of 5factories for metabolite study Extensive exposure monitoring for benzene, toluene, xylene Few other chemical exposures Five metabolites measured via GCMS (CAT, HQ, PH, ttMA, sPMA) High LOD for sPMA prevented analyses at lower exposures Five SNP's determined via RFLP in four genes encoding for activating or detoxification enzymes NQ01 465C >T, 609C >T CYP2E11019C >T MPO 463G >A GSTT1 null 0 G) c Statistical analyses on 4 metabolites and 12 blood indices via correlations, I OzmJ general linear models, change-point regressions 0 0 5 0 0c.o (j) (...) Factories studied Type Product I Process Workers Males Females A Rubber Rubber hoses &belts 352 250 102 B Shoe Glue soles to uppers 412 113 299 c Sealant Products (rubber) Diluent, adhesive 126 68 58 D Pharmaceutical Intermediates 128 116 12 E Rubber Rubber hoses 28 16 12 Metabolite Subpopulation A Rubber B Shoe 0 G) c I OzmJ 0 0 0 0c.o (j) ~ Same 279 199 80 Same 47 4 43 6 Population description Administered in-person questionnaire and consent form 95-99/o participation, similar across factories Smoking validated with cotinine for metabolite workers, >98/o agreement All Workers Metabolite Subpopulation Non-Alcohol Us Alcohol Users Non-Alcohol u Alcohol Users Smokers Smokers 0 Age G) c I OzmJ 0 30. <45 0 0 0c.o (j) 01 Age 30. <45 7 Exposure assessment 1046 workers 133 SEG's Evaluate homogeneity of SEG via random effects ANOVA; between worker variance 95% confidence limit ratio <4 88/133 (66%) homogeneous SEG's 734workers individually monitored - 2973 benzene - Weekly average samples benzene mg/m3 (x=4/ worker) Females: median: 10.9 (.07-717) Males: median: 5.9 (.07-872) Imputed weekly average from homogeneous SEG's for workers not individually monitored (n=194) 326workers individually monitored 0 G) c I OzmJ 0 0 0 0c.o (j) (j) Metabolite Subpopulation Closest benzene reading to blood I urine samples Females: median: 10.0 (.07-231) Males: median: 4.3 (.07-177) 190 same-day readings 8 Benzene I metabolite correlations 1 .81 .71 .65 .61 0 0 G) c I OzmJ 0 0 HQ and ttMA particularly highly correlated with one another (r=0.94) 9 0 0c.o (j) -..J Prediction models for metabolites Baseline Model Benzene~ CATECHOL 0.49*** HYDROQUINONE 0.54*** PHENOL 0.58*** ttMA 0.67*** *p<.05; ** p<.01; *** p<.001 Final Model (p coefficients) Benzene Benzene2 Toluene Smoking BMI 0.08 0.09** 0.28*** 0.11 0.25** 0.05* 0.10** 0.10 0.04* 0.38*** .. 0.27*** 0.21 0.55*** .. 0.16** 0.11 BZ*TOL term did not enter final models (BZ, toluene correlation= 0.70) No SNP terms were important metabolite predictors Additional models run for BZ, TOL, BZ*TOL only: Metabolite p-value for interaction term CAT <0.0001 0 G) HQ c I PH OzmJ ttMA 0 0 0 0c.o (j) (X) 0.37 0.21 0.72 10 Change-point regression results Change-point regressions determine response that is different than background response Lowest change point found for ttMA and HQ ~~~ill~----------------------------------------~ 5 . ,.......4 Change point= 0.5 ppm #e , ......3 .., .. ..,......2 0 G) c I 0 12 3 4 5 6 log (benzene) OzmJ 0 0 11 0 0c.o (j) c.o Benzene metabolite proportions across benzene concentrations Metabolite production rate across benzene concentrations 10000 Uncorrected Background metabolite values identified in 27 controls Different percentiles of control distribution used for correction factor Correction factor subtracted from metabolite concentration Corrected metabolite concentrations converted to micromoles f Q. -Q: ~ :::::; ............ 1000 -$ 0 .Q (lj 1i:i ~ q0:: ~ 100 Cf) ~ 8 Mln,P05 P10 P'd5 Median Mean P75 PYO Max,P95 P75 factor: stable metabolism Median factor: 3-4X Mean correction factor: P25 factor: 5-6X 10 2-3X enhanced metab <1 ppm II II I I I I I I I I I I . 0 G) 0.01 0.10 1.00 10.00 100.00 c I OzmJ Benzene in Air (ppm) 0 0 13 0 0c.o .-.....J. ...0...... 0 aCl) w -c 0 co 0N -m 0) -.c..a... cII: Cl) -.cJ:. ...... Cl) a.. CGU BEN0000972 Benzene effects on peripheral blood elements Twelve indices examined (6 WBC, 4 RBC, 2 PLT parameters) Continuous outcomes modeled via GLM, out-of-normal range defined using Chinese National norms and examined via logistic regression Covariates: smoking, age, BMI, alcohol, SNP's, gender Parameter Crude B(Benzene) Adjusted B(Benzene) WBC -0.06* Lymphocytes -0.01 Monocytes -0.00 Neutrophils -0.05** In (Eosinophils) 0.01 Basophils -0.00* RBC -0.06*** HGB -0.14* MCV 0.26*** RDW 0.03 Platelets -1.64 0 MPV -0.18*** G) c I OzmJ *p<.05; ** p<.01; *** p<.001 0 0 0 0c.o -..J (...) -0.06** -0.02 -0.00* -0.01* 0.01 0.00 -0.04*** -0.07*** 0.36*** 0.02 -2.32** -0.18*** 15 Effect of toluene exposure Toluene confounded several blood index I benzene relationships Toluene I benzene exposure correlation =0.66, thus collinearity may explain this observation Toluene effect significant I benzene effect non-significant Neutrophils Monocytes RBC MCV Hemoglobin Platelets Toluene increased I significant benzene effect Lymphocytes Eosinophils No toluene effect I significant benzene effect WBC MPV No toluene or benzene effect Basophils ROW Future analysis will assess toluene exposure and potential synergistic and antagonistic effects 0 G) c Present analyses is analogous to several studies in the literature where I OzmJ toluene co-exposure had occurred but was unaccounted for 0 0 16 0 0c.o -..J ~ Change-point regressions Examined whether background blood elements could be distinguished from benzene-induced effect Lower change points => more sensitive effect Still may not represent clinically relevant effect 12~ 11 WBC 10 9 8 0 7 6~(.) ""d 0 il,...0....., ,i:J ""d (!) .,.,...N........,, sro 1 I - - _ ~ - . 1 . - . - .. . '- j ... --" _&_: -'a:..:~4\' - - __ 00 :::::: -1 ... ---- .. --- . .!l -2 .- -11 -- - ,. I I I I I II II I II II I II I I I II I I I II I I I II I I I II I II III I II 0 G) -3 -2 -1 0 1 2 3 4 5 6 7 c I OzmJ ~ 0 0 17 0 0c.o -..J 01 Neutrophil change-point regression results Neutrophils u0 '"d 5 ..0s 4 ,..0 - .. - --. ., -.3'"d il) -N ~ 2 I 0 1 -... - --. ~.... - - - ~u -1 -2 -3 II I I I II I I I II I I I II I I I II I I I II I II III II III I IIII I I -3 -2 -1 0 1 2 , ; 'I 4 5 6 7 ~ 0 G) c I OzmJ Change point= 7.8 ppm 0 0 18 0 0c.o -..J (j) Benzene concentrations affecting different blood elements Neutrophils and MPV showed lowest change points Lymphocytes showed highest change point 0 0 G) c I OzmJ 0 0 0 0c.o -..J -..J ii)' ~~ ~~ 20 Benzene exposure (ppm) ~ ~ ~ ~ -....../ 40 19 Logistic regression results for clinically relevant blood elements Parameter WBC Lymphocytes Neutrophils Eosinophils RBC MCV HGB Platelets OR 1.18 1.04 1.05 1.07 1.28 1.68 1.11 1.28 95/o Cl 1.00-1.39 0.91-1.19 0.92-1.20 0.88-1.30 1.12-1.47 1.35-2.10 0.99-1.24 1.01-1.63 Significant effects for: leukopenia, anemia, high MCV, and thrombocytopenia Strongest effects for MCV and RBC 0 G) c I OzmJ 0 0 20 0 0c.o -..J (X) Q) s.... :::l fn c0 .. >< Q) Q) s::::::: Q) N s::::::: Q) ..c ..0.... "'C ..Q...). ca Q) ..s........ 0 U) .sa:::::. .....s::::::: fn 0s.... Q) :::l -:::l ca Q) :z > Q) C) css::.:a.::.:.: I '+- ..0..I.. :::l 0 0 ~ I --fn ~ ..s:::::: c.. ..0s........ ~ :::l Q) ~~CJ~~~OOI:"'--\01-f)~MN~O :z 0 CGU BEN0000979 MCV: out-of-range values by benzene exposure DLV IlU7 LD l 110 100 9) 8) A) ({) -3 -2 -1 0 1 2 3 4 5 6 7 nW-1gl ~ 0 1 Logistic regression results by exposure category (OR, 95/o Cl): 0 G) <1 ppm 1-<10ppm 10+ ppm c I OzmJ 5.65 (0.62, 51.1) 5.91 (0.75, 46.5) 17.7 (2.35, 134.1) 0 0 0 0c.o (X) 0 22 RBC: out-of-range values by benzene exposure rl rl:J:; 8 7 6 5 4 3 2 -3 -2 -1 0 12 3 4 5 6 7 lrftu:bllrl3Z tb:i..o 0 1 Logistic regression results by exposure category (OR, 95/o Cl): 0 G) <1 ppm 1-<10ppm 10+ ppm c I OzmJ 10.5 (1.39, 79.7) 4.68 (0.61, 36.1) 14.7 (1.97, 110) 0 0 0 0c.o .(.X...). 23 Summary I Conclusions Metabolism Higher metabolic levels: males, smokers, alcohol use, toluene co-exposure No strong effects for: age, SNP's Benzene levels of 0.5 ppm can distinguish metabolites (HQ, ttMA) from background levels Metabolism rate slightly enhanced (2-3x) for lower (<1 ppm) exposures, although correction factor value is critical Blood effects Benzene affects most blood indices, however, toluene co-exposure and collinearity under further investigation Most sensitive parameter for continuous indices is neutrophils (7.8 ppm) ... appears to be a mild effect When clinically relevant effects are examined, benzene has an effect on 0 WBC, RBC, PLT, and MCV G) c I Stronger effects for RBC and MCV, albeit at higher concentrations OzmJ 0 0 24 0 0c.o (X) 1\J Collaborators EMBSI and former EMBSI Yimei Zhou, Min Chen, Mark Nicolich, Tom Armstrong Ginpathogen I former Joint Molecular and Clinical Laboratory Patrick Kerzic, Rich Irons Fudan University Fu Hua, Lu Lin 0 G) c I OzmJ 0 0 0 0c.o (X) (...) 25 Acknowledgements 1078 study participants from Shanghai, China SHS consortium (BP, Chevron, Conoco, ExxonMobil, Shell Chemical) Science Review Panel Ethics Review Panel Shanghai Municipal IPHS and CDC (Zhu Surong) Fudan University (and former) Miao Liuzhong Data Processing I QA- Susan Marcella (EMBSI), Gail Jorgensen (former EMBSI) University of Colorado IRB Fudan University Ethics Panel 0 G) c I OzmJ 0 0 0 0c.o (X) ~ 26 t- N c. ~ I m~cua CGU BEN0000985 Lymphocyte change-point regression results ~ u0 -~ g'"d j ......... ,..0 '"d 1 il) ..N... ~ 0 ~ I -11 Lymphocytes .'l' -3 -2 -1 0 12 3 4 5 6 7 0 G) -c I OzmJ Change point= 38.1 ppm 0 0 28 0 0c.o (X) (j) Effect of NQ01*2 on hydroquinone levels Analysis of Covariance for logHQ_ug_ml 4 3 "E I biJ ;::;I I~ ~) } ...0...... L 1 0 23 4 0 lagClosest3~v1 G) Ic I NQOl o 1/vt ~- ~ \vt!vt ~X- \\1/'i\11 OzmJ 0 0 0 0c.o (X) -..J .5 29