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Roc Background Document: Saccharin; Oct. 30-31, 1997

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Roc Background Document: Saccharin; Oct. 30-31, 1997 NTP REPORT ON CARCINOGENS BACKGROUND DOCUMENT for SACCHARIN FINAL MARCH 1999 Prepared for the October 30-31, 1997, Meeting ofthe Report on Carcinogens Subcommittee ofthe NTP Board of Scientific Counselors Prepared by Integrated Laboratory Systems Post Office Box 13501 Research Triangle Park, North Carolina 27709 NIEHS Contract No. N01-ES-25346 NTP Report on Carcinogens 1997 Background Document for Saccharin TABLE OF CONTENTS Proposed Report on Carcinogens De listing for Saccharin ..•...•..••••.•.•..••.••.••• 1 Listing Criteria from the Report on Carcinogens, Eighth Edition••••••••••••.•.• 7 1.0 C~1\1DlC~ ~Rc=»~ER~~..•.......•.....•.•....•...•...•.......•....•.••.••.•..••.••.•.•...• ~ 1.1 Chemical Identification ..•.•.....•........•••......•••.••..•••.•.•...••••.•••••••.•••• 8 1.2 Physical-Chemical Properties.•.•.•...•.•..•••.•.•..••••...•••••.••.••.••.•••••••••• 9 2.0 HUMAN EXPc=»SU'RE ..•.•••.....•.•........••........•••.•...•.••......•.••••.•••••••..•••••.•••1 0 2.1 Production •••.•.•.•••••..•••...••••.••••...•.•••.•••.•••.•••••••••.•••••••••.•••••••••••••••10 Table 2-1 Forms of Saccharin Produced by PMC Specialties Group••••11 2.2 Use .•••••••••••..•••••••.•••••..•••...••••..••••...•••..•••.•••..••••••.••••••.•••••••••••••••••12 • 2.3 Environmental Exposure ..........•........••.......•........•.......••..•...•••..... 13 2.3.1 Environmental Releases........................................•........•13 Table 2-2 Releases of Saccharin to the Environment•••••••.••••....13 2.3.2 Environmental Occurrence ..•••...•..•••.•.•..••••...••.••••..•••••••••13 2.3.3 Drinking Water and Food •.•.•••.•••...••.••••....•..•...•••..•.••.•••.•14 2.3.4 Consumer Products•• ........•.......••........•.................•..........14 Table 2-3 USDA Nationwide Food Consumption Survey (1977-1978): Total Calculated Saccharin Intake Levels•••14 2.3.5 Biomarkers of Exposure.........................................••.......14 2.3.6 Occupational Exposure ....................................................15 Table 2-4 NIOSH National Occupational Exposure Survey (NOES, 1981-83): By Industry .•....•••.•.......••...••..•..••••••..••15 2.4 Regulations .......•..........••.........••.......•••................•..•...••......•.......16 2.4.1 Occupational Exposure Limits ••...••.••••.•••••••••.••••••••••••••••••16 2.4.2 Other Standards and Criteria••••.•••.••••••.••••••••••.•••••.•••••••••16 3.0 HUMAN ST'UDIES••••••.•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••19 3.1 IARC (1980) Review of Saccharin Epidemiology •.••.•..••••..••••••••.•••20 3.2 Human Studies Published Post IARC (1980) .•.••.•..•..•••••••..••••...•.•21 3.2.1 U.S. Case-Control Studies .••..•••.•....•.•.•....••••.•...•••.....••.....21 3.2.2 Canadian Case-Control Studies•.•.•.•••••• ..••••.••••••.••••••.••••••23 3.2.3 Case-Control Studies From Other Countries ••••••.•••••••••••23 3.2.4 Descriptive Studies .•.•.•......••.............•.•.•.....•••....•.......•....24 3.2.5 Meta-Analysis••.•••••••••••..•••••••••.•••••.••••••..••••••.••.••.••.••••.•..•24 Ill NTP Report on Carcinogens 1997 Background Document for Saccharin Table 3-1 Summary of Epidemiology Studies Published Post IARC (1980) •.••..•.••..•••....••..•••..•.•...••••.••••••••..••••••••••25 4.0 MAMMA.LIA.N CARC:IN"OGENICITY••.•••••••••••••••••••••••••.•••••.••••••••••••••••35 4.1 Mammalian Carcinogenicity of Saccharin •.•.•..•.••••••••••••••••••••••••••35 4.1.1 Hamsters ......•...•...........•.........•...............•..•..•..........•...••.36 4.1.2 Mi~~.•..•••.•••..•••.•.••..•••.•.•••.••••••.•..•••.•••••.•.•••••••••••••••••••••••••36 4.1.3 Rats•.••.•••••.••..••.•.•••..••••..•••.•••.••••.••..••..•••.••.••.••.•••••••••••••••37 4.1.4 Nonhuman Primates ..••••.•••.••••.•.•.•.••.••••••••••.•.•••••••••••••.•••40 Table 4-1 Mammalian Carcinogenicity•••.••••.••.•.••••••••.•.•.••.•••.••.41 4.2 Initiation/Promotion and Co-Carcinogenicity Studies ...•••..•••..•••.•48 4.2.1 Benzo[a]pyrene (BP) •.•.••....••....•.•...••.•...•..........••...•....•....48 4.2.2 N-Butyl-N-(4-hydroxybutyl)nitrosamine (BBN) ....•••...••..••48 4.2.3 2-Acetylaminofluorene (AAF) •.....•....••......••....•...•••...••....49 4.2.4 N-[4-(5-Nitro-2-furyl)-2-thiazolyl]formamide (FANFT) ••••49 4.2.5 N-Methyl-N-nitrosourea (MNU) .•••••••••.•.•••••••.••••••••••••••••••51 4.2.6 Freeze Ulceration ••••••••.•.•••••••••.••••.•••••••••••••••••.••.•••••••••••••52 Table 4-2 Initiation-Promotion and Co-Carcinogenicity ~tll(lies •••••••••••.•••••.•••••••••••.•••.••••••.••.•••.•••••••.•.•••••..•••••••••• ~~ ~.() G~~c:)~c:)~CITY ••.••••••••••••••.•••••••••••••••••.•••.••••.•••••••••••••••..•..••....••..••••.•6() ~.1 Noneukaryotic Systems •.••.••.••••••••.••.••..••••••••...••••...•••..••..•.•••...•..60 5.1.1 Gene Mutations .••••••••••••••••••••••••••••••••••••••••••••••.••••••••••••••60 5.1.2 DNA Damage •.•••.•.•••••.••••••••••••••••••.••••.•••••••••••••••••••••••••.••60 5.1.3 DNA Synthesis .•••••.•.•••.•.•••.•••••••••••••••••.••••••.•••.••••••••••••••••60 5.2 Lower E11karyotic Systems•••••••.•••••.•••••.••••.••••••.•••••••••••••••••••••.••.• 60 5.2.1 SaccharoN~Jces cerevisiae ••.•...•.••••••••..••••••.•••••.••••••••••••••••••60 5.2.2 Drosophila melanogaster•••••••••••••••••••••••••••••••••••••••.••••••••••• 60 5.2.3 Higher Plants••••.•.•.•••...•.•..••••..•••••••.•••••...••.••.••••••.•.••.••••.•61 5.~ Mammalian Systems In Vitro •••.••.••.••••..••.••••.•••.•••••.•••••••••••••••••..•61 5.3.1 Gene Mutations ••.•.•••.•••••.•••••.••••.••••.•.••••••••••••••••.••••••••••••61 5.~.2 DNA Damage ••••••••••.•••••••••••••••••••.••••••••••••.•••••••..••.••••.•••••61 5.3.3 Inhibition of DNA Repair •.•••••.•.•••••••••.•••.••••••••••••••••••••••••61 5.~.4 DNA Synthesis •.•••••.••••••.•••••••••.•••..•••.••••••.•••••••••••.•••••••••••61 5.3.5 Chromosomal Damage•••.•.•••.•••.••••••••.••••••••••.••.••••••••••••.••62 5.3.6 Cell Transformation.•..••.•...•••••.••....•••••..••••.•.•..•.•••••••••••••.62 5.4 Mammalian Systems In Vivo .•••••••••••••••.••••.••••••••••••••••••••••••••••••..•62 5.4.1 Gene Mutations and Dominant Lethal Mutations •••••.•••••.62 5.4.2 DNA Damage •••••••.•••••.••••••••••••••••••.•••••••••••••••••••••••.•••••••••63 5.4.3 Chromosomal Aberrations ..............................................63 lV NTP Report on Carcinogens 1997 Background Document for Saccharin 5.4.4 Induction of Micronuclei .................................................63 Table 5-1 Summary of Saccharin Genotoxicity Studies......••............•. 64 Figure 5-1 Genetic Activity Profile (GAP) for Saccharin •••.....•••••••••..67 Figure 5-2 Genetic Activity Profile (GAP) for Sodium Saccharin .......68 Figure 5-3 Schematic View of a Genetic Activity Profile ...........•.......69 6.0 OTiffiR RELEVANT DATA ..................................................................70 6.1 Absorption, Distribution, and Excretion ......................................70 tt.~ M~t=t1Jolism .................................................................................~4 6.3 Pharmacokinetics .......................................................................76 6.4 Structure-Activity Relationships .........•.•.•••••..........•....••.•••..•....•••76 Ci.:i ~ell PJr()lifer-~atiC>n ........................................................................7CJ 6.5.1 Hamsters ........................................................................76 CJ.~.:l Mi~te................................................................................7Ci CJ.~.~ ~s.ts ................................................................................7CJ ft.~." GuinteJt ~i~s.....................................................................~~ 6.~.~ NonhumJtn Prims.ttes .......................................................79 6.6 ~ell Proliferation with ~a-Administration of Known ~=-r~inogtens ............................................................................80 6.6.1 N-Butyl-N-(4-hydroxybutyl)nitrosamine (BBN) .........•...••.80 6.6.2 2-Acetylaminofluorine (AAF) ....•.....................•...............80 6.6.3 N-Methyl-N-nitrosourea (MNU)••••••••••••.••••••••••••••.•••••••••••80 Table 6-1 Cell Proliferation ..............................................................81 7.() ~~~~ ....................................................................................!)() 7.1 Mechanisms of Urinary Bladder Tumorigenesis Found Predominantly in Male Rats ••••..........••••••........••••.•.....••••••..•...•91 7.1.1 The Role of pH in the Promotion of Bladder Carcinogenesis in Male Rats .......•...........•...........•..........91 7.1.2 The Role of Sodium ~oncentration in the Promotion of Bladder Carcinogenesis in Male Rats.............................. 92 7.1.3 The ~ombined Effect of pH Level and Sodium ~oncentration ................................................................9" 7.1.4 The Association Between Increased Urinary Output and Sodium Saccharin-Induced Bladder Tumors ..•........•.94 7.2 Dose Response in ~ell Proliferation and Tumorigenesis ..............95 7.3 Relevance of Animal ~ancers to Humans ...................................97 7.3.1 ~omparative Bladder Anatomy and Urine ~hemistry ......97 7.3.2 Dose-Response Extrapolation ...•......................................99 7.4 Additional Mechanistic Information ..•••.••.........•.•...................... 100 v NTP Report on Carcinogens 1997 Background Document for Saccharin 7.4.1 Inhibition of Apoptosis .................................................. lOO 7.4.2 Intercellular Communication .................••...•...•...••......•. 100 Table 7-1 Effect of Various Forms of Saccharin on
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