CURRENT AWARENESS DOCUMENT



DIFUROXANTHONE-, DIFUROCOUMAROLACTONE- AND DIFUROANTHRAQUINONE-TYPE

                         ALKYLATING AGENTS
               CARCINOGENICITY AND STRUCTURE  ACTIVITY
            RELATIONSHIPS.   OTHER BIOLOGICAL  PROPERTIES.
              METABOLISM.   ENVIRONMENTAL  SIGNIFICANCE.
                            Prepared by:
                    Yin-Tak Woo,  Ph.D., D.A.B.T.
                        David Y. Lai, Ph.D.
                          JRB Associates/
                        Science  Applications
                     International Corporation
                        8400 Westpark Drive
                      McLean, Virginia  22102
                    EPA Contract No. 68-02-3948

                    JRB Project No.  2-813-07-409
             EPA Project Officer and Scientific Editor

                       Joseph C. Arcos, D.Sc*.



                 Extradivisional Scientific Editor

                        Mary F. Argus,  Ph.D.
                           February 1985

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 5.3.1.1  Difuroxanthone-, Difurocoumarolactone- and Difuroanthraquinone-type




 Alkylating Agents:  Aflatoxins, and Related Aspergillus Toxins





      5.3.1.1.1  Introduction.
     The existence of aflatoxins was discovered in England in  1960 when a




 Brazilian peanut meal used as a protein supplement to poultry  diets caused the




 acute deaths of over 100,000 young turkeys from liver damage or  turkey "X"




 disease (1).  At the same time, an outbreak of turkey X-linked disease in




 ducklings occurred in Kenya following ingestion of African peanut meals (2).




 Symptoms similar to turkey X disease were also reported in outbreaks of




 disease in other farm or domestic animals, fed peanut meals.   Coincidentally,




 an epizootic of liver cancer in hatchery-reared rainbow trout  occurred in the




 United States and Europe in I960 (3-6).  A commercial trout feed containing




 contaminated cottonseed meal was eventually found to be associated with the




 trout hepatoma problem (7).  The magnitude of the problem attracted intensive




 research efforts by investigators throughout the world.  The toxic agent in




 peanut meal was narrowed down to a mixture of aflatoxins (abbreviation for




Aspergillus flavus toxins) produced by a ubiquitous mold, Aspergillus flavus




 as secondary metabolites (8).  The mixture could be separated  into four main




 components by thin layer chromatography and were designated B^,  %2> Gi and G2




 according to their fluorescent colors (B for blue, G for green)  and relative




 mobility in the chromatogram (9, 10).  The molecular formulas  for aflatoxins




 Bj and G^ were deduced to be cu^]^206 and C17H12°7» respectively (9) and




 aflatoxins 82 and G£ were shown to be dihydro derivatives of Bj  and G^,




 respectively (11).  The correct chemical structures were finally elucidated by




 Asao et al. (12) in 1963 and confirmed by further studies (13, 14).

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     The carcinogenicity of aflatoxin mixture was first demonstrated in 1961




by Lancaster et al.  (15) by feeding aflatoxin-contaminated peanut meals to




rats.  Shortly afterwards, similar findings were reported by Schoental (16),




LeBreton _et__al_. (17), Salmon and Newberne (18) and other investigators (see




Section 5.3.1.1.3.2).  Subsequent studies using purified aflatoxins (see




Section 5.3.1.1.3.3) indicated that the carcinogenicity associated with afla-




toxin mixture of aflatoxin-contaminated feed was mainly attributable to afla-




toxin BI (AFBj).  The demonstration by Wolf and Jackson (7) that cottonseed




meal was repsonsible for the outbreak of hepatoma in hatchery-reared rainbow




trout soon led to the finding that the principal carcinogenic agent in the




contaminated cottonseed meal was AFBi (see Section 5.3.1.1.3.3).  To date,




AFBj or mixture containing AFBj has been found to be carcinogenic in eleven of




twelve animal species tested including nonhuraan primates.  In the most suscep-




tible species (such as rainbow trout, rats), AFBi is the most potent




"complete" hepatocarcinogen ever tested.  With the realization that human food




supply is susceptible to aflatoxin contamination, the possibility has been




suggested that these mycotoxins may be involved in human liver cancer (17,




19).  The first major epidemiological study was undertaken in Uganda in 1966-




1967 by Alpert _£t__al^ (20) who showed that the tribal variation of hepatoma




incidence was related to the frequency of aflatoxin contamination of their




food.  Subsequently, four separate field studies  in Kenya  (21), Mozambique




(22), Swaziland (23), and Thailand (24, 25) demonstrated an association




between aflatoxin consumption and liver cancer incidence,  and a dose-response




relationship was established (26).  Short of establishing  a direct causal




relationship, the data  provided  strong evidence for a contributory or etio-




logic role of aflatoxin in the induction of human liver cancer.

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     The concern over aflatoxins as contaminants of human food supply and




animal feeds, the importance of aflatoxins as potential environmental carcino




gen for humans, and the usefulness of aflatoxins as experimental animal car-




cinogens have generated literally innumerable publications reflected by the




large number of comprehensive monographs (27-35) and reviews (36-49) on this




subject.





     5.3.1.1.2  Physicochemical Properties and Biological Effects.





     5.3.1.1.2.1  PHYSICAL AND CHEMICAL PROPERTIES.





     The physical and chemical properties of aflatoxins and related compounds




have been extensively discussed in a variety of reviews and monographs (32,




33, 37, 38, 45, 50).  Hence, only a synoptic summary is presented in this




section.  The structures of a number of aflatoxins, their metabolites and




related compounds are depicted in Table I.  Physical and chemical properties




of some of these compounds are summarized in Table II.





     The nomenclature of aflatoxins was originally based on their fluorescent




color and chromatographic mobility.  The four major aflatoxins which occur




naturally in plant products were named B,, B2, G, and Gn with B standing for




blue, G for green and subscripts designating relative positions of these




fluorescent bands on the thin-layer chromatograph.  The trivial names afla-




toxins Mi, M«, GMi and GM2 were used to designate 4-hydroxy derivatives of




aflatoxins B^, ^^t Gj and 62, respectively, because AFM^ was  first discovered




as an excretory product of AFBi in cow's milk (M stands for milk).  The M




aflatoxins have since been detected as mammalian urinary as well  as  fungal




metabolites of aflatoxins.  The 0-demethylated metabolite of  AFBj was named




AFPi (P stands for phenolic) whereas another hydroxylated metabolite  (at the




position beta to the carbonyl group in the cyclopentenone ring) was named

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        0   0
      0   0
                                                               0   0
 AFB
  AFP,
AflatoxicoKAFL)
AFLH
                                                        AFLM
                                                                 0
                                                                     OH
Sterigmatocystin           Versicolorin  A
                                      0
                           Versicolorin  B
Table  I.   Structural Formulas of Aflatoxins and Related  Compounds.

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                                                  Table II
                    Physicochemical  Properties  of  Some  Aflatoxins  and  Related  Compounds8
Compound
Aflatoxin B,
Aflatoxin B£
Aflatoxin G,
Aflatoxin G~
Aflatoxin M,
Aflatoxin B2a
Aflatoxin P,
Aflatoxin Qj
Af latoxicol
Physical appearance
of crystals
Pale yellow
White needles
Colorless needles
Colorless needles
Colorless plates
Yellow plates
—
—
Colorless
Melting
point (8C)
268-269
288-289
244-246
237-240
299
240
> 320
—
230-234
UV Absorption ( £M)C at
[o4]Du 265 nm
-558° 12,400
-430° 12,100
-556° 9,600
-473° 8,200
-280° 14,150
10,300
(256 nm)
11,200
(267 nm)
11,450
(267 nm)
10,800
(261 nm)
360-362 nm
21,800
24,000
17,700
17,100
21,250
(357 nm)
20,400
(363 nm)
15,400
(362 nm)
17,500
(366 nm)
14,100
(325 nm)
Fluorescence
emission (nm)
425 (blue)
425 (blue)
450 (green)
450 (green)
425 (blue)
425 (blue)
yellow-green
yellow-green
425 (blue)
B d
RF
0.56
0.53
0.48
0.46
0.40
0.13
—
—
0.54
Summarized from data compiled by R.W. Detroy, E.B. Lillehoj and A. Ciegler:  In "Microbial Toxins," Vol. VI
 (A. Ciegler, S. Kadis and S.J. Aji, eds.), Academic Press, New York, 1971; J.G. Heathcote and J.R. Hibbert,
 "Aflatoxins:  Chemical and Biological Aspects," Elsevier, Amsterdam, 1978; World Health Organization,      ,
 "Environmental Health Criteria 11:  Mycotoxins," World Health Organization, Geneva, 1979.
 Optical rotation; all compounds dissolved in chloroform except aflatoxin Mi (in dimethylformamide).

°Molar extinction coefficient; all compounds dissolved in methanol except aflatoxin P.  (in ethanol).
 Relative mobility in thin-layer chromatography.  Solid phase:  silica gel G; solvent:   chloroform/methanol
 (97:3 v/v).

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to distinguish it from AFP^.   Aflatoxicol, a keto-reduced metabolite of AFBj,




was called aflatoxin RQ by many investigators; however, the term aflatoxicol




(abbreviated AFL) appears to be more commonly used following the discovery of




two other forms of aflatoxicol metabolites (AFLMj and AFLHj; see Section




5.3.1.1.4.1).  Two systems are currently used in numbering the carbon and




oxygen atoms in the aflatoxin molecule.  In the older conventional, but still




commonly used system, the atoms in the terminal furan ring are numbered 1, 2,




3, 4 starting from the oxygen.  The numbering of atoms in the rest of the




molecule (shown in parentheses in the formula to the left, below) does not
                                  Text  figure -j.
appear to have been uniformly adopted.  In the IUPAC system, the atoms on the




periphery of the molecule are numbered in a clockwise direction starting with




the first atom following ring fusion in the uppermost ring farthest to the




right.  (For details on the nomenclature of polynuclear compounds, see Section




5.1.1.1, Vol. IIA.)  Thus, the double bond in the terminal furan ring of both




AFBi and AFGi is called 2,3-double bond in the older, conventional system but




8,9-double bond for AFBj and 9,10-double bond for AFGj in the IUPAC system.




The systematic, IUPAC names (used by Chemical Abstracts) for AFB^ and AFGj are




2,3,6 ot. ,9 P(-tetrahydro-4-methoxycyclopenta[c]furo[3',2':4,5]furo[2,3-




h] [l]benzopyran-l,ll-dione and 3,4,7c/ ,10* -tetrahydro-5-methoxy-lH,12H-




furo[3*,2':4,5]furo[2,3-h]pyrano[3,4-c][l]benzopyran-l,12-dione, respec-




tively.  Aflatoxin Bj and related compounds are classified as difurocou-




marocyclopentenone whereas AFG^ and related compounds belong to




difurocoumarolactone.




                                       4

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1    02)
  (conventional)
                             OCH3
                   (IUPAC)
Text-Figure  1^

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     Naturally occurring aflatoxins are very slightly soluble in water (of the




order of 10-20 rag/liter), insoluble in nonpolar solvents, but freely soluble




in polar organic solvents such as chloroform, methanol and especially di-




methyIsulfoxide.  As pure substances, the aflatoxins are very stable even at




relatively high temperatures.  Little or no destruction of aflatoxins occurs




under ordinary cooking or pasteurization conditions.  Chloroform and benzene




solutions of aflatoxins are stable for years if kept cold and in the dark.




However, aflatoxins are relatively unstable when exposed to light (especially




UV) particularly when dissolved in highly polar solvents.  The lactone ring in




aflatoxins is susceptible to alkaline hydrolysis.  However, if the alkaline




treatment is mild, acidification will reverse the reaction to reform afla-




toxins.  Aflatoxins can be totally destroyed by autoclaving in the presence of




ammonia or by treatment with hypochlorite.





     Molecular orbital calculations by Heathcote and Hibbert (32, 51) indi-




cated that the double bond in the 2,3-position in AFB, and AFGi is the most




reactive molecular site and is susceptible to epoxidation.  This view is




supported by the finding that under mildly acidic condition, AFBt and AFGi are




readily hydrated to yield AFB2a and AFG2a, respectively (32, 52).  Incubation




of AFBj with an appropriate chemical oxidizing agent  (e.g., jn-chloroperbenzoic




acid) yields a reactive intermediate concluded to be AFB^-2,3-oxide  (53,




55).  The putative AFB^-2,3-oxide may react with nucleophiles  (55) or is




hydrolyzed to 2,3-dihydro-2,3-dihydroxyaflatoxin B^ (AFBj-dihydrodiol).   Both




AFBo- and AFBi-dihydrodiol are hemiacetals and readily tautomerize to dialde-




hyde under alkaline conditions; these can react with  amino groups to form




Schiff bases (see Section 5.3.1.1.4.2).  There is some evidence  that the




coumarin moiety of AFBj may be oxidized  to yield a variety of  oxidation pro-




ducts (54).  Besides  chemical activation, the  2,3-double  bond  of AFB^ and AFGj

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can also be activated photochemically to yield  reactive-intermediates  which




can bind covalently to DNA (56).   The mechanism of  photoactivation has been




postulated to involve excitation of the coumaryl chromophore (similar  to




photoactivation of psoralen;  see  Section 5.3.2.4),  followed  by intramolecular




energy transfer to the 2,3-double bond.  The nature of the photoadduct is  not




known but is believed to differ from AFB^-2,3-oxide produced by chemical




oxidation because photobinding of AFB, to DNA occurs preferentially at sites




rich in adenine and thymidine, whereas AFBj-2,3-oxide binds  preferentially to




guanine moieties (56).





     Sterigmatocystin, a difuroxanthone compound, and versicolorin A,  a




difuroanthraquinone compound, are biosynthetic  precursors of aflatoxins and




are structurally closely related (see Table 1).  The physical and chemical




properties of sterigmatocystin and versicolorin A (32, 45, 50) are similar to




those of AFBj.





     5.3.1.1.2.2  BIOLOGICAL EFFECTS OTHER THAN CARCINOGENICITY.





     Toxicity.  The toxicology of aflatoxins and related compounds has been




extensively reviewed (32-34,  37-40, 44, 57, 58).  The acute toxicity of AFBj




has been tested in a wide variety of animal species.  Table III summarizes the




acute, oral LD^Q data.  As the data in the table indicate, considerable




species difference in response to the toxic effects of AFBj has been




observed.  Ducklings, rabbits, rainbow trout, dogs, pigs, cats and newborn




rats are extremely susceptible, with LD^Q of less than 1 mg/kg, whereas




hamsters, mice and catfish are highly resistant.  In virtually all animal




species, the principal toxicity target organ is the liver.  Depending on the




species, the toxic effects observed may include necrosis  (centrilobular or




periportal), cirrhosis, fatty liver, bile duct  proliferation and  fibrosis (37,

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                                                                         p. 1 of 2
                                  Table  III
Acute Toxicity of Aflatoxins and Related Compounds in Various Animal Species
Compound Species
Aflatoxin B. Chick embryo
Duckling
Rabbit
Dog
Cat
Pig (weanling)
Rat (newborn)
(weanling, M)
(weanling, F)
(adult, M)
(adult, F)
Rainbow trout
Guinea pig
Sheep
Baboon
Monkey
(Macaca irus, M)
(Macaca
fascicularis , F)
Hamster
Catfish
Mouse
Aflatoxin 82 Duckling
Rat
Aflatoxin Gj Duckling
Rat
Rainbow trout
Route
injection
oral
oral or i.p.
oral
oral
oral
oral
oral
oral
oral
i.p.
oral
oral
oral
oral
oral
oral
oral

oral
oral
oral
oral
i.p.
oral
i.p.
i.p.
LD5Q (mg/kg)
11-40 ng/egg
0.24-0.73
0.3
0.5-1.0
0.55
0.62
0.56; 1.36
1.53
5.9; 6.0
7.2
0.65; 6.0
17.9
0.81
1.4
2.0
2.0
2.2
7.8

10.2
10-15
9; 60
1.7; 1.8
>200
0.78; 1.2; 1.8
1.5-2.0
1.9
Reference
(59,
(12,
(65)
(66)
(65)
(65)
(65,
(68)
(65,
(69)
(64,
(69)
(70)
(71)
(72)
(73)
(74)
(75)

(65)
(39)
(65)
(61,
(64)
(14,
(64)
(70)
60)
61-64)




67)
68)
69)




•




64)

61, 64)



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Table III  (continued)
Compound
Aflatoxin 62

Aflatoxin Mj
Aflatoxin M2
Aflatoxin Pj
Aflatoxin Q^
Tetrahydro-
deoxyaf la-
toxin BI
Sterigraato-
cystin
Species
Duckling
Rat
Duckling
Duckling
Chick embryo
Chick embryo
Rat
Monkey (vervet)
&
Rat (F)
(M)
Route
oral
i.p.
oral
oral
injection
injection
i.p.
i.p.
oral
oral
LD5Q (mg/kg)
2.8; 3.45
>200
0.32
1.22
>190 ng/egg
207 ng/egg
>200
32
120
165
Reference
(61, 64)
(64)
(63)
(63)
(76)
(60)
(64)
(77)
(78)
(78)

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39, 58, 65).  Fatty infiltration and focal necrosis may also occur in the




kidney and heart.  In AFBj-treated monkeys, cerebral edema may be prominent




whereas gall bladder edema and hemorrhage are distinctive features of acute




aflatoxicosis in dogs.  The acute toxicity of AFBj may be modified by a




variety of endogenous and exogenous factors.  Newborn animals appear to be




substantially more susceptible to the acute toxic effects of AFBj than




adults.  In the rat, the adult-to-neonate LDcn ratios may be as high as 9.2




(67) or 13-32 (65).  A significant sex difference has also been observed in




some strains of rats; castration removes most of the sex difference (68).




Diets high in lipid have a protective effect against aflatoxicosis in various




animal species.  Deficiency in vitamin A, D or riboflavin makes animals more




sensitive to aflatoxin while thiamine deficiency has the opposite effect (79).





     Acute toxicity data are relatively scant on other aflatoxins.  Compara-




tive toxicity studies using ducklings, trout and rats indicate that AFB^ is




slightly more toxic than AFGj (61, 64, 70).  Their 2,3-dihydro derivatives,




AFB2 and AFG2 are considerably less toxic (see Table III), suggesting that the




2,3-double bond plays an important role in the toxic effect of the afla-




toxins.  Aflatoxin Mj is almost as toxic as AFBj (0.32 mg/kg vs. 0.2A mg/kg)




in ducklings; whereas its dihydro derivative AFM2 is approximately four times




less toxic (63).  In chick embryo test, AFBj is considerably more toxic than




aflatoxins B2, Gj, G2 (59), Pj (76), Qx (60) and B2a (80).  The estimated LD5Q




of aflatoxins Qj  (60) and B2a (80) are at least 18 and 80 times higher than




that of AFBj.





     Aflatoxin Bj, sterigmatocystin and a number of  related compounds  are




highly cytotoxic  to cultured animal cells  (rev. 32)  as well as to a number of




microorganisms (81).  Using primary kidney  epithelial cells of monkey,




Engelbrecht and Altenkirk (82) carried out  a structure-cytotoxicity relation-

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ship study using 15 compounds in the sterigmatocystin,  aflatoxin_and related




structural area.  The  most  cytotoxic compounds  are,  in  decreasing order of




potency, sterigmatocystin,  AFBj, 0-methylsterigmatocystin,  AFGj and demethyl-




sterigmatocystin.   Dihydrosterigmatocystin,  AFB2 and open-ring furobenzofuran




compounds are only slightly cytotoxic.  Engelbrecht  and Altenkirk (82)  sug-




gested that the two principal structural requirements are the double bond in




the terminal furan ring and the  C*, ft -unsaturated carbonyl group in




o-lactone moiety of aflatoxins  or in Y~Pyrone moiety  of sterigmatocystin.




The cytotoxicity of aflatoxin compounds  differs from their genotoxicity in




several respects.   The genotoxic effects of  aflatoxin compounds appear  to be




expressed at a lower dose than cytotoxic effects (83).   Results obtained from




studies on cultured hepatoma cells indicate  that the enzymatic activities that




convert AFB^ into cytotoxic metabolites  are  distinct from those converting




AFBj into mutagenic metabolites  (84). There is some evidence that hepatocytes




become more resistant  to the cytotoxicity of AFB, during AFB,-induced carcino-




genesis (85).





     Apart from poisoning of farm animals by aflatoxin-contaminated feed,




aflatoxins have been associated with a number of acute  human poisonings (rev.




33, 34, 57).  In 1967, an outbreak of poisoning of 26 persons in two villages




in Taiwan occurred as  a result of consuming  moldy rice  (containing up to 200




ppm AFBj); three of them (children aged  4-8) died shortly afterwards.  The




symptoms observed included abdominal pain, vomiting, palpable liver and edema




of the lower extremities, but no fever (86).  Aflatoxin was suspected to be




associated with the death due to acute hepatitis of a 15-year-old Ugandan boy




whose diet consisted mainly of moldy cassava containing 1.7 ppm  aflatoxin




(87).  An epidemic outbreak of acute hepatitis occurred during the  last two




months of 1974  affecting several hundred persons in  150 villages  in adjacent
                                       8

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districts of two neighboring states in northwest India (88-91).  The outbreak




started after the consumption of recently harvested corn that was spoiled due




to unusual rainfalls in the areas.  Subsequent analysis of samples of corn




obtained from affected families revealed the presence of the aflatoxin-




producing mold Aspergillus flavus and AFBj levels ranging from 0.25 to 15.6




ppra.  Over one hundred persons died as a result of the poisoning, men being




affected approximately twice as often as women.  Histopathological studies




indicated extensive liver damage.  Besides liver disease, aflatoxins have been




implicated as one of the possible causes of Reye's syndrome (encephalopathy




with fatty degeneration of the viscera, EFDV), an acute, often fatal disease




affecting mainly infants and young children, that usually progresses from a




mild prodromal viral illness to severe cerebral involvement with coma.




Clustering of Reye's syndrome has been observed in northeast Thailand in




predominantly rural areas geographically and seasonally related to heavy




contamination of market food samples (92, 93).  In at least two cases, the




food consumed by the patients 2-3 days prior to the onset of Reye's syndrome




was found to be heavily contaminated with aflatoxins and toxigenic molds (93,




94).  Trace amounts of aflatoxins were detected in tissues, body fluids, or




gastrointestinal contents of 22/23 Thai patients who died from Reye's




syndrome; the liver specimens of two of these patients contained 47 and 93 ppb




AFBj (95).  The presence of aflatoxins was also demonstrated in the liver




specimens of a number of Reye's syndrome patients in New Zealand (96),




Czechoslovakia (97) and in the United  States  (98, 99); however, a dietary




source of aflatoxin was not identified in any of the above cases.   It should




be noted that not all Reye's syndrome  patients had detectable  amounts of




aflatoxins in their tissues or body fluids (100).  Moreover, no unusual




clustering of Reye's syndrome has been found  in other countries  with high




frequencies of food contamination with aflatoxins.




                                       9

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     Mutagenicity.  The mutagenicity of aflatoxins and related compounds has




been extensively investigated using a great variety of test organisms.  Both




A*"8! and a mixture of AFBj and AFGj have been shown to exhibit prophage-




inducing activity in Escherichia coli p4^6, Staphylococcus aureus LM 204 and




lysogenic Bacillus megaterium (101, 102).  They induce gene mutations in




transforming DNA of Bacillus subtilis (103), in a number of strains of




Salmonella typhimurium (see discussion below), in growing vegetative cultures




(but not resting conidia) of Neurospora crassa (104) and Saccharomyces




cerevisiae (Brusick, cited in 43), in Chlamydomonas reinhardii (105),




j)rosophila melanogaster (106), in cultured Chinese hamster cells (107) and




mouse lymphoma cells (108).  They also produce chromosomal aberrations in




seedling roots of Vicia faba (109), in Allium cepa (110), in a kidney-cell




line derived from rat kangaroo (111), and cultured human leucocytes (112-




115).  In most cases, AFBj is rautagenic only if metabolic activation system is




added to the incubation medium or when metabolically active cells are used.




In in vivo studies, Epstein and Schafner (116) reported the induction of




dominant lethal mutation in male mice treated with a high dose (68 mg/kg) of a




mixture of AFBj and AFG^.  Leonard ^t__al_. (117) indicated that AFBj alone,




given at a dose of 5 mg/kg, does not produce gross structural chromosome




changes in male mouse germ cells.  However, Fabry and Roberfroid  (115) showed




that AFBj (5 mg/kg) is clastogenic in bone marrow cells of mice,  producing




chromatid gaps and fragments and micronucleated cells.  Most of the earlier




mutagenicity data were reviewed by Ong  (43) in 1975 and by Hayes  (34) in




1981.  The following discussion focuses on mutagenicity studies using the Ames




Salmonella test, which has been widely  employed as a test  for the prediction




of carcinogenicity and for exploring structure-mutagenicity relationships.
                                       10

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     Over 20 aflatoxins and related compounds have been tested~for-mutagenic
activity using the Ames test.   Among the five commonly used tester strains
(TA98, TA100, TA1535, TA1537,  TA1538) of Salmonella typhimurium. strains TA98
(which detects frameshift mutagens) and TA100 (which detects base-pair substi-
tution mutagens but is also sensitive to frameshift mutagens) are considerably
more sensitive to AFBi than the other strains (118-121).  Most of the muta-
genicity studies on aflatoxins and related compounds have been carried out
with these two strains.  The results of these studies are summarized in Table
IV.  The compounds are classified as (a) metabolites and related compounds of
AFBj and AFGj, (b) biosynthetic precursors of AFBj, and (c) derivatives and
analogs of sterigmatocystin, and are assigned potency ranking for easier
comparison.

     The relationship between chemical structure and mutagenic activity of
aflatoxins and their mammalian metabolites has been extensively studied by
Wong and Hsieh (124).  Using TA98 as the tester strain, these investigators
showed that AFBi is considerably more mutagenic than any other aflatoxin or
the aflatoxin metabolites.  Among the metabolites of AFB^ tested, aflatoxicol
(AFL) is the most active, followed by AFMj, AFLHj and AFQj, while AFPj and
AFB2a are inactive.  Aflatoxin Gj is slightly mutagenic whereas aflatoxins 82,
Go and G2a are all nonmutagenic.  In terms of relative potency, AFL, AFGj,
AFMj, AFLHj and AFQj have about  22.8, 3.3, 3.2, 2.0  and  1.2%  of the  activity
of AFBi, respectively.  All the mutagenic compounds  possess a double bond in
the 2,3-position of  the terminal  furan ring, whereas  those  without the
2,3-double bond (except AFP,) are nonmutagenic.  The  presence of  rat  liver S-9
preparation  is required  for mutagenic activity.  These  findings  led  Wong  and
Hsieh (124) to conclude that the  2,3-double bond plays  a  role in  the mechanism
of mutagenicity of the aflatoxins,  and that  the 2,3-oxide generated  meta-
bolically is  the most probable ultimate mutagenic  form  of these  compounds.
                                       11

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                                                                     p.  1 of 2
                                   Table  IV
           Comparative Mutagenicity of Aflatoxins,  Sterigmatocystin
              and Related Compounds in the Ames Salmonella Test
Relative Mutagenic Potency
Strain TA98 Strain TA100
Compound With S-9 Without S-9 With S-9 Without S-9
Aflatoxins and Related Compounds
AFB, +••••»•+ +; - ++++ + ; -
AFL +++ - n.t. n.t.
AFGj ++ - n.t. n.t.
AFMj ++ ++
AFLHj + - n.t. n.t.
AFQj + - n.t. n.t.
AFPj - - n.t. n.t.
AFB2 - - -
AFB2a - - n.t.
AFG2 - - n.t. n.t.
AFG2a - - n.t. n.t.
2 ,3-Dichloro- n.t. +++ n.t. +++
2,3-dihydro-AFBj
2,3-Dihydro-2,3- n.t. - n.t.
dihydroxy-AFBj^
2,3-Dihydro-2- n.t. - n.t.
hydroxy-3-chloro-
AFBj
3a ,8a-Dihydrofuro- - - + -
[ 2 , 3-b ]benzof urana
Tetrahydrofuro- - - - -
References
(119-129)
(124)
(124, 128)
(119, 124)
(124)
(124)
(124)
(120, 123,
124)
(123, 124)
(124)
(124)
(123)
(123)
(123)
(126)
(126)
benzofurane

-------
                                                                       p.  2  of  2
                             Table  IV  (continued)
                           Relative Mutagenic Potency
                      Strain TA98            Strain TA100
Compound         With S-9  Without S-9   With S-9  Without S-9    References


Precursors of Aflatoxin B,

Sterigmatocystin    +++        •«•; -          +++          -         (121,  122,
                                                                  125,  127,
                                                                  128)

Versicolorin A      ++          -           ++         ++         (121,  125,
                                                                  127)

Versiconal           -                      n.t.       n.t.        (125)
acetate3

Averufin3            -           -            -          -         (121,  125)

Averantin3           +           +            +          +         (121)

Norsolorinic         -                        -          -         (121,  125)
acid3

Analogs and Derivatives of Sterigmatocystin

0-Methyl sterig-     -                        -                    (127)
matocystin

0-Acetyl sterig-     -           +          n.t.       n.t.        (128)
matocystin

Austocystin A3     -n-n-         -           ++                    (127)

Austocystin Da       *           +            +•          -         (127)


3For structural formulas, see below:
                                [Text-figure 2]

-------
          P,    OH   0    OH
CH3-(CH2)4-C,   ' "    '
          HO
         Norsolorinic acid
                                                 OH   0    OH
                                  CH3-(CH2)4-CH
Averantin
                                           OH   0
                                                                                            0
                                                                                     Averuf in
               0
               II
           CH3CO    0   OH
              v i     i|    §
  H..C

^ A HO
                     0
         Versiconal acetate
   3a,8a-Dihydrofuro-
   [2,3-b]benzofuran
                                                                                         Tetrahydrofuro-
                                                                                            benzofuran
                              H3CO    0   OCH3
                       X0    0  ^  0'

                            Austocystin A
                             OH   0   OH
                                                                     Austocystin D
                                               Text-Figure   2_

-------
     However, the 2,3-double bond is not the sole molecular moiety that deter-




mines the mutagenic activity of AFBj.  Alteration of the molecular structure




elsewhere invariably leads to reduction in mutagenic activity.  Thus, 0-de-




methylation of AFBj (yielding AFPj) completely abolishes the mutagenic




activity of the parent compound, while 4-hydroxylation (yielding AFMj),




replacement of the cyclopentenone ring with a terminal lactone ring (AFGj),




reduction of the keto group (yielding AFL), or hydroxylation of the cyclopen-




tenone ring (yielding AFQj), all result in significant decrease in mutagenic




activity.  Formation of the highly reactive AFBj-2,3-oxide (as the ultimate




mutagenic intermediate of AFBj) is supported by the study by Swenson et al.




(123) using 2,3-dichloro-2,3-dihydro-AFBj as a model compound for the




epoxide.  Like AFBj-2,3-oxide, the 2,3-dichloride derivative would be expected




to form a resonance-stabilized carbonium ion at carbon 2 and would act




directly as an electrophile.  2,3-Dichloro-2,3-dihydro-AFBj was indeed shown




to be a potent, direct-acting mutagen for both strains, TA98 and TA100.  Under




similar assay conditions (without the S-9 mix), AFBj, AFB2> AFB2a and the




dihydrodiol and chlorohydrin derivatives of AFBj (hydrolysis products of




2,3-dichloro-2,3-dihydro-AFBj) all showed little or no mutagenic activity  (see




Table IV).





     In other comparative studies, Uwaifo and Bababumi (119) reported that




TA100 is a more sensitive tester strain for AFBj and AFMj than TA98 and that




the  relative mutagenic potency of AFMj in strain TA100 (10% of that of AFBj)




correlates well with the relative carcinogenic potency of these two myco-




toxins.  Ueno _et^ _al_. (128)  found AFBj slightly mutagenic  for  strains  TA98  and




TA100 without metabolic activation.  Their data indicate  that the mutagenic




potency of AFBj increases by  at  least  100 times when  including the  S-9 mix.




Aflatoxin Gj is also mutagenic but considerably less  active than AFBj*
                                       12

-------
Wheeler et_al_* (120) showed that AFBj displays little or no mutagenic activity




using strains TA1538 and TA1535 but is highly mutagenic in TA98 and TA100.




Aflatoxin B2 is completely inactive.  Coles et^ al^. (126) found 3a ,8a-dihydro-




furo[2,3-b]benzofuran mutagenic for TA100 but not for TA98.  The double bond




in the terminal furan ring appears to account for the mutagenic activity in




TA100, since tetrahydrofurobenzofuran is inactive.  The lack of mutagenic




activity of 3a,8a-dihydrofuro[2,3-b]benzofuran in TA98 suggests that the rest




of molecular structure in AFBi is needed to confer frameshift mutagenic




activity.





     The biosynthesis of AFB, in fungi is believed to proceed via the path-




way:  norsolorinic acid ——>• averantin	^ averufin —>• versiconal




acetate 	^ versicolorin A 	> sterigmatocystin 	>• AFB, (see Section




5.3.1.1.5.2).  The bacterial mutagenicity of these precursors has been tested




in the Ames test (see Table IV).  Using TA98 as the tester strain, Wong et al.




(125) showed that norsolorinic acid, averufin and versiconal acetate are all




practically inactive while versicolorin A and sterigmatocystin are significant




mutagens with approximately 5.8 and 10.7% of the activity of AFB}, respec-




tively.  The most important difference between the mutagenic and nonmutagenic




compounds is the presence of the unsaturated bisfuran ring structure in the




former,  indicating the requirement of the 2,3-double bond  for the mutagenic




activity of AFBi.  In accord with conclusions derived from mutagenicity




studies  on mammalian metabolites of AFB,, besides the 2,3-double bond the




configuration and electronic structure of the entire molecule are  important




contributory  factors for mutagenic activity.  Substitution of the  coumarin




moiety of AFBj with xanthone (as in sterigmatocystin) or anthraquinone  (as  in




versicolorin A) results  in a reduction  in the mutagenic activity.   Essentially




identical results were obtained by Dunn^t__al_. (121)  in their mutagenicity
                                       13

-------
testing of norsolorinic acid, averantin, averufin, versicolorin A and sterig-




matocystin using tester strains TA98, TA100, TA1535,  TA1537 and TA1538.




However, the relative mutagenic potencies of versicolorin A and sterigmato-




cystin in tester strain TA100 were 1.8% and 53.6% of  that of AFBj, respec-




tively; averantin, a relatively recently discovered precursor of AFBj,




displayed weak mutagenic activity (0.1% of activity of AFB^).  It is interest-




ing that versicolorin A and averantin (both pigmented compounds with anthra-




quinone structure) display mutagenic activity even in the absence of metabolic




activation.





     Several derivatives and analogs of sterigmatocystin have been tested for




mutagenicity.  Wehner et al. (127) found the 0-methyl derivative of sterig-




matocystin to be devoid of mutagenic activity.  The 0-acetyl derivative of




sterigmatocystin is, however, weakly mutagenic in the absence of metabolic




activation, but not significantly active in the presence of S-9 mix (128).  In




contrast to the lack of mutagenic activity of 0-methylsterigmatocystin, its




close analog austocystin A (in austocystin A, the xanthone moiety is fused to




the bisfuran ring structure in a linear configuration instead of angular




configuration as in sterigmatocystin) is highly mutagenic in the frameshift




mutation tester strain TA98, with activity comparable to that of AFBj.  The




closely related austocystin D, which is polyhydric and substituted with a




bulky substituent, is only weakly mutagenic.





     Teratogenicity.  In contrast to extensive testing of carcinogenicity and




mutagenicity of aflatoxins and related compounds, relatively few studies have




been undertaken to investigate the teratogenicity of these  compounds.  More-




over, most of these studies were carried out using chick embryos.  Verrett et




al. (59) reported first that AFBj induced  teratogenic effects  (mainly  leg




deformities) in White Leghorn chicks after  injection into yolk-sac of  the






                                      14

-------
embryos at early stages of development.  No teratogenic effects were observed



with AFBj when injected into the air sac of the embryos.   The teratogenicity



of AFBj was confirmed by Bassir and Adekunle (130)  using White Rock chick



embryos.  The effect apppears to be nonspecific; malformations of the eyes,



skull and limbs were observed.  These abnormalities were described by Bassir



and Adekunle (130) as being similar to those observed  by Keraper (131) in



testing of thalidomide in chick embryos.  Aflatoxin Bj was also teratogenic  to



tadpoles of Rana temporaia, causing mainly limb defects (132).




     Among mammalian species tested, AFB, was reported to be teratogenic in



golden hamsters, but inactive in strain C3H/He mice (133) and in Wistar rats



(134).  In hamsters the greatest teratogenic response  was observed when AFBj



was injected intraperitoneally on day 8 of gestation at the dose of 4 mg/kg



body weight (133, 135).  Animals were sacrificed on days 9, 11, 13 and 15 of



gestation.  The most severe malformations (anencephaly, disorganization of



cranial end of neural tube, ectopic cordis, head malformations) and the
                    O


greatest number of malformed fetuses were found on days 9 and 11.  These



malformations are usually incompatible with life.   On days 13 and 15 of gesta-



tion, many dead or resorbed fetuses were found; the malformations noted



(microcephaly and umbilical hernia) were less severe and probably compatible



with postuterine life.  No information was provided in these reports (133,



135) to indicate whether AFB, caused a significant increase in the incidence



of malformations in the offspring at birth.  In strain C3H/He mice, a single



intraperitoneal injection of 8 mg/kg body weight AFB,  on day  8 or 12 of



gestation, or repeated injections of AFBj at the dose of 4 mg/kg body weight,



led to high incidences of dead or resorbed fetuses but produced no evidence  of



teratogenicity (133).  In Wistar rats, oral administration of AFBj (equivalent



to 1/4 of LD^g) early  in pregnancy had no significant teratogenic effect.
                                      15

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Retardation in fetal growth was observed when AFBj  was administered late in




pregnancy (i.e.,  after completion of organogenesis).   The  effect  was con-




sidered to be a secondary effect occurring as a result of  maternal liver




damage (134).





     In addition to AFBi, several metabolites or derivatives have been tested




using chick embryos.  Aflatoxins B2a and Qj were at least  80 and  18 times less




embryotoxic than AFB,, respectively (60, 80).  Aflatoxin Pj was also signifi-




cantly less embryotoxic than AFBj (76).   Neither of the above three




metabolites or derivatives produced teratogenic effects in chick embryos.




Sterigmatocystin is at least 16 times less embryotoxic than AFBj  in chick




embryos (136).  Teratogenic effects were observed occasionally but they did




not appear to be consistent.  The most common deformity was twisted feet.




There was no difference in teratogenic response between injection of Sterig-




matocystin into the air cell or into the yolk sac of the chick embryo.  Afla-




toxin G, was teratogenic to tadpoles of Rana temporaia; the dose required to




produce teratogenic effects was approximately 10 times higher than that of




AFBj (132).





     5.3.1.1.3  Carcinogenicity and Structure-Activity Relationships.





     5.3.1.1.3.1  OVERVIEW.





     Since the first report in 1961 of carcinogenicity of aflatoxin-




contaminated groundnut meal in rats, aflatoxin mixture (which mainly consists




of aflatoxin Bj and Gi and traces of Bo and Go) or purified AFBi was found to




be carcinogenic in  11 of the 12 animal species tested.  Great variation  in the




susceptibility of these animal species to the carcinogenic effect of AFBj was




observed.  In the highly susceptible species (e.g., rainbow trout, rat,  duck),




AFBi is the most potent hepatocarcinogen presently known, inducing tumors  in
                                      16

-------
animals maintained on diets containing only parts per billion (ppb) levels of




the mycotoxin.





     Over 20 aflatoxins and related compounds have been tested for carcino-




genic activity.  These compounds include metabolites, synthetic derivatives




and structural analogs of AFBj, AFGj and sterigmatocystin.   Structurally, they




represent difurocoumarocyclopentenone, difurocoumarolactone,  difuroxanthone,




difuroanthraquinone, cyclopentenonecoumarin and coumarin derivatives.  The




most important finding of these studies is that the presence  of a double bond




at the 2,3-position of terminal furan ring is a critical structural require-




ment for carcinogenic activity.  Thus, while AFBj, AFGj, sterigmatocystin and,




to a lesser extent, versicolorin A are carcinogenic, their corresponding




dihydro derivatives, AFBo, AFGoj dihydrosterigmatocystin and  versicolorin B




are practically inactive.  This finding is consistent with (a) metabolism and




mutagenicity studies implicating AFBj-2,3-oxide as the genotoxic reactive




intermediate (see Section 5.3.1.1.2.2), (b) the demonstration of direct-acting




carcinogenic activity of 2,3-dichloro-2,3-dihydroaflatoxin Bj (123), which is




expected to have similar electrophilic activities as AFBj-2,3-oxide, and (c)




molecular orbital calculations (32, 51) which show that the double bond in the




2,3-position in AFB^, AFGj, sterigmatocystin and versicolorin A is the most




reactive molecular site and is susceptible to epoxidation.  Besides the




2,3-double bond, the configuration and the electron distribution in the rest




of the molecule are important contributory factors in the carcinogenic activ-




ity of the aflatoxins and mold metabolites. The Bi congener appears to repre-




sent the structure most optimal for the hepatocarcinogenic activity of the




aflatoxins; ring substitution, or substitution of  the coumarocyclopentenone




moiety with coumarolactone, xanthone or anthraquinone moiety,  invariably  leads




to a reduction in carcinogenic activity.  The  lower  carcinogenic activity  of
                                      17

-------
hydroxylated derivatives of AFBj (e.g. ,  AFMj, AFQj) may be related to changes

in pharmacoki.netic properties as a result of an increase in hydrophilicity.

Heathcote and Hibbert (32, 51) attributed the weaker carcinogenic activity of

versicolorin A to the presence of a reactive L-region.*  Moreover, as among

other polynuclear carcinogens (see Section 5.1.1.2, Vol. IIA), the absence of

angular annelation of the rings may be an additional feature responsible for

the lower carcinogenicity of versicolorin A.  From the structural standpoint

the aflatoxins and sterigmatocystin bridge the distance between the lactone

and polynuclear carcinogens, 'and bear a relationship to the heteroaromatic

polynuclear lactone carcinogens investigated in some detail by Buu-Hoi and

coworkers (see "Notes" following Section 5.1.1.4, Vol. IIA).


     5.3.1.1.3.2  CARCINOGENICITY OF AFLATOXIN MIXTURES OR AFLATOXIN-

CONTAMINATED FEEDS.


     Most of the early carcinogenicity studies on aflatoxins were conducted

using aflatoxin-contaminated feed or semipurified aflatoxin mixtures consist-

ing of approximately equal amounts of AFB, and AFG, and traces of AFB^ and

AFG2-  Lancaster £t^^l_- (15) were the first to report in 1961 the hepatocar-

cinogenic effect of aflatoxin-contaminated groundnut meal  in rats.  Continuous

feeding of a purified diet containing 20% highly toxic groundnut meal for 6

months led to the induction  of  liver tumors  in 9 of 11 rats.  Shortly after-

ward, similar findings were  reported by Schoental  (16), LeBreton et al. (17),
 *According  to  the  "electronic  K-L  region  theory"  actively promoted between
  about  1945 and  1970 by the French school of  theoretical  chemists led by the
  Pullmans to account for  the carcinogenic activity  of  polycyclic hydrocarbons
  and  related polynuclears  (see Section  5.1.1.6.1, Vol.  IIA),  these compounds
  must have  —  in order to  be carcinogenic —  a  reactive double bond (termed the
  "K-region" and  equated in the angular  polynuclears with  the  meso-phenanthrenic
  double bond)  and  if a compound also has  a meso-anthracenic region (termed
  "L-region") it  must be rather unreactive.


                                      18

-------
Salmon and Newberne (18)  and other investigators (see Table V).  The final




concentrations of aflatoxin (mainly Bi  and Gi)  in the contaminated diets that




elicited a carcinogenic response ranged from 0.8-4 ppm (144).  Using a par-




tially purified aflatoxin Bj and Gj mixture, Barnes and Butler (147) showed




that feeding a diet containing 1.75 ppm aflatoxin for 89 days (corresponding




to a total dose of only about 2.5 mg/animal) was sufficient to induce liver




tumors in rats.  In addition to the induction of hepatocarcinomas, carcinomas




of the glandular stomach, kidney, lung, lachrymal duct and salivary gland were




occasionally seen (144-146).  Carnaghan (139) showed that a single oral




administration of a sublethal dose of a mixture of AFBj and AFGj (equivalent




to 5.1 mg AFBj/kg body weight) leads to the induction of hepatic tumors in




7/16 rats with an average latency period of 26 months.  In a more recent




study, Fong and Chan (148) found that feeding for 22 months a purified diet,




in which aflatoxin-contaminated peanut  oil (obtained from local markets) was




used as the fat source, induced sarcomas in 3/76 rats.  None of the 90 control




rats developed malignant tumors.  The estimated AFBj content in the diet was




5-7 ppb.  Norred and Morrissey (143) found a liver tumor incidence of 100% in




rats fet a diet containing aflatoxin-contaminated corn for 91 weeks; the esti-




mated dietary levels were 150 ppb AFBj, 8 ppb AFGj, and 18 ppb AFB2-  The




hepatocarcinogenicity of the feed was completely abolished if the corn was




subjected to decontamination with ammonia.





     Besides oral administration, aflatoxin-contaminated feed or partially




purified aflatoxin mixture was shown to be carcinogenic in rats by  subcuta-




neous injection, intratracheal administration, or by the transplacental/lacta-




tional route.  Dickens et al. (137,  138, 149) reported that  twice-weekly




subcutaneous injections of 2, 10, 50 or 500 ug of a mixture  of aflatoxins  B^




and Gj induce local sarcomas with a virtually 100% incidence.  No distant
                                      19

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                                   Table V
     Carcinogenicity of Aflatoxin Mixtures  or Aflatoxin-Contaminated Feed
                          in Various  Animal Species3
Animal Species
Mouse
Rat




Syrian hamster
Rainbow trout
Duck
Ferret
Sheep
Monkey
Route
B.C.
oral
>

s .c
intratracheal
transplacental
and/or lactational
oral or i.p.
oral
oral
oral
oral
i.ra. and oral
Principal Organs
Affected
Local sarcoma
Liver
Liver, stomach,
multiple sites
Liver, colon,
s.c. tissue
Local sarcoma
Trachea, liver
Liver
Harderian gland
Liver
Liver
Liver
Liverb (?)
Liverb
References
(137)

(15-18, 138-143)
(144-147)
(148)

(137, 138,
(138)
(150)
(151)
(152-155)
(156)
(141)
(157)
(158, 159)

149)








aSee Table VI for carcinogenicity study on purified aflatoxin Bi,

 Only a small number of animals were used in the study.

-------
tumors were noted.   By intratracheal administration (300 ug in 30 ul oil,




twice weekly for 30 weeks),  the aflatoxin mixture induced a variety of local




and distant tumors  including tracheal squamous carcinomas in 3/6 and hepatomas




in 4/6 rats.  One rat developed a renal adenoma,  a carcinoma at the pyloric




portion of the intestine, as well as a hepatoma.   Grice _et_ _al/ (150) fed 6




groups of 10 pregnant Wistar rats a diet containing either 25% or 50% toxic




groundnut meals (contaminated with 10 ppm AFBi and 2 ppm AFB£) from (a) day 10




of gestation to parturition, (b) day 1 to day 10  post-partum, or (c) day 10 of




gestation to day 10 post-partum.  The females and the progeny were then main-




tained on uncontaminated diet and observed for up to 36 months.  Liver tumors




were found in 1/36  male offspring in group (a), 1/28 female offspring in group




(b), and 2/38 female offspring in group (c); in addition, a number of off-




spring displayed hyperplastic changes in the liver.  None of the 60 control




females and 65 control progeny developed liver tumors.  The data provide some




suggestive evidence that low levels of AFB, or its metabolites (such as AFM,),




possibly reach embryos or nursing neonates through the placenta or milk.





     In addition to the rat, aflatoxin-contaminated feed or partially purified




aflatoxin mixture has been shown to induce liver tumors in the rainbow trout,




duck, ferret, sheep and monkey (see Table V).  The rainbow trout is the




species most susceptible to the hepatocarcinogenic effect of the aflatoxins;




studies in different laboratories (152-155) concur that aflatoxins produce




hepatoma in rainbow trout when fed as low as at parts per billion (ppb)  level




(see also Section 5.3.1.1.3.3).  In a study by Jackson  et_ al_.  (155) the  esti-




mated carcinogenic  dietary level of aflatoxin in rainbow  trout was 0.4 ppb.




Ducks and ferrets are also quite sensitive to aflatoxin carcinogenesis.




Carnaghan (156) reported that 8 of 11 ducks fed a diet  containing 0.5% toxic




groundnut meal  (which contained 7 ppm aflatoxin, assayed  as AFBi, giving a
                                      20

-------
final dietary concentration of approx.  30 ppb)  developed liver tumors




(parenchymal tumor nodules, bile duct adenomas) after 14 months; none occurred




in 10 controls.  Lancaster (141) noted that all ferrets (of an unspecified




number) maintained on a diet containing 3% toxic groundnut meal (which con-




tained about 10 ppm aflatoxins) had liver tumors after 31 months.  The




carcinogenicity studies reported on sheep and monkeys involved a limited




number of animals.  Lewis et al. (157) found a  parenchymal cell carcinoma in a




sheep which died after 3.5 years on a diet containing toxic groundnut meal.




Go pa Ian ^t__al^. (158) and Tilak (159) each reported the induction of a liver




tumor in a rhesus monkey exposed to a mixture of aflatoxins (44% AFBj, 44%




AFGj, 2% AFB2 and AFG2) initially through intramuscular injections (50-100




ug/day, 5 days/week for 1 year) and subsequently by gavage (100-200 ug/day for




4.5 years).





     In contrast to the above studies, Herrold  (151) found Syrian hamsters to




be highly resistant to the hepatocarcinogenic effect of aflatoxins.  She




observed no evidence of regenerative nodules, cirrhosis, or tumors of the




liver in 20 female hamsters which received (by  intragastric administration)




0.1 mg aflatoxin mixture (mostly AFBj^ and AFGj  with traces of AFB2 and AFG2) ,




2 times a week for 10-11 months or by intraperitoneal injection 0.2 mg afla-




toxin mixture weekly for 6-8.5 months; the hamsters were then observed for the




rest of their lifespan.  Four of the 20 animals developed tumors of the




Harderian gland, histologically identified as solid and papillary cyst-




adenomas.  In mice, twice weekly subcutaneous injections of 10 ug aflatoxins




(mixture of Bj and Gi) led to the induction of local sarcomas  in  15/17 animals




(137).
                                      21

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     5.3.1.1.3.3  CARCINOGENICITY OF PURIFIED AFLATOXIN Bj.





     The carcinogenicity of purified AFBj has been tested  in nine animal




species (see Table VI).   The results indicate that the carcinogenicity of




aflatoxin mixtures or of aflatoxin-contaminated feed is mainly attributable to




AFBj.  Significant species and age differences in susceptibility to carcino-




genesis by AFBi have been observed.





     Among the animal species tested, the mouse is the most  refractory.  In




this species significant carcinogenic effects were observed  only in studies in




which infant mice or very high AFB, doses were used; however, there are




notable strain differences in susceptibility.  Wogan (160) found no signifi-




cant carcinogenic effects of AFBj in adult random-bred and inbred strains of




mice maintained on a diet containing 1,000 ppm AFBj for up to 70 weeks.  On




the other hand, using 2-month-old female A/He mice, Wieder et al. (161) noted




lung adenomas in all the 14 mice that survived 20 weeks after 12 thrice-weekly




intraperitoneal injections of a very high AFBi dose (20 rag/kg body weight).




In contradistinction to the above strain, in newborn Charles River CD-I mice,




Swenson et al. (123) detected only a small increase in the incidence of lung




adenomas (10/107 experimental vs. 2/95 control) 14 months after  3 intraperi-




toneal injections of 0.32 iimole/kg AFBj.  In the same study, topical applica-




tions (0.34 uraole/application, twice weekly for 20 weeks) of AFBj failed to




elicit any significant carcinogenic effect.  Four- and 7-day-old male  (C57 x




C3H)Fj mice were, on the other hand, highly responsive to the hepatocarcino-




genic effect  of AFB^ (162).  A total dose of 4 umole/kg, given  intraperi-




toneally from the 4th to 16th day of age in 5 administrations,  was sufficient




to induce hepatomas  in 89% of the mice after 82 weeks.  A liver tumor  inci-




dence of 23%  was noted among male mice that received  a single dose of  6.4




umole/kg AFBj the first day after birth.  Parallel  studies  indicate  that







                                      22

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                                   Table  VI
     Carcinogenicity of Purified Aflatoxin Bj in Various Animal Species3
Animal Species
Mouse


Rat



Syrian golden
hamster
Rainbow trout


Coho salmon
Guppy
Tree shrew
Marmoset
Monkey
Route
oral
i.p.
topical
oral
i.p.
s .c.
transplacental
and oral
oral
oral
i.p.
embryonic
exposure
oral
oral
oral
oral
oral and i.p.
Principal Organs
Affected
None
Lung
Liver
Nonec
Liver
Liver, kidney
Liver, colon
Liver
Local sarcoma
Liver, local
sarcoma
Liver, colon
Liver
Liver
Liver
Liver
None
Liver
Liver
Liver
Liver, pancreas,
multiple sites
References
(160)
(123, 161)
(162)
(123)
(64, 139, 140,
163-169)
(170, 171)
(140, 172, 173)
(64)
(64, 137)
(123)
(173)
(169)
(155, 174-181)
(182)
(179, 183-185)
(174, 175)
(186)
(187)
(188)
(189, 190)
aSee also Table V for carcinogenicity studies using aflatoxin-contaminated
 feed or aflatoxin mixtures.
 Mice were treated during infancy.
cActive when used as a tumor-initiator followed by promotion with croton oil.

-------
female mice are much less susceptible; liver tumors, with an incidence of 7%,




were detected only in the group that received AFBi at day 7 of age.





     Studies in various laboratories (summarized in Table VI) show that puri-




fied AFBj is a highly potent hepatocarcinogen in the rat and clear dose-




response relationships have been established (140, 165, 170).  In male Fischer




rats, a dietary level as low as 1 ppb AFBj is demonstrably carcinogenic.  The




incidence of liver carcinomas in rats fed diets containing 0, 1, 5, 15, 50 and




100 ppb AFB1 was 0 (0/18), §.1 (2/22), 4.5 (1/22), 19 (4/21), 80 (20/25) and




100% (28/28), respectively.  The time of appearance of the earliest tumor in




the AFBj-treated groups was 104, 93, 96, 82 and 54 weeks, respectively




(165).  There is some evidence for strain difference in the susceptibility of




rats to AFBj carcinogenesis.  For example, feeding a diet containing 100 ppb




AFBj leads to the induction of liver tumors in 100% (28/28) male Fischer rats




(165) but in only 48% (24/50) male Sprague-Dawley rats (172).  For male Wistar




rats, the liver tumor incidence was 61% (8/13) in a group fed 250 ppb AFB^




(170).  Wistar strain rats are also unusual in being especially prone to




develop kidney tumors when exposed to AFB,; the renal tumor incidence ranged




from 25 to 50% in rats fed 0.25 to 3.0 ppm AFBj (170, 171).  A low incidence




of colon carcinomas was observed in Fischer and Sprague-Dawley rats (140,




172); the incidence was enhanced by vitamin A-deficient diets (see Section




5.3.1.1.3.6).  However, a more recent study (173) with a thorough examination




of the colon at autopsy, indicated that the incidence of colon carcinoma may




be as high as 9 to 40% in Fischer rats exposed to AFB, (2 ppm in diet)  for




lifetime either from conception (i.e., prenatal plus lifetime exposure) or




from 6-7 weeks of age.  Also, AFBj appears to have  significant  local  carcino-




genic activity, indicated by the high incidence of  local sarcomas  at  or near




the site of multiple subcutaneous injections of AFBj (64,  123,  137).   In  one
                                       23

-------
of these studies, subcutaneous injections of AFB,  led to induction of liver




tumors as well as local sarcomas (123).  The carcinogenicity of AFBj may be




modified by different factors, principally sex hormones and the composition of




the diet; these topics will be discussed in some detail in Section




5.3.1.1.3.6.





     An early study by Herrold (151) using a crude aflatoxin mixture indicated




that Syrian golden hamsters are refractory to the hepatocarcinogenic effect of




the aflatoxins (see Section 5.3.1.1.3.2).  The refractoriness of hamsters has




been re-examined by Moore et al. (169) using high doses of purified AFBj in




view of the finding that microsomes from hamsters actively metabolize AFB, to




its reactive intermediate, AFBj-2,3-oxide.  Male hamsters were given, by




gavage, 2 mg/kg AFBj, 5 days/week for 6 consecutive weeks and were then




observed for up to 78 weeks.  Parallel studies were conducted using male




Fischer rats.  The hepatic parenchymal cells of hamsters were indeed much more




resistant to the carcinogenic effect of AFBj than were those of rats.  Only 1




of 25 hamsters developed hepatocellular carcinoma as compared to all of 25




similarly treated rats.  In contrast, the bile duct cells of hamsters were




susceptible; of the 25 hamsters, 8 had cholangiocarcinoma and 17 had micro-




scopic cholangiomas.  As in the study of Herrold (151), adenomas of the




Harderian gland were observed; however, they were not attributed to AFB,




treatment because of their occurrence in control hamsters.





     Similarly to the rat, the rainbow trout (Salmo gairdneri)  is another




species which is extremely susceptible to the hepatocarcinogenic effect of




AFBj.  In accord with studies using aflatoxin-contaminated  feed, studies  using




purified AFBj indicate that lifetime  feeding of only ppb  levels of AFBi induce




hepatocellular carcinomas  in  the fish.  For rainbow  trout of  the Mt.  Shasta




strain, the reported incidences of hepatomas after 12 months  of feeding of






                                       24

-------
diets containing various levels of AFBj were:  0.5 ppb, 20% (181); 2 ppb, 61%




(181); 4 ppb,  25-48% (176,  177, 179);  8 ppb,  70% (176); and 20 ppb, 78-83%




(176, 179, 180).  A very short exposure duration of only 10 days to a diet




containing 20  ppb AFBi  is sufficient to induce liver tumors in 45% of the fish




(181).  The embryos of rainbow trout are even more sensitive to AFBi than are




juvenile trout exposed to an AFBj-containing  diet.  A single 1-hour exposure




of 14-day-old  trout embryos (i.e., fertile eggs) to an aqueous solution con-




taining 0.5 ppm AFBi produced liver tumors in 40-53% of the hatched fish one




year later (179, 183-185).   Using 21-day-old  embryos, Wales et^ _al_. (184)




determined the amount of AFB^ that could be absorbed by an egg during the




1-hour exposure and found it to be as much as 67 times less than the amount




ingested by a  fish during 12-month feeding of a diet containing 4 ppb AFBj.



Besides feeding and embryonic exposure, liver tumors were also induced in




rainbow trout  by intraperitoneal injections (182); twice weekly injection of




50 tig/kg AFB,  for 25 weeks produced liver tumors in 16 of 24 fish that sur-




vived 50 weeks.  There is some evidence of possible strain differences in the




susceptibility of rainbow trout to AFB,.  Rainbow trout from the Netherlands




appear to be not as susceptible as are those  from Mt. Shasta; after 16-month




the  liver tumor incidence in Dutch trout fed a diet containing 5.8 ppb AFBj




was  less than 13% (178).  Also, steelhead trout is less susceptible to AFB^




carcinogenesis than the Mt. Shasta strain rainbow trout (184) when the eggs of




the  trout were exposed to the aflatoxin.





      In addition to the rainbow trout, two other species of  fish have been




tested for susceptibility to AFB^ carcinogenesis.  Halver ^t__al_.  (175) found




that,  in sharp contrast to the rainbow trout, the coho salmon  (Oncorhynchus




kisutch) is refractory to hepatoma induction by AFBj.  Chronic  feeding of  a




diet  containing 20 ppb AFBj for 20 months did not induce any liver tumors  in
                                      25

-------
coho salmon.  Even embryonic exposure to AFBj failed to induce tumors in coho




salmon (J.D. Hendricks and R.O.  Sinnhuber,  unpublished data,  cited in 191).




Sato et al. (186) fed 1-month-old guppies (Lebistes reticulatus) a diet con-




taining 6 ppm AFBi for several months.  Hepatic tumors were found in 2 of 5




fish after 9 months and 7 of 11  fish after 11 months.  Thus,  the guppy is also




responsive to AFBi carcinogenesis although its susceptibility appears to be




much lower than that of the rainbow trout.





     Besides rodents and fish, AFBi has been shown to be hepatocarcinogenic  in




several species of nonhuman primates.  Reddy et al. (187) fed 18 tree shrews




(Tupaia glis) a diet containing  2 ppm AFBj intermittently for up to 172




weeks.  Among the 12 animals that survived for more than 74 weeks, 6 of 6




females and 3 of 6 males developed hepatocellular carcinomas.  The estimated




total dose ranged from 24 to 66  mg.  None of the eight controls had liver




tumors.  The tree shrews are small squirrel-like mammals found throughout




Southeast Asia and are regarded  as primitive primates.  Lin et al. (188)




induced hepatocellular carcinomas in 1 of 9 marmosets fed AFBj at a dietary




level of 2 ppm, and in 2 of 7 marmosets injected with hepatitis virus along




with AFBj feeding.  Adamson et al. (189) administered various doses of AFBj to




a group of 20 rhesus (Macaca mulatta), 20 cynomologus (Macaca fascicularis),




and 2 African green (Cercopithecus aethiops) monkeys for periods of up to 9




years.  At the time of the report  (189), 27 of the 42 monkeys were still




alive.  Of the 15 monkeys that were necropsied, 3 bore malignant primary liver




cancers.  The estimated total AFBj doses administered to these three  tumor-




bearing monkeys were 99, 119 and 842 mg.  A more recent update (190)  of the




study (including  5 additional monkeys) reported that  13 of 35 monkeys necrop-




sied at the end of 13 years developed one or more malignant  tumors, yielding




an overall tumor  incidence of 28%.  There were 5 primary liver  cancers,  2
                                      26

-------
osteogenic sarcomas, 6 carcinomas of the gall bladder of the bile duct, 3




tumors of the pancreas and its duct, and one carcinoma of the urinary




bladder.  Fifteen of the 22 necropsied monkeys without tumors showed




histological evidence of liver damage.  These results indicate the




susceptibility of primates to AFBj hepatocarcinogenesis and lend support to




the likelihood that humans exposed to AFBj are at risk of developing liver




cancer.





     5.3.1.1.3.4  CARCINOGENICITY OF COMPOUNDS RELATED TO AFLATOXIN Bj —




STRUCTURE ACTIVITY RELATIONSHIPS.





     The carcinogenicity of close to 20 metabolites, derivatives and struc-




tural analogs of AFBj has been tested in the two most susceptible test species




— the rat and the rainbow trout — and in the mouse.  The results of these




studies are summarized in Tables VII and VIII.





     Comparative carcinogenicity studies of aflatoxins B,, Hy, G, and 62 and




several metabolites of AFBj have been conducted by Sinnhuber et al (176, 177,




179,  180, 192), Wogan_e£^l_.  (64, 193), Butler et_ al_. (164) and Canton et al.




(178) using the rat and the rainbow trout.  The results obtained from studies




on these two so different animal species are remarkably concordant (see Table




VII).  Except for the induction of kidney tumors in rats by high doses of




AFBj, the liver is virtually  the only carcinogenicity target organ of the




various aflatoxins.  Among the four naturally occurring aflatoxins, the rela-




tive  carcinogenic potency follows the order:  AFBj > AFGj » AFB2 in  the rat




and AFBj > AFG^ _>. AFB~ > AFG2 in the rainbow trout.  Using male Fischer rats,




Wogan £t^ jl_. (64)  found that  all the  51 rats given  small  doses  of AFB,, total-




ing 0.5, 1.0 or 1.5 mg by stomach tube or 1.3 mg by  i.p.  injections over a




period of 4-8 weeks,  developed hepatocellular carcinomas  within 74  weeks.   Two
                                      27

-------
                                        Table  VII
Relative Potency of Aflatoxins and Related Compounds in the Induction of Liver Tumors in
           Rats or Rainbow Trout After Oral or Intraperitoneal Administration
                                                                                                p. 1 of 3

Compound3
Aflatoxin Bj (AFBj)



Aflatoxin BZ (AFB2>

Aflatoxin Gj (AFGj)
Aflatoxin G0 (AFG0)
Ratc
Dietary
level
Total dose (mg) % Incidence References (ppb)
0.277 40 (192) 4
0.5; 1.0; 1.3; 1.5 100 (64, 193)
1.0; 2.0 (MRC) 30; 63d (164) 20

5.8
1.0; 150 0; 33 (64) 20
1.0 (MRC) 0 (164)
0.7; 1.4; 2.0 0; 60; 100e (164) 20
1.0; 2.0; 6.0 (MRC) 10; 10f; 81£ (164)
20
Rainbow trout^
% Incidence
25; 48; 48
(12-month)
* 60 (16-month)
56 (8-month)
78; 83; 83
(12-month)
13 (16-month)h
5 (12-month)
0 (16-month)
5 (12-month)
17 (16-month)
0 (16-month)

References
(176, 177,
179)
(177)
(180)
(176, 179,
180)
(178)
(176)
(176)
(176)
(176)
(176)

-------
                                                Table VII  (continued)
                                                                                                               p.  2 of 3
t
Compound3 Total dose (rag)
Aflatoxin Mj (AFM^


AFMi (racemic mixture) 1.0
Aflatoxin 0^ (AFQj)
Aflatoxicol (AFL)

Aflatoxicol diastereomer
(AFL')
AFLrAFL1 (1:1 mixture) 0.279; 1.12
Tetrahydrodeoxy-AFBj
5 ,7-Dimethoxycyclopente- 156
Ratc
Dietary
level
% Incidence References (ppb)
4; 16;
32; 64

5.9; 27.3
3 (193)
20; 100
29

61
20; 70 (192)
20
0 (64) 10
Rainbow trout*
% Incidence
13; 70; 61; 60
(12-month)
40; 65; 95; 95
( 16-month)
0; 2 (16-month)h

0; 11 (12-month)
26 (8-month)
81 (12-month)
0 (8-raonth)
24 (12-month)

1 (12-month)
0 (12-month)

References
(177)
(177)
(178)

(179)
(180)
(180)
(180)
(180)

(176)
(176)
none[2,3-c]coumarin

-------
                                                                                                                p.  3  of 3
                                                 Table VII  (continued)

Compound3 Total dose (rag)
5, 7-Diraethoxycyc lopent e- 156
nonef 3,2-c Jcoumarin
5 , 7-Dimethoxycyc lopente- 156
none [c ] coumar in
Isobergaptene
7-Ethoxy-4-methylcoumarin
Ratc
Dietary
level
% Incidence References (ppb)
0 (64)
0 (64)
20
20
Rainbow trout*5
% Incidence References
0 (12-month) (176)
0 (12-month) (176)
aSee Table I for structural formulas.
 For structural formulas see below:
cExcept where indicated, male Fischer rats were used in these studies.
 Two of 15 male rats also developed  kidney tumors.
eFour of 26 male rats also developed kidney tumors.
 Five of 15 male rats in the medium dose group and 6 of 11 male rats in the high dose group also developed kidney
 tumors.
^Except where noted, rainbow trout of the Mt. Shasta strain were used.
 Rainbow trout of Dutch origin.
                                                      [Text-Figure  3]

-------
                                                 0    0
                 OCH3

Tetrahydrodeoxy-AFB]
      H,CO
    5,7-Dimethoxycyclopentene-
          [c] coumarin
5,7-Dimethoxycyclopenten-
  one-[2,3-c] coumarin
     Isobergaptene
                                  H,CO
5,7-Dimethoxycyclopenten-
  one-[3,2-c| coumarin
7-Ethoxy-4-methylcoumarin
                                      Text-Figure  3_

-------
                                                 Table VIII
                  Comparative Carcinogenicities of Derivatives of Aflatoxin Bi in Rodents
                                 by Subcutaneous or Topical Administration3
Compound
Aflatoxin Bj (AFB^)

2 , 3-Dichloro-2 , 3-d ihydro-AFBj
( AFBj-2 , 3-d ichlor ide)

Aflatoxin B?
Aflatoxin ftja
Species
and Route
Mouse, topical
Rat, s.c.
Mouse, topical
Rat, s.c.
Rat, s.c.
Mouse, topical
2,3-Dihydro-2,3-dihydroxy-AFBj Mouse, topical
2,3-Dihydro-2-hydroxy-3-
chloro-AFBj
Aflatoxin Gi
aExcept where indicated, the
Res. 15_, 3811 (1975)].
Expressed as umole compound
Mouse, topical
Rat, s.c.
Total Doseb
0.34 or 0.39
0.39 + COC
0.13
0.64
1.28d
2.3-4.7e
0.034
0.1; 0.34
0.39 + CO
0.13; 0.64
38. 2d
0.39 + CO
0.39 + CO
0.39 + CO
3.6-7.9e
data were summarized from D.H.
per animal.
cTest for tumor-initiating activity only; CO =
Summarized from G.N. Wogan, G.S. Edwards and
croton oil .
P.M. Newberne
Duration
of Study
Neoplasm
70 or 33 weeks None
29 weeks Skin carcinoma
20 months
20 months
58 weeks
18-37 weeks
70 weeks
70 weeks
29 weeks
20 months
78-86 weeks
29 weeks
29 weeks
29 weeks
30-65 weeks
Swenson, J.A.
[Cancer Res.
None
Liver carcinoma
Local sarcoma
Local sarcoma
Local sarcoma
Skin papilloma
Skin carcinoma
Skin carcinoma
Local sarcoma
None
Skin carcionma
None
None
Local sarcoma
Incidence
2/29
3/15
5/15
9/9
6/6
2/22
9/24; 14/17
14/24
6/15; 12/15
—
1/30
—
—
4/6
Miller and E.G. Miller [Cancer

31, 1936 (1971)].


Summarized from F. Dickens and H.E.H. Jones (Br. J. Cancer 19, 392 (1965)].

-------
rats in the highest dose group (40 x 37.5 ug over 8 weeks) developed hepato-




cellular carcinomas within 6 weeks after the termination of dosing.  For AFGj,




the incidences of hepatocellular carcinomas were 0/3, 3/5 and 18/18 for rats




receiving, by stomach tube, a total dose of 0.7, 1.4 and 2.0 mg, respec-




tively.  In the high dose group (40 x 50 ug over 8 weeks), 4 of 26 rats also




developed renal adenocarcinomas.  No tumors were found in rats given orally a




total dose of 1.0 mg AFB2 (10 x 100 ug over 2 weeks) after 78 weeks.  Only 3




of 9 rats which received a considerably higher total dose of AFB2 (150 mg; 40




x 3.75 mg over 8 weeks) by i.,p. injection developed hepatocellular carcinomas




after 57-59 weeks; for comparison, 9 of 9 rats given a total i.p. dose of 1.3




mg AFBi had liver tumors within 46 weeks.  The same relative order of carcino-




genic potency of aflatoxins Bi, Gi and Bo in the induction of liver tumors was




found by Butler et_ _aJU (164) using MRC rats of both sexes.  The respective




incidences of liver tumors were 30 and 63% for rats receiving a total dose of




1 and 2 mg AFBj via drinking water, 10, 10 and 81% for rats receiving 1,2 and




6 mg AFGj, and 0% for rats receiving 1 mg AFB2.  However, AFG^ appears to be a




more potent renal carcinogen in male rats, inducing kidney tumors  in 5/15 and




6/11 rats in the medium (2 mg) and high (6 mg) dose groups compared to 2/15 in




rats receiving 2 mg AFBj.  There was no sex difference in the incidence of




liver tumors in the MRC rats.  Ayres et al. (176) reported that in rainbow




trout of the Mt.  Shasta strain, fed a diet containing 20  ppb AFBj, AFGj, AFB2




or AFGo> the incidences of hepatomas at 12 months were 78, 5, 5 and 0%,




respectively.  In another  experiment by the same investigators, the 16-month




hepatoma incidences in fish fed 20 ppb AFG^, AFB2 and AFG2 were  17, 0 and 0%,




respectively.





     Several metabolites of AFB^ have been tested  for carcinogenic activity  in




rats and rainbow  trout.  The relative carcinogenic potency follows the
                                       28

-------
order:  AFBj _>. AFL » AFMj in the rat and AFBj > AFL > AFMj > AFQj in the




rainbow trout.  Studies by Sinnhuber and associates using rainbow trout of the




Mt. Shasta strain indicated that aflatoxicol (AFL)  was close to one half as




potent as AFBj.  At 8 months, the incidence of hepatomas at 8 months in fish




fed 29 ppb AFL was 26% compared to 56% in fish fed  20 ppb AFBj.  At 12 months,




the difference (81% for AFL versus 83% for AFBj) was less evident because the




carcinogenic response to AFB, was near maximum expression.  An unnatural




diastereomer (AFL1) of AFL, obtained by chemical reduction of AFBi, was con-
                           *                                     1



siderably less carcinogenic than (about 15% as active as) its natural isomer;




the incidences of hepatomas in fish fed 61 ppb AFL1 were 0 and 24% at 8 and 12




months, respectively (180).  Comparison of the hepatoma incidences at 12




months (13% versus 48%) in rainbow trout of the Mt. Shasta strain, fed 4 ppb




AFMj or AFBj,  suggested that AFMi was about one third as potent as AFB^




(177).  In a comparative study (178) using the less susceptible strain of




rainbow trout obtained from the Netherlands AFM, appeared to be even much less




potent, at least 20-30 times less than AFBj.  Aflatoxin Qi has a potency about




l/100th that of AFBj in Mt. Shasta strain rainbow trout; only 11% of the fish




fed a diet containing 100 ppb of the compound developed hepatomas after 12




months compared to 48% of the fish fed 4 ppb AFB^ (179).  In studies using




male Fischer rats, Wogan and Paglialunga (193) found that a synthetic, racemic




mixture of AFM^ was a very weak carcinogen.  Only one of  29 rats given the




AFMi mixture by stomach tube in 40 doses totalling  1 mg developed a hepatocel-




lular carcinoma at 96 weeks.  For comparison, all the 9 rats given a total




dose of 1 mg AFBj developed liver tumors within 53  weeks.  Nixon £t__al_. (192)




reported  the unexpected finding that a synthetic, racemic mixture  of AFL was




highly carcinogenic in male Fischer  344 rats.  The  incidences of  liver tumors




were  20 and 70% in rats fed diets containing  50 and 200  ppb AFL:AFL' mixture
                                      29

-------
(equivalent to a total dose of 0.279 or 1.12 ing),  respectively, compared to




40% of rats fed 50 ppm AFBj.  Considering the fact that  the racemic mixture




contains 50% of the considerably less active, unnatural  diastereomer (AFL1),




the data suggest that in male Fischer 344 rats the natural diastereomer (AFL)




may be nearly as carcinogenic as AFBj .





     Six derivatives and structural analogs of AFBi ,  namely, tetrahydrodeoxy-




AFBj , 5 , 7-dimethoxycyclopentenone [ 2 , 3-c ] coumarin ,  5 , 7-d imethoxycyclopente-




none[3,2-c]coumarin, 5,7-dimethoxycyclopentenone[c]coumarin, isobergaptene and




7-ethoxy-4-raethylcoumarin (see Table VII for structural  formulas) have been




tested for carcinogenic activity in either the rat or the rainbow trout by




oral administration.  With the exception of a questionable carcinogenic activ-




ity (a tumor incidence of only 1%)  of tetrahydrodeoxy-AFBj in the rainbow




trout, none of these compounds exhibited any carcinogenic activity.  These




results suggest that in AFBi the coumarocyclopentenone moiety is not directly




responsible for the carcinogenic activity of AFBj, but is necessary for pro-




viding a favorable molecular size,  shape and/or electronic structure.
     Comparative carcinogenicity studies on aflatoxins Bj, Gj and 62*




several metabolites and derivatives of AFBi have been carried out in rodents




also by subcutaneous injection and topical application (see Table VIII).  Like




the studies involving oral or intraperitoneal administration, bioassays by




subcutaneous administration indicate that the carcinogenic potency of the




three naturally occurring aflatoxins follows the order:  AFBj > AFGj » AFB£




(inactive).  A study by Dickens and Jones (137) showed that AFBj (20 ug doses,




twice weekly for up to 65 weeks) induced tumors in more rats and more rapidly




than equal doses of AFGj.  Local sarcomas were found within 18-37 weeks at the




site of subcutaneous injection in 6 of 6 rats given AFB,.  Four of 6 rats




given AFGj developed local sarcomas, with the first appearing at 30 weeks and






                                      30

-------
the last at 50 weeks.  Wogan _et^ _al_. (64) induced local sarcomas in 9 of 9 rats




by twice weekly s.c.  injections of 10 ug AFBj for 20 weeks.  Aflatoxin B2> at




30 times higher doses, induced no tumors in rats after 78 weeks.





     Structure-activity correlation and metabolism studies have strongly




implicated the highly unstable metabolite AFBj-2,3-oxide as the probable




ultimate carcinogen of AFBi.  To test this hypothesis, Swenson et al.  (123)




synthesized a 2,3-dichloro derivative of AFB, and showed that the derivative




had chemical properties (e.g. , electrophilic carbon-2, high reactivity, rapid




hydrolysis, interaction with nucleic acid or protein) expected for AFB^-2,3-




oxide.  Comparative carcinogenicity studies indicated that 2,3-dichloro-2,3-




dihydro-AFBi was indeed a more potent direct-acting carcinogen than AFBj.




Subcutaneous injection of a total dose of 0.13 or 0.64 iimole 2,3-dichloro-2,3-




dihydro-AFB, led to the induction of local sarcomas after 20 months in 6/15




and 12/15 rats, respectively;  the corresponding incidences for AFBj were 0/15




and 5/15.   In mouse skin carcinogenesis studies, 2,3-dichloro-2,3-dihydro-AFB^




was active  as a "complete" carcinogen (while AFBj was not) and was a more




potent  skin tumor-initiator than AFBj.  Among the hydrolysis products of




2,3-dichloro-2,3-dihydro-AFB1, aflatoxin B2a had a marginal skin tumor-




initiating  activity while the chlorohydrin (2,3-dihydro-2-hydroxy-3-chloro-




AFBj) and the dihydrodiol (2,3-dihydro-2,3-dihydroxy-AFBj) were devoid of




tumor-initiating activity.





      5.3.1.1.3.5  STERIGMATOCYSTIN,  VERSICOLORIN AND  RELATED COMPOUNDS.





      The carcinogenicity of sterigmatocystin has been tested in three  species




of rodents  and  two species  of  fish.  The  compound  is  carcinogenic  in mice,




rats, rainbow trout and medaka;  its  potency  is  generally  lower  than that  of




AFBj.   The  results of  the  studies  on sterigmatocystin and several  of  its




derivatives are summarized  in Table  IX.
                                       31

-------
                                Table  IX
Carcinogenicity of Sterigmatocystin, Versicolorin and Related Compounds
Compound
Sterigmatocystin
















Dihydrosterigmato-
cystin
0-Methyl Sterigmato-
cystin
0-Acetyl sterigraato-
cystin
Versicolorin A


Versicolorin B
Species and Route
Mouse, oral
Mouse, s.c.


Mouse, oral
Rat, oral


Rat , i . p .

Rat , s.c.

Rat, topical
Guinea pig, oral
Rainbow trout ,
embryo exposure
Medaka, oral
Rat, i.p.
Medaka, oral
Medaka, oral

Rat, i.p.

Rainbow trout,
embryo exposure
Medaka, oral
Medaka, oral
Principal
Organs Affected
Lung
Liver, brown fat
tissue, multiple
sites
Lung, liver
Liver, miltiple
sites
Liver
Peritoneum,
liver
Local sarcoma,
liver
Skin, liver
None
Liver

Liver
None
None
Liver

Liver

Liver

Liver
None
References
(194)
(195)


(196)
(197)

(198-200)
(201)

(138)

(197)
(202)
(185)

(203)
(201)
(203)
(203)

(201)

(185)

(203)
(203)

-------
     Zwicker et al.  (194)  fed groups of three-week-old ICR Swiss mice of both




sexes diets containing 5 ppm sterigmatocystin  (in pure form or in a rice




culture of Aspergillus versicolor)  for periods of two weeks alternating with




two-week periods on  control  diet,  for a total  of 54-58 weeks.   Pulmonary




adenomas developed in 21/25  (84%)  and 33/55 (60%) of the treated mice, respec-




tively, compared to  4/37 (11%) in  control mice.   There was no  significant sex




difference in the incidence  of pulmonary adenomas.  Pulmonary  adenocarcinoraas




were also observed in 9/25 (36%) and 3/55 (6%) of the treated  mice, but not  in




control mice.  In the group  fed pure sterigmatocystin, most of the pulmonary




adenocarcinomas developed  in female mice (8/10 females vs. 1/15 males).  The




incidence of other tumors  was not  affected by  feeding the mycotoxin.  Enomoto




et ^1. (195) confirmed the carcinogenicity of  sterigmatocystin using female




(C57BL/6NCr x DBA/2NCrj)Fj mice.   However, the principal carcinogenicity




target tissues of the compound in  this strain  of mice are the  liver and the




dorsal brown-fat tissue (which is  known to be  rich in vascular tissue), with




angiosarcoma the predominant tumor type.  Of the 53 mice that  survived more




than 43 weeks of feeding 30  ppm sterigmatocystin (equivalent to a daily intake




of about 2.5 mg/kg body weight),  34 (64.2%) developed hepatic  angiosarcomas,




14 (26.4%) had hepatic hemangioendotheliomas and 6 (11.3%) had angiosarcomas




in the subcutaneous  brown-fat tissue located between the bilateral scapulas  of




the back.  When exposed to a higher dose, 120  ppm, 27/51 (52.9%) of the mice




developed angiosarcomas in the dorsal brown-fat tissue.  Interestingly, no




angiosarcomas of the liver were found in the high-dose group.   A few angio-




sarcomas of the ovary and the lung, and increases in the incidences of lung




and hepatocellular adenomas  were also observed in both test groups.  Newborn




mice are much more susceptible to  the carcinogenic effects of sterigmatocystin




in agreement with the results of carcinogenicity studies with AFB^  (see
                                      32

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Section 5.3.1.1.3.3 above).   Fujii _et_ al_. (196) reported that a single s.c.




injection of 5 or 1 iig/kg body weight sterigmatocystin (suspended in 1%




gelatin solution) to (BALB/c x DBA/2)Fj mice within 24 hours after birth gave




rise to a significant increase in the incidence of lung and liver adenomas in




the animals sacrificed at the end of one year.  There was a sex difference in




the incidences of these tumors, with males being substantially more suscept-




ible than females.  The results show that even a very small dose of sterig-




matocystin may be tumorigenic in newborn animals.





     Rats are relatively more susceptible to the carcinogenic effects of




sterigmatocystin than are mice.  Purchase and Van der Watt (197) administered




to weanling Wistar-derived rats daily doses of 0.15-2.25 mg sterigmatocystin




(about 88% pure) in the diet (10-150 ppm) or by gavage, 5 days/week for 52




weeks.  Among the rats that survived more than 42 weeks of treatment, 39/50




(78%) eventually developed hepatocellular carcinomas.  Eight other types of




tumors were found in the uterus, ovary, omenturn and liver; moreover,




acanthotic changes occurred in the stomachs of 30 out of 39 rats examined.




The acanthomas were not considered malignant, although "pearls" and marked




folding of the basal cell layers were observed.  No tumors occurred in 19




control rats.  Based on a comparison of tumor yield, Purchase and Van der Watt




(197) concluded  that sterigmatocystin is at least one tenth as potent as AFBj




in this strain of rats by oral administration.  The potent hepatocarcinogenic-




ity of sterigmatocystin in rats has also been demonstrated by using rice




contaminated with Aspergillus versicolor.  Enomoto et_ _al_.  (198) reported  that




hepatic tumors developed in 2/6 Fischer rats  fed moldy rice containing only  1




ppm sterigmatocystin for 40 weeks.  Ohtsubo et al. (199)  found hepatic tumors




(mostly hepatocellular carcinomas) in 23/36 male Donryu  rats  given  a  diet  to




which moldy rice culture was  added to provide 5  or 10  ppm sterigmatocystin
                                       33

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(equivalent to daily intake of 75 or 150 ug/rat)  for 709 days beginning at




about 6 weeks of age.   The average latent period  was 470 days.  These authors




(199) considered sterigmatocystin a carcinogen nearly equipotent to AFBj.




Maekawa^jiK (200) fed 11-week-old male ACI/N rats a diet containing 0.1, 1




or 10 ppm pure sterigmatocystin for their lifespan.   Liver tumors were




observed in the 1 ppm and 10 ppm groups; however, the incidences (1/29 and




5/26, respectively) were substantially lower than those reported in the




studies described above.  The authors (200) suggested that ACI/N rats may be




more resistant to the hepatocarcinogenic effect of sterigmatocystin than the




other strains.  Moreover, the age of the animals  at  the start of the experi-




ment also plays a role in susceptibility to carcinogenesis.





     In addition to its systemic hepatocarcinogenic  activity, sterigmatocystin




displays direct-acting carcinogenic activity in rats.  Dickens ^t^ _al^ (138)




injected subcutaneously 0.5 mg sterigmatocystin to a group of 6 rats twice




weekly for 24 weeks.  Local sarcomas were observed in 3/6  animals at the end




of the 65-week study; no such tumors occurred in  control rats.  However,




sterigmatocystin is a substantially weaker local  carcinogen than AFBi in the




rat by subcutaneous route.  Dickens et al. (138)  considered a 0.5 mg dose of




sterigmatocystin to be comparable to a 2 ug dose of AFB,.  Purchase and Van




der Watt (204) applied 1 mg sterigmatocystin (dissolved  in dimethyl sulfoxide




or acetone) onto the shaved dorsal skin of male Wistar-derived  rats twice




weekly for 70 weeks.  By 40 weeks, skin papillomas developed  and by 70 weeks




all  skin-painted rats had either  papillomas (7/20 rats)  or squamous cell




carcinomas (13/20 rats).  None of the control animals had  any skin tumors.




The  authors  (204) emphasized  the  potential carcinogenic  risk  of human exposure




through skin contact.  Terao  (201) injected approximately  1 mg  sterigmato-




cystin (dissolved in a 50% aqueous solution of dimethyl  formamide)  into the
                                      34

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peritoneal cavity of 40 male Wistar rats once a week for 23 weeks and observed

the animals for an additional 57 weeks.   Twenty-five rats were alive at 20

weeks, 21 at 40 weeks and 5 at 80 weeks.  Twenty of the rats developed meso-

theliomas in the peritoneal cavity with  the first tumor appearing at 40

weeks.*  None of the 30 control rats had any mesothelioma.  In each of the

above three studies, liver tumors were also observed in the rats, but the

incidences (2/6 in the study by Dickens  etal., 12/20 in the study by Purchase

and Van der Watt, and 1/40 in the study  by Terao) were lower than those of

local tumors.

     In addition to mice and rats, sterigmatocystin has been tested for car-

cinogenic activity in guinea pigs, rainbow trout, and medaka (Orizias latipes,

a small aquarium fish).  Mabuchi (202) reported that guinea pigs were very

sensitive to the toxicity of the mycotoxin but no tumors developed.  Hendricks

et al. (185) exposed 14-day rainbow trout (Salmo gairdneri) embryos to an

aqueous suspension of 5 ppm sterigmatocystin for one hour and observed 1 year

later a 13% incidence of hepatocellular carcinomas (compared to 0% for

controls) among survivors.  The relative carcinogenic potency of sterigmato-

cystin was estimated to be about one fourth of that of AFB,.  Terao et al.

(203) gave medaka a diet containing 5 ppm sterigmatocystin  for 12 weeks and a

control diet for an additional  12 weeks.  At 24 weeks, when the medaka were

killed, 10/18 (56%) of the fish were found to have hepatomas.
 *The  induction  of mesotheliomas by  sterigmatocystin  is  highly unusual  in view
  of the  fact that virtually all mesothelioma-inducing substances  are in fibrous
  or in crystalline  form  (see  Section  5.5).  Although sterigmatocystin  is known
  to form fine needle-like crystals  in a  50% aqueous  dimethylformamide  solution,
  two  closely related  analogs  (dihydrosterigmatocystin and  0-acetylsterigmato-
  cystin) fail to induce mesotheliomas under similar  condition.


                                       35

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     Only three derivatives of sterigmatocystin have been testecMror carcino-

genic activity.  Dihydrosterigmatocystin was found inactive in both rats and

raedaka (see Table IX) indicating that, like aflatoxins, the presence of a

double bond in the terminal furan ring of sterigmatocystin is an essential

structural requirement for carcinogenicity.  0-Acetylation of sterigmatocystin

appears to modify the carcinogenicity target tissue of the mycotoxin admini-

stered intraperitoneally to rats.  Terao (201) reported that 0-acetylation

eliminated the local carcinogenic activity of sterigmatocystin in the peri-

toneal cavity, but enhanced its hepatocarcinogenic activity.  He suggested

that 0-acetylsterigmatocystin may be readily absorbed from the peritoneum,

thus eliminating the possibility to display local carcinogenic effects.

Another 0-substituted derivative, 0-methylsterigamtocystin, has been tested by

feeding to medaka (203).  Under comparable conditions (5 ppm in diet for 12

weeks followed by 12 weeks control diet), the 0—methyl derivative induced

slightly more hepatomas (18/27 medaka, or 66%) than the parent compound (10/18

medaka, or 56%).  Versicolorin A, a biosynthetic precursor of sterigmato-

cystin, has also been tested in the same study; the compound was only weakly

carcinogenic inducing hepatomas in 3/44 (7%) medaka.  Versicolorin B, the

dihydro derivative of Versicolorin A, was completely inactive indicating the

requirement of double bond in the terminal furan ring for carcinogenic activ-

ity.  Versicolorin A has also been shown to be hepatocarcinogenic in rainbow

trout.  Hendricks et al. (185) exposed 21-day trout embryos to 3% dimethyl

sulfoxide  solutions containing 5 or 25 ppm Versicolorin A and observed hepato-

cellular carcinoma incidences of 42 and 68%, respectively, among survivors

after one  year.  The authors (185) estimated that the carcinogenic  potency  of

versicolorin A is between  1/50 to 1/16 of that of AFBj.  In the same study,
               *
the carcinogenic potency of sterigmatocystin is about one-fourth of that  of
                                      36

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AFBj.  Thus, the study of both lerao et_£l_. (203)  and Hendricks et_ al_. (185)




indicate that the linearly annelated (acene-type)  versicolorin A is less




carcinogenic than the angularly annelated (phene-type) sterigmatocystin.





     5.3.1.1.3.6  MODIFICATION OF AFLATOXIN CARCINOGENESIS.





     The carcinogenicity of aflatoxins may be modified by a variety of host




and environmental factors.  These include hormonal status, nutrients, simul-




taneous exposure to environmental chemicals, viral infection as well as (arti-




ficial) sunlight.  The study of these factors is of great importance in




assessing the carcinogenic risk of human exposure to aflatoxin in the environ-




ment and in developing strategies for cancer prevention.  A comprehensive




review of the factors that may modify aflatoxin carcinogenesis has been pub-




lished by the World Health Organization (33) in 1979.  In this subsection,




only the major findings of modification studies are discussed, with emphasis




on recent studies.  A more detailed discussion will be presented in Vol. IV of




this series of monographs.





     Effect of diet.  Dietary modification of aflatoxin carcinogenesis has




attracted much attention in view of the occurrence of nutritional deficiencies




in certain parts of the world where aflatoxin exposure can be considerable.




The dietary factors studied include protein, lipid, lipotropic agents,




vitamins, and natural and synthetic dietary components.





     The effect of dietary protein on AFBj-induced hepatocarcinogenesis has




been studied by a number of investigators.  Early studies  in  1966  and  1968 by




Newberne _e£_al_. (163, 205) indicated that rats maintained  on  a low (9%)




protein diet developed more tumors in a shorter time  in  response to AFB,  than




those maintained on a high (20%) protein diet.  However,  subsequent studies




tend to support the opposite view.  Madhavan and GopaIan  (206) reported that
                                      37

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AFBj-treated rats fed a 5% casein diet developed fewer liver tumors than those




fed a 20% casein diet.  Wells et al.  (207)  maintained rats on diets with three




different levels of casein and found that the incidence of AFBj-induced liver




tumors increased as the level of dietary protein increased.  Lee et al. (208)




found that the incidence of AFBi-induced hepatoma was significantly higher in




rainbow trout fed a diet containing 49% fish protein than those fed a 32%




protein diet.  Bailey _et_^U (181) showed that the enhancing effect of protein




diet on AFBi hepatocarcinogenesis was even more dramatic with higher protein




concentration; the 9-month hepatoma incidences in rainbow trout fed 20 ppb




AFBj and a 40, 50, 60 or 70% protein diet were 33, 48, 68 and 90%, respec-




tively.  The enhancing effect was evident even in fish exposed to AFBj as




embryos and then reared on high protein diets suggesting that high protein




enhanced transformation following DNA damage by AFB,.  There is some evidence




that low dietary protein inhibits the initiation (adduct formation) stage




(209) as well as the promotion stage (210) of AFBi hepatocarcinogenesis in the




rat.  In the rainbow trout, high dietary protein has no significant effect on




covalent binding of AFB, to  liver DNA suggesting that it enhances hepatocar-




cinogenesis through a promotional mechanism (181, 191).





     There  is growing evidence that dietary lipids may play a significant




contributory role  in the induction of cancer (this topic will be discussed in




detail in Vol.  IV  of this series of monographs).  Specially interesting




constituents of lipids, principally of plant origin, are the cyclopropenoid




fatty acids  (CPFA).   Studies by  Sinnhuber  and associates have shown that  CPFA




act  as potent synergists or  promoters in hepatocarcinogenesis by AFBj  (180,




181, 211),  AFMj (177), AFQj  (179), and AFL (180)  in rainbow trout.  For




example, in a 9-month feeding study, the incidence of hepatocellular  carci-




nomas was 0%  for  fish fed 0.5 ppb  AFB^  2% for  fish fed  20 ppm  CPFA but
                                       38

-------
increased to 63% for fish fed 0.5 ppb AFBj plus 20 ppm CPFA (181)._ The




enhancing effect of CPFA on AFBj in rats, however, appears to be much less




prominent (212) or negligible (213, 214).  The major constituents of CPFA are




malvalic acid and sterculic acid.  They occur in triglycerides of plants in




the order Malvales (215) and may be present in human foods derived from




cottonseed or kapok oil (181).





     Newberne and Rogers have studied the modifying effect of lipotropic




agents on AFBj carcinogenesis in rats.  Diets high in fat and marginally




deficient in the lipotropic agents methionine, choline and vitamin B,^ pro-




tected rats against the acute toxic effects of AFBj, but enhanced the inci-




dence of liver tumors and shortened the latent period of tumor induction (216-




218) .  The enhancing effect was attributed to marginal deficiency in lipo-




tropic agents because high dietary fat content alone appeared to inhibit




rather than contribute to enhancement of AFBj carcinogenesis (Rogers et al.,




cited in 33).  However, in other experiments severe dietary deficiency in




lipotrops caused inhibition rather than enhancement of AFB^ carcinogenesis




(218, 219).





     Several vitamins and micronutrients have been tested as potential modi-




fiers of aflatoxin carcinogenesis.  Temcharoen et al. (220) reported that




dietary  supplementation with  vitamin  B,~ (a weakly lipotropic agent) enhanced




liver tumor incidence in rats fed a mixture of AFB^ and AFGj and maintained on




a  20% protein diet; however,  in  rats  maintained on a  5% protein diet, vitamin




Bio  appeared to reduce rather than enhance tumor  incidence.  Newberne and




Rogers  (172) showed that marginal deficiency  in vitamin A had no  significant




effect on AFBj hepatocarcinogenesis in rats; however, an  apparent  increase in




the  incidence of colon carcinomas was observed.   This finding was confirmed in




a  further study by Newberne and  Suphakarn  (221);  moreover,  supplementation






                                       39

-------
with excessive vitamin A had no protective effect against AFB,  carcinogenesis




in either the liver or the colon.  Dietary selenium (222) and ascorbic acid




(223) also appeared to have no effect on AFB^ carcinogenesis in rats.   There




is some evidence that photosensitized riboflavin may protect rat against AFBj




hepatocarcinogenesis (see discussion on "Effect of other environmental




factors").





     Sinnhuber and associates have examined the ability of a number of natural




and synthetic dietary components to modify AFBj hepatocarcinogenesis in rain-




bow trout.  Several flavonoid and indole compounds such as  ^-naphthoflavone,




indole-3-carbinol, and possibly quercitin and a tangeritin-nobilitin mixture




have been shown to inhibit AFB, hepatocarcinogenesis when fed prior to and




during AFBi exposure (181).  On the other hand, dietary cruciferous vegetables




(such as cauliflower, broccoli, brussel sprouts) and associated isothiocyanate




compounds does not exhibit any modifying activity (224).  The possible




mechanism by which  A-naphthof lavone inhibits AFB, hepatocarcinogenesis in




trout has been explored (181).  The mechanism of this inhibition by




 ft-naphthoflavone  (a well known  inducer of microsomal mixed-function oxidases)




appears to be to redirect AFBi metabolism from the production of the highly




carcinogenic metabolite, aflatoxicol to the less carcinogenic metabolite,




AFMj.  In the rat, there is some evidence that dietary cauliflower and cabbage




act  as inhibitors  of AFB^ hepatocarcinogenesis, whereas  ingestion of beets as




part of the diet has the opposite effect (168, 225); the mechanisms of these




modifying effects  remain to be elucidated.





     Effect of hormones.  Investigations with aflatoxin-contaminated  feed or




purified AFBj suggest that, in some  strains of rats  (e .g. ,  Fischer),  females




are  less susceptible to AFBi hepatocarcinogenesis than males (e.g., 140,




 163).  Consistent  with this finding, Newberne and Williams  (226) noted  that






                                       40

-------
the incidence of AFB^-induced liver carcinomas in male rats was significantly




reduced from 71% to 20% by simultaneous oral administration of the synthetic




estrogen, diethylstilbestrol.  Cardeilhac and Nair (227) reported that castra-




tion of male rats soon after weaning abolished the hepatocarcinogenic response




of the rats to a combined treatment of AFB^ and carbon tetrachloride (which




act synergistically).   In vitro DNA binding studies by Gurtoo et al. (228)




indicate that the sex difference in susceptibility is associated with dif-




ference in the binding of AFBi to DNA.  Besides castration, hypophysectomy has




a dramatic modifying effect on the carcinogenic response of rats to AFBi.




Goodall and Butler (229) showed that 14 of 14 rats fed 4 ppm AFBj developed




liver carcinomas within 49 weeks, whereas none of the 14 hypophysectomized




rats developed tumors at the same time period despite receiving slightly




higher amounts of AFBj.  Hypophysectomy of rats has also been shown to inhibit




in vivo binding of AFBj to DNA (223).





     Effect of chemical agents.  A variety of pharmacologically active com-




pounds have been tested for their ability to modify or act synergistically




with aflatoxin carcinogenesis.  Carcinogens which are known at present to act




synergistically with AFBj are ethionine (in rats) (205), AFB2 (i-n trout)




(176), carbon tetrachloride  (in mice)  (230) and cyclopropenoid fatty acids  (in




rainbow trout) (181).  There  is no evidence for syncarcinogenesis between




urethan and aflatoxin in rats (231).   Lasiocarpine, a pyrrolizidine alkaloid,




alters the histopathology but does not affect the incidence of AFBj-induced




liver tumors  in  rats  (232).   In contrast, o^-hexachlorocyclohexane  (c<-BHC)  is




a potent inhibitor of AFBj hepatocarcinogenesis (167) possibly by inducing




enzymes detoxifying AFBj.   in mouse  skin carcinogenesis  studies, AFB^  showed




tumor-initiatory activity which can be promoted by croton  oil  (233).   There is




some evidence that  3-methylcoumarin  (a noncarcinogenic  compound  which  is
                                      41

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structurally related to AFBj)  may function as cocarcinogen when fed simul-

taneously with AFBi  to trout (176).


     Phenobarbital,  an inducer of microsomal mixed-function oxidases, has been


shown in two studies (142,  223) to inhibit AFBj hepatocarcinogenesis in

rats.  In another study in  which rats and Syrian golden hamsters were fed


large doses of AFBi, phenobarbital apparently had no modifying effect (169).

Novi (234) reported  the interesting finding that reduced glutathione admini-


stered JJ__t£_2^jn££ths_afte_r_ AFB^ treatment to rats, bearing AFBj-induced

liver tumors, caused regression of tumor growth.  Novi recommended further

investigation on the use of glutathione as a potential antitumor drug.
                                       0

     In addition to  the studies reviewed above, a number of other mycotoxins


have been tested as  potential modifiers of AFBj carcinogenesis.  Rubratoxin B

displayed no effect  on AFB, carcinogenesis when fed simultaneously with AFBj

to rats for 60 weeks (64).   Two Fusarium toxins (T-2 toxin and diacetoxy-

scirpenol) were ineffective as tumorigenesis promoters in mouse skin initiated

by painting with AFBj (233).


     Effect of other environmental factors.  The effect of exposure to light


on the carcinogenicity of AFBi was investigated by Joseph-Bravo et al.

(166).  Two groups of rats were given intragastrically a very large dose of

riboflavin, followed by 25 jug AFBi 5 days/week for 3 weeks.  Thirty minutes


after dosing with AFB,, one group of rats were irradiated for 2 hours with

artificial sunlight  and the other group served as unirradiated control.  At

the end of the 53-week study, all (11/11) unirradiated rats developed liver

tumors whereas only 5 of 12 irradiated rats had such lesions.  The investi-

gators postulated that photosensitized ribloflavin may complex with AFB^ and

prevents its activation to a carcinogenic metabolite.  Lin et al.  (188)
                                      42

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studied the long-term effects of a combined exposure to AFB,  and viral

hepatitis on marmoset liver.   Liver cirrhosis was  much more severe after

exposure to both AFB^ and hepatitis virus than after exposure to either agent

alone.  However, the effect of combined exposure on carcinogenesis appears to

be nil:  liver tumors were observed in 2/7 marmosets given AFBj and hepatitis

virus, 3/9 marmosets given AFBi alone and 0/7 marmosets given the virus alone.


     5.3.1.1.4  Metabolism and Mechanism of Action


     5.3.1.1.4.1  METABOLISM


     It is now generally accepted that most of the toxic actions, particularly

carcinogenicity and mutagenicity, of naturally occurring aflatoxins require

metabolic activation.  Owing to their potent carcinogenicity and ubiquitous
i
environmental occurrence, the metabolism of aflatoxins has been extensively

studied.  The role of metabolism in the activation of aflatoxins has been the

subject of many reviews (e.g., 32-34, 44, 46, 49).


     Metabolism of Aflatoxin B, (AFBj).  Aflatoxin Bj is actively metabolized

in a variety of animal species.  Figure 1 depicts  the map of known metabolic

pathways of AFB^.  The relative importance of each individual pathway varies

substantially depending on the animal species and  the experimental condi-

tions.  Essentially, initial metabolism of AFB, involves three  principal types

of reactions:   (a) hydroxylation,  (b) epoxidation, and  (c) ketoreduction.  The

former  two reactions are believed  to be carried out principally by a micro-

somal mixed-function oxidase system while the latter by a cytosolic NADPH-

dependent reductase.  In most  animal species, the hydroxylated  AFB, metabo-

lites may undergo phase II metabolism by conjugating with glucuronic  acid or

sulfate.  The role of each individual metabolic pathway in the  overall  toxic

effects of AFBj is discussed below.
                                      43

-------
         0    OH
         II
              0
OH
                                             OCH3

                                  Aflatoxicol(AFL)
               0    OH
  GSH-conjugate'
                                 AFBr2,3-oxide
Covalent binding to DMA,

  RNA and protein
                                                               SrXX'^^OH
                                                                  AFPi
                                                0    0
                                                II
                                                                          0'
                                                           HO,
icrV^

  AFBr2,3-dihydrodiol
                    Fig.  1.  Metabolic pathways of aflatoxin B

-------
                              Legend to Figure 1              -	









     Fig. 1.  Metabolic pathways of aflatoxin Bj.   (Aflatoxin Bj metabolites




containing 2,3-double bond can be further metabolized to corresponding




2,3-oxide.  The conversion of AFBi  to AFBoa predominantly occurs nonenzyraatic-




ally under acidic condition.  Both AFB2a and AFB1~2,3-dihydrodiol can bind




covalently to protein via Schiff base formation.)

-------
     Epoxidation of the 2,3-double bond (or 8,9-double bond by _the__IUPAC




nomenclature) of AFBi is now generally accepted to be the key metabolic reac-




tion eliciting the carcinogenic or mutagenic effect of the mycotoxin.  That




the 2,3-double bond is a critical structural requirement for carcinogenicity




and mutagenicity has been pinpointed by structure-activity relationships




studies on a variety of structural analogs of AFBj (see Section 5.3.1.1.2.2




and 5.3.1.1.3.4).  Moreover, quantum mechanical calculations have shown that




the 2,3-double bond is the most reactive site in the molecule (32, 51).




Although attempts to isolate the putative reactive intermediate, AFBi-2,3-




oxide, have been unsuccessful because of its instability, its formation can be




deduced from its reaction products with cellular constituents and its hydrol-




ysis products.  Aflatoxin Bi binds covalently to nucleic acids after in vitro




metabolic activation by liver microsomes (53, 55, 235-239) as well as in in




vivo studies (49, 191, 223, 238, 240-243).  The major acid hydrolysis products




of AFBj-DNA adducts were identified as 2,3-dihydro-2-(N7-guanyl)-3-hydroxy-




aflatoxin Bi and 2,3-dihydro-2-(2,6-diaraino-4-oxo-3,4-dihydropyrimid-5-yl-




formamido)-3-hydroxyaflatoxin B^ (see Section 5.3.1.1.4.2) indicating the




involvement of AFB^-2,3-oxide.  In the absence of exogenous nucleophiles,




2,3-dihydro-2,3-dihydroxyaflatoxin B^, an expected hydrolysis product of




AFB^-2,3-oxide, is a major metabolite in the incubation of AFBj with rat,




hamster and trout liver microsomes (244-247).  An AFB^-GSH conjugate, tenta-




tively identified as 2,3-dihydro-2-(_S_-glutathionyl)-3-hydroxyaflatoxin  Bj was




also detected as an  in vitro as well as in vivo metabolite of AFBj in the




rat.  The AFBj-GSH conjugate accounted for about  10% of the administered AFBj




dose  in this study  (248).





     The hepatic microsomal enzyme system that  catalyzes  2,3-epoxidation of




     exhibits the typical characteristics of a mixed-function oxidase  (239,
                                      44

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249, 250).  Pretreatment of animals with phenobarbital (but not with 3-methyl-




cholanthrene) greatly enhances the in vitro formation of adducts of AFBj with




nucleic acids (235, 239, 249, 251, 252) suggesting the involvement of a cyto-




chrome P-450-dependent system.  However, somewhat inconsistent results have




been obtained from reconstitution experiments using purified cytochromes.  In




two of these studies (253,  254) purified hepatic cytochrome P-448 species




obtained from polychlorinated biphenyl- or 3-methylcholanthrene-treated rats




were more effective than purified phenobarbital-induced cytochrome P-450, in




catalyzing the formation of a reactive intermediate that binds to DNA or




exerts a mutagenic effect.   In a third study (247), purified phenobarbital-




induced rat liver cytochrorae P-450 was more active than  /3-naphthof lavone-




induced cytochrome P-448 in catalyzing the formation of AFBj-DNA adduct.  A




purified form of trout liver cytochrome P-450 was found to be at least 10




times more active than rat  liver P-450.  There are also discrepancies between




in vitro and in vivo studies; the in vivo formation of AFBi-DNA adducts was




reduced rather than enhanced by phenobarbital pretreatment (223, 240).  The




difference was attributed to a possible change in the pharmacokinetics of AFB,




metabolism with more metabolism proceeding via detoxification pathways (such




as conversion to AFQ^ which  is also enhanced by phenobarbital) in the animal,




than in an in vitro system in the presence of excess substrate and cofactors




(240).  In this respect, it  is interesting to note that the apparent K   for




conversion of AFBj to AFQj (l^ = 0.07 mM) by rat liver microsomes (255)




appeared to be substantially  lower than that of metabolic  activation of  AFB^




to DNA-binding metabolites (l^ = 1-97 mM) (256).  Besides  liver microsomes,




rat liver nuclei  (257,  258)  and mitochondria (259, 260) have  also been  shown




to contain mixed-function oxidase systems that are capable of catalyzing




covalent binding  of AFBj to  DNA.  In view of the high  reactivity  and  insta-
                                      45

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bility of AFBj-2,3-oxide, nuclear activation is potentially more important in




the covalent binding of AFBi  to DNA than microsomal activation, because of




spatial proximity.  Mitochondrial activation may also be of great importance




because of the presence of mitochondria! DNA.  In fact,  a recent study by




Niranjan _et^ jil^ (261) showed that the in vivo covalent binding of AFB, to




mitochondrial DNA was three to four times higher than that of nuclear DNA (see




Section 5.3.1.1.4.2).





     The formation of 2,3-dihydro-2,3-dihydroxyaflatoxin B^ (AFBj-dihydrodiol)




as an in vitro metabolite of AFBi was not demonstrated until relatively




recently.  The difficulty stems from the fact that the dihydrodiol is highly




unstable at alkaline or neutral pH, and may bind to microsomal protein, gluta-




thione or amines (including the widely used tris-hydroxymethyl aminomethane




"Tris" buffer).  Lin ^t_ ^1_. (244) found that less than 3% of AFBj was con-




verted to AFB,-dihydrodiol when incubated with rat and hamster liver micro-




somes and NADPH (at pH 6.5) in the absence of an exogenous nucleophile.  Much




smaller amounts of the dihydrodiol were detected at physiological pH or in the




presence of exogenous DNA.  Addition of inhibitors of epoxide hydrase to the




incubation medium did not lower the yield of the dihydrodiol, suggesting that




the hydrolysis of AFBj-2,3-oxide to the dihydrodiol is mainly nonenzymatic.




Neal and Colley (246) presented evidence that AFBj-dihydrodiol is indeed a




major metabolite of AFBj produced by rat liver microsomes, but it is removed




by binding to microsomal proteins.  When Tris is used as  the buffer, most  of




the dihydrodiol binds to Tris, forming Tris-diol.  Williams and  Buhler  (247)




reported that using a purified form of cytochrome  P-450  from trout  liver  in  a




reconstituted system, the formation of AFBj-dihydrodiol  (including  those




trapped by Tris buffer)  accounted  for as much as 72%  of  total  AFBi metabo-




lized.  Besides hydrolysis, reduced glutathione  (GSH) may compete for  inter-
                                      46

-------
action with AFB1~2,3-oxide.   Lotlikar ^ jil^  (262)  observed that the addition


of cytosolic fraction inhibits the hamster hepatic  microsome-mediated covalent


binding of AFBj to DNA.   Depletion of GSH or  heat treatment of the cytosolic


fraction abolishes the inhibitory activity indicating the involvement of


glutathione S-transferase.   The inhibition of AFBj-binding to DNA suggested


the formation of an AFBj-GSH conjugate.  Indeed,  an AFBj-GSH conjugate was


detected as a major in vivo  metabolite of AFB, in the rat (248).


     Besides epoxidation, interconversion between AFBj and aflatoxicol (APL;


also called aflatoxin RQ) may also play a role in AFBj carcinogenesis.  Afla-


toxicol has been shown to be the most mutagenic (see Section 5.3.1.1.2.2) and


carcinogenic (see Section 5.3.1.1.3.3) metabolite of AFB^.  Its carcinogenic


potency is about one-half that of AFBj in the rainbow trout (180) and is only


slightly less than or may be even comparable  to that of AFB, in the rat


(192).  In vitro studies by  various investigators (255, 263-266) have indi-


cated that the conversion of AFB, to AFL proceeds through a NADPH-dependent


reductase present in the cytosolic (100,000 x g)  fraction of liver homogenate


from a number of animal species.  The reaction is reversible (264) possibly


through the action of a NADPH-dependent AFL dehydrogenase (266), which is


inhibited by steroid hormones (267).  Species comparison  studies have shown a


reasonably good correlation between susceptibility to AFBi carcinogenesis and


API-forming activity.  This metabolic pathway is highly active  in two very


susceptible species, the rainbow trout (265,  266) and the duck  (255, 263, 264)


as well as  in rabbits (266) (susceptibility not known), but  is  low or inactive

                   .-•
in less susceptible or resistant species, such as the guinea pig, mouse,


hamster and monkey (255, 266, 268).   In vitro studies, using as enzyme  source


the liver of a highly susceptible species, the rat,  showed  little  (266)  or  no


(255) AFL-forming activity; however,  an in vivo  study by  Wong  and  Hsieh  (268)
                                      47

-------
found that AFL is in fact the major metabolite of AFBj in^rat plasma.  In the




same in vivo study, AFL was not detected in the plasma of AFBj-treated rhesus




monkey and mouse.  In vitro  studies using human liver samples indicated low




(266) or negligible (255) AFL-forming activity.  The finding by Bailey et al.




(181) that /3-naphthoflavone, which protects rainbow trout against AFB^ car-




cinogenesis, alters the metabolic profile by lowering AFL but increasing AFM^




production is consistent with the view that AFL may play a contributory role




in AFBi carcinogenesis.  The possible role by which the AFL pathway may con-




tribute to AFBj carcinogenesis is not clearly understood.  The reversible




nature of the pathway suggests that the formation of AFL may serve as a meta-




bolic storage reservoir of AFB^ (264, 269).  Alternatively, the possibility




that AFL may act as a proximate carcinogen of AFBj cannot be ruled out.





     The metabolism of AFB, to AFM,, AFPi and AFQ, is generally regarded as




detoxification pathways.  Both AFM^ and AFQ^ are substantially less carcino-




genic and mutagenic than AFB, while AFP, is not mutagenic in the Ames test




(see Sections 5.3.1.1.2.2 and 5.3.1.1.3).  Moreover, the hydroxylated metabo-




lites are more polar than the parent compound and are expected to be more




readily excreted.  Conjugation of the hydroxylated metabolites with glucuronic




acid or sulfate  further  facilitates renal excretion.  Aflatoxin M, has been




detected in the milk or urine of the cow (270; rev. 271), sheep (272, 273),




rat  (274), mouse (274), guinea pig (275), monkey  (276, 277)  and of humans




(278) exposed to AFBj.  The excretion of AFMj (which still retains some  car-




cinogenic activity) in the milk of farm animals fed contaminated  feed has been




an agricultural  problem of concern (see Section 5.3.1.1.5.2).  The conversion




of AFBj to AFM^  has also been demonstrated  using  liver microsomal or  post-




mitochondrial fractions  from rats  (251, 256,  279-282), trout  (181), mice




(252), monkey (281, 283), humans  (284), dogs  (266,  282), chickens (281),
                                      48

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hamsters, cows, lambs and pigs (282).  Considerable species differences in


AFMj-forming activity have been observed (266, 281, 282).  The in vitro AFMj-


fortning activity of liver microsomes from rat, mouse and rainbow trout is


markedly enhanced by pretreatment of the animals with 3-methylcholanthrene,


2,3,7,8-tetrachiorodibenzo-p-dioxin, polychlorinated biphenyls, or ft -naphtho-
                                                                   t

flavone (181, 252, 253, 256, 282, 285).  These results, along with studies


using inbred strains of mice with genetically different responsiveness to


enzyme induction (252, 286), suggest that a cytochrome P-448-dependent enzyme


system is responsible for 4-hydroxylation of AFBj to AFMj.  This has been con-


firmed using purified cytochrome P-448 in a reconstitution experiment (253).



     Aflatoxin P^ is a major metabolite (mostly as glucuronide and sulfate) of


AFBj in the urine of monkey following intraperitoneal administration of AFBj


(276).  However, AFP^ is only a minor urinary metabolite when AFBj is given


orally to monkeys (277).  The 0-demethylation of AFBj appears to be a minor


p."t:hway in the in vitro metabolism of AFB, by most animal species.  Aflatoxin


p, was not detected in an in vitro study by Masri et al. (281) using monkey,


rat and chicken liver.  Roebuck and Wogan (255) detected the generation of


AFPi by human, monkey and mouse liver, but not by duck and rat liver, incu-


bated with AFBj.  Dahms and Gurtoo (251), however, reported that mouse liver


microsomes actively 0-demethylate AFBi; the amount of AFPj produced by mouse


liver microsomes was  10 times greater  than that by rat  liver microsomes.


Pretreatment of mouse or rat with phenobarbital slightly increased the in


vitro AFP|-forming activity (251).



     Aflatoxin Qj is  the major  in vitro metabolite produced by human (255,


287), monkey (255, 281, 283), and rat  (251, 255,  256)  liver.  The  in vitro


AFQj-forming activity  is relatively  low using mouse  (251,  2 52 )_or...chicken


(281) liver, and negligible with duck  liver (255).   The  conversion of AFE^  to




                                       49

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AFQj by liver microsomes can be substantially enhanced by pretreatment of




animals with phenobarbital but not with 3-methylcholanthrene, suggesting the




involvement of a cytochrome P-450-dependent enzyme system (245, 251, 252, 256,




281, 285, 288).  However, in reconstitution experiments using purified cyto-




chromes, both cytochrome P-448 and P-450 can convert AFBj to AFQ^ (253).





     Aflatoxin B2a (2,3-dihydro-2-hydroxyaflatoxin Bj) is a potential degrada-




tion product of AFBj.  Being a hemiacetal, AFB2a is unstable at physiological




pH and may readily bind covalently to microsomal protein (see Section




5.3.1.1.4.2).  Aflatoxin &2a ^s relatively nontoxic and nonmutagenic (see



Section 5.3.1.1.2.2); however, it is believed to contribute to the toxic (but




not the carcinogenic) action of AFB, if formed metabolically in target organs




(44).  Aflatoxin B2a can be formed nonenzymatically by acid hydration of AFB,




(52); it has been detected in acidic gastric juices (289) and in urine (290)




of animals fed AFBj.  Several investigators (250, 280, 291, 292) reported in




        •eduction of "AFB2a" from AFBi by rat liver microsomes; the reaction




re^.    • tfADPH and is inhibited by SKF-525A, a typical inhibitor of microsomal




mixed-function oxidases  (250).  However, a more recent study by Lin et al.




(244) indicates that the metabolite of AFB^ generated by a NADPH-dependent




system reported in the above  study was most likely  2,3-dihydro-2,3-dihydroxy-




aflatoxin  Bj rather than AFB2a.





     In  addition to the various metabolites discussed  in the preceding  para-




graphs,  two other in vitro metabolites of AFB^ have been identified.  Salhab




and Hsieh  (293) detected the  formation of aflatoxicol  Hj (AFLHj;  see Fig. 1




for structural formula) as a major metabolite of AFBi  produced by human  and




rhesus monkey  liver in vitro.  Both the microsomal  hydroxylase and  the  cyto-




solic reductase system are required for the formation  of AFLHj-   It  is  not




known whether  AFLH^ is formed by  reduction of AFQi  or  hydroxylation of  AFL  or






                                      50

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both.  The compound is nonmutagenic in Ames test.  Another relatively new




metabolite is aflatoxicol Mj (AFLMj) (294).  Aflatoxicol Mj may be produced by




hydroxylation of AFL using dog liver microsomes or by ketoreduction of AFMj by




rabbit liver cytosol.  It may be oxidized to AFMj by a carbon monoxide-




insensitive dehydrogenase present in human liver microsomes.  Aflatoxicol M,




has also been detected as an in vitro metabolite of AFBj using trout liver




microsomes (181).  No information is available on the genotoxic potential of




this metabolite.





     In addition to microsomal activation, AFB, may also be photochemically




activated.  Shieh and Song (56) irradiated a solution of AFBj^ and calf thyraus




DNA with near-UV light under anaerobic condition and detected a significant




amount of covalent binding of AFBj to DNA (1 AFBj per 1,300 nucleotides).  The




AFBj-DNA adduct showed a substantial inhibition of its DNA template activity




for DNA synthesis and for RNA transcription in vitro.  The photobinding of




AFBj to DNA was greater than that of AFGj.  The photobinding of their dihydro




derivatives, AFBo and AFGo. was low or negligible consistent with the require-




ment for the 2,3-double bond in the terminal furan ring.  The nature of photo-




adduct remains to be explored.  The mechanism for photobinding of AFBj is




believed to differ from that occurring by microsomal activation, because




photobinding to DNA occurs preferentially at the A-T sequence rather than at




the G-C sequence.  Shieh and Song (56) proposed a multi-step activation




mechanism involving the photoexcitation of the coumaryl chromophore (similar




to photoactivation of psoralen) and an intramolecular energy transfer from  the




coumaryl chromophore to activate the 2,3-double bond of AFBj.  The biological




significance of photoactivation of aflatoxins  is unclear.   It would be of




interest to investigate in this context whether near-UV light may contribute




to skin carcinogenesis by AFBi.
                                      51

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     Metabolism of other aflatoxins and related compounds.  Compared to AFB,,




relatively little information is available on the metabolism of other afla-




toxins and related compounds.  In general, it is probable that the map of




metabolic pathways of AFBj is valid to most of the other aflatoxins.  The




metabolism of aflatoxin Bo (AFB2) includes 2-hydroxylation to form AFB2a




(290), 4-hydroxylation to form AFM2 (252, 290, 291), ketoreduction to




2,3-dihydroaflatoxicol (292).  It was suggested that a small amount of AFB«




may be converted to AFBj which accounts for the weak carcinogenicity of AFB2




(about 1% of potency of AFBj) (64).  An in vivo study by Swenson et_ al_. (223)




indicates that AFB2 may indeed be converted to AFBj in the rat liver in vivo




to an extent (about 1%), which supports the postulate that AFB2 exerts its




carcinogenic action via AFBi.  Aflatoxin Mi is metabolized at a much slower




rate by rodent liver microsomal  (245) or postmitochondrial (282) fraction than




AFBj.  Aflatoxicol Mi has been identified as a metabolite of AFM> after incu-




bation with rabbit liver cytosolic preparation; the reaction appears to be




reversible and may be analogous to. interconversicn between AFBj and AFL




(294).  Aflatoxin M^ may bind to nucleic acid through the formation of reac-




tive 2,3-oxide intermediate as indicated by the detection of 2,3-dihydro-2-




(N -guanyl)-3-hydroxyaflatoxin M, (49, 243).  Aflatoxin P, was reported to be




not metabolized by rat liver microsomes (245); however, 2,3-dihydro-2-(N'-




guanyl)-3-hydroxyaflatoxin P^ has been detected in the liver of rat given AFB^




(49).  Aflatoxin Qi may be metabolized by rat liver microsomes in the absence




of NADPH to an unidentified metabolite; there is some evidence that in the




presence of NADPH a small amount of AFQj may be metabolized back to AFBj




(245).  One possible metabolite  of AFQj is AFLH]^ through ketoreduction




(293).  Aflatoxin GX can be 4-hydroxylated to form aflatoxin GMj (290, 291),




2-hydroxylated to form aflatoxin G2a  (290) and 0-demethylated  (as evidenced by
                                      52

-------
the detection of formaldehyde in the incubation media)  to some as yet uniden-




tified metabolite(s) (295).   Covalent binding of AFGj to nucleic acid




presumably involves 2,3-epoxidation because its 2,3-dihydro derivative (AFG2)




does not bind to any significant extent (293, 296).   The metabolic activation




of sterigmatocystin has also been shown to involve epoxidation of the double




bond in the terminal furan ring as deduced from the  chemical structure of the




sterigmatocystin-DNA adduct  (243, 297).





     5.3.1.1.4.2  Mechanism  of Action.





     There is now a considerable body of evidence to indicate that covalent




binding of metabolically activated aflatoxins to cellular macromolecules




(particularly DNA) is principally responsible for their mutagenic and carcino-




genic actions.  Mechanistically, the presence of adducts in DNA should lead to




infidelity of replication or transcription, alteration of gene function, gene




rearrangement, or induction  of an error-prone repair process indirectly caus-




ing fixation of molecular lesions.  These initiating events ultimately lead to




transformation of normal cells into cancer cells by processes that are still




not clearly understood.  The high potency of AFB, as a carcinogen has been




attributed to its preferential binding to DNA, nonrandom distribution of this




binding and persistency of the AFBi-DNA adduct.





     The covalent binding of AFBi to cellular macromolecules has been exten-




sively studied.  Both in vitro (235, 239) and in vivo (223, 240, 241) studies




showed that metabolically activated AFBi binds to nucleic acids much more




effectively than to protein.  With nucleic acids from various sources




different degrees of binding efficiency were observed, with the relative order




being micrococcus DNA > calf thymus DNA = rat liver DNA > rat liver  RNA  > rat




liver tRNA (239).  The binding of AFBj to DNA does not appear to proceed in  a
                                      53

-------
random fashion.  Activated AFB^ preferentially binds to guanine residues in




DNA (see discussion on the nature of AFBi-DNA adduct).   Studies by Misra,




Muench and Humayun (298, 299) revealed that guanine residues in DNA strands




show a "sequence-specific" proneness to serve as targets for AFBj-2,3-oxide




binding.  In general, guanine residues flanked by AT sequences are poor




targets while certain, but not all, guanine residues in GC base-paired




clusters are very susceptible targets.  For example, guanine residues in




sequence such as 5'-CCG-3" and its complement 5'-GGC-3' are excellent targets




for AFBj alkylation.  It appears that a sequence-specific "precovalent" asso-




ciation between double-stranded DNA and AFBj occurs before covalent binding




actually takes place.  The nonrandora binding of AFB, is believed to have a




greater chance of causing DNA damage on both strands at closely set sites than




random distribution of binding throughout both the strands (298).  Aflatoxin




Bj binding to DNA also displays a "domain-specificity."  Bailey et al. (300)




showed that AFB, preferentially binds to internucleosomal DNA in rainbow




trout.  Yu (301) found that AFBi, after either ir. vivo or in vitro metabolic




activation, binds preferentially to the active regions of rat liver nucleolar




chromatin.  This binding specificty is apparently conferred by the nucleolar




chromosomal proteins.  The binding of AFBj to an active region of chromatin




may be expected to have a more highly deleterious effect than binding to a




dormant region because of the greater chance of propagating the DNA lesion.




Mitochondrial DNA is also a preferential target for AFE^ binding.  In an in




vivo study using rats, Niranjan et al. (261) found that the level of covalent




binding of AFBi to mitochondrial DNA was three to four times higher than that




of nuclear DNA.  They suggested that the mitochondrial genetic system may  play




a role in AFBj hepatocarcinogenesis.
                                      54

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     The nature of AFB^-DNA adducts and the efficiency of excision repair of




these adducts have been the focus of attention of many investigators.  The




most abundant AFB^-DNA adduct present in the acid hydrolysis products of DNA




from livers of AFBi-treated animal or from in vitro incubation in presence of




activated AFBj is 2,3-dihydro-2-(N7-guanyl)-3-hydroxyaflatoxin Bj (AFBj-N7-




Gua) (55, 236, 242, 302-305).  The absolute configuration of AFBj-N^Gua has




been unambiguously established (49; see Fig. 2).  Using  H-labeled AFBi , it




has been established that AFBj-N -Gua accounts for more than 80% of all the




AFBj-DNA adducts present in rat liver (49, 236, 302, 304).  The second most




abundant AFBi-DNA adduct has been characterized as 2,3-dihydro-2-(2,6-diamino-




4-oxo-3,4-dihydropyrimid-5-yl-formaroido)-3-hydroxyaflatoxin B^ (AFB^-FAPy)




which results from the hydroxyl ion-catalyzed opening of the imidazole ring of




AFBj-^-Gua (49, 302, 304, 306, 307) (see Fig. 2).  Other DNA adducts present




in the livers of AFBj-treated rats include AFPj-N7-Gua and AFMi~N7-Gua (49),




suggesting that the two hydroxylated metabolites of AFB, can undergo metabolic




activation to 2,3-oxides and then bind to DNA.  Small amounts of AFBj-N-*-




adenine adduct have also been detected (308).





     The AFBi-N -Gua adducts in DNA are chemically unstable, because the




imidazole ring of the modified guanine residue carries a positive charge  (see




Fig. 2).  They may undergo three major spontaneous reactions:  (a) release of




2,3-dihydro-2,3-dihydroxy-AFB, with reconstitution of the guanine residues




intact, (b) release of AFBj-N7-Gua due to hydrolysis of the N-glycosidic bond




with the concomitant formation of apurinic  sites  in DNA, and  (c) conversion  to




AFBj-FAPy adducts as described above.  The half-life of AFB^-N7-Gua  adducts  in




DNA repair-deficient cultured human fibroblasts from a xerodenna pigmentosum




patient is of the order of 20 hours, while  that in normal fibroblasts  is  only




5-6 hours (304).  In the rat, the apparent  half-life of AFB^-N7-Gua  adduct  in
                                      55

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           N


           DMA
         AFB,-

         2,3-oxide
0   R
          If
          DNA
         H®
      0   R
H2N
   AFB,-N-Gua
                                   0   R
                                          H
             N  OH


             DNA
e
                                   Q   R
   H2
                                       DNA
        0
    ziyrV^NHg"
      AFB,-FAPy
                                                                       OH
                                   0   R
                                       DNA
                                     H®
                                                       s   ?
                                                   H-N-~VNH  H
                                                    Adduct A
      Fig.  2.   Mechanism of formation of the major AFB..-DNA adducts.

-------
                              Legend to Figure 2









     Fig. 2.  Mechanism of formation of the major AFBj-DNA adducts, AFB^-N -




Gua, and its conversion to formamidopyrimidine derivatives.  The chemical




names of the adducts are:  AFB^-N -Gua, 2,3-dihydro-2-(N'-guanyl)-3-hydroxy




aflatoxin B^; AFB^-FAPy, 2,3-dihydro-2-(2,6-diamino-4-oxo-3,4-dihydropyrimid-




5-yl formamido)-3-hydroxy aflatoxin Bj; adduct A, 2,3-dihydro-2-(2-amino-6-




formamido-4-oxo-3,4-dihydropyrimid-5-yl araino)-3-hydroxy aflatoxin Bj.




(Adapted from J.M. Essigmann, R.G. Croy, R.A. Bennett and G.N. Wogan:  Drug




Metab. Rev. _13_, 581 [1982], P.J. Hertzog, J.R. Lindsay Smith and R.C.




Garner:  Carcinogenesis 3, 723  [1982]; the heavy arrow indicates the




predominant pathway.)

-------
liver DNA is approx.  7.5  hours (49,  309).   In contrast,  the AFB,rFAPy adduct




in DNA is highly stable and persistent.   Interestingly,  in cultured human




fibroblasts, the level of AFB|-FAPy  adducts increased during the posttreatment




incubation period up  to a maximum of 20  hours (after removal of AFBj from the




incubation medium).   There was no evidence of spontaneous removal or excision




repair during this period (304).   A  similar pattern was  observed in the rat in




an in vivo study (309).  The level of AFBi-FAPy adducts  accumulating during




the posttreatment period  reached  a maximum at about 24 hours, at which time




AFBj-FAPy became the  most abundant adduct.  Approximately 20% of the AFBj-N7-




Gua adducts initially formed were converted to AFBj-FAPy.  The AFBj-FAPy




adducts in DNA were slowly removed,  if at all, during a  72-hour study




period.  Thus, the conversion of  AFBj-N^-Gua to AFBj-FAPy adduct represents a




transformation of a repairable lesion into a nonrepairable one.  It appears




reasonable to speculate that the  persistence of AFBi-FAPy adducts in rat liver




DNA may provide a longer  expression  time for AFB,  to register its carcinogenic




or mutagenic effect.   As  previously  mentioned, the mitochondrial DNA in rat




liver is a preferential target for AFBi  binding.  It is  interesting to note




that although the mitochondrial DNA-AFBi adducts are also very persistent,




there was no evidence of  excision repair of the lesions  after 24 hours (261).





     In addition to AFBi, the covalent binding of a number of other aflatoxins




and of sterigmatocystin to cellular  macromolecules has been demonstrated.




Essigmann et al. (49, 243) reported  that administration of a racemic mixture




of AFMj to rat liver by perfusion results in covalent binding of AFMj to




DNA.  Like AFBj, AFM, is  metabolically activated to AFMj-2,3-oxide and




preferentially binds to guanine residues.  The conversion of AFMj-N^-Gua to




its imidazole-ring-opened derivative has also been observed.  Aflatoxin ^2a




and 2,3-dihydro-2,3-dihydroxyaflatoxin Bj (AFBj-dihydrodiol) bind  covalently
                                      56

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to microsomal protein after their in vitro formation at physiological pH (123,




244, 246, 250).  The mechanism involves alkaline hydrolysis to dialdehyde




intermediates (see Fig. 3) and subsequent condensation of the aldehyde groups




with terminal amino groups in protein to form Schiff bases (Aflatoxin-CH=N-




Protein).  It was suggested (44, 310) that AFB2a could play a role in the




acute toxicity of AFBi by binding to and inhibiting key enzymes of cellular




metabolism.  It is conceivable that the same could apply to AFB,-dihydro-




diol.  In fact, it has been suggested (244) that the "AFB2a" identified in




earlier metabolic studies should actually be AFB^-dihydrodiol.  The covalent




binding of sterigmatocystin to rat liver DNA has been studied by Essigmann et




aj. (243, 297).  The results indicate that sterigmatocystin is metabolically




activated via epoxidation of the double bond in the terminal bisfuran ring in




the same manner as is AFB^.  The epoxide of sterigmatocystin preferentially




binds to the N -position of guanine residues in DNA; the major adduct in the




acid hydrolysate of sterigmatocystin-treated DNA is the sterigmatocystin-N -




guanine.





     The relationship between covalent binding to DNA and carcinogenic action




of aflatoxins has been extensively studied (revs. 32, 44, 49).  Organotropism,




species comparison and modification studies all indicate a positive correla-




tion between in vivo covalent binding to DNA and carcinogenicity of AFB^.




Garner and Wright (241) compared the in vivo covalent binding of AFBj to




cellular macromolecules in the rat (a susceptible species) and the hamster (a




resistant species).  Rat liver DNA bound four times as much AFBi (approxi-




mately 20 ng AFBj/mg DNA) and rRNA ten times as much AFBj (approximately 45 ng




AFB^/mg rRNA) as hamster liver DNA and rRNA 6 hours after carcinogen  admini-




stration, at which time the binding reached its maximum.  No significant




difference in covalent binding to liver protein and to kidney  (a nontarget
                                      57

-------
                                                                              Oe   0
                                                                 OHCX/R  QX^N
                                                                OHC
                                                                      a
                                                                       s?^S>
OCH,
Fig. 3.   Mechanism of alkaline hydrolysis of AFB    (R = H)  and  2,3-dihydro-
                                             2a

2,3-dihydroxyaflatoxin B^  (R = OH) to dialdehyde intermediates.

-------
tissue) macromolecules was observed.  Consistent with the critical importance



of DNA binding for carcinogenesis,  Croy and Wogan (309) found that the level



of covalent binding of AFBj to rat  liver DNA was ten times higher than kidney



DNA (1,250 vs.' 124 AFBj modification/107 nucleotides) 2 hours after AFBj



administration.  Similarly, the level of covalent binding to liver DNA and



kidney DNA were 23 and 76, respectively, in the mouse (a resistant species).



The data are consistent with a comparative study of Lutz et al. (311) who



reported that the "covalent binding index" of AFBj, defined as (umol afla-



toxin/mol DNA nucleotides)/(mmol aflatoxin/kg animal) was 10,400 for rat liver



DNA and 240 for mouse liver DNA 6-8 hours after AFBj administration.  The



covalent binding index of AFMi (which is about 1/3 as potent as AFBj in Mt.



Shasta strain rainbow trout) in rat liver DNA was 2,100.  Pig liver DNA showed



very high covalent binding indexes, 19,100 and 13,300 at 24 and 48 hours after



AFBi administration.  It would be interesting to investigate whether the pig



is acutally highly susceptible to AFBi carcinogenesis as predicted by the



covalent binding index.  The finding of Witham et al. (191) is significant in



this regard, showing that the covalent binding of AFB, to liver DNA in coho



salmon, which is refractory to AFBi carcinogenesis, is more than 20-fold lower



than that in the rainbow trout (10.6 vs. 243 pmol AFB^/mg DNA) at 24 hours



after the administration of the mycotoxin.  A number of inhibitory agents  and



factors of AFBj carcinogenesis, such as phenobarbital (223, 240);  ^3-naphtha-
                                                                   •


flavone (181, 191), and hypophysectomy (223) have been shown to inhibit JLn



vivo binding of AFBj to DNA.  In vitro DNA binding data may explain the



greater susceptibility of male Sprague-Dawley rats than females to AFBj



hepatocarcinogenesis (228).  However, liver microsomes  from phenobarbital-



pretreated rats enhanced rather than inhibited the in vitro covalent binding



of AFBj to DNA (240, 247); the difference between  in vivo and  in vitro binding



data was attributed to the complex pharmacokinetics in AFBj metabolism  (240).



                                      58

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     The molecular mechanism of carcinogenesis which proceeds following cova-




lent binding of AFBi to DNA is poorly understood.   As a bulky adduct, AFB^ may




be expected to affect the template function of DNA (312); yet there is no




direct evidence for a cause-effect relationship between N -guanine adduct




formation by AFBj and mutagenesis and carcinogenesis.  It appears that the




secondary lesions such as apurinic sites and AFBj-FAPy adducts may be more




important for AFB^-induced mutagenesis/carcinogenesis than the primary




AFBj-N'-Gua adducts.  Although depurination has been considered to be nonmuta-




genic under normal conditions (313), there is evidence that depurination




causes mutations in "SOS-induced" cells (314).  Although the "SOS response,"




an inducible, error-prone DNA repair pathway, has generally been observed in




Escherichia coli (315), a similar response may exist in mammalian cells (316,




317).  Since AFB, binding to guanine appears to display sequence-specific




clustering (298), the resulting depurination could lead to double strand DNA




breaks which can lead to micromutation (small deletion) and gross chromosomal




rearrangement.  Although alkylation at the N -position of guanine is generally




not expected to affect template function to a significant extent, an imidazole




ring-opened adduct (2,6-diamino-4-hydroxy-5-N-inethyl-formamidopyriinidine) does




affect template activity of DNA if present in sufficient amount (318).  This




finding suggests that the corresponding AFBj-FAPy adducts may be potentially




more deleterious to the cells than AFB,-N^-Gua adducts.  Amstad j;t_ jil_. (305)




have recently conducted an experiment which suggests that secondary lesions




such as AFBj-FAPy adducts and possibly apurinic sites may indeed be more




important for AFBj-induced in vitro cell transformation than the primary




AFBj-N'-Gua adducts.  These investigators treated confluent  cultures of mouse




embryo fibroblasts (C3H/10T1/2 cells) with AFBj and  then allowed the resulting




AFBj-N -Gua adducts to undergo spontaneous or enzymatic conversion to
                                      59

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secondary lesions by incubating in fresh media for 0,  8,  16 or 40 hours.  At




the end of the various incubation periods,  the cells were harvested for deter-




mination of the concentrations of AFBj-N'-Gua and AFB,-FAPy adducts and then




replated at low density (i.e., released from confluency holding) in order to




determine the potential to develop into transformed foci.  It was found that




the level of AFBj-N -Gua declined rapidly with time whereas the level of AFB^-




FAPy increased with time reaching a maximum at 16 hours and remained unchanged




up to 40 hours.  The potential to form transformed foci increased with time




reaching a maximum at 16 hours but declined afterwards.  Thus, while there was




no simple relationship between the concentrations of adducts and cell trans-




formation, the results did indicate the greater importance of secondary




lesions.





     The covalent binding of AFB, to mitochondrial DNA leads to inhibition of




both mitochondrial transcription and translation (261, 319).  These results,




coupled with the finding that mitochondrial DNA is a  preferential target for




AFBj binding, led these investigators to suggest that  the mitochondrial




genetic system may be one of the direct targets of AFB^ hepatocarcinogenesis.




The modification of mitochondrial DNA may directly or  indirectly contribute to




carcinogenic process through mitochondrial mutational  events or through long-




term inhibition of mitochondrial biosynthetic processes, respectively.





     Apart from direct interaction with DNA, AFB, induces a variety of bio-




chemical effects which may contribute to possible epigenetic mechanisms of




carcinogenesis.  It is not known, however, whether any of these effects is




causally related to carcinogenesis.  Several studies have demonstrated that




AFBi inhibits protein synthesis through a number of different mechanisms;




random  inhibition of selective protein synthesis could lead to  disturbance  of




gene expression and loss of control of nuclear function.  Bhattacharya  and






                                      60

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Aboobaker (320) showed that AFBj inhibits the acceptor activity of rat liver




tRNA.  The most significantly inhibited tRNA species were those for proline,




aspartic acid and leucine.  These functional changes of tRNA were attributed




to covalent interaction of activated metabolite of AFBj with tRNA.  Wagner and




Unterreiner (321) reported that chronic administration of AFBj lead to reduc-




tion of protein synthesis mainly through inhibition of rat liver aminoacyl-




tRNA synthetases.  Sidransky et al. (322) observed disaggregation of both




hepatic free and membrane-bound polyribosomes by AFBj.  An in vivo study by




Sarasin and Moule (323) suggests that AFB, inhibits protein synthesis in rat




liver initially (up to 5 hours) at the polyribosome level by blocking polypep-




tide chain elongation and termination, and later (beyond 7 hours) at the




initiation step (as a consequence of transcription impairment).  Kensler et




al. (324) found that AFB, significantly inhibits the nuclear binding capacity




of the glucocorticoid-cytosol receptor complex.  The effect was near maximal




after 2 hours and persisted for at least 36 hours.  Although the relevance of




this finding to AFBi carcinogenesis is unclear, hormones are known to modify




AFBj carcinogenesis (see Section 5.3.1.1.3.6).





     5.3.1.1.5  Environmental Significance.





     5.3.1.1.5.1  EPIDEMIOLOGICAL EVIDENCE.





     There is a considerable body of evidence to implicate aflatoxins as an




important etiologic factor in human liver cancer (revs. 26, 33, 47, 57).




Epidemiologic studies established a positive association between  the geo-




graphic distribution of areas of high liver cancer incidence  and  that of




prevalence of aflatoxin contamination of  foodstuffs.  A dose-response rela-




tionship between aflatoxin consumption and liver cancer incidence has been




demonstrated using data from four separate field studies  in Kenya,  Mozambique,
                                      61

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Swaziland and Thailand.   Aflatoxins have been detected with a relatively high


frequency in the tissues and body fluids of liver cancer patients.   Although


the evidence does not provide information on latent period, and does not


constitute a definitive  scientific proof of the principal etiologic role of


aflatoxins in human liver cancer, the weight of the evidence appears to be


quite strong.  Future follow-up studies on survivors of the recent  outbreak of


aflatoxin-induced acute  toxic hepatitis in India (see Section 5.3.1.1.2.2) or


other heavily exposed population groups may shed more light on the  importance


of aflatoxin as a human  hepatocarcinogen.


     The hypothesis that mycotoxins may play an etiologic role in the induc-


tion of human liver cancer was first proposed by Oettle (19) in 1965.  The


first major epidemiologic study was undertaken in Uganda in 1966-1967 by


Alpert et al. (20).  They found that the variation of hepatoma incidence in


various tribes in different parts of the country was related to the frequency


of aflatoxin contamination of their food.  Keen and Martin (325) attributed


the difference in hepatoma incidences between two tribes in Swaziland to their


eating and cooking habits, particularly to the consumption of groundnuts


stored under conditions  that favored aflatoxin contamination.  A subsequent


study by Peers _et_ jil^ (23) showed a positive correlation between tumor inci-


dence and aflatoxin consumption.  An extensive series of studies by Shank et


al. (24, 25, 326-328) showed that the high incidence of liver cancer in tropi-


cal southeast Asia, particularly Thailand, is associated with dietary exposure


to aflatoxin-contaminated food.  Peers and Linsell (21) selected the popula-

                   .;
tions of three areas of  different altitude in the Murang's district of Kenya


for studies on the hepatoma incidences as related to the extent of  food con-


tamination by aflatoxins.  As predicted, the difference in the climates of


these three areas yielded differences in the extent of  food contamination with
                                      62

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aflatoxin, which correlated positively the hepatoma incidences of the three



population groups.  Perhaps the highest incidence of primary liver cancer in



the world (110 cases/100,000 persons/year for males; 29 cases/100,000



persons/year for females)  was reported in Lourenco Marques, Mozambique



(329).  Van Rensburg _et^ al_. (22) found that the liver cancer incidence in the



Inhambane district of Mozambique was also unusually high, with values of 35.5



and 24.5/100,000/year for the 1964-1968 and 1969-1971 periods.  The food



consumed by the population in the Inhambane district was found to be heavily
                           *


contaminated with aflatoxins.  The estimated daily intake was 15 jug per adult



(or 222.4 ng/kg body weight), probably the highest value ever found in a



population group.  Besides the studies mentioned above, food contamination



with aflatoxin or Aspergillus flavus has been suspected to contribute to the



induction of liver cancer in individuals or population groups in Senegal



(330), Taiwan (331), the Philippines (332), in Poland (333), Transkei (334)



and Hong Kong (335).




     Convincing evidence for a dose-response relttionship between aflatoxin



consumption and liver cancer incidence has been provided by Peers and Linsell



(26).  Combining the data from four separate field studies in Kenya (21),



Thailand (24, 25), Mozambique (22) and Swaziland (23), Peers and Linsell (26)



demonstrated a high degree of positive correlation between the estimated daily



intake of aflatoxin [expressed as ng/kg body weight/day (X)], on one hand, and



the adult incidence rate of  liver cancer  [expressed as cases/10* adults/year



(Y)], on the other hand (see Table X).  The correlation equation was given



as:  Y = 7.6 log X - 3.6 (significant at  p < 0.001).




     A number of factors may affect or confound the relationship between



aflatoxin consumption and liver cancer incidence.  Using data  from Kenya and



Swaziland, Peers and Linsell (26) showed  that men were substantially more





                                      63

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                                   Table X
           Summary of Data Supporting a Dose-Response Relationship
          Between Aflatoxin Consumption and Liver Cancer Incidence3
Country
Kenya
Thailand
Swaziland
Kenya
Swaziland
Kenya
Swaziland
Thailand
Swaziland
Mozambique
Area
High altitude
Songkhla
High veld
Middle altitude
Mid veld
Low altitude
Lebombo
Ratburi
Low veld
Inhambane
aAdapted from F.G. Peers and
Aflatoxin
intake
(ng/kg/day)b
3.5
5.0
5.2
5.9
8.9
10.0
15.4
45.0
43.1
222.1
C.A. Linsell

Number
of cases
4
2
11
33
29
49
4
6
42
>101
[Ann. Nutr
Liver cancer
Incidence
(no./100,000 persons/yr)c
1.23
2.00
2.18
2.51
3.83
4.01
4.27
6.00
9.18
16. 1-25. 4d
. Alira. 31, 1005 (1977)]
 and World Health Organization:  "Environmental Health Criteria 11:  Myco-
 toxin," WHO, Geneva,  1979.   Periods covered were 1 year in Thailand, 3 years
 in Mozambique, and 4 years  each in Kenya and Swaziland.
 Estimated average daily intake (excluding native beers) of aflatoxin by
 adults expressed as ng aflatoxin/kg body weight/day.

clncidence expressed as number of new cases per 100,000 population per year.

 A recent revision by Van Rensburg (cited in WHO, 1979) gave an incidence of
 13.0.

-------
susceptible to the apparent carcinogenic effect of aflatoxin than women.  The


correlation equation was Y = 21.96 log X - 11.17 (p < 0.001) for males and


Y = 4.14 log X - 0.80 (p < 0.05) for females.   It is interesting to note that


in areas of high liver cancer incidence in the world, the male to female ratio


for hepatocellular carcinoma is considerably higher than that in areas of low


liver cancer incidence.  For example, the male to female ratio was 3:1 in


Kenya (21), 3.5:1 in Singapore (336), 4:1 in Swaziland (23, 325), and between


5:1 and 6:1 in Thailand (25) compared to between 1:1 and 1.5:1 in areas of low


liver cancer incidence (47).  Hepatitis B viral infection has been considered


to be a possible confounding factor (26, 47).   Hepatitis B infection is common


in countries with a high incidence of primary liver cancer.  It has been sug-


gested (337, 338) that tumors may arise as a late manifestation of liver


cirrhosis resulting from viral hepatitis.  It  is also possible that aflatoxin


and viral hepatitis act synergistically in the induction of liver cancer.


Moreover, the nutritional status is an important modifying factor in aflatoxin


carcinogenesis (see Section 5.3.1.1.3.6) in animals; whether the same holds


for humans remains to be investigated.



     In addition to reports on the induction of human cancer due to ingestion


of aflatoxin-contaminated foodstuffs, there are two reports of cancer induc-


tion due to occupational exposure.  Van Nieuwenhuize et al. (339) followed up


on a group of 55 workers known to be exposed for 2-9 years to dust containing


aflatoxin in a mill crushing groundnut and other oil seeds.  The estimated

                                                                     O
airborne aflatoxin level in the workplace ranged from 0.87 to 72 ng/m  .  The


total amount of aflatoxin, to which the mill workers were exposed throughout


the exposure period, was calculated to range from 160 to 395 tig.  Eleven of


these 55 exposed workers developed cancers (including one  liver  cholangiocar-


cinoma) within an observational period of up to  11 years; only 4 cases  of
                                      64

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cancer (no liver cancer)  were found in an age-matched group of 55 workers from




a different factory in the same area.   Deger (340)  reported two cases of




induction of carcinoma of the colon in two research workers (in the same




laboratory) who had been  involved in purifying substantial amounts of afla-




toxins for research purposes.  These reports emphasize the extreme precaution




needed in handling aflatoxin in the workplace.





     There are a number of reports of detection of  aflatoxin in the liver or




body fluids of liver cancer patients in various countries.  Pang, Husaini and




Karyadi (cited in 33) reported that in a 2-year study in Indonesia, AFBi was




chromatographically detected in extracts of liver tissue biopsy samples from




41 of 71 (57.7%) patients with primary liver cancer; extracts of liver tissues




from 15 patients without  liver cancer did not contain aflatoxin.  Phillips et




al. (341) detected AFB, (estimated to be 520 ng/gm  wet weight) in a sample of




liver biopsy from a 56-year-old rural resident of Missouri, U.S.A., suffering




from cancer of the liver and rectum.  Stora et al.  (342) found evidence (by




direct fluorescence microscopic examination) of the presence of AFBj in liver




extracts from 13 of 15 liver cancer patients in Czechoslovakia; in at least 5




cases, the presence of AFBi was confirmed by chemical identification on thin-




layer chromatography.  Onyemelukwe'et al. (343) detected aflatoxins Bj, 62, G^




and Go i-n sera of 20 of 20 Nigerian patients with primary liver cell




carcinoma; in 3 of these patients, the concentration of AFBi exceeded 150




ng/ml.  Aflatoxin Bi was also detected in the serum of a U.S. resident




suffering from primary hepatoma (344).  These reports provide additional




supporting evidence for an association between aflatoxin  intake and induction




of liver cancer in humans.
                                      65

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     5.3.1.1.5.2  ENVIRONMENTAL FORMATION, OCCURRENCE AND EXPOSURE.





     Environmental formation.   The environmental formation and the biosyn-




thesis of aflatoxins, sterigmatocystin and related mycotoxins, and the




environmental conditions that  are conducive to mycotoxin production, have been




extensively reviewed by Detroy et_ al_. (38), Stoloff (345, 346), Heathcote and




Hibbert (32), and the World Health Organization (33).  Aflatoxins are produced




by certain strains of two species of fungi, Aspergillus flavus Link and_A.




parasiticus Speare, in a geographic area where environmental conditions are




suitable for the development of the mold.  Both species are members of the _A.




flavus group; they are practically indistinguishable from each other to inves-




tigators untrained in the fine details of mold taxonomy.  There is some




evidence that j\. parasiticus is more likely to be encountered in warmer




environments and is the species more likely to produce a greater variety of




aflatoxins.  Not all strains of A. flavus produce aflatoxins; however, depend-




ing on the substrate, a high proportion (20-98%) of the strains isolated are




aflatoxin-producers.  The presence of extensive mold growth in foodstuffs is




not, by itself, indicative of presence of aflatoxin because some strains are




non-producers and producing strains can be affected by the presence of compet-




ing microorganisms.  There are a number of reports of aflatoxin production by




a variety of other fungi such as A. oryzae (used for the production of miso




and soy sauce), Penicillium sp. (present in moldy peanuts), Streptomyces sp.




and Rhizopus sp. (rev. 38); however, none of these findings could be confirmed




by other investigators (38, 346, 347).  The precursors of aflatoxins, sterig-




matocystin and versicolorin A are produced by certain strains of A^. versicolor




as well as of _A. flavus and _A. parasiticus (rev. 32).





     The biosynthesis of aflatoxins and related mycotoxins has J>een exten-




sively studied (rev. 32).  Under laboratory conditions, Mg, Mo, Zn  and  Fe  are







                                      66

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essential minerals required for aflatoxin production.  The molds, can use most




carbohydrates as sole carbon source, although optimum production occurs in




media supplemented with glucose or sucrose.  The initial step of biosynthesis




is believed to involve head-to-tail assembly or condensation of acetate to




form polyhydroxyanthraquinones (e.g., norsolorinic acid), but the exact molec-




ular mechanism has not clearly established.  The resulting polyhydroxyanthra-




quinones are then further modified to yield various aflatoxins.  For AFB^,




recent studies (32, 348-351) suggest the following biosynthetic pathway:




norsolorinic acid  • > averantin —^ averufin —V- versiconal acetate —>•




versicolorin A—y sterigmatocystin—^- aflatoxin Bj (see Tables I and IV for




chemical structures).





     The environmental conditions known to affect aflatoxin production in




agricultural commodities and their products are:  (a) humidity and moisture,




(b) temperature, (c) aeration, and (d) the type and condition of the substrate




(revs. 32, 33, 38, 352).  The relative humidity is a crucial factor for the




growth of A. flavus which appears to be more fastidious in moisture require-




ment than many other molds.  Depending on the moisture content of the




substrate, a relative humidity of 80-85% is considered to be a minimal




requirement; beyond 95%, the yield of aflatoxin production generally increases




with an increase of relative humidity.  The lower limit of moisture content




that supports growth of ^. flavus is 18.3-18.5% on a wet weight basis  for




starchy, cereal grains such as maize, rice, oat, wheat, barley and  sorghum,




and 9-10% for commodities with a higher oil content such as groundnuts, tree




nuts, copra and sunflower seeds (33).  Aspergillus flavus has been  classified




as a mesophilic fungus.  Depending on the humidity and the type of  substrate,




the minimal, optimal and maximal temperature ranges for aflatoxin production




are 11-12°C, 25-32°C, and 40-42°C, respectively.  The biosynthesis  of  afla-
                                      67

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toxin is an aerobic process.   Adequate aeration is an important factor for




optimal aflatoxin production  in fermentors.   Atmospheric gases can have a




significant effect on aflatoxin production by A.  flavus growing on a solid




substrate such as groundnut.   Decreasing oxygen levels below 5% or increasing




carbon dioxide levels above 20% significantly reduce the yield of aflatoxin




(38).  The yield of aflatoxin is also dependent on the type of substrate




used.  Freshly grated coconut, wheat, rice and cottonseed are among the list




of favorable solid substrates for aflatoxin production (38).  Damaged agricul-




tural commodities, either mechanically or by insects, often provide favorable




opportunities for mold growth (33, 346).  A study by Lillehoj et al. (353)




showed that contamination with A. flavus (and aflatoxin) in Iowa (U.S.A.) corn




before harvest occurred exclusively in insect-damaged ears of corn.





     Environmental occurrence and exposure.  Human exposure to aflatoxins




occurs mainly as a result of  consumption of contaminated foodstuffs.  The




environmental occurrence of aflatoxins has been reviewed by Campbell and




Stoloff (354), Stoloff (346), Rodricks and Stoloff (355), and the World Health




Organization (3_3).  As may be expected from the favorable environmental




conditions for mold growth, aflatoxin contamination of agricultural commodi-




ties and their products is mainly confined to the tropical and subtropical




regions of the world.  Seasonal variations and unusual weather conditions may




play a significant role in encouraging mold growth, by providing a humid




environment or by causing crop damage.  It should be noted that reports of




aflatoxin occurrence in the scientific literature are not always reliable; a




scrutiny of the methodology used is often needed to assess the reliability of




the data [for a recent review of the recommended analytical methods,  see




Ciegler et_a±. (356)].
                                      68

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     The agricultural commodities that are most susceptible to aflatoxin




contamination include corn,  peanuts, cottonseed and copra.   Small grains




(wheat, oats, rice, rye,  grain sorghum, millet) are rarely contaminated unless




improperly stored or prepared.  In most contaminated samples, AFBj is the




principal aflatoxin; AFGj and, to a lesser extent,  AFM^,  AFB2 and AFG2 have




also been detected.  Table XI summarizes some of the representative data of




occurrence of AFBj in selected agricultural commodities and their products in




four countries.   In addition to the commodities tabulated in Table XI, cotton-




seed and related products are often contaminated with aflatoxin.  Stoloff




(345) reported that AFBj  was detected in 6.5-8.8% of more than 3,000 samples




of unprocessed cottonseed collected in three successive crop years (1964-1967)




in U.S.A. an in 12.8-21.5% of more than 3,000 samples of  cottonseed meal.




Relatively high levels (maximum 2.58 mg/kg) of aflatoxin  were found in an area




in southern California.   A survey by Marsh et al. (357) of cottonseeds in




11-13 locations in corn belt of U.S.A. showed aflatoxin contamination in three




regions.  Considerable levels, as high as 200-300 mg AFBj per kg cottonseed,




were found in seeds from some individual lots.  Vedanayagam et al. (358) found




frequent aflatoxin contamination of cottonseeds in  India; samples from humid




areas were more than two times (78%j/s_. 31%) more likely to be contaminated




than those from dry areas.  Coconut copra is another frequently contaminated




commodity; Stoloff (345)  found aflatoxin in 88% of  72 samples of copra with




concentration ranging from trace to 30 ug/kg.  Edible oil extracted from poor-




grade peanuts or cottonseed may be contaminated with aflatoxins.  Fong et al.




(335) detected AFBi in 3 of 11 samples of peanut oil purchased from local




markets in Hong Kong; the concentration of AFB, ranged from  98-150 ug/kg.  The




contamination was presumed to originate from the use of poor-grade peanuts for




the extraction of oil.  Analysis of 10 samples of such peanuts  indicated the
                                      69

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                                   Table XI
              Occurrence of Aflatoxin B, in Selected Foodstuffs
Country
Philippines
(1967-1969)






Thailand
(1967-1969)






Uganda
(1966-1967)





United States
(1964-1975)







Number of
contaminated
samples /number
Foodstuff examined
Peanut butter
Peanuts, whole
Peanut candies
Corn, whole
Corn products
Beans
Root and tuber products
Rice products
Peanuts
Corn
Chili peppers
Wheat and barley
Dried fish/shrimp
Beans
Cassava starch
Rice
Corn
Beans
Peanuts
Sorghum
Millet
"Cassava
Rice
Corn and corn meals

Peanut products
Grain sorghum
Oats
Wheat
Rye
Rice
Barley
145/149
80/100
47/60
95/98
22/32
26/29
48/62
1/72
106/216
22/62
12/106
5/44
7/139
10/322
2/65
7/364
19/48
15/64
29/150
16/69
6/55
2/34
0/11
72/175*
44/1, 763b
269/1, 416d
10/786
3/416
3/1,828
2/35
1/170
0/254
Average
AFBj in
contaminated
samples
(ug/kg) Reference
213
98
38
110
32
35
44
< 1
870
270
80
38
104
106
60
10
133
500
363
152
26
879
0
44
< lc
lc
12
6
8
trace
5
0
(332)







(327)







(20)






(346)








aSamples collected from Southeast regions in 1969-1970 and 1974.
bSamples collected from Corn Belt in 1964-1965, 1967 and  1974.
cAverage of all samples.
 Including some samples collected from Canada.

-------
presence of AFBj in all the samples with concentrations of 95 ug/kg to 1.05




mg/kg.  Abalaka and Elegbede (359) found AFBj at levels of 450-860 yug/kg in




peanuts and cottonseeds used in a Nigerian oil extraction plant.  The crude




and refined peanut oil contained 98 and 9 iig/kg AFBj while the crude and




refined cottonseed oil contained 65 and 23 ug/kg AFB^, respectively.




Interestingly, fresh vegetables are not known to be susceptible to ^. flavus




and aflatoxin contamination.  However, a recent study by Mertz et al. (360)




indicated that lettuce seedlings grown in soil adulterated with AFBj can




absorb and retain measurable amounts of the mycotoxin.  In view of the common




practice of disposal of large amounts of aflatoxin-contaminated plant material




in the soil, agricultural commodities grown on such soil should be closely




monitored for possible aflatoxin contamination.





     Apart from plant foods and their products, a lesser source of human




exposure to aflatoxins is through consumption of milk or edible tissues of




animals that may have received aflatoxin in their feed.  The occurrence of




aflatoxin in animal feeds has been frequently encountered (revs. 33, 355).  In




rural areas, moldy food rejected by humans are often fed to farm animals.




Surveys in Belgium (361), Germany (362-364), India (365), the Netherlands




(366), South Africa (367) and in the U.S.A. (368) have indicated the presence




of AFMj in 0-67% of liquid or dried cow's milk or milk products; the highest




concentration reported was 13.3 ug/kg in one milk sample collected  in India.




A number of studies (369-371; jrev. 355) have reported the detection  of AFBj




and AFMi residues  in eggs and meat animals intentionally dosed  with  AFBj-




contaminated feed.  The liver contained the highest amount of aflatoxin resi-




due.  The estimated ratios of AFBi concentration in the  feed to the  expected




AFBj concentration in the liver of common meat animals were:  beef,  14,000:1;




swine, 800:1; broiler chicken,  1,200:1.  The corresponding ratio for eggs  was
                                       70

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2,200:1 (346, 355).  This led to the recommendations that the use of contami-




nated feed for dairy cows should be more strictly controlled and that uncon-




taminated or low contamination feed should be fed to meat animals in the




period shortly before slaughtering.





     In addition to ingestion, human exposure to aflatoxin may also occur via




inhalation under occupational settings.  Van Nieuwenhuize _et__al_. (339) esti-




mated that the level of airborne aflatoxin in the work place of a Dutch mill




for crushing peanuts and oil seeds ranged from 0.87 to 72 ng/m .  Thus, the




exposed workers appeared to have an increased liver cancer risk (see Section




5.3.1.1.5.1).  Workers and farmers handling contaminated commodities are also




expected to be at risk from inhaling contaminated grain dust.  An approach to




analyze the potential risk associated with such exposure has been discussed by




Baxter _£t_ jO_« (372).





     The importance of aflatoxin as a potential environmental carcinogen for




humans has prompted worldwide efforts to control aflatoxin contamination




through prevention of molding as well as decontamination', of aflatoxin-




containing foodstuffs.  This topic has been the subject of several extensive




reviews (32, 373, 374).  Education of farmers to improve crop quality and




storage, close monitoring of foodstuffs and animal feeds for aflatoxin con-




tamination, and application and development of effective food-processing tech-




nology to remove contaminated crop or to destroy aflatoxins in situ are




several components of effective programs to control aflatoxin contamination




discussed in the above reviews.  Approaches to regulatory control of aflatoxin




in foodstuffs and feeds have varied from one country to another; the tolerance
                                       71

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limits for aflatoxin in foodstuffs ranged from zero (or the lowest limit of




detection) to 50 iig/kg (346).  These limits are merely intended as guidelines




to implement aflatoxin control programs and should not be mistaken as provid-




ing an absolute protection against carcinogenic risk associated with aflatoxin




exposure.  The problems associated with assessment of carcinogenic risk of




human exposure to low levels of dietary aflatoxin have been discussed by Shank




(375).  In the absence of reliable human carcinogenicity data for low level




exposure and the limitations of extrapolation from trout and rat carcinogenic-




ity data to assessment of human risk, it would be prudent to adopt a conserva-




tive approach to the control of aflatoxin.
                                      72

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References to Section 5.3.1.1









   1.  Blount, W.P.:   Turkeys 9.  52 (1961).




   2.  Asplin, F.D.,  and Carnaghan, R.B.A.:   Vet.  Record 73,  1215 (1961).




   3.  Rucker, R.R.,  Yasutake, W.T., and Wolf,  H.:   Prog.  Fish-Culturist 23,  3




       (1961).




   4.  Hueper, W.C.,  and Payne, W.W.:  J. Natl. Cancer Inst.  27, 1123 (1961).




   5.  Wood,  E.M.,  and Larson, C.P.:  Arch.  Pathol.  71,  471 (1961).




   6.  Ghittino,  P.,  and Ceretto,  F. :  Tumori 48,  393 (1962).




   7.  Wolf,  H.,  and  Jackson, E.W.:  Science 142,  676 (1963).




   8.  Sargent, K., Allcroft, R.,  and Carnaghan, R.B.A.:  Vet. Record 73,  865




       (1961).




   9.  Nesbitt, B.F., O'Kelly, J., Sargent,  K., and  Sheridan,  A.:  Nature




       (London) 195,  1062 (1962).




  10.  Hartley, R.D., Nesbitt, B.F. , and O'Kelly,  J. :  Nature  (London) 198^,




       1056 (1963).




  11.  Van der Merwe, K.J.,  Fourie, L. ,  and  de Scott, B. :   Chem. Ind. 1660




       (1963).




  12.  Asao,  T.,  Buchi, G.,  Abdel  Kader, M.M.,  Chang, S.B., Wick, E.L.,  and




       Wogan,  G.N.:  J. Am.  Chem.  Soc. 85,  1706 (1963).




  13.  Chang,  S.B., Abdel Kader,  M.M., Wick, E.L.,  and Wogan,  G.N.:   Science




       142, 1191  (1963).




  14.  Asao,  T.,  Buchi, G.,  Abdel  Kader, M.M.,  Chang, S.B., Wick, E.L.,  and




       Wogan,  G.N.:  J. Am.  Chem.  Soc. 87,  882 (1965).




  15.  Lancaster, M.C., Jenkins,  F.P., and  Phelp,  J.  McL.:   Nature (London)




       192, 1095  (1961).




  16.  Schoental, R. :  Br.  J. Cancer; 15, 812 (1961).
                                      73

-------
17.   Le Breton, E.,  Frayssinet, C., and Boy,  J.:   C.R.  Acad. Sci. 255, 784




     (1962).




18.   Salmon,  W.D.,  and Newberne, M. :   Cancer  Res.  23,  511 (1963).




19.   Oettle,  A.G.:   S. Afr.  Med. J. 39. 817 (1965).




20.   Alpert,  M.E.,  Hutt,  M.S.R., Wogan, G.N., and  Davidson, C.S.:  Cancer




     28, 253  (1971).




21.   Peers, F.G.,  and Linsell, C.A.:   Br. J.  Cancer  27, 473 (1973).




22.   Van Rensburg,  S.J.,  van der Watt, J.J.,  Purchase,  I.F.H., Coutinho,




     L.P.,  and Markham, R.:   S. Afr.  Med. J.  48,  2508a  (1974).




23.   Peers, F.G.,  Gilman, G.A., and Linsell,  C.A.:   Int.  J. Cancer 17, 167




     (1976).




24.   Shank, R.C.,  Gordon, J.E., Wogan, G.N.,  Nondasuta, A., and Subhamani,




     B.:  Food Cosmet. Toxicol. 10, 71 (1972).




25.   Shank, R.C.,  Bhamarapravati, N,  Gordon,  J.E.,  and  Wogan, G.N.:  Food




     Cosmet.  Toxicol. j.0, 171 (1972).




26.   Peers, F.G.,  and Linsell, C.A.:   Ann. Nutr.  Aliment. 31, 1005 (1977).




27.   Goldblatt, L.A. (ed.):   "Aflatoxin.  Scientific Background, Control,




     and Implications," Academic Press, New York,  1969, 470 pp.




28.   Purchase, I.F.H. (ed.):  "Mycotoxins in  Human Health," MacMillan,




     London,  1971.




29.   Purchase, I.F.H.:  "Mycotoxins," Elsevier, Amsterdam,  1974.




30.   Rodricks, J.V.  (ed.):   "Mycotoxins and Other  Fungal Related Food




     Problems," ACS Monograph No.  149, American Chemical Society,




     Washington, D.C., 1976.




31.   Rodricks, J.V., Hesseltine, C.W., and Mehlman,  M.A. (eds.):   "Myco-




     toxins in Human and  Animal Health," Pathotox,  Park Forest  South,




     Illinois, 1977, 807  pp.
                                    74

-------
32.  Heathcote, J.G., and Hibbert, J.R.:  "Aflatoxins:   Chemical and Bio-




     logical Aspects," Elsevier, Amsterdam,  Holland, 1978, 212 pp.




33.  WHO:   "Mycotoxins," Environmental Health Criteria  11, World Health




     Organization,  Geneva,  Switzerland, 1979, 127 pp.




34.  Hayes, A.W.:   "Mycotoxin Teratogenicity and Mutagenicity," CRC Press,




     Boca  Raton, Florida, 1981,  121 pp.




35.  Shank, R.C. (ed.):  "Mycotoxins and N-Nitroso Compounds:  Environmental




     Risks," Vol.  I,  CRC Press,  Boca Raton,  Florida, 1981, 285 pp.




36.  Wogan, G.N.:   Bacteriol. Rev. 30, 460 (1966).




37.  Schoental, G.:  Ann. Rev. Pharmacol. 7, 343 (1967).




38.  Detroyer, R.W.,  Lillehoj , E.B., and Ciegler, A.:  Aflatoxin and Related




     Compounds. _In_ "Microbial Toxins, Vol.  VI, Fungal  Toxins" (A. Ciegler,




     S. Kadis, and  S.J. Aji, eds.), Academic Press, New York, 1971, p. 3.




39.  Edds, G.T.:  J.  Am. Vet. Med. Assoc. 162, 304 (1973).




40.  Wogan, G.N.:   Aflatoxin Carcinogenesis.  In "Methods in Cancer




     Research" (M.  Bush, ed.), Academic Press, New York, 1973, p. 309.




41.  Wogan, G.N.:   Ann. Rev. Pharmacol. 15, 437 (1975).




42.  Wogan, G.N.:   Mycotoxins and Other Naturally Occurring Carcinogens.  _In




     "Environmental Cancer" (H.F. Kraybill and M.A. Mehlman, eds.),




     Hemisphere, Washington, D.C., 1977, p.  263.




43.  Ong,  T.-M.:  Mutat. Res. 32, 35 (1975).




44.  Campbell, T.C.,  and Hayes,  J.R.:  Toxicol. Appl_. PharmacoK 35, 199




     (1976).




45.  IARC:  "Some Naturally Occurring  Substances,"  IARC Monographs on  the




     Evaluation of the Carcinogenic Risk of Chemicals to Man, Vol. 10,




     International Agency for Research on Cancer, Lyon, France,  1976,  353




     pp.
                                    75

-------
46.  Shank, R.C.:  J. Toxicol. Environ. Health 2, 1229 (1977).




47.  Shank, R.C.:  Epidemiology of Aflatoxin Carcinogenesis.   _In_ "Environ-




     mental Cancer" (H.F. Kraybill and M.A. Mehlman, eds.), 1977, p. 291.




48.  Hayes, A.W.:  Mycopathologia 65, 29 (1978).




49.  Essigmann, J.M., Croy, R.G., Bennett, R.A.,  and Wogan, G.N.:  Drug




     Me tab. Rev.  13, 581 (1982).




50.  Roberts, J.C.:  Fortschr. Chem. Org. Naturst. 31, 119 (1974).




51.  Heathcote, J.G., and Hibbert, J.R.:  Br. J.  Cancer 29, 470 (1974).




52.  Dutton, M.F., and Heathcote, J.G.:  Chem. Ind. , 418 (1968).




53.  Garner, R.C.:  Chem.-Biol. Interact. ,6, 125  (1973).




54.  Lhoest, G.,  Dumont, P. Mercier, M., and Roberfroid, M. :  Pharm. Acta




     Helv. 50, 145 (1975).




55.  Martin, C.N., and Garner, R.C.:  Nature (London) 267, 863  (1977).




56.  Shieh, J.-C., and Song, P.-T.:  Cancer Res.  40, 689 (1980).




57.  Shank, R.C.:  Environmental Toxicoses in Humans.  In "Mycotoxins and




     N-Nitroso Compounds:  Environmental Risks" (R.C. Shank, ed.), Vol. I,




     CRC Press, Boca Raton, Florida, 1981, p. 107.




58.  Newberne, P.M., and Rogers, A.E.:  Animal Toxicity of Major  Environ-




     mental Mycotoxins.  In "Mycotoxins and N-Nitroso Compounds:  Environ-




     mental Risks" (R.C. Shank, ed.), Vol. I, CRC Press, Boca Raton,




     Florida,  1981, p. 51.




59.  Verrett,  J.M., Marliac, J.P.,  and McLaughlin, J., Jr.:   J. Assoc.  Off,




     Anal. Chem.  47, 1003  (1964).




60.  Hsieh, D.P.H., Salhab, A.S.,  Wong, J.J., and Yang, S.L.:   Toxicol.




     Appl.  Pharmacol. 30,  237  (1974).




61.  Carnaghan,  R.B.A.,  Hartley,  R.D., and O'Kelly,  J. :  Nature (London)




     200,  1101 (1963).
                                    76

-------
62.  Lijinsky, W.,  and Butler, W.H.:  Proc.  Soc.  Exp. Biol. Med. 123, 151




     (1966).




63.  Purchase, I.F.H.:  Food Cosmet. Toxicol. 5,  339 (1967).




64.  Wogan, G.N., Edwards,  G.S., and Newberne,  P.M.:  Cancer Res. 31, 1936




     (1971).




65.  Newberne, P.M., and Butler, W.H.:  Cancer Res.  29, 236 (1969).




66.  Newberne, P.M., Harrington, D.H., and Wogan, P.N.:  Lab. Invest. 15,




     962 (1966).




67.  Hayes, A.W., Cain, J.A.,  and Moore, B.C.:   Food Cosmet. Toxicol. 15, 23




     (1977).




68.  Purchase, I.F.H., Steyn,  M., and Gilfillan,  T.C.:  Chem.-Biol.




     Interact. _7, 283 (1973).




69.  Butler, W.H.:   Br. J.  Cancer L8, 756 (1964).




70.  Bauer, D.H., Lee, D..I., and Sinnhuber,  R.D.:  Toxicol. Appl. Pharmacol.




     _L5, 415 (1969).




71.  Butler, W.H.:   J. Pathol. Bacteriol. 91. 277 (1966).




72.  Ambrecht, B.H., Shalkop,  W.T., and Rollins,  L.D.:  Nature (London) J25,




     1062 (1970).




73.  Peers, F.G., and Linsell, C.A.:  Food Cosmet. Toxicol.  14,  227  (1976).




74.  Rao, K.S., and Gehring, P.J.:  Toxicol. Appl. Pharmacol. 19, 169




     (1971).




75.  Shank, R.C., Johnson,  D.O., Tanticharoenyoz, P., Wooding, W.L., and




     Bourgeois, C.H.:  Toxicol. Appl. Pharmacol.  20, 277  (1971).




76.  Stoloff, L., Verrett,  J.M., Dantzman, J., and Reynaldo, E.F.:   Toxicol.




     Appl. Pharmacol. 23, 528 (1972).




77.  van der Watt,  J.J., and Purchase,  I.F.H.:  Br.  J. Exp.  Pathol.  51,  183




     (1970).
                                    77

-------
78.  Purchase, I.F.H., and van der Watt, J.J.:   Food Cosmet. Toxicol. 7, 135

     (1969).

79.  Hamilton, P.B.:  Fed. Proc. 36, 1899 (1977).

80.  Pohland, A.E., Cushmac,  M.E., and Andrellos,  P.J.:   J.  Assoc.  Off.

     Anal. Chem. 51, 907 (1968),

81.  Burmeister, H.R., and Hesseltine, C.W.:  Appl. Microbiol. 14,  403

     (1966).

82.  Engelbrecht, J.C., and Altenkirk, B.:   J.  Natl. Cancer Inst. 48, 1647

     (1972).

83.  Green, C.E., Rice, D.W., Hsieh, D.P.H., and Byard,  J.L.:   Food Cosmet.

     Toxicol. 20, 53 (1982).

84.  Billings, P.C., Uwaifo,  A.O., and Heidelberger, C.:  Toxicol.  Appl.

     Pharmacol^.  66, 297 (1982).

85.  Judah, D.J., Legg, R.F., and Neal, G.E.:   Nature (London) 265, 343

     (1977).

86.  Ling, K.H., Wang, J.J.,  Wu, R. , Tung,  T.C., Lin, C.K., Lin, S.S., and

     Lin,  T.M.:   J. Formosan. Med. Assoc. 66,  517  (1967).

87.  Serck-Hanssen, A.:  Arch. Environ. Health 20, 729 (1970).

88.  Krishnamachari, K.A.V.R., Bhat, R.V.,  Nagarajan, V., and  Tilak,

     T.B.G.:  Indian J. Med.  Res. 63. 1036  (1975).

89.  Krishnamachari, K.A.V.R., Bhat, R.V.,  Nagarajan, V., and  Tilak,

     T.B.G.:  Lancet 1, 1061  (1975).

90.  Tandon, B.N.,  Krishnamurthy, L., Koshy, A., Tandon, H.D.  ,

     Ramalingaswami, V., Bhandari, J.R., Mathur, M.M., and Mathur,  P.D.:
                                                •
     Gastroenterology 12, 488 (1977).

91.  Tandon, H.D.,  Tandon, B.N., and Ramalingaswami, V.:  Arch. Pathol. Lab.

     Med.  102, 372  (1978).
                                    78

-------
 92.   Olson,  L.C.,  Bourgeois,  C.H.,  Cotton,  R.B.,  Harikul,  S., Grossman,


      R.A., and  Smith,  T.J.:   Pediatrics  47,  707  (1971).


 93.   Bourgeois,  C.H.:   Encephalopathy and Fatty  Viscera:   A Possible


      Response to Acute Aflatoxin  Poisonins.  _In_"Reye's  Syndrome" (J.D.


      Pollack, ed.),  Grune  and Stratton,  New York,  1975,  p. 131.


 94.   Bourgeois,  C.H.,  Shank,  R.C.,  Grossman,  R.A.,  Johnson, D.O., Wooding,


      W.L., and  Chandavimoi,  P.:   Lab. Invest.  24,  206 (1971).


 95.   Shank,  R.C.,  Bourgeois,  C.H.,  Keschamras, N.,  and Chandavimoi, P.:


      Food Cosmet.  Toxicol. _9_, 501 (1971).


 96.   Becroft, D.M.O.,  and  Webster,  D.R.:  Br.  Med.  J. 14,  117 (1972).

          i.-.    >         '             i           '
 97.   Dvorackova, L., Kusak,  V.,  Vesely,  D.,  Vesela, J.,  and Nesnidal, P.:


      Ann. Nutr.  Aliment. 31,  977  (1977).


 98.   Chaves-Carralo, E., Ellepson,  R.D., and Gomez, M.R.:   Mayo Clin. Proc.


      51.  48  (1976).


 99.   Hogan,  G.R.,  Ryan, N.J., and Hayes, A.W.:   Lancet 1,  561 (1978).


100.   Shank,  R.C.:  The Role  of Aflatoxin in Human Disease.  In "Mycotoxins


      and  Other  Fungal  Related Food Problems" (J.V.  Rodricks, ed.), ACS Symp.


      Ser. No.  149, Araer. Chera. Soc. ,  Washington,  D.C., 1976, p.  51.


101.   Legator, M.S.:   J. Am.  Vet.  Med. Assoc. 155, 2080 (1969).


102.   Lillehoj,  E.B., and Ciegler, A.: _App_l_. Microbiol.  20, 782 (1970).


103.   Maher,  V.M.,  and  Summers, W.C.:   Nature (London) 225, 68 (1970).


104.   Ong, T.:   Mol Gen. Genet. Ill, 159  (1971).


105.   Schimmer,  0., and Werner, R.:   Mutat. Res.  26, 423 (1974).


106.   Lamb, M.J., and Lilly,  L.J.:  Mutat. Res.  11,  430 (1971).


107.   Velazquez,  A.,  de Nava,  C.,  Coutino, R., and Pulido,  J.:  Mutat. Res.


      21,  241 (1973).
                                     79

-------
108.   Maclnnes,  M.A.,  Friedrich,  U.,  van Daalen Wetters,  T., and Coffino,




      P.:   Mutat.  Res.  95.  297  (1982).




109.   Lilly, L.J.:  Nature  (London) 207, 433 (1965).




110.   Reiss, J.:  jSxperientia 27, 971 (1971).




111.   Green, S., Legator, M. , and Jacobson, C.:  Mammalian Chromosome




      Newsletter 8,  36  (1967).




112.   Withers,  R.F.J.:   The Action of Some Lactones and Related Compounds  on




      Human Chromosomes.  In  "Proceedings of the Symposium on the Mutational




      Process"  (Z. Landa, ed.),  Czechoslovakia Academy of Sciences, Prague,




      1966, p.  359.




113.   Dolimpio,  D.A.,  Jacobson,  C., and Legator, M.S.:  Proc. Soc. Exp. Biol,




      Med.  127,  559  (1968).




114.   Promchainant,  C., Baitnai,  V., and Nondasuta, A.:  Mutat. Res. 16, 373




      (1972).




115.   Fabry, L. , and Roberfroid,  M. :   Toxicol. Lett.  7_> 2^5 (1981).




116.   Epstein,  S.S., and Schafner, H.:   Nature (London) 219, 385 (1968).




117.   Leonard,  A., Deknudt, G. ,  and Linden, G.:  Mutat. Res. 28, 137 (1975).




118.   Ames, B.N.,  Durston,  W.E.,  Yamasaki, E., and Lee, F.D.:  Proc. Nat.




      Acad. Sci. U.S.A. 70, 2281  (1973).




119.   Uwaifo, A.O.,  and Bababunmi, E.A.:  Cancer Lett. 7, 221 (1979).




120.   Wheeler,  L., Halula,  M.,  and Demeo, M.:  Mutat. Res. 83, 39  (1981).




121.   Dunn, J.J.,  Lee,  L.S.,  and  Ciegler, A.:  Environ. Mutagenesis 4,  19




      (1982).




122.   McCann, J.,  Springarn,  N.E., Kobori, J. , and Ames, B.N.:  Proc. Nat.




      Acad. Sci. U.S.A. 72, 979 (1975).




123.   Swenson,  D.H., Miller,  J.A., and Miller, E.G.:  Cancer Res.  35, 3811




      (1975).
                                     80

-------
124.  Wong, J.J.,  and Hsieh,  D.P.H.:   Proc.  Nat.  Acad.  Sci.  U.S.A. 73, 2241




      (1976).




125.  Wong, J.J.,  Singh,  R.A.,  and Hsieh,  D.P.H.:   Mutat.  Res. 44, 447




      (1977).




126.  Coles, B.F., Smith, J.R.L., and Garner,  R.C.:  Biochem. Biophys. Res.




      Commun.  76,  888 (1977).




127.  Wehner,  F.C., Thiel, P.G.,  Van  Rensburg,  S.J. ,  and Demasius, I.P.C.:




      Mutat. Res.  58. 193 (1978).




128.  Ueno, Y.,  Kubota,  K.,  Ito,  T.,  and Nakamura,  Y.:   Cancer Res. 38, 538




      (1978).




129.  Venger,  B.H., Hansch,  C., Hatheway,  G.J., and Amrein,  Y.U.:   J. Med.




      Chem. 22.  473 (1979).




130.  Bassir,  0.,  and Adekunle, A.:  J. Patno1. 102,  49 (1970).




131.  Kemper,  F.:   Lancet 2,  836  (1962).




132.  Gabor, M., Puscario, F.,  and Dear, C.:   Arch. Roam.  Pathol.  Exp.




      Microbiol. 32, 269  (1973).




133.  DiPaolo,  J.A., Elis, J.,  and Erwin,  H.:   Nature (London) 215, 638




      (1967).




134.  Butler,  W.H., and  Wigglesworth, J.S.:   Br.  J. Exp. Pathol. 47,  242




      (1966).




135.  Elis, J.,  and DiPaolo,  J.A.:  Arch.  Pathol. 83, 53 (1967).




136.  Schroeder, H.W., and Kelton, W.H.:  Appl. Microbiol. 30, 589 (1975),




137.  Dickens,  F., and Jones, H.E.H.:  Br. J.  Cancer 19, 392  (1965).




138.  Dickens,  F., Jones, H.E.H., and Waynforth,  H.B.:   Br.  J. Cancer 20,  134




      (1966).




139.  Carnaghan, R.B.A.:   Br. J.  Cancer 21,  811 (1967).




140.  Wogan, G.N., and Newberne,  P.M.:  Cancer Res. 27, 2370  (1967).
                                     81

-------
141.   Lancaster,  M.C.:   Cancer Res.  28,  2288 (1968).




142.   McLean,  A.E.M., and  Marshall,  A.:   Br. J.  Exp.  Pathol.  52," 322 (1971).




143.   Norred,  W.P.,  and Morrissey,  R.E.:   Toxicol.  Appl.  Pharmacol.  70, 96




      (1983).




144.   Butler,  W.H.,  and Barnes, J.M.:   Br. J. Cancer  17,  699  (1963).




145.   Butler,  W.H.,  and Barnes, J.M.:   Nature (London)  209, 90 (1966).




146.   Butler,  W.H.,  and Barnes, J.M.:   Food Cosraet. Toxicol.  6, 135  (1968).




147.   Barnes,  J.M.,  and Butler, W.H.:   Nature (London)  202, 1016 (1964).




148.   Fong, L.Y.Y.,  and Chan,  W.C.:   Food Cosmet. Toxicol. 19. 179 (1981).




149.   Dickens, F.,  and  Jones,  H.E.H.:   Br. J. Cancer  17,  691  (1963).




150.   Grice, H.C.,  Moodie, C.A., and Smith, D.C.:  Cancer Res. 33, 262




      (1973).




151.   Herrold, K.M.:   Br.  J.  Cancer 23,  655 (1969).




152.   Ashley,  L.M.,  Halver,  J.E., Gardner, W.K., Jr., and Wogan, G.N.:  Fed.




      Proc. 24, 627 (1965).




153.   Sinnhuber,  R.O.,  Wales,  J.H.,  Engebrecht,  R.H., Amend,  D.E., Ayres,




      J.L., Ashton,  W.E.,  and  Kray,  W.:   Fed. Proc. 24, 627 (1965).




154.   Sinnhuber,  R.O.,  Wales,  J.H.,  Ayres J.L.,  Engebrecht, R.H., and Amend,




      D.L.:  J. Natl.  Cancer Inst.  41, 711 (1968).




155.   Jackson, E.W.,  Wolf, H., and Sinnhuber, R.O.:  Cancer Res.  28,  987




      (1968).




156.   Carnaghan,  R.B.A.:  Nature (London) 208, 308 (1965).




157.   Lewis, G.,  Markson,  L.M., and Allcroft, R.:  Vet. Record 80. 312




      (1967).




158.   Gopalan, C.,  Tulpule,  P.G., and Krishnamurthi, D.:   Food Cosmet.




      Toxicol. 10,  519  (1972).




159.   Tilak, T.B.G.:   Food Cosmet.  Toxicol.  13,   247  (1975).
                                     82

-------
160.  Wogan, G.N.:   Prog.  Exp. Tumor Res. 11, 134 (1969).




161.  Wieder, R., Wogan,  G.N., and Shimkin,  M.B.:   J.  Nat 1. Cancer Inst. 40,




      1195 (1968).




162.  Vesselinovitch, S.D., Mihailovich, N., Wogan, G.N., Lombard, L.S., and




      Rao, K.V.N.:   Cancer Res.  32, 2289 (1972).




163.  Newberne, P.M., and  Wogan, G.N.:   Cancer Res. 28, 770 (1968).




164.  Butler, W.H.,  Greenblatt,  M., and Lijinsky,  W.:   Cancer Res. 29, 2206




      (1969).




165.  Wogan, G.N.,  Paglialunga,  S., and Newberne,  P.M.:  Food Cosmet.




      Toxicol. 12.  681  (1974).




166.  Joseph-Bravo,  P.I.,  Findley, M.,  and Newberne,  P.M.:  J. Toxicol.




      Environ. Health 1,  353 (1976).




167.  Angsubhakorn,  S., Bhamarapravati, N.,  Romruen,  K., Sahaphong, S.,




      Thamavit, W.,  and Miyamoto, M.:  Br. J. Cancer  43, 811 (1981).




168.  Boyd,  J.N., Babish,  J.G.,  and Stoewsand, G.S.:   Food Chem. Toxicol. 20,




      47 (1982).




169.  Moore, M.R.,  Pitot,  H.C.,  Miller, E.G., and Miller, J.A.:  J. Natl.




      Cancer Inst.  68,  271 (1982).




170.  Epstein, S.M., Bartus, B., and Farber, E.:   Cancer Res. 29,  1045




      (1969).




171.  Merkow, L.P.,  Epstein, S.M., Slitkin,  M., and Pardo, M. :  Cancer Res.




      33,  1608 (1973).




172.  Newberne, P.M., and  Rogers, A.E.:  J.  Natl.  Cancer Inst. 50, 439




      (1973).




173.  Ward,  J.M.,  Sontag,  J.M.,  Weisburger,  E.K.,  and Brown, C.A.:  J. Nat 1.




      Cancer Inst.  55,  107 (1975).
                                     83

-------
174.   Halver,  J.E.,  Ashley,  L.M.,  Smith,  R.R.,  and Wogan,  G.N.:   Fed.  Proc.


      27,  552  (1968).


175.   Halver,  J.E.,  Ashley,  L.M.,  and Smith,  R.R.:  Nat.  Cancer  Inst.


      Monograph 31.  141  (1969).


176.   Ayres,  J.L., Lee,  D.J.,  Wales, J.H.,  and  Sinnhuber,  R.O.:   J.  Natl.


      Cancer  Inst. 46, 461  (1971).


177.   Sinnhuber, R.O., Lee,  D.J.,  Wales,  J.H.,  Landers, M.K.,  and Keyl,


      A.C.:   J. Natl.  Cancer Inst. 53, 1285 (1974).


178.   Canton,  J.H.,  Kroes,  R., van Logten,  M.J.,  van Schothorst, M.,

                                   t t
      Stavenuiter, J.F.C.,  and Verhulsdonk, C.A.H.:  Food  Cosmet. Toxicol.


      1J3,  441  (1975).


179.   Hendricks, J.D.,  Sinnhuber,  R.O., Nixon,  J.E., Wales, J.H., Masri,


      M.S.,  and Hsieh, D.P.H.:  J. Natl.  Cancer Inst. 64,  523 (1980).


180.   Schoenhard, G.L.,  Hendricks, J.D.,  Nixon, J.E., Lee, D.J., Wales, J.H.,


      Sinnhuber, R.O.,  and Pawlowski, N.E.:  Cancer Res.  41, 1011 (1981).


181.   Bailey,  G., Taylor, M.,  Selivonchick, D., Eisele, T. , Hendricks, J.,


      Nixon,  J., Pawlowski,  N., and Sinnhuber,  R.:  Basic Life Sci.  21, 149


      (1982).


182.   Scarpelli, D.G.:   Prog.  Exp. Tumor Res. 20, 339 (1976).


183.   Sinnhuber, R.O.,  and Wales,  J.H.:  Fed. Proc. 33, 247 (1974).


184.   Wales,  J.H., Sinnhuber,  R.O., Hendricks,  J.D., Nixon, J.E., and Eisele,


      T.A.:   J. Natl.  Cancer Inst. 60, 1133 (1978).


185.   Hendricks, J.D., Sinnhuber, R.O., Wales,  J.H., Stack, M.E., and Hsieh,


      D.P.H.:   J. Natl.  Cancer Inst. 64, 1503 (1980).


186.   Sato, S., Matsushima, T., Tanaka, N., Sugimura, T. ,  and Takashima,


      F.:   J.  Natl. Cancer  Inst.  50, 765 (1973).


187.   Reddy, J.K., Svoboda, D.J., and  Rao, M.S.:   Cancer  Res. 36, 151 (1976).
                                     84

-------
188.   Lin, J.J., Liu, C., and Svoboda, D.J.:  Lab. Invest. 30. 267 (1974).




189.   Adamson,  R.H.,  Correa,  P.,  Sieber, S.M., Mclntire, K.R., and Dalgard,




      D.W.:   J. Natl. Cancer  Inst. 57. 67 (1976).




190.   Sieber, S.M., Correa,  P., Dalgard, D.W., and Adamson, R.H.:   Cancer




      Res. j[9_,  4545 (1979).




191.   Whitham,  M.,  Nixon, J.E., and Sinnhuber, R.O.:   J. Natl. Cancer Inst.




      68.  623 (1981).




192.   Nixon, J.E.,  Hendricks, J.D., Pawloswki, N.E.,  Loveland, P.M., and




      Sinnhuber, R.O.:   J.  Natl.  Cancer Inst. 66, 1159 (1981).




193.   Wogan, G.N.,  and Paglialunga, S.:  Food Cosmet.  Toxicol. 12, 381




      (1974).




194.   Zwicker,  G.M.,  Carlton, W.W., and Tuite, J.:  Food Cosmet. Toxicol. 12,




      491  (1974).




195.   Enomoto,  M.,  Hatanaka,  J.,  Igarashi, S., Uwanuma, Y., Ito, H., Asaoka,




      S.,  lyatomi,  A.,  Kuyama, S., Harada, T., and Hamasaki, T.:  Food Chem.




      Toxicol.  20,  547 (1982).




196.   Fujii, K., Kurata, H.,  Odashima, S., and Hatsuda, Y.:  Cancer Res.  36,




      1615 (1976).




197.   Purchase, I.F.H., and van der Watt, J.J.:  Food Cosmet. Toxicol. J3, 289




      (1970).




198.   Enomoto,  M.,  Mabuchi,  M., Miyata, K., Naoe, F.,  Takada, N., and




      Yamazaki, M.:  St. Marianna Med. J. _5, 308 (1977).




199.   Ohtsubo,  K.,  Saito, M., Kimura, H., and Tsuruta, 0.:  Food Cosmet.




      Toxicol.  16,  143 (1978).




200.   Maekawa,  A.,  Kajiwara,  T., Odashima, S., and Kurata, H.:  Gann 70,  777




      (1979).




201.   Terao, K.:  Gann 69. 237 (1978).
                                     85

-------
202.  Mabuchi, M.:   Jpn.  J.  Exp. Med.  49, 165 (1979).




203.  Terao,  K.,  Aikawa,  T.,  Hatanaka, J., and Abo, Y.:   Carcinogenicity of




      Sterigmatocystin-Related Compounds in Medaka (Orizias latipes).




      Proceeding  of 38th  Annunal Meeting of Japanese Cancer Association,




      Japanese Cancer Association, Tokyo, Japan, 1979, p. 50.




204.  Purchase, I.F.H. ,  and  van der Watt, J.J.:  Toxicol. Appl. Pharmacol.




      26, 274 (1973).




205.  Newberne, P.M., Russo,  R., and Wogan, G.N.:  Pathol. Vet. J. 3, 331




      (1966).




206.  Madhavan, T.V., and Gopalan, C.:  Arch. Pathol.  85, 133 (1968).




207.  Wells,  P.,  Aftergood,  L., and Alfin-Slater, R.B.:   J. Am. Oil Chem.




      Soc. J?3, 559  (1976).




208.  Lee, J., Sinnhuber, R.O., Wales, J.H., and Putnam, G.B.:  J. Natl.




      Cancer  Inst.  60,  317  (1978).




209.  Preston, R.S., Hayes,  J.R., and Campbell, T.C.:   Life Sci.  19, 1191




      (1976).




210.  Appleton, B.S., and Campbell, T.C.:  Nutr. Cancer 3, 200  (1982).




211.  Lee, D.J.,  Wales,  J.H., and Sinnhuber, R.O.:  Cancer Res. 31, 960




      (1971).




212.  Lee, D.J.,  Wales,  J.H., an Sinnhuber, R.O.:  J. Natl. Cancer Inst. 43,




      1037 (1969).




213.  Friedman, L., and Mohr, H.:  Fed. Proc.  27,  551 (1968).




214.  Nixon,  J.E.,  Sinnhuber, R.O., Lee, D.J., Landers, M.K., and Harr,




      J.R. :  J. Natl. Cancer  Inst. 53, 453 (1974).




215.  Carter, F.L., and  Frampton, V.L.:  Chem. Rev. 64, 497  (1964).




216.  Rogers, A.E., and Newberne, P.M.:  Cancer Res.  29,  1965  (1969).




217.  Rogers, A.E., and  Newberne, P.M.:  Nature (London)  229,  62  (1971).
                                     86

-------
218.   Rogers, A.E.:   Cancer Res. 35, 2469 (1975).




219.   Newberne, P.M., and Rogers, A.E.:   Aflatoxin Carcinogenesis in Rats:




      Dietary Effects.  In "Mycotoxins in Human Health" (I.F.H. Purchase,




      ed.),  MacMillan, London,  1971, p.  195.




220.   Temcharoen, P., Anukarahanonta, T., and Bhamarapravati, N.:  Cancer




      Res.  38, 2185  (1978).




221.   Newberne, P.M., and Suphakarn, V.:  Cancer 40, 2553 (1977).




222.   Grant, K.E., Conner, M.W., and Newberne, P.M.:  Toxicol. Appl.




      Pharmacol. ^1_, 166 (1977).




223.   Swenson, D.H., Lin, J.K., Miller,  E.G., and Miller, J.A.:  Cancer Res.




      37, 172 (1977).




224.   Haight, L.E.,  Nixon, J.E., Hendricks, J.D., and Sinnhuber, R.O.:  Fed.




      Proc.  40, 948  (1981).




225.   Boyd,  J.N., Sell, S., and Stoewsand, G.S.:  Proc. Soc. Exp. Biol. Med.




      161,  473 (1979).




226.   Newberne, P.M., and Williams, G.:   Arch. Environ. Health 19, 489




      (1969).




227.   Cardeilhac, P.T., and Nair, K.P.C.:  Toxicol. Appl. Pharmacol. 26, 393




      (1973).




228.   Gurtoo, H.L.,  Motycka, L.E., and Parker, N.:  J. Med.  7, 1 (1976).




229.   Goodall, C.M., and Butler, W.H.:  Int.  J. Cancer. 4, 422 (1969).




230.   Arora, R.G.:  Acta Pathol. Microbiol. Scand. Sect. A 89, 303  (1981).




231.   Newberne, P.M., Hunt, C.E., and Wogan,  G.N.:  Exp. Molec. Patho^. 6,




      285 (1967).




232.   Reddy, J.K., and Svoboda, D. :  Arch. Pathol. 93, 55 (1972).




233.   Lindenfelser,  L.A., Lillehoj, E.B., and Burmeister, H.R.:  J. Nat 1.




      Cancer Inst. 52, 113 (1974).
                                     87

-------
234.  Novi, A.M.:  Science 212, 5A1 (1981).




235.  Garner,  R.C.,  Miller,  E.G.,  and Miller,  J.A.:   Cancer ResT 32, 2058




      (1972).




236.  Essigmann, J.M.,  Croy, R.G., Nadzan, A.M., Busby, W.F., Jr., Reinhold,




      V.N., Bu'chi, G.,  and Wogan,  G.N.:  Proc. Nat.  Acad. Sci. U.S.A. 74,




      1870 (1977).




237.  Swenson, D.H., Miller, J.A., and Miller, E.G.:  Biochem. Biophys. Res.




      Connnun.  53, 1260  (1973).




238.  Swenson, D.H., Miller, E.G., and Miller, J.A.:  Biochem. Biophys. Res.




      Commun.  60, 1036  (1974).




239.  Gurtoo,  H.L.,  and Dave, C.V.:  Cancer Res. 35, 382 (1975).




240.  Garner,  R.C.:   Biochem. Pharmacol. 24, 1553 (1975).




241.  Garner,  R.C.,  and Wright, C.M.:  Chem.-Biol.  Interact.  11,  123 (1975).




242.  Croy, R.G., Essigmann, J.M., Reinhold, V.N.,  and Wogan, G.N.:  Proc.




      Nat. Acad. Sci. U.S.A. 75, 1745 (1978).




243.  Essigmann, J.M.,  Donahue, P.R., Story, D.L.,  Wogan, G.N., and




      Brunengraber,  H.:  Cancer Res. 40, 4085 (1980).




244.  Lin, J.-K., Kennan, K.A., Miller, E.G.,  and Miller, J.A.:   Cancer Res.




      38, 2424 (1978).




245.  Neal, G.E., and Colley, P.J.:  Biochem.  J. 174, 839 (1978).




246.  Neal, G.E., and Colley, P.J.:  FEES Letters 101, 382 (1979).




247.  Williams, D.E., and Buhler,   D.R.:  Cancer Res. 43, 4752 (1983).




248.  Degen, G.H., and  Neumann, H.-G.:  Chem.-Biol.  Interact. 22,  239  (1978)




249.  Garner,  R.C.,  Miller, E.G.,   Miller, J.A., Garner,  J.V., and Hanson,




      R.S.:  Biochem. Biophys.  Res. Commun. 45, 774 (1971).




250.  Gurtoo,  H.L.,  and Campbell,   T.C.:  Mol. Pharmacol. 10,  776  (1974).
                                     88

-------
251.   Dahms,  R.,  and Gurtoo, H.L.:   Res. Connnun. Chem. Pathol. Pharmacol. 15,



      11 (1976).



252.   Gurtoo, H.L.:   Mol. Pharmaco^. 18, 296 (1980).


253.   Yoshizawa,  H., Uchimaru, R.,  Kamataki, t., Kato, R., and Ueno, Y.:



      Cancer Res. 42, 1120 (1982).



254.   Robertson,  I.G.C., Zieger, E., and Goldstein, J.A.:  Carcinogenesis 4,



      93 (1983).


255.   Roebuck, B.D., and Wogan, G.N.:  Cancer Res. 37, 1649 (1977).



256.   Gurtoo, H.L.,  and Dahms, R.P.:  Biochem. Pharmacol. 28, 3441  (1979).


257.   Vaught, J.B.,  Klohs, W., and Gurtoo, H.L.:  Life Sci. 21.  1497 (1977).


258.   Yoshizawa,  H., Uchimaru, R. ,  and Ueno, Y.:  J. Biochem. (Tokyo)  89, 443



      (1981).



259.   Niranjan,  B.C., and Avadhani, N.G.:  J. Biol. Chem. 255. 6575 (1980).



260.   Niranjan,  B.C., and Avadhani, N.G.:  jSiochem. Biophys.  Res. Commun. 94,



      1021 (1980).


261.   Niranjan,  B.C., Bhat, N.K., and Avadhani, N.G.:  Science 215, 73
                                                          F ~ ~ ~™~~


      (1982).



262.   Lotlikar,  P.O., Insetta, S.M., Lyons, P.R., and Jhee, E.-C.:   Cancer



      _Lett_. _9» 1*3 (1980).


263.   Patterson,  D.S.P., and  Roberts, B.A.:  Food Cosmet. Toxicol.  9,  829



      (1971).


264.   Patterson,  D.S.P., and  Roberts, B.A.:  Food Cosmet. Toxicol.  10, 501



      (1972).



265.   Schoenhard, G.L., Lee,  D.J.,  Howell,  S.E., Pawlowski,  N.E.,  Libbey,



      L.M., and Sinnhuber, R.O.:  Cancer Res. 36, 2040 (1976).



266.   Salhab, A.S., and Edwards, G.S.:   Cancer Res.  37,  1016  (1977).



267.   Patterson,  D.S.P., and  Roberts, B.A.:  Experientia  28,  929 (1972).
                                      89

-------
268.  Wong, Z.A., and Hsieh, D.P.H.:  Science 200, 325 (1978).




269.  Hsieh,  D.P.H.,  Wong,  Z.A.,  Wong, J.J., Michas, C.j an Ruebner, B.H.:




      Comparative Metabolism of Aflatoxin.  In "Mycotoxins in Human and




      Animal  Health"  (J.V.  Rodricks, C.W. Hesseltine and M.A. Mehlman, eds.),




      Pathotox, Park Forest South, Illinois, 1977, p. 37.




270.  Allcroft, R.,  Roberts, B.A., and Lloyd, M.K.:   Food Cosmet. Toxicol. 6,




      619 (1968).




271.  Stoloff, L.:  J. Food Prot. 43. 226 (1980).




272.  Allcroft, R.,  Rogers, H., Lewis, G., Nabney, J., and Best, P.E.:




      Nature  (London) 209,  154 (1966).




273.  Nabney, J., Burbage,  M.B.,  Allcroft, R., and Lewis, G.:  Food Cosmet.




      Toxicol. _5, H  (1967).




274.  Steyn,  M., Pitout, M.J., and Purchase, I.F.H.:  Br. J. Cancer 25, 291




      (1971).




275.  Roes, M.T., Forrester, L.J., and Brawn, H.D.:   Food Cosmet. Toxicol.




      11, 463 (1973).




276.  Dalezios, J.I., and Wogan, G.N.:  Cancer Res.  32, 2297  (1972).




277.  Dalezios, J.I., Hsieh, D.P.H., and Wogan, G.N.:  j*ood Cosmet. Toxicol.




      11, 605 (1973).




278.  Campbell, T.C., Caedo, J.P., Jr., Bulatao-Jayne, J.,  Salamat, L., and




      Engel,  R.W.:  Nature (London) 227, 403 (1970).




279.  Bassir, 0., and Emafo, P.O.:  Biochem. Pharmacol. 19,  1681  (1970).




280.  Bassir, 0., and Emerole, G.O.:  Xenobiotica 3, 201  (1973).




281.  Masri,  M.S., Booth, A.N., and Hsieh, D.P.H.:  Life  Sci.  L5, 203 (1974).




282.  Rice, D.W., and Hsieh, D.P.H.:  Res. Commun. Chem.  Pathol.  Pharmacol.




      35, 467 (1982).
                                     90

-------
283.  Krieger, R.I., Salhab, A.S., Dalezios, J.I., and Hsieh, D.P.H.:  Food




      Cosmet.  Toxicol.  13,  211 (1975).




284.  Merrill, A.H., Jr., and Campbell, T.C.:   Toxicol. Appl. Pharmacol. 27,




      210 (1974).




285.  Metcalfe, S.A., and Neal, G.E.:  Carcinogenesis 4. 1007 (1983).




286.  Gurtoo,  H.L.,  Dahms,  R.T.,  Ranter, P., and Vaught, J.B.:  J. Biol.




      Chem. 253. 3952 (1978).




287.  Buchi, G.H., Muller,  P.M.,  Roebuck, B.D., and Wogan, G.N.:  Res.




      Commun.  Chem.  Pathol. Pharmacol. _8_, 585  (1974).




288.  Wong, Z.A.,  Wei,  C.-I., Rice, D.W., and  Hsieh, D.P.H.:  Toxicol. Appl.




      Pharmacol. 60, 387 (1981).




289.  Purchase, I.F.H., and Steyn, M.:  Br. J. Cancer 23, 800 (1969).




290.  Dann, R.E.,  Mitscher, L.A., and Couri, D.:  Res. Commun. Chem. Pathol.




      Pharmacol. _3»  667 (1972).




291.  Schabort, J.C., and Steyn,  M.:   Biochem. Pharmacol. 18, 2241  (1969).




292.  Paterson, D.S.P., and Roberts,  B.A.:  Food Cosmet. Toxicol. 8, 527




      (1970).




293.  Salhab,  A.S.,  and Hsieh, D.P.H.:  Res. Commun. Chem. Pathol.  Pharmacol.




      10, 419  (1975).




294.  Salhab,  A.S.,  Abramson, P.P., Geelhoed,  G.W., and Edwards,  G.S.:




      Xenobiotica 7. 401 (1977).




295.  Domngang, F.,  and Emerole,  G. :   Biochem. Pharmacol. 31, 2327  (1982).




296.  Lijinsky, W.,  Lee, K.Y., and Gallagher,  C.H.:  Cancer Res.  30, 2280




      (1970).




297.  Essigmann, J.M., Barker, L.J.,  Fowler, K.W., Francisco, M.A.,  Reinhold,




      V.N., and Wogan, G.N.:  Proc. Nat. Acad. Sci. U.S.A.  76,  179  (1979).
                                     91

-------
298.   Misra, R.P., Muench,  K.F., and Humayun, M.F.:   Biochemistry 22, 3351




      (1983).




299.   Muench, K.F., Misra,  R.P., and Humayun, M.Z.:   Proc.  Nat. Acad. Sci.




      U.S.A. 80, 6 (1983).




300.   Bailey, G.S., Nixon,  J.E., Hendricks, J.S., Sinnhuber, R.O., and van




      Holde, K.E.:  Biochemistry 19, 5836 (1980).




301.   Yu, F.-L.:  Carcinogenesis 4, 889 (1983).




302.   Lin, J.K., Miller, J.A.,  and Miller, B.C.:   Cancer Res. 37, 4430




      (1977).




303.   Autrup, H., Essigmann, J.M., Croy, R.G., Trumps, B.F., Wogan, G.N., and




      Harris, C.C.:  Cancer Res. J9, 694 (1979).




304.   Leadon, S.A., Tyrrell, R.M., and Cerutti,  P.A.:  Cancer Res. 41, 5125




      (1981).




305.   Amstad, P.A., Wang, T.V., and Cerutti, P.A.:  J. Natl. Cancer Inst. 70,




      135 (1983).




306.   Hertzog, P.J. , Lindsay Smith, J.R., and Garner, R.C.:  Careinogenesis




      _3, 723 (1982).




307.   Chetsanga, C.J., and Frenette, G.P.:  Carcinogenesis 4, 997  (1983).




308.   D'Andrea,  A.D., and Hasseltine, W.A.:  Proc. Nat. Acad. Sci. U.S.A. 75,




      4120  (1978).




309.   Croy, R.G.,  and Wogan, G.N.:  J. Natl. Cancer Inst.  66, 761  (1981).




310.   Patterson, D.S.:  good Cosmet. Toxicol. 11, 287 (1973).




311.   Lutz, W.K.,  Jaggi, W., Luthy, J., Sagelsdorff,  P., and Schlatter, C.:




      Chem.-Biol.  Interact. 32, 249 (1980).




312.   Miller, J.A., and Miller, E.G.:  Ultimate Chemical Carcinogens  as




      Reactive Mutagenic Electrophiles.   In "Origins  of Human Cancer"  (H.H.




      Hiatt, J.D.  Watson, and J.A. Winsten, eds.), Book B,  Cold  Spring  Harbor




      Laboratory,  1977, p.  605.




                                     92

-------
313.  Drake, J.W.,  and Blatz, R.H.:  Ann. Rev.  Biochem. 45, 11 (1976).




314.  Schafer,  R.M.,  and Loeb, L.A.:   Proc.  Natl.  Acad. Sci. U.S.A. 78, 1773




      (1981).




315.  Witkin, E.M.:   Bacteriol. Rev.  40, 869 (1976).




316.  Saras in,  A.R.,  and Hanawait,  P.C.:  Proc.  Nat.  Acad. Sci. U.S.A. 75,




      346 (1978).




317.  Laval, F.:  Proc. Nat. Acad.  Sci. U.S.A.  77, 2702 (1980).




318.  Boiteux,  S.,  and Laval, J.:  Biochem.  Biophys.  Res. Commun. 110, 552




      (1983).




319.  Bhat, N.K.,  Emeh, J.K., Niranjan, B.C., and  Avadhani, N.G.:  Cancer




      Res. 42,  1876  (1982).




320.  Bhattacharya,  R.K., and Aboobaker, V.S.:   J. Biosci. 3, 215 (1981).




321,  Wagner, G.,  and Unterreiner,  A.M.:  Chem.-Biol. Interact.  37, 233




      (1981).




322.  Sidransky, H. ,  Verney, E., Murty, C.N., Sarma,  D.S.R., and Reid, M. :




      Chem.-Biol.  Interact.  18, 69 (1977).




323.  Sarasin,  A.,  and Moule, Y.:  Eur. J. Biochem. 54, 329 (1975).




324.  Kensler,  T.W.,  Busby,  W.F., Jr., Davidson, N.E., and Wogan, G.N.:




      Biochim.  Biophys. Acat 437, 200 (1976).




325.  Keen, P., and Martin,  P.:  Trop. Geogr. Med. 23. 44  (1971).




326.  Shank, R.C.,  Wogan, G.N., and Gibson, J.B.:   Food Cosmet.  Toxicol.  10,




      51 (1972).




327.  Shank, R.C., Wogan, G.N., Gibson, J.B., and Nondasuta, A.:   Food




      Cosmet. Toxicol. 10, 61  (1972).




328.  Shank, R.C., Siddhichai, P., Subhaman, B.,  Bharaarapravati, N.,  Gordon,




      J.E., and Wogan, G.N.:   Food Cosmet. Toxicol.  10,  181  (1972).




329.  Prates, M.D., and Torres,  P.O.:   J. Natl. Cancer  Inst.  35, 729  (1965).
                                     93

-------
330.   Payet,  M.,  Cros, J. ,  Quenum, C., Sankale, M.,  and Moulanier, M.:  La


      Presse  Medical 74,  649 (1966).


331.   Lin^ T.-Y.:  Scand.  J. Gastroent. Suppl.  6, 223 (1970).


332.   Campbell,  T.C., and  Salamat, I.:  Aflatoxin Ingest ion and Excretion by


      Humans. ^In_ "Mycotoxins in Human Health"  (I.F.H. Purchase, ed.),


      MacMillan,  London,  1971, p. 271.


333.   Aleksandrawicz, J.,  and Smyk, B.:  Texas  Rep.  Biol. Med. 31, 727


      (1973).



334.   Van Rensburg, S.J.,  and Van Schalwayk, D.J.:  Chem. Rundsch. 25, 12


      (1979).


335.   Fong, L.Y.Y., Ton,  C.C.T., Koonanuwatchaidet,  P., and Huang, D.P.H.:


      Food Cosmet. Toxicol. 18, 467 (1980).


336.   Simmons, M.J., Yap,  E.H., Yu, M., Seah, C.S.,  Chew, B.K., Fung, W.P.,


      Tan, A.Y.O., and Shanmugaratnam, K.:   Lancet 1, 1149 (1971).


337.   Sherlock,  S., Fox,  R.A., Niazi,  S.P., and Scheuer, P.:   Lancet 1,  1243


      (1970).


338.   Bagshawk,  A.P., Parker, A.M., and Jindani, A.:  Br. Med. J. _1_, 88


      (1971).


339.   Van Nieuwenhuize, J.P., Herber,  F.M., De Bruin, A., Meyer, P.B., and


      Duba, W.C.:  T. Soc.  Geneeskd.  51, 754 (1973).


340.   Deger,  G.E.:  Ann.  Int. Med. 85, 204  (1976).


341.   Phillips,  D.L., Yourtee, D.M.,  and Searles, S.:  Toxicol. Appl.


      Pharmacol.  36, 403 (1976).

                      i"    i
342.   Stora,  C.,  Dvorackova, I., and Ayraud, N.:  Res. Commun. Chem. Pathol.


      Pharmacol.  31, 77 (1981).


343.   Onyemelukwe, G.C., Ogbadu, G.H., and  Salifu, A.:  Toxicol. Lett. 10,



      309 (1982).
                                     94

-------
344.   Wray, B.B., and Hayes, A.W.:   Environ.  Res.  22,  400 (1980).




345.   Stoloff,  L.:   Occurrence of Mycotoxins  in Foods  and Feeds.  In




      "Mycotoxins and Other Fungal Related Food Problems" (J.V. Rodricks,




      ed.), ACS Monograph No. 149,  American Chemical Society, Washington,




      D.C., 1976, p. 23.




346.   Stoloff,  L.:   Aflatoxins — An Overview.  In "Mycotoxins in Human and




      Animal Health" (J.V. Rodricks, C.W. Hesseltine and M.A. Mehlman, eds.),




      Pathotox, Park Forest South,  Illinois,  1977, p.  7.




347.   Wilson,  B.J.,  Campbell, T.C., Hayes, A.W.,  and Hanlin, R.T.:  Appl.




      Microbiol. 16. 819  (1968).




348.   Lee, L.S., Bennett, J.W., Cucullu, A.F., and Ory, R.L.:  J. Agric. Food




      Chem. 24, 1167 (1976).




349.   Hsieh, D.P.H., Lin, M.T., Yao, R.C., and Singh,  R.:  J. Agric. Food




      Chem. 24, 1171 (1976).




350.   Hsieh, D.P.H., Singh, R. , Yao, R.C., and Bennett, J.W.:  Appl. Environ.




      Microbiol. 35, 980  (1978).




351.   Bennett,  J.W., Lee, L.S., Shoss, S.M.,  and Boudreaux,  G.H.:  Appl.




      Environ.  Microbiol. 39, 835 (1980).




352.   Davis, N.D.,  and Diener, U.L.:  Environmental Factors  Affecting the




      Production of  Aflatoxin.  In "Proceedings of the First U.S.-Japan




      Conference on Toxic Microorganisms" (M. Herzberg, ed.), U.S. Government




      Printing  Office, Washington, D.C., 1970, p.  43.




353.   Lillehoj, E.B., Fennell, D.I., and Kwolek, W.F.:   Science  193, 495




      (1976).




354.   Campbell, T.C., and Stoloff, L.:  J. Agr. Food Chem.  22,  1006  (1974).
                                     95

-------
355.  Rodricks, J.V.,  and Stoloff, L.:   Aflatoxin Residues from Contaminated

      Feed in Edible  Tissues of Food-Producing Animals.  JLn_ "Mycotoxins in

      Human and Animal Health" (J.V. Rodricks, C.W. Hesseltine and M.A.

      Mehlman, eds.),  Pathotox, Park Forest South,  Illinois, 1977, p. 67.

356.  Ciegler, A., Burmeister, H.R., Vesonder, R.F., and Hesseltine, C.W. :

      Mycotoxins:   Occurrence in the Environment.  In "Mycotoxins and

      N-Nitroso Compounds:  Environmental Risks" (R.C. Shank, ed.), Vol. I,

      CRC Press, Boca Raton, Florida, 1981, p. 2.

357.  Marsh, P.B., Simpson, M.E., Craig, G.O., Donoso, J., and Ramey, H.H.,

      Jr.:  J. Environ. Quality 2, 276 (1973).
             *
358.  Vedanayagam, H.S., Indulkar, A.S., and Rao, S.R.:   Indian J. Exp. Biol,

      ^9, 410 (1971).

359.  Abalaka, J.A.,  and Elegbede, J.A.:  Food Cosmet. Toxicol. 20, 43

      (1982).

360.  Mertz, D., Edward, T., Lee, D., and Zuber, M.:  J.  Agric. Food Chem.

      29, 1168 (1981).

361.  Van Pee, W., Van Brabant, J., and Joostens, J.:  Rev. Agric.

      (Bruxelles)  30.  403 (1977).

362.  Fritz, W. , Donath, R., and Engst, R.:  Nahrung 21,  79 (1977).

363.  Kiermeier, F.,  Weiss, G., Behringer, G., Miller, M., and Ranfft, K.:

      Z. Lebensmitt.-Unters.-Forsch. 163,  171 (1977).

364.  Polzhofer, K.:   Z. Lebensmitt.-Unters.-Forsch. 163.  175  (1977).

365.  Paul, R., Kalra, M.S., and Singh, A.:   Indian  J. Dairy  Sci.  29,  318

      (1976).

366.  Schuller, P.L., Verhulsdonk,  C.A.H., and Paulsch,  W.E.:  Pure  Appl.

      Chem. 35, 291 (1973).
                                     96

-------
367.  Luck, H.,  Steyn, M.,  and Wehner, F.C.:  S.  Afr. J. Dairy Technol. j^, 85



      (1977).
                                                             •


368.  FDA:  "Report on Action Level for Aflatoxin Mj in Milk," Bureau of



      Foods, U.S. Food and  Drug Administration, Washington, D.C., 1977.



369.  Murthy,  T.R.K., Jemmali, M., Henry, Y., and Frayssinet, C.:  J. Anirn^



      Sci. 41,  339 (1975).


370.  Jacobson,  W.C., Harmeyer, W.C., Jackson, J.E., Annbrecht, B., and



      Wiseman,  H.G.:  Bull. Environ. Contain. Toxicol. 19, 156 (1978).



371.  Neff, G.L., and Edds, G.T.:  Food Cosmet. Toxicol. 19, 739 (1981).


372.  Baxter,  C.S., Wey, H.E., and Burg, W.R.:  Food Cosmet. Toxicol. 19, 765



      (1981).


373.  FAO:  "Mycotoxins,"  Report of the Joint FAO/WHO/UNEP Conference on



      Mycotoxins, Nairobi,  September 19-27, 1977, Food and Agriculture


      Organization of the United Nations, Rome, Italy, 1977, 105 pp.



374.  Castegnaro, M., Hunt, D.C., Sansone, E.B., Schuller, P.L., Siriwardana,


      M.G., Telling, G.M.,  Van Egmond, H.P., and Walker, E.A. (eds.):



      "Laboratory Decontamination and Destruction of Aflatoxins Bj, B2» G^,



      G2 in Laboratory Wastes,"  IARC Sci. Publ. No.  37,  International Agency


      for Research on Cancer, Lyon, France, 1980, 59 pp.



375.  Shank, R.C.:  Mycotoxins:  An Assessment of Risks.  ^In_ "Mycotoxins  and



      N-Nitroso Compounds:   Environmental Risks" (R.C. Shank, ed.), Vol.  I,



      CRC Press, Boca Raton, Florida, 1981, p. 141.
                                      97

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