CURRENT AWARENESS DOCUMENT
POLYNUCLEAR LACTONE-TYPE AND RELATED ALKYLATING AGENTS
        CARCINOGENICITY AND STRUCTURE ACTIVITY
     RELATIONSHIPS.   OTHER BIOLOGICAL PROPERTIES.
       METABOLISM.   ENVIRONMENTAL SIGNIFICANCE.
                     Prepared by:
                 David Y. Lai, Ph.D.
             Yin-Tak Woo, Ph.D.,  D.A.B.T.
                   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.
                      March 1985

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5.3.1.2  Polynuclear Lactone-type and Related  Alkylating Agents:   Penicillium




Toxins.
     5.3.1.2.1  Introduction.





     The Penicillium represent  another important  fungal  group containing




species which elaborate toxigenic  as well  as carcinogenic metabolites.




Several Penicillium toxins,  which  have been tested  for carcinogenic activity,




are shown in Table XII.





     Like the Aspergillus, members of the  Penicillium group occur frequently




as natural contaminants of  foods and feeds and have been implicated as  the




causative agents in many instances of illness and death  of humans and farm




animals.  A case in point is the outbreak  of the  "yellowed rice disease" in




Japan shortly after World War II.   The incident,  which led to many deaths, has




been attributed to rice heavily contaminated with _P. islandicum, the mold that




produces luteoskyrin, cyclochlorotine and  islanditoxin.   P. viridicatum, which




elaborates ochratoxin A, citrinin, griseofulvin and penicillic acid, is one of




the major contaminants of stored corn and  various types  of decaying vegetation




(see rev. 1).





     Early interest in the  studies of griseofulvin, citrinin, patulin,  peni-




cillic acid, penicillin G and rugulosin arose largely because of their  poten-




tial usefullness as antibiotics.  Since the discovery of aflatoxin in the




1960's, awareness of the importance of natural chemicals as environmental




contaminants has intensified; the biochemical, toxicological and human health




effects of these and other mycotoxins have attracted dramatically increased




attention in the last two decades.  Several publications summarize current




knowledge of these effects  of Penicilliurn  toxins  (2-8).
                                      100

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                                      Table XII
       Penicillium  Toxina Which Have Been Tested for Carcinogenic Activity
      i°°H         "
       Ochratoxin A
            CH3  CH3
           Citrinin
                                                                                          CHO
  H3C  "'"     CH,
PR toxin
                          HO
                       ff
                 0  OCH3
              V  II  I   ^
              ,C-C-C=CH-
         0
         II
        -C-HN-
Patulin
Penicillic acid
        Penicillin G

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                              Table XII  (Continued)
 H3CO   0 OCH3
  3  i    ii  v
        -c.
H.CO
   Cl


Griseofulvin
                                                          CH2OH     CH2CH3    CH2OH

                                     CO-NH-CH-CH2-CO-NH-CH        CH-CO-NH-CH-CO-NH-

                             HO-CH2-CH                   CO        NH
                                     NH-CO-CH-NH-CO

                                            CH2

                                            CH3         Cl    Cl

                                        Cyclochlorotine
                                                                I
                                                                CO-CH2-CH-NH-CO
CH2OH

•CH

CO
                  0
                   Rubratoxin B
                                             OH   0
                                                            H
                                                                     Islanditoxin
                                                       OH   0    OH
                                                            II
                                                 R    0  |H1     II
                                                 1     IJ     l\\\  0     R
                                                Luteoskyrin   R=OH

                                                Rugulosin    RrH
     CI2

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     5.3.1.2.2  Physicochemical Properties and Biological Effects.





     5.3.1.2.2.1  PHYSICAL AND CHEMICAL PROPERTIES.





     Penicillium toxins display wide variations in their chemical structure




(see Table XII) as well as in physicochemical properties.  The ultraviolet,




infrared, nuclear magnetic resonance and mass spectral data of many of these




compounds have been compiled (9, 10).  Some other important physical proper-




ties of Penicillium toxins are summarized in Table XIII.





     Ochratoxin A is a 7-carboxy-5-chloro-8-hydroxy-3,4-dihydro-3-R-methyl




derivative of isocoumarin linked to the amino group of L-y§-phenylalanine .




Upon acid or enzymic hydrolysis, L- A-phenylalanine and the isocoumarin acid




are formed.  Ochratoxin A is quite stable in stored foods, but decomposes




readily under fluorescent light (9, 11).





     Citrinin (4,6-Dihydro-8-hydroxy-3,4,5-trimethyl-6-exo-3H-2-benzopyran-7-




carboxylic acid) resembles structurally the isocoumarin derivative of ochra-




toxin A.  The compound is thermally stable in hexane or ethanol, but is ther-




mally labile in acid or alkaline solution.  It is also unstable under fluo-




rescent light and is inactivated by cysteine (9).





     PR toxin (7-Acetoxy-5,6-epoxy-3,5,6,7,8,8a-hexahydro-3',8,8a-trimethyl-3-




oxospiro[naphthalene-2(1H),2'-oxirane]-3'-carboxaldehyde)  has a eremophilane




ring system with an acetoxy group, an aldehyde, and an  O^,B -unsaturated




ketone, two epoxides and three methyl groups.  The compound reacts with




ammonia and free amino acids (12).





     Both patulin (a furopyrone) and penicillic acid have  a five-membered  lac-




tone ring unsaturated  in the  c(,& -position to the carbonyl group.   In aqueous




solution, penicillic acid is in equilibrium with  the corresponding open-chain




hexanoic acid  (see Table XII).  Patulin  is stable under  acidic conditions  or







                                      101

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                                                 Table XIII
                               Physical  Properties  of  Some  Penicilliutn Toxins3
   Toxin
  Physical Form
                                             m. p.
                     Optical Rotation
                        Solubility
Ochratoxin A
Citrinin
PR toxin
Patulin
Colorless crystals
Yellow needles
Colorless crystals
Colorless to white
crystals
Penicillic acid   Colorless crystals
Penicillin G
Amorphous white powder
Griseofulvin
Colorless octahedra
or rhombs
89-95°C (benzene)0
  169°C (xylene)c


  178°C
  155°C
                            87°C
  220°C
       = _H8
       - -27.7C
                     Inact ive
                     Inactive
                            = +269°
                                                                    17 _
[<*ID  = +370C
Slightly soluble in
water; soluble in polar
organic solvents

Insoluble in water;
soluble in dilute alkali,
ethanol and dioxane

Insoluble in water,
dilute acid or alkali;
soluble in organic
solvents

Soluble in water and
polar organic solvents

Soluble in water,
ethanol, ether, benzene
and chloroform

Sparingly soluble in
water; soluble in
methanol, ethanol,
acetone, ether, chloro-
form and ethyl acetate

Insoluble in water,
petroleum or ether;
slightly soluble in
ethanol, methanol,
acetone, benzene, chloro-
form, ethyl acetate and
acet ic ac id

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                                           Table XIII (continued)
                                                                                                          kf  2
   Toxinb
Rubratoxin B
Luteoskyrin
Rugulosin
  Physical Form
Colorless crystals
Yellow, rectangular
crystals
Yellow, prism-like
crystals
Cyclochlorotine   White needles
                                             m.p.
169°C
287°C
290°C
                           251°C
                   Optical Rotation
                 Solubility
= -880
= +492
                          = -92.9C
Sparingly soluble in
water; soluble in
ethanol, ethyl acetate,
dioxane and acetone

Insoluble in water;
soluble in sodium bicar-
bonate and most organic
solvents

Insoluble in water;
soluble in sodium bicar-
bonate and most organic
solvents

Soluble in water and
n-butanol
aSummarized from IARC Monographs, Vol.  10,  1976; P.M.  Scott,  Penicillium Mycotoxins.   In  "Mycotoxin  Fungi,
 Mycotoxins, Mycotoxicoses, An Encyclopedic Handbook"  (T.D. Wyllie  and  L.G. Morehouse, eds.),  Vol.  1,  Part  2,
 Marcel Dekker, New York,  1977, p.  283; The Merck  Index,  10th  ed. ,  Merck &  Co.,  Rahway, NJ,  1983.

 See Table XII for structural formulas.

""Solvents used in crystallization.

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in chloroform, but is unstable in alkaline solutions or in methanol.   The




secondary alcohol group of the hetniacetal moiety of patulin may be esterified




to form a monoacetate, benzoate or cinnamate.   Various derivatives of patulin




can also be formed involving the carbonyl group (9, 13).   Unlike patulin,




penicillic acid is stable under either acid or alkaline conditions.  The




reaction of penicillic acid with phenylhydrazine or excess diazomethane yields




a pyrazoline derivative.  Both patulin and penicillic acid react readily with




sulfhydryl-containing amino acids or proteins  (9, 13).





     Penicillin G (benzylpenicillinic acid) consists of a thiazolidine ring




linked to a beta-lactam ring,  to which a benzyl side chain is attached.




Removal of the benzyl side chain chemically or by the action of amidase yields




6-aminopenicillanic acid (see  rev. 14).





     Griseofulvin (7-Chloro-4:6:2 f-trimethoxy-6'-methylgris-2'-en-3 :4'-dione)




is a polycyclic chlorine-containing compound.   Acid hydrolysis of griseofulvin




gives griseofulvic acid which, upon further hydrolysis with 0.5 H sodium




hydroxide, yields norgriseofulvin and decarboxygriseofulvic acid (15).





     Rubratoxin B is a substituted analog of byssochlamic acid in which the




ethyl group is replaced by a 6-carbon  0( ,K -unsaturated lactone.  Oxidation of




rubratoxin B with chromic acid in acetone at 0°C yields monoketone deriva-




tives.  The toxin is stable in sodium bicarbonate  (16).





     Luteoskyrin is a substituted bis-polyhydroxydihydroanthraquinone.  Reac-




tion of leuteoskyrin with 60% sulphuric  acid yields islandicin and irido-




skyrin.  Rugulosin, also an anthraquinone, is chemically  related to  luteo-




skyrin.  Both toxins can chelate divalent cations  such as magnesium  and cal-




cium ions  (see rev. 17).
                                      102

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     Cyclochlorotine is a water-soluble cyclic pentapeptide containing resi-




dues of a dichloroproline,  06-aminobutyric acid, serine,  /J-amino- fl-phenyl-




butyric acid, and serine.  The compound gives a positive result in biuret




test, but is negative in the ninhydrin reaction (cited in 10).






     Islanditoxin is a cyclic peptide isomeric with cyclochlorotine.   The




physicochemical properties  of islanditoxin resemble those of cyclochlorotine.






     5.3.1.2.2.2  BIOLOGICAL EFFECTS OTHER THAN CARCINOGENICITY.






     Toxic Effects.   The presence of fungi in foods and animal feeds  has long




been incriminated in outbreaks of human diseases and poisonings of poultry,




swine and cattle.  The common deleterious effects on farm animals include




reduced feed intake, decreased weight gains and lower production of egg and




milk.  Consumption of large doses of mycotoxins generally results in animal




deaths.  The LDcQ values of some Penicillium toxins in laboratory rodents are




shown in Table XIV.   Among  all compounds, the "yellowed rice" toxins  cyclo-




chlorotine and islanditoxin are the most potent ones; rubratoxin B is also




extremely toxic to the rat  and mouse when administered intraperitoneally.  In




a chick embryotoxicity test, the lethal doses for several Penicillium toxins




are:  ochratoxin A,  0.1 ^ug; PR toxin, 0.1 pg; rubratoxin B, 0.1 ,ug; patulin,




1.0 /ug; citrinin, 10 .ug; penicillic acid, 10.ug; and griseofulvin, 100 ug




(34).  As many of these mycotoxins may occur simultaneously in mold-




contaminated foods and feeds, the possibility of toxic interaction is receiv-




ing increasing attention.  A synergistic effect between the acute toxicities




of ochratoxin A and citrinin (35-37) and between the acute toxicities of




ochratoxin A and penicillic acid (27, 35, 38) in rodents has been reported.






     Pathological observations indicate that different organ system may be




characteristically affected by particular mycotoxins.  Ochratoxin A and
                                      103

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                                                          1  of  2
                Table XIV
Acute Toxicity of Some Penicillium Toxins

Toxin3
Ochratoxin A
Citrinin





PR toxin




Patulin








Penicillic acid



Penicillin G
Griseofulvin
Rubratoxin B




Luteoskyrin



Species and Route
Rat, oral
Rat , s .c . , i.p.
Mouse, oral
s.c. , i.p.
i .v.
Rabbit, i.v.
Guinea pig , s.c.
Rat, oral
i .v .
i.p.
Mouse, oral
i.p.
Rat, oral
s.c.
i.p.
Mouse, oral
s.c.
i.p.
Hamster, oral
s.c.
i.p.
Mouse, oral
s.c.
i .v .
i.p.
Mouse, i.v.
Rat, i.v.
Rat , oral
i.p.
Mouse, oral
s.c.
i.p.
Mouse, oral
s.c.
i .v .
i.p.
LD5Q (mg/kg)
28
67
110
35
38
19
37
115
8.2
11.6
72
5.8
55
11
10
48
10
7.5
31.5
23
10
600
110
250
70
168
400
400
0.36
400
6.8
2.6
221
147
6.6
40.8
Reference
18
19
20
19
20
19
19
21
22
21
12
22
23
23
23
24
24
24
25
25
25
26
26
26
27
28
8
29
29
8
30
29
17
17
17
17

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                               Table  XIV (continued)
                                                                              2 of 2
Toxin3
Rugulosin

Cyclochlorotine


Islanditoxin


Species and Route
Rat, i.p.
Mouse, i.p.
Mouse, oral
s .c .
i .v.
Mouse, oral
s .c.
i .v .
LD5Q (mg/kg)
44
55
6.55
0.48
0.34
6.5
0.47
0.3
Reference
31
31
32
32
32
Cited in
Cited in
Cited in






33
33
33
See Table XII for structural formulas

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citrinin are primarily nephrotoxic, causing kidney enlargement, tubular




necrosis and disruption of renal functions in varying animal species (39,  40;




rev. 9).  These two toxins have been suspected to be the etiologic agents  of




porcine nephropathy in Denmark (41).  There is also epidemiologic evidence




suggesting that these two mycotoxins nay be involved in the endemic "Balkan




nephropathy," a renal disorder of approximately 20,000 people living along the




Danube River in Romania, Bulgaria, and Yugoslavia (42, 43).





     Chu and associates (44,  45) have studied the relationships between the




structure and toxicity of ochratoxin A and its derivatives in ducklings.




Whereas the methyl ester and  the ethyl ester (ochratoxin C) of ochratoxin  A




are as toxic as ochratoxin A, the dechlorinated analog (i.e. , ochratoxin B) of




ochratoxin A, the 4-hydroxylated ochratoxin A (i.e. , ochratoxin D) and the




hydrolysis products of ochratoxin A (i.e., ochratoxin ££,) and of ochratoxin B




(i.e. , ochratoxin A ) are much less toxic.  On the basis of these findings,




Chu and coworkers (44, 45) suggested that the presence of a chlorine atom




and/or a phenolic hydroxyl group in the dissociated form are important for the




toxicity of these compounds.   It was noted that the higher the pK value, the




less toxic the compound; for  instance, the pK value of ochratoxin A and some




of its derivatives are:  ochratoxin A, 7.07; ochratoxin C, 7.14; ochratoxin B,




7.95, and ochratoxin 
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disease mimic those of acute beriberi and are characterized by vomiting,




convulsions, ascending paralysis,  and respiratory arrest  (46).





     In the mouse, the liver is also a target organ of griseofulvin, a potent




porphyrogenic and antimitotic agent which produces various types of liver




damage (47). -Like the well-known spindle poison colchicine, griseofulvin




inhibits the assembly of microtubule and disrupt the mitotic apparatus of the




cell (e .g_. , 48).   The antimitotic effect is due to the interaction of the




toxin with the sulfhydryl group of either tubulin (49) or other microtubule-




associated proteins (50, 51).





     Patulin is classified principally as a neurotoxin (8, 52).  However, the




compound also produces pulmonary edema, hepatic necrosis  and gastrointestinal




hyperaemia in the rat, mouse and hamster (23-25, 53).  Oral administration to




humans has been reported to result in nausea and stomach  irritation.  Applica-




tion of ointment  containing 1% patulin to the human skin  caused edema (cited




in 9).  Studies in mice showed that the toxicity of patulin is enhanced by




treatment with SKF-525A, indicating that the parent compound, not a metabo-




lite, is the toxic form of this mycotoxin (53).  On the other hand, penicillic




acid, which causes a generalized necrosis of hepatocytes  and various histo-




pathological lesions of the kidney and thyroid gland in mice, is possibly be




metabolized into a more toxic intermediate(s), since the  acute toxicity of




penicillic acid in the mouse is increased by pentabarbital and 3-methylchol-




anthrene pretreatment but decreased by SKF-525A (54).





     PR toxin causes edema in the lung and direct damage  to the liver, kidney




and heart in mice, rats and cats (12, 22).  Comparison between the  chemical




structures and the biological properties of some eremophilane compounds




related to PR toxin suggested to Moule et al. (55) that the aldehyde group  in
                                      105

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position 12 rather than the two epoxide moieties, or the acetyl group on the




eremophilane ring is associated with the toxic effects.  This is supported by




the finding that PR imine, an analog of PR toxin without the aldehyde group in




12, is considerably less toxic in the mouse than the parent compound (12, 55).





     Penicillin G possesses potent antimicrobial activity against gram-




positive and gram-negative cocci, gram-positive bacilli, spirochetes, actino-




mycetes and psittacosis virus.  In some individuals receiving sodium penicil-




lin G for treatment of infectious diseases, local and generalized allergic




reactions, convulsions, bronchospasm and nephropathy may occur (see rev. 14).





     Mutagenic Effects.  The mutagenicity of Penicillium toxins has been




tested in Salmonella typhimurium, Bacillus subtilis, Escherichia coli,




Aspergillus nidulans,  Saccharomyces cerevisiae and several mammalian systems




(Table XV).





     According to the  data from the studies using S. typhimurium strains TA98,




TA100, TA1535 and TA1538, only PR toxin shows positive results in one study




(61) using strain TA98 with the addition of S-9 mix; all other toxins were




negative with and without S-9 mix (8, 56, 57, 60, 61, 64, 66, 75, 77, 83).




However, considerable  concern has been voiced regarding the sensitivity and




adequacy of such screening systems for these toxins since these tester strains




detect only reverse mutations representing only limited types of genetic




alterations.  Indeed,  Stark et al. (83) showed the mutagenicity of rugulosin




and a photoproduct of luteoskyrin (lumiluteoskyrin) in_£. typhimurium strain




TM677 which detects forward mutations.  The. mutagenesis assay was carried out




in suspension at low concentrations for long exposure periods.  Addition of




rat liver microsomes to the assay system diminished the mutagenicity.   In




1982, a new Salmonella tester strain, TA97, was developed to replace strain
                                      106

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                                   Mutagenicity of  Some  Penicillium  Toxins
Toxin3
Ochratoxin A
Citrinin
PR toxin
Patulin
Penicillic acid
Penicillin G
Griseofulvin
Rubratoxin B
Luteoskyrin
Rugulosin
Cyclochlorotine
Salmonella
typhfmurium
- (56,57)c
- (56,57,60,61)
+ (61,63)d
- (64)
- (56-59,66)
- (57,60,61)
- (75)
- (56,57,61,77,78)
- (56,60)
- (57,61,83)
+e (83)
- (61,83)
- (8)
Bacillus
subtilis

- (58)
+ (58)
+ (58)
+ (58)
+ (58)
- (76)
- (58,76)
- (58)
+ (58)
+ (58)
n.t.f
Saccharomyces
cerevisiae

- (56)
- (56)
+ (65)
+ (67)
- (56)
- (56)
n.t.
- (56)
- (56)
+ (84)
+ (84)
n.t.
Chromosomal
Aberrations
- (59)
+ (62)
n.t .
+ (59,68-70)
+ (59,74)
n.t .
- (77)
+ (81)
- (59)
n.t .
n.t.
Other
Tests
n.t .
-g (62)
-8 (64)
+8 (71)
-8 (68)
-h (72,73)
n.t .
+k (76)
-h (79)
-^ (80)
+J (78)
+h (82)
n.t.
n.t .
n.t .
aSee Table XII for structural formulas.
bStrains TA98, TA100, TA1535, TA1537 and/or TA1538.
c"+" = positive; "-" = negative; numbers in parenthesis are references,
dStrains TA97, TA98.
eStrain TM677.
 n.t.  = not tested.
&Sister-chromatid exchange assay.
 Mouse dominant lethal assay.
1Aspergillus nidulans.
JSperm abnormality assay in mice.
k
 Escherichia coll.

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TA1537 for the detection of frameshift mutagens (63).   The mutagenicity of PR




toxin was again demonstrated in this more sensitive strain (63).  Other




Penicillium toxins have not been tested for their mutagenic properties in




strain TM677 or strain TA97 of _S. typhimurium.





     When the genotoxicity of Penicillium toxins was studied in the rec assay




in the recombination-deficient mutant of Bacillus subtilis M45 (rec-) and in




the parent strain H17 (rec+), positive results  were found with citrinin, PR




toxin, patulin, penicillic acid, luteoskyrin and rugulosin (58).  Penicillin G




(76), ochratoxin A, griseofulvin and rubratoxin B (58) were not mutagenic.




The latter three compounds, as well as citrinin, patulin and penicillic acid




were also not mutagenic in Saccharomyces cerevisiae strain D3 (56).  Studies




of Wei et al. (65), on the other hand, showed that PR toxin is a direct acting




mutagen toward J3. cerevisiae strains D4 and D7, causing reverse mutation, gene




conversion and mitotic crossing-over without metabolic activation.  In agree-




ment with the toxicity results reported by Moule et al. (55), structure-




mutagenicity relationship analysis revealed that the aldehyde and the keto




groups but not the two epoxide moieties play the key role in the genetic




activity of PR toxin.  Patulin was reported to  be mutagenic in an extrachromo-




somal mutation system of a haploid strain of S. cerevisiae (67).  Luteoskyrin




and rugulosin, at low concentrations, induced a high frequency of mutations in




a respiratory-deficient mutant strain of _S_. cerevisiae (84).  Studies using




the Escherichia coli DNA-repair assay system showed that penicillin G is




mutagenic in the absence of microsomal activation (76).





     In accord with the negative results obtained in some microbial assay




systems, which detect point mutations, cytogenetic studies showed that ochra-




toxin A (59) and griseofulvin (77) had little effects on the incidence of DNA




single-strand breaks and chromosome aberrations in mouse cells.  Also, treat-







                                      107

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raent of somatic or sperm cells of the mouse with luteoskyrin did not produce




any increase in the rate of chromosomal aberrations (59).  However, in the




experiments of Kappas and Georgopoulos (80), low concentrations of griseo-




fulvin caused increased frequencies of somatic segregation due to chromosome




nondisjunction in a diploid strain of Aspergillus nidulans.  Data obtained




from the sperm abnormality assay of the mouse also showed that griseofulvin is




mutagenic (78).  Citrinin (62), patulin (59, 68-70), penicillic acid (59, 74)




and rubratoxin B (81) have all been demonstrated to be clastogenic in cells of




the mouse, hamster or humans.  Whereas citrinin (62), patulin (68) and PR




toxin (64) are inactive in the sister-chromatid exchange (SCE) assay in




Chinese hamster V79 cells, patulin induces significantly elevated frequency of




SCE in human lymphocytes (71).  Rubratoxin B (82) but not patulin (72) or




griseofulvin (79) showed any rautagenic effects in the mouse dominant lethal




assay.  The result is also negative for patulin in a dominant lethal assay in




rats (73).  The structural requirement for the dominant lethal effect of




rubratoxin B is the (?(, /^-unsaturated lactone ring (82).
     Teratogenic Effects.  Ochratoxin A, rubratoxin B, griseofulvin, PR toxin




and patulin have all been demonstrated to be embryotoxic and teratogenic in




experimental animals.





     Exposure of pregnant mice during early stage of gestation  (days 8 and 9)




to ochratoxin A resulted in increased prenatal mortality and a variety of




gross and skeletal abnormalities.  The major abnormalities are  cranio-facial




cleft associated with exencephaly and open eyelid, and skeletal defects




involving ribs and vertebrae (85).  When mice were exposed to the  toxin during




the 15th, 16th and 17th day of gestation, significant developmental delay was




noted in the pups as indicated by performance in several behavioral tests




(86).  Teratogenic effects similar to those in mice were found  in  fetuses from







                                      108

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pregnant rat given low doses (0.25, 0.50 or 0.75 mg/kg) of ochratoxin A by




gavage on day 20 of gestation (87).  At doses higher than 1 mg/kg, ochratoxin




A was embryocidal in the rat (87-89).  Golden hamsters are more resistant to




the fetotoxic effects of ochratoxin A.  The toxin is also highly teratogenic




in this species, since high, incidence of malformations such as micrognathia,




hydrocephalus, micromelia, and heart defects occurred in offspring of pregnant




golden hamsters injected intraperitoneally with 2.5-20 mg/kg ochratoxin A on




gestation day 7, 8, 9 or 10.  The highest dose (20 rag/kg) caused increased




prenatal mortality when given on day 7, 8 or 9 of gestation (90).  Ochratoxin




A also induces embryotoxic and teratogenic effects in chicken.  Injection of




ochratoxin A (0.5-7 yug/egg) into embryonating eggs resulted in malformations




including short and twisted limbs and neck, microphthalmia, exencephaly,




everted viscera, and decreased length of survival and body size of the chicken




(91).





     Like ochratoxin A, rubratoxin B is also teratogenic and induces similar




abnormalities in chick embryos (92).  Intraperitoneal administration of rubra-




toxin B (0.4-1.5 mg/kg) to mice resulted in a dose-related increase  in early




fetal deaths as well as in the incidences of fetal defects (82, 93,  94).  The




most striking developmental defects caused by rubratoxin B in the mouse are




exencephaly, malformed pinnae and jaws, umbilical hernia and "open eye"




(93).  In structure-activity relationship studies it was found that  saturation




of the o(.,A-unsaturated lactone ring in the molecule abolishes teratogenicity




(82).





     Klein and Beall (95) administered 125-1,500 mg/kg of  griseofulvin orally




to groups of pregnant rats during organogenesis.  Increased frequency of




skeletal abnormalities and decreased pre- and postnatal  survival  rates were




observed in the offspring of dams treated with high doses  of griseofulvin







                                      109

-------
(1,250 and 1,500 mg/kg).   Scott _et_ a\_. (96) reported multiple congenital




malformations in kittens  of three cats given oral doses of 500 or 1,000 mg




griseofulvin at weekly intervals during pregnancy.  In a chick embryotoxicity




screening test, embryonic death and abnormal development of the caudal trunk




were observed after administration of 100 ug and 10 ug of griseofulvin,




respectively (34).   The corresponding doses with PR toxin to exert such




effects in this test were merely 0.1 yug and 0.01 /ug.  Griseofulvin causes




embryonic death and abnormalities in newborn animals by interfering with the




formation of cell organelles, especially with the mitotic spindle (see Section




5.3.1.2.2.2).





     Treatment of pregnant mice with 10-40 mg/kg citrinin (97) or 30-90 mg/kg




penicillic acid (98) caused a significant increase in prenatal mortality of




the offspring at the highest doses, but no malformations were noted in the




surviving fetus.  There were no defects in the fetuses of mice (99) or rabbits




(100) given daily doses of 30-300 mg/kg (mice) or 10-100 mg/kg (rabbits)




penicillin G during pregnancy.  Similarly, no evidence of teratogenicity was




found in the mouse (72) or rat (73, 101) administered patulin in the range of




1.5-15 mg/kg body weight.  However, Ceigler and associates (102) observed




various skeletal abnormalities in chick embryos treated with patulin.  Upon




incubation of human placenta with patulin, Fuk-Holmberg (101) noted sharp




increases in the activities of malate dehydrogenase and RNase.  These effects




of patulin on placental enzymes were interpreted by the author as indicating




physiological and functional disorders in the tissue.





     5.3.1.2.3  Carcinogenic ity and Structure-Activity Relationships





     The carcinogenicity of Penicillium toxins were first suggested by the




observations that chronic ingest ion by mice or rats of diets containing cul-
                                      110

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tures of molds (producing these toxins)  resulted in the induction of neo-




plasms.   In Swiss mice fed a rice culture of _P_.  viridicatum (the fungus that




produces ochratoxin A, citrinin, penicillic acid and griseofulvin) in the diet




(7.5%),  a 57% higher incidence of pulmonary tumors was observed than in the




controls (103).   Similarly, administration to  30 rats of diets containing rice




cultures of P. islandicum (which produces luteoskyrin, cyclochlorotine and




islanditoxin) led to the development of hepatomas in 5 animals (104).





     So  far, only a small number of Penicillium  toxins has been studied




adequately for carcinogenicity in long-term experiments, due probably to their




potent toxicity and to the limited production  of these metabolites by fungi.




The evidence is substantial for the carcinogenicity of ochratoxin A, griseo-




fulvin,  luteoskyrin and cyclochlorotine in experimental animals.  Results from




preliminary studies also point to a carcinogenic potential of citrinin, PR




toxin and rugulosin.  Although carcinogenicity has not been demonstrated by




other routes of administration, patulin, penicillic acid, and penicillin G are




tumorigenic in rats following subcutaneous injection.  Islanditoxin, a cyclic




peptide  isomeric to cyclochlorotine, was described as a carcinogenic mycotoxin




(105).  The carcinogenicity studies on Penicillium toxins are summarized in




Table XVI.  It is interesting to note that ochratoxin A, patulin and penicil-




lic acid all contain a lactone moiety in their molecules.  Like aflatoxin and




sterigmatocin, citrinin, griseofulvin, luteoskyrin and rugulosin are biosyn-




thesized by the acetate-malonate pathway (124; rev. 9) and all contain a




phenol or quinone moiety (see Table XII).





     In  general, the organ or tissues which are  susceptible to toxic effects




of these toxins are also the targets for tumor induction.  The hepatotoxins




luteoskyrin, rugulosin, cyclochlorotine and griseofulvin all induce  liver




neoplasms whereas the nephrotoxin citrinin is  carcinogenic toward  the kidney







                                      111

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                                     Table  XVI
                       Carcinogenicity of Penicillium  Toxins

Toxin3
Ochratoxin A


PR toxin
Citrinin
Patulin

Penicillic acid


Penicillin G
(sodium salt)
Griseofulvin








Rubratoxin B
Luteoskyrin

Rugulosin

Cyclochlorotine
Principal Organs Affected
Species and Strain and Route
Mouse, ddY
Rat, F344
Rat , Wistar
Rat, albino
Rat, F344
Rat , — c
Rat, Sprague-Dawley
Rat, — c

Mouse, — c
Rat, — c

Mouse, Alderley Park
Mouse, Charles River albino
Mouse , Swiss
Mouse, white, nunu
Mouse, Swiss
Rat, MRC-Wistar
Rat , Wistar
Rat, guinea pig, rabbit, — c
Hamster, Syrian
Rat , Fischer
Mouse, ddNi , ddN
Mouse, ODD
Mouse, ddYS
Rat , F344
Mouse, ddNi, ddN
Liver, kidney; oral
Liver ; oral
None ; oral , s . c .
Neck, uterus; oral
Kidney; oral
Local sarcoma; s.c.
None; oral
Local sarcoma; s.c.

Local sarcoma; s.c.
Local sarcoma; s.c.

Liver; oral
Liver; oral
Liver ; s.c.
Liver; — c
Liver; oral
Thyroid; oral
None ; i . p .
None; oral
None; oral
None; oral
Liver; oral
Liver; oral
Liver; oral
Liver ; oral
Liver; oral
Reference
106
107
108
109
110
111
112
111, 113,
114
114
111, 113

115
116
117, 118
119
120
120
121
115
120
29
32
122
123
107
32
See Table XII for structural formulas.
Based on the initiating and promoting activities in liver carcinogenesis.

Strain/route of administration not reported.

-------
(see Table XVI).  However, studies of griseofulvin and PR toxin have also




revealed tumor induction in the thyroid, uterus and/or neck of animals, indi-




cating that several target tissues are affected by Penicillium toxins.  The




histogenesis and ultrastructural changes of liver tumor cells following treat-




ment with hepatotoxic raycotoxins of this class have been fully described and




were shown to be similar to findings in human hepatomas (125).





     Ochratoxin A.  In 1971, a pilot study on the carcinogenicity of ochra-




toxin A was conducted in rainbow trout (Salmo garidneri) .   Hepatomas were




noted in rainbow trout fed ochratoxin A at the level of 20 ppb together with




the cocarcinogen, sterculic acid.  However, no tumors were found when ochra-




toxin A was fed alone at the levels of 16, 32 or 64 ppb for 8 months (126).





     Ochratoxin A is a fairly strong carcinogen toward the liver and kidney of




the mouse.  Feeding 40 ppm ochratoxin A in the diet for 44 weeks produced  8




hepatic cell tumors, 5 renal cell tumors, and 18 cyctic adenomas of the kidney




in 19 ddY mice.  Whereas dosing with aflatoxin B, (a single dose of 20 rag/kg)




alone elicited only 2 hepatic cell tumors and no renal cell tumors in  18 mice,




administration of aflatoxin B, followed by ochratoxin  feeding (40 ppm, 44




weeks) induced 15 hepatic and 3 renal cell tumors in 20 mice, indicating a




synergistic effect of aflatoxin Bi on hepatocarcinogenesis of ochratoxin




(106).





     In the rat  (Wistar-derived), Purchase and Van der Watt  (108) failed to




induce a significant incidence of tumors by administering either 2.5 mg/kg




ochratoxin A subcutaneously twice weekly for  17.5 weeks or 0.3 rag ochratoxin  A




orally 5 times/week for 50 weeks.  They have noted a hamartoma of the  kidney




in one of the  ten rats which received ochratoxin A orally.   Using F344 rats,




Imaida et al.  (107) investigated initiation and promotion by  ochratoxin A  in
                                      112

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liver carcinogenesis.   In these bioassays, N-2-fluorenylacetamide (200 ppm in




diet) was used as an initiator (or a promoter)  and ochratoxin A was given to




the rats at a dietary level of 50 ppm for 6 weeks during the initiation stage




(or the promotion stage).  Ochratoxin A displayed both initiating and promot-




ing activity and was termed a hepatocarcinogen (107).





     PR Toxin.  The carcinogenic potential of PR toxin in the rat has been




investigated by Polonelli _e_t^ _al_. (109).  A group of 10 albino weanling rats of




both sexes was given 200 ppm PR toxin in drinking water for 52 days.  About 13




months after the treatment, a squamous epithelioma developed in the neck




region of one rat and after about 3 more months of observation, an uterine




sarcoma was detected in another rat.  None of the 10 matched control animals




developed any tumors during the same course of the study.  Although the tumor




incidences are not statistically significant and further studies are needed,




the development of these tumors, particularly the squaraous epithelioma in the




neck, was considered treatment-related on the basis of historical data showing




that spontaneous tumor of this type is rare in the rat.





     Citrinin.  Early investigations have demonstrated both the  tumorigenesis




initiating and promoting activity of critinin in the rat.  Imaida and co-




workers (107) showed that administration of citrinin to F344 rats  in the




initiating stage and of N-2-fluorenylacetamide in the promoting  stage signifi-




cantly increased the number and area of liver hyperplastic nodules  as compared




with those in the control group (which did not receive citrinin  pretreat-




ment).  Whereas N-(3,5-dichlorophenyl)succinimide (NDPS) or citrinin alone  did




not induce kidney tumors in Sprague-Dawley rat,  feeding of NDPS  for  8 weeks




followed with citrinin (0.02%)  for  20 weeks resulted in renal  cell  tumor  in 4




of  18 rats (127).  Moreover, the kidney tumor incidence in rats  treated with
                                      113

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citrinin following dimethylnitrosamine (DMN) was much higher than the inci-




dence in rats treated with DMN alone (127).





     Arai and Hibino (110) were the first to present direct evidence showing




that citrinin is indeed carcinogenic,  producing kidney adenomas in the rat.




Among 48 male F344 rats given 0.1% citrinin in the diet for up to 80 weeks, 35




(72.9%) developed renal epithelial tumors (not found in the controls).





     Patulin and Penicillic acid.  Interest in the carcinogenicity studies of




patulin and penicillic acid arose in the early 1960's when F. Dickens and




H.E.H Jones of England drew attention to the possible carcinogenic activity of




chemicals having a lactone ring in the molecule (see Vol. IIIA, Section




5.2.1.1.6 on lactones).  Patulin and penicillic acid, both having a five-




membered lactone ring and an  ct_, B-unsaturated bond, are clearly carcinogenic




by repeated injections into rats (111, 113, 114).  When 0.2-2.0 mg patulin was




injected twice weekly into subcutaneous sites in the flank of 2-month-old male




rats, local sarcomas arose in six of eight rats that survived for 1 year.




Penicillic acid, at doses of 1 mg in arachis oil, gave rise to highly malig-




nant tumors at the injection sites in all four rats that survived 64 weeks of




treatment (111).  Later experiments showed that a dose of penicillic acid  as




low as 0.1 mg is sarcomatogenic  in one of four animals surviving for 94 weeks




(113, 114).  Subcutaneous injections of aqueous solution of penicillic acid (2




rag/0.5 ml water) also produced sarcomas in 4 of 5 surviving rats indicating




that the oil vehicle dose not play a significant role  in the tumorigenicity




(113).  Similarly, local sarcomas occurred  in 6 of  19 mice receiving sub-




cutaneous doses of 0.2 mg penicillic acid twice weekly for 65 weeks  (114).





     Patulin is not carcinogenic in animals by oral administration.  A total




oral dose of 358 mg patulin/kg given over a period of  64 weeks produced no




tumors in 50 female Sprague-Dawley rats (112).





                                      114

-------
     Penicillin G.  Dickens and Jones (111, 113) have investigated the car-




cinogenic potential of penicillin G in rats by subcutaneous injection for 65




weeks.  In an early study, tumors at the injection site were observed in 2 of




8 animals that survived for at least 59 weeks (111).   In a subsequent study, 5




of 11 animals developed fibrosarcomas after 108 weeks; one of the tumors was




highly malignant and was transplantable (113).  Interestingly, 6-aminopeni-




cillanic acid, a penicillin analog which lacks the benzyl side chain, is a




much less potent carcinogen under the same study conditions (114).  The car-




cinogenic action of other members of the penicillin group (see rev. 14), which




contain various side chains, has not been tested.





     Griseofulvin.  The mouse is highly susceptible to the hepatocarcino-




genicity of griseofulvin.  The presence of hyperplastic nodules is readily




seen in the livers of Swiss mice following griseofulvin administration  (2.5%




in the diet) for 6 to 8 months (128, 129).  High incidence of hepatomas have




been repeatedly reported in various strains of mice following on  prolonged




administration of griseofulvin either orally (115, 116, 119,  120) or paren-




terally (117, 118).  Among 13 Alderly-Park strain mice which  ingested 1%




griseofulvin in the diet for 435 days, 10 were found to bear multiple hepa-




tomas; 5 of 20 mice fed a 0.5% diet also developed tumors in  the  liver




(115).  Rustia and Shubik (120) reported that the liver tumor incidence  show a




dose-response in Swiss mice given 0, 0.3,  1.5 and 3.07, griseofulvin  in  the




diet daily (during alternating 5-week periods for life).  At  the  3.0% dietary




level, the incidences of hepatoraas  in male and  female mice were 83.3% and




87.0%, respectively; the corresponding liver tumor incidences at  the  1.5%




dietary level were 68.0% and 53.6%; no significant liver  tumors were  found  in




the mice at the 0.3% dose level.  In addition to nodular  hyperplasia, neo-




plasms of the liver have also occurred in mice  of "nunu"  strain after  12-14
                                      115

-------
months of griseofulvin treatment (119).  DeMatteis and coworkers (116) noted a




marked sex difference in hepatoma incidence of Charles River albino mice which




received 1% griseofulvin orally for 12-16 months; the male animals showed a




higher incidence as well as multiplicity of these tumors than the females.




Significant incidence of hepatomas was also found in Swiss mice subcutaneously




injected a total dose of 3 mg griseofulvin at birth and infancy (117, 118).




Moreover, cocarcinogenic and promoting effects upon skin tumorigenesis in




Swiss-Webster mice were noted when low doses (10—15 mg/kg) of griseofulvin




were administered orally before, during or following topical applications of




methylcholanthrene (130).  In agreement with the tumorigenesis-promoting




activity of griseofulvin in the mouse, in vitro transformation of Swiss 3T3




cells infected with tsA mutants of the virus SV40 was enhanced following




exposure to either griseofulvin or to the potent tumorigenesis promoter,




phorbol ester (131).





     In MRC-Wistar rats oral administration of griseofulvin to groups of  30




males and females life resulted in significant incidence of thyroid tumors in




a dose-response manner at dietary levels of 0.2, 1.0 and 2.0% (120).  However,




groups of Syrian golden hamsters given 0.3, 1.5 or 3.0% griseofulvin in the




diet for the whole lifespan did not develop tumors (120).  Other studies  using




rats (115, 121), guinea pigs or rabbits (115) yielded little information  on




the carcinogenicity of.griseofulvin.  The .failure of several experiments  (115,




121) to elicit tumors  in these species appears to have resulted  from the  too




short exposure periods and/or the small number of animals used.





     Rubratoxin B.  The carcinogenic potential of rubratoxin B has only been




explored by Wogan and  coworkers (29) during a chronic toxicity  study of rubra-




toxin B in the rat.  Groups of 10-20 Fischer rats of both sexes  were intubated




with rubratoxin B at a dose of 5 or 10 mg/kg 3 times weekly  for  60 weeks.   No







                                      116

-------
evidence of preneoplastic or neoplastic lesions was observed in animals killed




after 82-87 weeks.   Also, there was no enhancement  of the carcinogenic activ-




ity of aflatoxin B^ by rubratoxin B when rats were  exposed simultaneously to




both toxins.





     Nonetheless, in view of the reported mutagenicity of the compound (see




Section 5.3.1.2.2)  and the presence in the molecule of reactive carbonyl




groups and ethylenic double bonds, further exploration on the possible car-




cinogenic activity  of rubratoxin B in other assay systems appears desirable.





     Luteoskyrin and Cyclochlorotine.  Long-term feeding studies in the mouse




have shown that these two mycotoxins exhibit similar chronic effects and are




both carcinogenic toward the liver.  In a series of experiments conducted by




Uraguchi and  coworkers (32), significant incidences of benign and malignant




liver tumors  were induced in a dose-response manner in groups of 8-30 ddNi and




ddN strain mice fed luteoskyrin (0, 50, 150 or 500  ug/day) or cyclochlorotine




(0, 40 or 60 ^ug/day) for up to 2 years.  Of 26 DDD strain mice given daily




doses of 160 ug luteoskyrin in the diet for 328 days, 17 were found by Ueno et




al. (122) to bear hepatomas of various histological types.





     Rugulosin.  In a preliminary study in which groups of 16 DdYS male mice




were administered daily doses of 12 or 25 rag/kg rugulosin in the diet  for over




800 days, 4 animals bearing hyperplastic nodules composed of hepatocytes were




found in both groups.  In addition, one animal bearing a hepatocellular




adenoma was found in the high-dose group.  None of the 14 control mice had




such lesions in the liver.  These results led the authors (123) to  suggest




that rugulosin is possibly a weak hepatocarcinogen in mice with a potency




about one tenth that of luteoskyrin.  The carcinogenic potential of rugulosin




was supported by a study demonstrating that rugulosin possesses initiating as




well as promoting activity in hepatocarcinogenesis in the rat  (107).





                                      117

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     5.3.1.2.4  Metabolism and Possible Mechanism of Action
     Information regarding the metabolism of these mycotoxins is scanty and




their mechanisms of carcinogenic action is unknown.  Previously, we have




discussed the reaction mechanisms of carcinogenic  ^-lactones with nucleo-




philic centers (Section 5.2.1.1.7, Vol. IIIA).   Similar reactions probably




also occur between nucleophiles and carcinogenic mycotoxins of this group




since they all (with the exception of cyclochlorotine and islanditoxin)




possess one or more lactone or ketone carbonyl  groups with &(.,$ -unsaturation




which, upon metabolic oxidation, can be transformed into alkylating inter-




mediates (e.g., epoxides).   Consistent with results of mutagenicity studies,




patulin, penicillic acid, rubratoxin B and luteoskyrin all form adducts with




DNA and/or chromatin.  The interaction between the sulfhydryl and amino group




of proteins, on one hand, and patulin, penicillic acid, ochratoxin A, luteo-




skyrin and rubratoxin B, on the other hand, is  well documented.  Such reac-




tions have been postulated to account for a wide range of their biological and




biochemical activities including alteration of carbohydrate and lipid metabo-




lism, inhibition of protein and nucleic acids synthesis and impairment of cell




respiration, membrane transport, etc.  It is possible that one or a constella-




tion of these activities acting in a concerted  manner may bring about perma-




nent structural and functional changes in the cells, leading eventually to




neoplasia.





     Ochratoxin A.  The metabolism of ochratoxin A has been studied in  several
animal species including the rat (132-134), the pig (135) and the cow  (cited




in ref. 9).  After a single intraperitoneal injection into rats, ochratoxin A




was detected in the serum, liver and kidney (132, 134).  Part of ochratoxin A




was metabolized to ochratoxino(, (the isocoumarin acid derived  from  the  loss




of the phenylalanine moiety of  ochratoxin A) and 4-hydroxyochratoxin A which,







                                      118

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along with the unchanged toxin,  were excreted  primarily in the urine.   Ochra-




toxin 06  is also the major metabolite in pigs  (135),  cows  (cited in ref.  9)  or




rats (133) dosed orally with ochratoxin A.   Although  ochratoxin^  is  much




less toxic than ochratoxin A toward chick embryos  (136),  ducklings (44)  and




rainbow trout (137), it is more  inhibitory than the parent compound to the




respiration of isolated rat liver mitochondria (138).





     Ochratoxin A interacts strongly with serum albumin both in vitro  (139)




and in vivo (134).   There is no  evidence as yet for the binding of ochratoxin




A to nucleic acids.  Treatment of rats with ochratoxin A results in signifi-




cant depletion of liver glycogen and decrease  of the  activities of hepatic




enzymes such as cyclic AMP-protein kinase, carboxypeptidase and phenylalanine




t-RNA synthetase, etc.  In certain bacteria ochratoxin A is a potent inhibitor




of protein and RNA synthesis (see 140).





     Citrinin.  In rats (141), rabbits or dogs (142)  citrinin is rapidly




absorbed and excreted.  Peak citrinin levels in the serum, liver and kidney




were attained within 30 minutes  after parenteral administration.  At a non-




nephrotoxic dose of 3 mg/kg, about 74% of the administered citrinin was




excreted, mostly unchanged, in the urine of rats by 24 hours after administra-




tion.  However, in rats, rabbits, and dogs, which received higher doses




citrinin, a much smaller percentage of the toxin or its metabolites were




detected in the urine.  The metabolites of citrinin have not been identified




as yet.  Some of its metabolites are suspected to be dihydrocitrinins (142).





     Disturbance of carbohydrate metabolism (143) and inhibition of




proteolysis in kidney phagolysomes (144) were noted in mice treated with




citrinin.
                                      119

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     PR Toxin.  In addition to mutagenicity data indicating the genotoxicity




of PR toxin, macromolecular binding studies have shown that the compound binds




significantly to RNA, DNA and protein in cultured cells as well as in isolated




nuclei (145).  Moreover, Moule et al.  (145) have shown that the toxin cross-




links between DNA and protein in the chromatin.  The authors implicated exclu-




sively the aldehyde group in the PR toxin molecule, which would form a




methylene bridge between an araino groups in DNA and a functional group in




chromatin protein.  However, the present writers feel that cross-linking via




the reactive epoxide groupings in the PR toxin molecule cannot be dis-




counted.  PR toxin has also been shown to impair liver cell metabolism by




inhibiting macromolecule synthesis (146).





     Patulin and Penicillic acid.  Both patulin and penicillic acid are




rapidly absorbed in the gastrointestinal tract.  In metabolic studies with




[14C]-patulin (147) or [14C]-penicillic acid (148)  in rats, most of the [14C]-




radioactivity was recovered from urine and feces within 24 hours after dos-




ing.  However, appreciable levels of radioactivity  remained in the red blood




cells, liver, kidney and lung for up to 7 days.  Significant amount of radio-




activity becomes bound to DNA, RNA and protein in the liver cells following




administration of [^4C]-penicillic acid to rats (148).  The metabolites of




patulin and penicillic acid have not been identified.





     Patulin and penicillic acid are potent inhibitors of polymerases (149),




ATPases (150, 151) and various thiol enzymes (152,  153) in vitro.  The effects




are presumed to be due to interaction of the toxins with sulfhydryl and amino




groups of these enzymes.  Indeed, patulin and penicilTic acid are known to




readily combine with sulfhydryl compounds to form S-alkylated adducts by




interaction of the nucleophilic sulfhydryl group with the double bond(s)  (154,




155).  Penicillic acid also reacts, albeit at a slow rate, with  lysine,







                                      120

-------
arginine and histidine, at pH 7.0 (154).   The inactivation of polymerases,




ATPases, and thiol enzymes probably accounts for the inhibitory effects of




patulin and penicillic acid on raacromolecular synthesis (156), active membrane




transport (157, 158) and cellular respiration (159).  Although the relation-




ship between these biochemical effects and the mechanism of their carcinogenic




action is not clear, investigation of the reaction of unsaturated TT-lactones




with cysteine has shown that S-alkylated  adducts are formed only with carcino-




genic lactones but not with noncarcinogenic lactones (160).





     Penicillin G.  In humans, about 30%  of an oral dose of penicillin G is




absorbed in the small intestine, while a  large quantity remains unabsorbed and




passes into the colon.  The absorbed penicillin G is widely distributed in the




body fluids and tissues.  Significant levels of penicillin G can be found in




the liver, bile, kidney and plasma.  The  compound is excreted mainly through




the kidney and bile; a small amount is excreted in milk and saliva.  One of




the urinary metabolites has been identified as 6-aminopenicillanic acid (see




rev. 14), which is a less potent carcinogen than penicillin G.  Since the




benzyl side chain is absent in 6-aminopenicillanic acid, Dickens and Jones




(114) speculated that the side chain might contribute to the carcinogenic




action of penicillin G.  On the other hand, penicillins were suggested to act




as alkylating or acylating agents (see rev. 161) by way of the probable reac-




tion mechanisms (shown in Fig. 4), which  would be influenced little if at all




by the benzyl side chain.





     Griseofulvin.  The metabolic fate of griseofulvin in mammalian species




have been critically reviewed by Lin and  Symchowicz (162).  In the mouse, rat,
                                      121

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           C02H
Penicillins
                          	N
                       0'      H
                                             C02H
                                                                 r-"
                                                                       N
                                                                       H
                                                      Alkylation


                                                        Nu:
                                                      Acylation
COoH
                                                                x  VCH
                                                                    pCH
                                                                      HN -
                                                                             ^
    Fig.  A.  Probable reaction mechanisms of alkylation

penicillins.
                                                          and acylation by

-------
rabbit, dog and human, the rate of absorption is rapid and most of the com-




pound is excreted in the urine as metabolites.   Studies in the rat showed that




the highest level of griseofulvin occurs in the liver after oral administra-




tion and in the lung following subcutaneous injection.  In the mouse and rat,




both A-desmethylgriseofulvin and 6-desinethylgriseofulvin are the major metabo-




lites; in rabbits, dogs and humans, on the other hand, the only major




metabolite is 6-desmethylgriseofulvin.  In the rabbit, griseofulvin is also




metabolized to 3-chloro-4,5-dimethoxysalicylic acid (163).  Several unidenti-




fied additional metabolites of griseofulvin have been found in human urine




(164).





     In the mouse liver, griseofulvin induces the proliferation of the smooth




endoplasmic reticulum, it increases the amount of NADPH-cytochrome c reduc-




tase, and stimulates the metabolism of other exogenous chemicals (165).





     Rubratoxin B.  Hayes (166) studied the distribution and excretion




patterns of rubratoxin B in mice and rats.  During the first 24-hour period




following administration of [C]-rubratoxin B (0.05 mg/kg, i.p.) to mice and




rats, 30-40% of the radioactivity was excreted through respiration as COj,




6-9% was recovered in the urine and a small amount was found in the feces.   In




both species, the concentration of radioactive substances was higher in  the




liver than in other tissues.  In the liver, radioactivity was about 54-80%  in




the cytosol, 14-25% in the mitochondrial fraction, 7-12%  in the nuclear  frac-




tion and 3-10% in the microsomal fraction.  Consistent with the findings of




the subcellular distribution studies, rubratoxin B inhibits oxygen uptake,




ATPase activity and electron transport in  liver mitochondria (167), binds to




DNA (cited in rev. 168)  and causes disaggregation of  polysomes  (169).
                                      122

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     Luteoskyrin and Rugulosin.  Pharmacoki.netic studies in the mouse (170,
                                              o
171) showed slow uptake and slow excretion of  H-luteoskyrin following sub-

cutaneous or oral administration.  During the 18 days after dosing, only 19%
                           o
and 6% of the administered  H-luteoskyrin were excreted in the feces and

urine, respectively.  The liver accumulated 83-94% of the total organ

localized radioactivity; only a minute quantity of radioactivity was present
                                           o
in the lung, kidney and spleen (170).  The  H-luteoskyrin level in the liver

of male mice is about twice as high than in the liver of females, but is only

about 15% of that in suckling mice (171).  Subcellular distribution studies

showed that about 50% of the radioactivity in liver homogenate is localized  in

the mitochondria; the nuclear and microsomal fractions contain only small

amounts of radioactivity.  More than 80% of the radioactivity in the mito-

chondria represents unchanged  H-luteoskyrin (171).  Pretreatment of male mice

with 3-methylcholanthrene or promethazine inhibits considerably the accumula-

tion of luteoskyrin in the liver, suggesting that the microsomal mixed-

function oxidases play a role in the detoxification of luteoskyrin (123).  The

pharmacokinetics and the distribution pattern of rugulosin in the mouse was

reported to be similar to those of luteoskyrin (cited in rev. 172).

     In vitro studies with mitochondrial preparations and whole  liver homo-

genates have shown that luteoskyrin inhibits oxidative phosphorylation through

a mechanism similar to that of dinitrophenol in uncoupling phosphorylation  and

to oligomycin in inhibiting electron transport (173).  In the presence of

divalent cations (e.g. , Mg++, Mn"1"*"), luteoskyrin forms complexes with single-

stranded as well as double-stranded nucleic acids (174-176).  Flow dichroism

studies established that luteoskyrin is  oriented parallel to  the axis of the

double helix of native DNA (176).  The binding of luteoskyrin to deoxyribo-

nucleohistone in vitro has also been reported  (177).  Because of its  ability
                                      123

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to interact with single-stranded nucleic acids, it was suggested that luteo-




skyrin binds to nicked DNA and interferes with DNA repair synthesis.  Indeed,




Mouton and Fromageot (178) showed that the repair of UV-induced DNA lesions in




Tetrahymena cells is inhibited by luteoskyrin.  There is also evidence that




luteoskyrin interacts with the transcription complex and inhibits the syn-




thesis of RNA in Escherichia coli (179).





     Rugulosin is believed to have similar DNA-binding properties as luteo-




skyrin (180).





     Cyclochlorotine.  Cyclochlorotine is highly resistant to the proteolytic




effects of tissue proteases.  Following subcutaneous administration to male




mice, cyclochlorotine is rapidly absorbed and transported to the liver and is




primarily excreted unchanged by the kidney.  In vitro studies showed that only




specific proteolytic enzymes having an ability to hydrolyze cyclic peptides




can degrade cyclochlorotine.  Removal of the two chlorine atoms of cyclo-




chlorotine by treatment with ammonia or alkali results in loss of toxicity of




the toxin (see rev. 172).  Studies with liver preparations have shown that




cyclochlorotine inhibits glycogenesis, decreases the incorporation of amino




acids into proteins and enhances the incorporation of acetate into lipids




(cited in rev. 140).  Cyclochlorotine inhibits Na^-dependent glycine transport




in rabbit reticulocytes (158).





     5.3.1.2.5  Environmental Significance.





     Penicillium toxin-producing fungi can grow at considerably low moisture




content and at wide ranges of temperature and pH, and thus occur ubiquitously




in the environment.  Like the Aspergillus, the Penicillium are among the most




common storage fungi in foods throughout the world.  Humans may be exposed  to




Penicillium toxins by direct contact, by inhalation, by  therapeutic use or by
                                      124

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ingestion of the contaminated foodstuffs.   Although mounting evidence links




liver cancer to aflatoxin contamination of food corps  (see Section 5.3.1.1),




epidemiological evidence on the Penicillium toxin-induced cancer in humans is




lacking.  This is not too surprising since epidemiological studies on many of




these toxins are still in their infancy.  Nonetheless, fungal toxins are




increasingly suspected to be possible etiological  agents of some human cancers




(see refs. 181, 182).





     Table XVII summarizes the natural occurrence  of several carcinogenic




Penicillium toxins, which has been the subject of  many reviews (e.g., 9, 10,




183).





     Ochratoxin A.  Ochratoxin A has been detected in corn (0.083-0.166 ppm),




wheat (0.03-27 ppm), rye (0.24 ppm), mixed oat and barley (22 ppm), beans




(0.02-2.1 ppm) and peanuts (4.9 ppm) during surveys in Canada (184, 185) and




in the United States (186, 187).  In districts of  Denmark where a high inci-




dence of porcine nephropathy occurred, up to 27.5  ppm and 0.067 ppm of ochra-




toxin A were found in about 20% of the plant (cereals) and animal (pork,




poultry) products sampled, respectively.  Residues of ochratoxin A have also




been detected in various food commodities of seven other European countries




(see rev. 188).





     Citrinin.  Citrinin was detected in  13 of 29 grain samples from Canadian




farms at concentrations of 0.07 to 80 ppm.  These samples were mainly wheat,




but there were also samples of rye, oats  and mixed oats, and barley containing




citrinin (185).  In addition to ochratoxin A, low levels  (0.16 to 2 ppm) of




citrinin were found in 3 samples of cereals from Denmark  (41).  There are  also




reports on the presence of citrinin in moldy ground nut (189) and in rotten




apples  (190).  One of the citrinin-producing fungi (P_. c itrinum) was isolated




from the Japanese "yellowed rice" imported from Thailand (see rev.  17).





                                      125

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                                  Table XVII
                Natural Occurrence of Some Penicillium Toxins'
    Toxin
        Producing Fungus
                                                            Occurrence
Ochratoxin A


Citrininc



PR toxin
Patulind


Penicillic acid°
P. viridicatum; P_. purpurescens ;
P. palitans; P. commune;
P. eye 1opium; P. variabile

P. citrinum; P. citreviride;
P- viridicatum; P. citreo-viride;
P. fellutanum;  P.  lividum;  etc.
P_. jroquefort i
P. patulum; P.  expansum;
£• urticae; P_.  c yd opium;
P. lapidosum; P. terrestre

P. puberulum; P. viridicatum;
P. thomii;  P. suavolens;
P. martensii ; _P_. palitans ;
P. expansum; P^. commune;
P. qlivino-yiride; etc.
P. griseofulvin; P. viridicatum;
_P. nigricans; _P_. urticae;
P. jpatulum
                                                        Corn, wheat, oat,
                                                        rye, barley, bean,
                                                        peanut, pork, poultry

                                                        Wheat, oat, barley,
                                                        groundnut, apple,
                                                        rice

                                                        Silage
                                                        Apple
                                                        Corn, bean, tobacco
                                                        Wheat, bean,  flour
                    P. chrysogenum; P. notatum
                    —' rubrum; ,£.• purpurogenum
                    _P_. is land icurn
                    P. rugulosum; P. brunneum;
                    P. tardurn; P. ^yariabile
                    P. islandicum
                    P. islandicum
                                     Wheat,  flour,  rice,
                                     fermented foodstuffs
                                     Corn,  bean,  peanut,
                                     silage

                                     Rice
                                     Rice

                                     Rice
                                     Rice
Griseofulvin


Penicillin G


Rubratoxin B


Luteoskyrin
Rugulosin6

Cyclochlorotine
Islanditoxin        	  	

References cited in J.M. Hamburg, P.M. Strong and E.B.  Smalley,  J.  Agr.  Food
 Chem. 17. 443 (1969); IARC Monographs, Vol.  10,  1976;  P.M.  Scott,  Penicillium
 Mycotoxins, In "Mycotoxic Fungi, Mycotoxins, Mycotoxicoses,  An Encyclopedia
 Handbook" (T.D. Wyllie and L.G. Morehouse, eds.), Vol.  1,  Part 2,  Marcel
 Dekker, New York,  1977, p. 283.
 Also produced by Aspergillus ochraceus, A. sulphureus, _A.  alliaceus, _A.
 sclerotorium, A. melleus, A. ostianus and A_. j>etrakii.
cAlso produced by Aspergillus terreus, A. niveus, A.  candidus and Clavariopsis
 aquatica.
 Also produced by Aspergillus flavus, £. clavatus, _A.  giganteus,  _A.  terreus
 and Byssochlamys nivea.
eAlso produced by Myrothecium verrucaria.

-------
     PR Toxin.  PR toxin is the major fungal metabolite isolated from moldy




silage associated with cases of bovine poisoning in Wisconsin (191).  Several




strains of PR toxin-producing fungus are used in the ripening of roquefort




cheese (see ref. 65).





     Patulin.  Patulin occurs primarily in rotten apples and related products




since patulin-producing fungi are common causes of the storage rot of apples




(see rev. 9).  The toxin has been detected in 8 of 13 samples of apple juice




from the United States at levels of 49 to 309 jug/liter (192).  Also, five of




11 apple juice samples from Canada contained 20 to 120 ug patulin/liter




(193).  The concentration of patulin in apple cider made from rotten apples




may be as high as 45 mg/liter (194).





     Penicillic acid.  Penicillic acid has been identified in moldy corn (195)




and in poultry feed (196).  Thorpe and Johnson (197) found the toxin in 7 of




20 samples of commercial corn (5-230/ug/kg) and in 5 of 20 samples of commer-




cial dried beans (11-179 /ug/kg) from the United States.  Snow£t__aJ_. (198)




found 110 and 230 /ug/kg of penicillic acid in two samples of moldy tobacco.





     Penicillin G.  Penicillin was introduced for therapeutic use in the early




1940's.  The drug was extracted from cultures of Penicillium notatum.  Since




then, many new derivatives of the basic penicillin nucleus have been dis-




covered and produced.  Presently, members of this important group of anti-




biotics remain drugs of choice against a wide variety of infectious




diseases.  Penicillin G is the most effective against infectious diseases




caused by gram-positive and gram-negative cocci, gram-positive bacilli, spiro-




chetes, actinomyces and psittacosis virus.  Preparations of penicillin G for




oral and parenteral administration, as well as for topical, ophthalmic and




vaginal uses are all available (see rev. 14).
                                      126

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     Penicillin G and several natural penicillins, are presently prepared from




a strain of Penicillium chrysogenum that grows on the stem of cantaloupes.




High yields of penicillin G are produced by submerged fermentation of a mutant




of the mold, induced by x-rays (see rev. 14).   Penicillium chrysogenum has




been detected occasionally in wheat, rice and  in some fermented foodstuffs




consumed daily by most Japanese (183, 199).





     Griseofulvin.  Griseofulvin is produced by many species of Penicillium




(see Table XVII).  These fungi have been detected in wheat, beans and flour




(183).  Griseofulvin is often used in human medicine for the treatment of




dermatophytoses.   The annual sales of griseofulvin in the United States are




estimated to be in the order of 25,000 kg (see ref. 10).





     Rubratoxin B.  Owing to difficulties in detecting rubratoxin B in complex




substrates, there are as yet no reports about  its natural occurrence in agri-




cultural products.  However, fungi that produce rubratoxin B have been




repeatedly isolated from cereal and legume products, corn, peanuts and from




feeds which have  caused liver disease in farm animals (see ref. 168).





     Luetoskyrin, Rugulosin, Cyclochlorotine and Islanditoxin.  These are




commonly referred to as "yellowed rice toxins" because they are metabolites of




predominant storage fungi associated with heavily moldy rice ("yellowed rice")




of Japan.  Contamination by fungi which produce these toxins was found in rice




both originated from Japan and imported from Thailand, Burma or other Asian




countries.  Since rice constitutes a major part of the diet of Asian popula-




tions, the high incidence of liver disease, including cancer, has been sus-




pected to be related to consumption of rice contaminated by these carcinogenic




toxins (see ref.  200).  Yellowed rice toxin-producing fungi are also major




isolates from Danish barley as well as from various African grains (see rev.




201).
                                      127

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