ORNL
Oak Ridge
National
Laboratory
Operated by
Union Carbide Corporation for the
Department of Energy
Oak Ridge, Tennessee 37830
  ORNL/EIS-86
EPA
United States
Environmental Protection
Agency
Office of Research and Development
Health Effects Research Laboratory
Cincinnati, Ohio 45268
EPA-600/1-78-024
     REVIEWS OF THE ENVIRONMENTAL
     EFFECTS  OF POLLUTANTS:
     II.  Benzidine

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                RESEARCH REPORTING SERIES

Research reports of the Office of Research and Development, U.S. Environmental
Protection Agency, have been grouped into nine series. These nine broad cate-
gories were established to facilitate further development and application of en-
vironmental technology.  Elimination  of  traditional grouping was consciously
planned to foster technology transfer and a maximum interface in related fields.
The nine series are:

      1.   Environmental Health Effects Research
      2.   Environmental Protection Technology
      3.   Ecological Research
      4.   Environmental Monitoring
      5.   Socioeconomic Environmental Studies
      6.   Scientific  and Technical Assessment Reports (STAR)
      7.   Interagency Energy-Environment Research and Development
      8.   "Special" Reports
      9.   Miscellaneous Reports
This report has been assigned to the ENVIRONMENTAL HEALTH EFFECTS RE-
SEARCH series. This series describes projects and studies relating to the toler-
ances of man for unhealthful substances or conditions. This work is generally
assessed from a medical viewpoint, including  physiological or psychological
studies. In addition to toxicology and other medical specialities, study areas in-
clude biomedical instrumentation and health research techniques utilizing ani-
mals — but always  with intended application to human health measures.
This document is available to the public through the National Technical Informa-
tion Service, Springfield, Virginia 22161.

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                                                    ORNL/EIS-86
                                                    EPA-600/1-78-024
                                                    April 1978
REVIEWS OF THE ENVIRONMENTAL EFFECTS OF POLLUTANTS:  II.  BENZIDINE
                                by

         Carole R. Shriner, John S. Drury, Anna S. Hammons,
       Leigh E. Towill, Eric B. Lewis, and Dennis M. Opresko
         Information Center Complex, Information Division
                   Oak Ridge National Laboratory
                    Oak Ridge, Tennessee  37830

                            operated by
                     Union Carbide Corporation
                              for the
                       Department of Energy
                       Technical Reviewer
                         Howard Klemmer
                      University of Hawaii
                     Honolulu, Hawaii  96816
                Interagency Agreement No. D5-0403
                          Project Officer

                          Jerry F. Stara
                  Office of Program Operations
               Health Effects Research Laboratory
                     Cincinnati, Ohio  45268
                   Date  Published;  May  1978
                           Prepared for
                HEALTH EFFECTS RESEARCH LABORATORY
                OFFICE OF RESEARCH AND DEVELOPMENT
               U.S. ENVIRONMENTAL PROTECTION AGENCY
                      CINCINNATI, OHIO  45268

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     This report was prepared as an account of work sponsored by an agency
of the United States Government.  Neither the United States Government nor
any agency thereof, nor any of their employees, contractors, subcontractors,
or their employees, makes any warranty, express or implied, nor assumes any
legal liability or responsibility for any third party's use or the results
of such use of any information, apparatus, product or process disclosed in
this report, nor represents that its use by such third party would not
infringe privately owned rights.

     This report has been reviewed by the Health Effects Research Laboratory,
U.S. Environmental Protection Agency, and approved for publication.  Approval
does not signify that the contents necessarily reflect the views and policies
of the U.S. Environmental Protection Agency, nor does mention of trade names
or commercial products constitute endorsement or recommendation for use.

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                               CONTENTS
Figures	     V
Tables	   vii
Foreword	    ix
Acknowledgments	    xi
Abstract	xiii
1.   Summary	     1
    1.1  Introduction	     1
    1.2  Benzidine Chemistry 	     1
         1.2.1  Physical Properties	     1
         1.2.2  Chemical Properties	     1
         1.2.3  Biochemical Reactions	     2
         1.2.4  Methods of Analysis	     2
    1.3  Uses and Production	     3
    1.4  Environmental Distribution and Fate 	     4
         1.4.1  Distribution in Air	     4
         1.4.2  Distribution in Water	     4
         1.4.3  Distribution in Soil	     4
         1.4.4  Mobility and Persistence 	     5
         1.4.5  Food Chain Accumulation	     5
    1.5  Biological Aspects in Microorganisms, Plants, and Wild
           and Domestic Animals	     5
         1.5.1  Microorganisms 	     5
         1.5.2  Plants	     6
         1.5.3  Wild and Domestic Animals	     6
    1.6  Biological Aspects in Humans	     6
         1.6.1  Metabolism	     6
         1.6.2  Effects	     8
    1.7  The Problem	    11
    1.8  Conclusions	    11
2.  Physical and Chemical Properties and Analysis	    14
    2.1  Summary	    14
    2.2  Physical and Chemical Properties	    15
         2.2.1  Benzidine and Salts	    15
         2.2.2  3,3'-Dichlorobenzidine and Salts 	    29
         2.2.3  3,3'-Dimethylbenzidine and Salts 	    33
         2.2.4  3,3'-Dimethoxyben7.idine and Salts	    35
         2.2.5  4-Aminobiphenyl	    37
         2.2.6  4-Nitrobiphenyl	    39
         2.2.7  Other Benzidine Congeners	    41
    2.3  Analysis for Benzidine	    41
         2.3.1  Sampling and Sample Preparation	    46
         2.3.2  Methods of Analysis	    50
         2.3.3  Comparison of Analytical Procedures	    64
3.  Biological Aspects in Microorganisms 	    74
4.  Biological Aspects in Plants  	    77
5.  Biological Aspects in Wild and Domestic Animals	    79
6.  Biological Aspects in Humans  	    81
    6.1  Summary	    81
                                   iii

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                                   iv
    6.2  Metabolism	     82
         6.2.1  Uptake	     82
         6.2.2  Distribution and Accumulation	     83
         6.2.3  Biotransformation and Elimination	     89
    6.3  Effects	     97
         6.3.1  Physiological Effects	    100
         6.3.2  Toxicity	    100
7.   Environmental Distribution and Transformation	    123
    7.1  Summary	    123
    7.2  Production and Use	    123
         7.2.1  Benzidine	    123
         7.2.2  3,3'-Dichlorobenzidine 	    123
         7.2.3  3,3'-Dimethylbenzidine 	    124
         7.2.4  3,3'-Dimethoxybenzidine	    124
    7.3  Distribution in the Environment	    124
         7.3.1  Distribution in Soils	    124
         7.3.2  Distribution in Water	    124
         7.3.3  Distribution in Air	    125
    7.4  Environmental Fate	    125
         7.4.1  Mobility and Persistence	    125
         7.4.2  Accumulation in Food Chains	    125
8.   Environmental Assessment 	    128
    8.1  Production, Uses,  and Potential Environmental
           Contamination 	    128
         8.1.1  Production	    128
         8.1.2  Uses	    128
         8.1.3  Losses to the Environment.	    128
    8.2  Environmental Persistence 	    129
         8.2.1  Physical and Chemical Degradation	    129
         8.2.2  Biodegradation	    130
    8.3  Effects on Aquatic and Terrestrial Organisms	    131
         8.3.1  Nonlaboratory Organisms	    131
         8.3.2  Laboratory Animals 	    131
    8.4  Effects on Human Health	    132
         8.4.1  Toxic Effects	    132
         8.4.2  Teratogenic Effects	    132
         8.4.3  Mutagenic Effects	    132
         8.4.4  Carcinogenic Effects 	    132
    8.5  Potential Health Hazards	    133
         8.5.1  Industrial Workers 	    133
         8.5.2  Laboratory Workers 	    134
         8.5.3  General Population 	    134
    8.6  Potential Environmental Hazards 	    134
    8.7  Regulations and Standards	    135

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                                 FIGURES


2.1  Formation of reactive esters and aminonium cations from
       2-acetylaminofluorene (AAF) and N-methyl-4-aminoazobenzene
       (MAB)	27

2.2  The in vitro reaction of N-acetoxy-AAF and methionylglycine. .  . 28

2.3  The in vitro reaction of N-acetoxy-AAF with guanosine	29

2.4  Early version of all glass Greenburg-Smith and midget impingers. 47

2.5  Types of dry, cascade impingers	  . 48

2.6  Procedure for pretreatment of sample prior to analysis by gas-
       liquid chromatography (GLC), thin-layer chromatography (TLC),
       or colorimetry	49

2.7  Schematic diagram of a gas chromatograph	53

2.8  Resolution of four aromatic amines by the column mixture OV-17
       (4.7%), QF-1 (5.0%), and DC-200 (0.5%) on 80- to 100-mesh
       Gas-chrom Q, using PTGC (150-250°C at 3°/min, holding 12 min
       at 150°C)	54

2.9  Spectrum of benzidine oxidation product	60

6.1  Concentration in blood after intravenous administration of
       0.2 mg of 1'*C-labeled 3,3'-dichlorobenzidine or benzidine per
       kilogram body weight to rats	84

6.2  Concentration in blood after intravenous administration of
       0.2 mg of lilC-labeled 3,3 '-dichlorobenzidine or benzidine per
       kilogram body weight to dogs	 85

6.3  Trends of mean urinary concentration of quinonizable substance
       (expressed as benzidine) at different times of day over
       two-week periods in June and December 1950	92

6.4  Comparative excretion of N-oxidation products of 4-amino-
       biphenyl by monkeys and dogs	98

6.5  Graph of time from initial exposure to benzidine to diagnosis
       of tumors	106

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                                TABLES


2.1   Commercial dyes derived from benzidine	20

2.2   Cotton dyes derived from benzidine	20

2.3   Possible mechanisms of chemical carcinogenesis 	 30

2.4   Physical properties of 3,3'-dichlorobenzidine dihydrochloride.  . 31

2.5   Some dyes or pigments manufactured from 3^'-dichloro-
        benzidine in 1971	32

2.6   Commercial dyes derived from 3,3'-dime thy Ibenzidine	34

2.7   Some dyes manufactured from 3,3'-dimethoxybenzidine in 1971. .  . 36

2.8   Other benzidine congeners	42

2.9   Methods for determining benzidine	51

2.10  Solvents used for chromatographic separation of
        4,4'-dinitrobiphenyl, benzidine, and their respective
        metabolic products .	56

2.11  Composition of spraying reagents used for chromatographic
        separation of 4,4'-dinitrobiphenyl, benzidine,  and
        their respective metabolic products	56

2.12  Chromatographic behavior of 4,4'-dinitrobiphenyl, benzidine,
        and their metabolites	57

2.13  Retardation factor values of 4,4'-dinitrobiphenyl, benzidine,
        and their most important metabolites 	 58

2.14  Wavelengths used and relative intensities observed during
        analysis of benzidine and its congeners	61

2.15  Analysis of two biological growth media spiked with benzidine,
        two congeners, and their salts at 0, 0.10, and  1.0 ppm .... 62

2.16  Analysis of wastewater spiked with benzidine, two congeners,
        and their salts at 0 and 20 ppb.	63

3.1   Mutagenic activity of benzidine analogues to Salmonella
        typhimuviwri in the presence or absence of liver mixed
        function oxidase 	 75

6.1   Relationship between environmental conditions and benzidine
        concentrations in urine of six pressroom workers 	 83
                                   vii

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                                  viii
6.2   Distribution pattern 1 and 4 hr after intravenous administration
        of 0.2 mg of 14C-labeled 3,3'-dichlorobenzidine or benzidine
        per kilogram body weight to rats and dogs	86

6.3   Distribution pattern 7 and 14 days after intravenous administra-
        tion of 0.2 mg of li'C-labeled 3,3'-dichlorobenzidine or
        benzidine per kilogram body weight to rats, dogs, and
        monkeys	87

6.4   The concentration and distribution of free and total diazo-
        tizable material in rat tissues following a single intra-
        peritoneal injection of 100 mg benzidine per kilogram of
        body weight	88

6.5   Metabolites formed by biotransformation of benzidine and
        benzidine derivatives in animals 	 90

6.6   The urinary and biliary metabolites of benzidine produced by
        various experimental animals 	 94

6.7   Excretion in the first seven days after intravenous
        administration of 0.2 mg of lilC-labeled 3,3'-dichloro-
        benzidine or benzidine per kilogram body weight to rats,
        dogs, and monkeys	96

6.8   Effects of benzidine, its congeners, and metabolites on
        various animal species 	 99

6.9   Development of proteinuria and anemia in four female rats
        fed a diet containing N,N'-diacetylbenzidine	101

6.10  Survival and hyperplastic changes of epithelium in embryonic
        kidney tissue cultures treated transplacentally with
        3 ,3'-dichlorobenzidine and 3,3'-dimethylbenzidine	103

6.11  Bladder and liver changes produced in Albino Delph mice
        administered benzidine or dihydroxybenzidine by subcutaneous
        injection	108

6.12  Tumors induced in rats receiving 20 mg of diorthotolidine
        either by subcutaneous injection or subcutaneous implantation
        of pellets	Ill

6.13  Comparison of tumor incidence between workers exposed to
        dichlorobenzidine and those exposed to dichlorobenzidine
        plus benzidine	113

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                               FOREWORD
     A vast amount of published material is accumulating as numerous
research investigations are conducted to develop a data base on the
adverse effects of environmental pollution.  As this information is
amassed, it becomes continually more critical to focus on pertinent,
well-designed studies.  Research data must be summarized and interpreted
in order to adequately evaluate the potential hazards of these substances
to ecosystems and ultimately to public health.  The Reviews of the Environ-
mental Effects of Pollutants (REEPs) series represents an extensive com-
pilation of relevant research and forms an up-to-date compendium of the
environmental effect data on selected pollutants.

     Reviews of the Environmental Effects of Pollutants:  II.  Bensidine
includes information on chemical and physical properties; pertinent
analytical techniques; transport processes to the environment and sub-
sequent distribution and deposition; impact on microorganisms, plants,
and wildlife; toxicologic data in experimental animals including metabo-
lism, toxicity, mutagenicity, teratogenicity, and carcinogenicity; and an
assessment of its health effects in man.  The large volume of factual
information presented in this document is summarized and interpreted in
the final chapter, "Environmental Assessment," which presents an overall
evaluation of the potential hazard resulting from present concentrations
of benzidine in the environment.

     The REEPs are intended to serve various technical and administrative
personnel within the Agency in the decision-making processes, i.e., in
the development of criteria documents and environmental standards, and
for other regulatory actions.  The breadth of these documents makes them
a useful resource for public health personnel, environmental specialists,
and control officers.  Upon request these documents will be made available
to any interested individuals or firms, both in and out of the government.
Depending on the supply, the document can be obtained directly by writing
to:

     Dr. Jerry F. Stara
     U.S. Environmental Protection Agency
     Health Effects Research Laboratory
     26 W. St. Glair Street
     Cincinnati, Ohio  45268
                                     R. J. Garner
                                     Director
                                     Health Effects Research Laboratory
                                   ix

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                             ACKNOWLEDGMENTS
     The authors are particularly grateful to R. A. Griesmer, National
Cancer Institute, J. K. Selkirk and C. H. Ho, Oak Ridge National Laboratory
(ORNL), and Thomas J. Haley, National Center for Toxicological Research,
for reviewing preliminary drafts of this report and for offering helpful
comments and suggestions.  The advice and support of Gerald U. Ulrikson,
Manager, Information Center Complex, and Jerry F. Stara, EPA Project Officer,
and the cooperation of the Toxicology Information Response Center, the
Environmental Mutagen Information Center, and the Environmental Resource
Center of the Information Center Complex, Information Division, ORNL, are
gratefully acknowledged.  The authors also thank Carol Brumley, editor,
and Donna Stokes and Patricia Hartman, typists, for preparing the manu-
script for publication.

     Appreciation is also expressed to Bonita M. Smith, Karen L. Blackburn,
and Donna J. Sivulka for EPA in-house reviews and editing and for coordinat-
ing contractual arrangements.  The efforts of Allan Susten and Rosa Raskin
in coordinating early processing of the reviews were important in laying
the groundwork for document preparation.  The advice of Walter E. Grube
was valuable in preparation of manuscript drafts.  The support of R. John
Garner, Director of Health Effects Research Laboratory, is much appreciated.
Thanks are also expressed to Carol A. Haynes and Peggy J. Bowman for typing
correspondence and corrected reviews.
                                    XI

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                               ABSTRACT
     This study is a comprehensive, multidisciplinary review of the health
and environmental effects of benzidine and specific benzidine derivatives.
More than 200 references are cited.

     Benzidine and its congeners are used in industry primarily for the
synthesis of azo dyes.  Available data indicate that U.S. production and
importation of benzidine and benzidine compounds may exceed 3.5 million
kilograms per year.  Benzidine and its derivatives are not naturally occur-
ring compounds and are not thought to be generally dispersed in the environ-
ment; however, little information is available for documentation.

     In most animal species tested, the greatest damage from benzidine expo-
sure occurred to the liver, kidney, and urinary bladder.  Following adminis-
tration of sublethal doses, tumors have developed in almost all species
tested.  Little information is available on the effects of benzidine on
plants or on domestic and wild animals.

     Epidemiological evidence leaves no doubt that exposure to benzidine can
lead to bladder cancer in humans.  An exact quantitative relationship between
the degree of exposure to benzidine, the length of the exposure period, and
the incidence of bladder cancer has not been established.  Benzidine com-
pounds are believed to become active carcinogens only after metabolic altera-
tions.  Since 1974, when the Occupational Safety and Health Administration
of the U.S. Department of Labor instituted more stringent industrial stand-
ards, the risk of cancer from industrial exposure to benzidine has been
substantially reduced.  There is no evidence that benzidine or its congeners
act as human teratogens; however, some tests suggest that these compounds
may be mutagenic.  Benzidine compounds are also known to cause dermatitis,
cystitis, and hematuria.

     This report was submitted in partial fulfillment of Interagency
Agreement No. D5-0403 between the Department of Energy and the U.S. Environ-
mental Protection Agency.  The draft report was submitted for review
June 1976.  The final report was completed in October 1977.
                                 xiii

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                               SECTION 1

                                SUMMARY
1.1  INTRODUCTION

     Benzidine is an aromatic amine that does not occur naturally; it
was first prepared by Zinin in 1845 and is now used in the synthesis of
commercial dyes.  3,3'-Dichlorobenzidine, 3,3'-dimethylbenzidine, and
3,3'-dimethoxybenzidine are benzidine derivatives widely used in the
United States and therefore are included in this discussion.   Two ben-
zidine congeners, 4-aminobiphenyl and 4-nitrobiphenyl, are discussed
because of structural and chemical similarities to benzidine.

1.2  BENZIDINE CHEMISTRY

1.2.1  Physical Properties

     Benzidine is a colorless, crystalline compound with a molecular
weight of 184.23, a density of 1.250 (20/4°C), a melting point of 115°C
to 120°C  (slow heating) or 128°C  (fast heating), and a boiling point of
400°C.  It is soluble in alcohol and ether and is slightly soluble in
water.  3,3'-Dichlorobenzidine, a colorless, crystalline compound, has
a molecular weight of 253.1 and a melting point of 132°C to 133°C.  It
is soluble in ethanol, benzene, and glacial acetic acid, is slightly
soluble in dilute hydrochloric acid, and is almost insoluble in cold
water.  3,3'-Dimethylbenzidine is a white to reddish crystalline com-
pound which has a molecular weight of 212.28 and a melting point of 131°C
to 132°C; it is highly soluble in ethanol, ethyl ether, and acetone and
is slightly soluble in water.  3,3'-Dimethoxybenzidine, a colorless,
crystalline compound that turns violet on standing, has a molecular
weight of 244.3 and a melting point of 137°C to 138°C.  It is soluble in
ethanol, ethyl ether, acetone, benzene, and chloroform and is poorly
soluble in water.  4-Aminobiphenyl is also a colorless, crystalline
compound that darkens on oxidation.  The molecular weight is 169.2, the
melting point is 53°C to 54°C, and the boiling point is 191°C.  It is
soluble in lipids, hot water, and nonpolar solvents and is slightly
soluble in cold water.  The compound 4-nitrobiphenyl occurs as white to
yellow needles.  It has a molecular weight of 199.2, a boiling point of
340°C, and a melting point of 114°C.  4-Nitrobiphenyl is soluble in
benzene, chloroform, and ether, is slightly soluble in cold alcohol, and
is almost insoluble in water.

1.2.2  Chemical Properties

     Benzidine is both a primary aromatic amine and a diphenyl derivative;
it undergoes chemical reactions which are characteristic for each class
of compounds as well as some which are peculiar to it alone  (Section
2.2.1.2).   Benzidine forms stable salts with mineral acids and complexes
with a large number of metallic salts.  It is sensitive to oxidation and
can be readily acetylated, alkylated, and diazotized.  The acetylated

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product is readily nitrated and halogenated.   The chemical reaction lead-
ing to the diazotized product has commercial  value since this product
couples with many different aromatic amines and phenols to yield a wide
variety of azo dyes.

     The benzidine derivatives 3,3'-dichlorobenzidine, 3,3'-dimethylben-
zidine, 3,3'-dimethoxybenzidine, and 4-aminobiphenyl (Sections 2.2.2.1,
2.2.3.1, 2.2.4.1, and 2.2.5.1) undergo chemical reactions similar to
those displayed by benzidine.  They can be acetylated, alkylated, and
diazotized.  The latter reaction is commercially important as the first
step in their use in the synthesis of azo dyes.  Because 4-nitrobiphenyl
(Section 2.2.6.1) contains no reactive amino group, its chemical reactions
differ.  However, it is readily reduced to 4-aminobiphenyl.

1.2.3  Biochemical Reactions

     In a manner similar to the biochemical reactions of aromatic amines
in general, benzidine is conjugated through the functional amino groups
(usually only one group is conjugated) and hydroxylated in the ortho
position with respect to the amine.  Hydroxylation of benzidine requires
mediation by an enzyme system consisting of a hepatic microsomal enzyme,
oxygen, and reduced nicotinamide adenine dinucleotide phosphate.  The
hydroxy groups of the hydroxybenzidine thus formed may be conjugated
with sulfate and with glucuronic acid through mediation of other required
enzyme systems.

     Less attention has been given to the biochemical reactions that occur
with benzidine derivatives, but, with the exception of 3,3'-dichloroben-
zidine, the reactions thought to occur are similar to those for benzidine -
namely, acetylation, sulfation, and orthohydroxylation.  Because of the
in vivo stability of the chlorine atom linkage to the benzidine molecule,
3,3'-dichlorobenzidine apparently does not form 3-hydroxy products.  This
compound appears to be relatively stable in vivo.

     Although the process is still somewhat speculative, it appears that
the azo dyes prepared from benzidine and its derivatives may be reduced
in vivo to release the parent materials.  A recent report on this possible
reduction is discussed in Section 2.2.1.4.

1.2.4  Methods of Analysis

     Several methods of analysis of benzidine, its derivatives, and their
metabolites are used for qualitative and quantitative determinations in
environmental and biological media.  These methods are gas-liquid chroma-
tography, thin-layer chromatography, spectrophotometry  (chloramine-T),
spectrophotometry  (diazo dye), and spectrophotofluorometry  (Section 2.3.2).
None of these is officially sanctioned for determining low levels of
benzidine in environmental or biological samples, but several appear ade-
quate  for assessment of gross amounts of aromatic amines.  Gas-liquid
chromatography seems to be the most promising method of benzidine analysis
because of its high degree of sensitivity, selectivity, versatility, and

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speed.  This is the only available method which easily determines ben-
zidine in the presence of its derivatives.

     The oldest and best developed analytical methods are the diazo and
chloramine-T spectrophotometric methods.  Recent refinements allow sensi-
tivity in the parts-per-billion range by instrumentation available in
most laboratories.  However, neither method can be used to distinguish
between benzidine and benzidine derivatives in mixed samples.  Furthermore,
the diazo method is responsive to aromatic amines in general, while the
chloramine-T method is photosensitive.  Nevertheless, the U.S. Environ-
mental Protection Agency has designated the chloramine-T method as the
interim method for determining benzidine.

     The thin-layer chromatographic method is simple to perform and fre-
quently is used qualitatively for separating and identifying benzidine,
benzidine derivatives, and metabolites.  Although it can be used quantita-
tively, it is relatively insensitive.

     Spectrophotofluorometry has had only limited use with benzidine
compounds.  The method combines inherent sensitivity with simplicity and
rapidity.  However, the fluorescent spectra produced by benzidine and its
derivatives tend to overlap and vary greatly in their intensity, thus
preventing the method from being used to quantitatively distinguish such
compounds in mixed samples.

1.3  USES AND PRODUCTION

     Benzidine and its salts are used principally in the manufacturing
of dyestuffs based on the coupling of tetrazotized benzidine with phenols
and aromatic amines.  At least 250 commercial dyes are based on benzidine.
Many of these dyes are economically important because of their ability to
dye cotton without the use of mordants.  In analytical chemistry, benzi-
dine  is used to detect inorganic ions  (Section 2.2.1.3), as a chromogenic
spray reagent in chlorinated organic pesticide thin-layer chromatography,
and as a reagent for determining hydrogen peroxide, nicotine, sugars,
occult blood, and bacterial cytochromes.  Benzidine is also used as a
hardener for polyurethane and as an agent to reveal bank check altera-
tion.  Production in the United States was 680.9 metric tons in 1972.

     The benzidine derivatives 3,3'-dimethylbenzidine, 3,3'-dimethoxy-
benzidine, and 3,3'-dichlorobenzidine are used in the manufacture of
dyestuffs.  These dyestuffs are used to color plastics, lacquer, paint,
rubber, leather, paper, and textiles.  They are used in the detection
and determination of various inorganic ions.  3,3'-Dichlorobenzidine
and 3,3'-dimethoxybenzidine are used as curing agents for polyurethane
elastomers; the latter of these two compounds is also used in the manu-
facturing of the diisocyanate compound for isocyanate-based adhesive
systems.  4-Aminobiphenyl has been used as an antioxidant in rubber.
4-Nitrobiphenyl is an intermediate in the manufacture of 4-aminobiphenyl.

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     Production in the United States of benzidine,  3,3'-dichloro.benzidine,
3,3'-dimethylbenzidine, and 3,3'-dimethoxybenzidine is believed to amount
to many millions of kilograms annually.  Benzidine  and 3,3'-dichlorobenzi-
dine are produced in greatest quantities.  Large-scale production of
4-aminobiphenyl and of 4-nitrobiphenyl in the United States is believed
to have ceased following the general recognition in 1955 of the carcino-
genicity of the former compound;  however, small amounts are still synthe-
sized for research and pilot plant use.

1.4  ENVIRONMENTAL DISTRIBUTION AND FATE

     Since the melting points of benzidine and its  derivatives are above
ambient environmental temperatures, these compounds exist in the undis-
solved state as aerosols, dusts, or crystals and in the dissolved state
in aqueous or organic solutions.

1.4.1  Distribution in Air

     At one time, benzidine and its derivatives were manufactured and
used in open systems which permitted loss of the compounds to the atmo-
sphere, the worker, and the work site.  In some operations, average con-
centrations of 2.5 to 17.6 mg/m3 of air were observed.  Large-scale
manufacturers are now believed to utilize closed systems which prevent
this hazard, except possibly during cleaning of the closed-system equip-
ment.  At present, small-scale manufacturing may be proceeding without
the use of closed systems.

     The use by the general public of benzidine yellow pigments in pres-
surized containers of lacquers and paints presents  an exposure of cur-
rently unknown potential and hazard.  This pigment  is derived from
3,3'-dichlorobenzidine.

1.4.2  Distribution in Water

     In the Sumida River of Japan, benzidine has been measured downstream
from dye factories.  In the United States, benzidine and its derivatives
have been detected in manufacturing and dye factory wastes but not in the
drainage areas into which these wastes feed; however, few attempts at
actual measurements seem to have been made.  Lack of detection of these
compounds is thought to result from degradation, mostly before the release
of the wastes, and from dilution of residual concentrations to below the
detection limit.  Unfortunately, the chloramine-T method of detection
used evidently will measure only the parent benzidine compounds and may
therefore have failed to measure the possible presence of slightly de-
graded products, including those of carcinogenic potential.  Newer analyt-
ical methods now under study should be more versatile  (Section 1.2.4).

1.4.3  Distribution in Soil

     No data were found concerning the distribution of benzidine compounds
in soil.  Benzidine has been shown to be adsorbed to some clays and,
because of its physical properties, is probably immobilized rapidly in
soils and sediments.

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1.4.4  Mobility and Persistence

     Benzidine is thought to be volatile and soluble enough to have the
potential for wide dispersion.  According to several investigators, it
probably persists for a time in the environment.  The principal reaction
of benzidine in air and water is believed to be oxidative degradation by
free radical, enzymatic, or photochemical processes, but actual data on
reaction rates are not available.  Half-life reaction rates have been
estimated to be 1 to 60 days in air and 100 days in water for benzidine
and 3,3'-dichlorobenzidine.  Under experimental water waste treatment
conditions, air oxidation of benzidine proceeded readily, and there was
also some evidence of biological oxidation.

1.4.5  Food Chain Accumulation

     Since benzidine and its derivatives are soluble in many organics,
movement of these compounds may take place within the food chain.  Accu-
mulation is expected to occur, and recent laboratory findings indicated
that bluegill fish concentrated li'C-benzidine to a level 44 times that
present in water.

1.5  BIOLOGICAL ASPECTS IN MICROORGANISMS, PLANTS, AND WILD AND DOMESTIC
     ANIMALS

     Very little information is available concerning the metabolism and
effects of benzidine and its derivatives in these classes of organisms.

1.5.1  Microorganisms

     The metabolism of benzidine by microorganisms has received little
attention.  It is known, however, that benzidine-based azo dyes are
reduced to benzidine by certain bacteria.

     Little is known about the toxicity of benzidine and its derivatives
to microorganisms.  At low concentrations, benzidine appears to be oxi-
dized by microorganisms present in the activated sludge of waste treatment
plants, but at higher concentrations it may inhibit these microorganisms
and prevent general biooxidation of the organic material present.  Benzi-
dine and some of its derivatives have been shown to be mutagenic to strains
of Salmonella typh-imuY"Liffn during testing by an assay method developed for
measuring the mutagenic and carcinogenic potential of a wide variety of
chemicals.

     The benzidine-based azo dye Congo Red has been used as a bacterio-
static agent in the selective culture of the tubercle bacillus and as an
indicator dye in the culture of other species of bacteria.  Congo Red and
other azo dyes have been shown to have antiviral activity and to inhibit
phage production by one species of bacteria.

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1.5.2  Plants

     No data are available on benzidine metabolism or on effects from
benzidine exposure in higher plants.  Benzidine has not received much
attention in this area since it is not a natural environmental constit-
uent and is not believed to be widely dispersed from industrial sources.
Benzidine (0.3 mg/liter) stimulates growth of Anti£hamni,on plumula (red
algae).  It is oxidized by peroxidases from several plant species, in-
cluding horseradish and green algae.

1.5.3  Wild and Domestic Animals

     Information pertaining to wild and domestic animals and benzidine
compounds does not exist except for laboratory research on a few species
under experimental conditions.  Benzidine has been shown to be toxic to
the red shiner and fathead minnow at TLSO values of 2.5 mg/liter and
20 mg/liter, respectively, and to cause liver damage, including hyper-
plasia, in guppies fed a diet containing 30 mg benzidine per 100 g of
dry feed.  When injected into eggs, benzidine caused morphological abnor-
malities in immature chick embryos.  Other research findings with the
more usual laboratory animals (e.g., rat, mouse, and dog) are summarized
in Section 1.6 since such data provide useful comparative information for
studying the metabolism and toxicity of benzidine compounds in humans.

     Because benzidine and its derivatives may possibly find their way
into the open environment, much more research is needed to determine
species differences in the uptake, accumulation, metabolism, and excre-
tion of these compounds and in the toxic effects that may occur through
exposure.

1.6  BIOLOGICAL ASPECTS IN HUMANS

     Benzidine exposure in humans is primarily an industrial problem.
Because benzidine and its derivatives are not natural constituents of
the environment and the general population is therefore not exposed to
these chemicals, information concerning human exposure is restricted to
industrial exposure.

1.6.1  Metabolism

1.6.1.1  Uptake, Distribution, and Accumulation — Benzidine compounds
enter the body through the respiratory tract, by penetration of the skin,
or by ingestion.  The inhalation of these compounds is believed to be
minimized by the use of closed systems during manufacture and use
(Section 1.4.1); a concentration of 0.02 mg benzidine per cubic meter of
air has been suggested as a safe level of exposure.  Penetration through
the skin is believed to be the most important avenue of uptake.  Penetra-
tion is increased at elevated air temperatures and humidities which cause
sweaty skin.  Some compounds penetrate more readily than others (benzidine
> 3,3'-dimethoxybenzidine > 3,3'-dichlorobenzidine).  Ingestion via
contaminated food is not generally thought to be an important route of
uptake, but ingestion is believed to be responsible for some cancer

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induction among Japanese kimono painters because of their habit of
moistening brushes that have been dipped in benzidine-based azo dyes
with their lips.

     Information is lacking on the distribution or accumulation of benzi-
dine and its derivatives in human tissues.  Indirect evidence afforded
by repeated measurements of benzidine in urine samples from exposed
workers indicated a lack of any appreciable accumulation.

     Data collected from experimental animals is more complete.  In the
rat, dog, and monkey, administered concentrations of benzidine and
3,3'-dichlorobenzidine were distributed within hours to various tissues.
Prior to the elimination of these compounds, which was virtually complete
in one week, concentrations were noticeably higher in liver and lung
tissues than in other tissues.  In similar testing, 3,3'-dimethylbenzidine
administered to the rat was found in highest concentration in the Zymbal's
gland.  The liver and Zymbal's gland tissues of the rat are among those
tissues most prone to tumor induction by benzidine and its derivatives,
perhaps because of the tendency of these compounds to concentrate within
such tissues  (Section 6.3.2.2).

     There is indirect evidence for possible placental transfer of benzi-
dine or its derivatives since some of these compounds have been found to
affect embryonic kidney tissue following subcutaneous injection of preg-
nant mice and, later, explantation and culture of the embryonic tissue
 (Section 6.3.2.1.4).

     Although there is no evidence of any significant bioaccumulation of
benzidine or its derivatives in humans or in the usual experimental
animals, it has been reported recently that edible portions of bluegill
fish contained a 44-fold increase in residues of 14C-benzidine over those
present in water during a radiometric study.

1.6.1.2  Eiotransformation and Elimination — Benzidine and its derivatives
are biotransformed in humans and in experimental animals.  The metabolites
as well as the parent materials are eliminated via the urine, bile, and
feces.  Some of the metabolites produced are thought to be the actual
carcinogenic forms of these compounds (Sections 2.2 and 6.2.3).

     Humans metabolize benzidine primarily to 3-hydroxybenzidine and
secondarily to monoacetylbenzidine, diacetylbenzidine, and N-hydroxy
acetyl amino benzidine.  These compounds, as well as benzidine, are
eliminated largely through urinary excretion.  Urinary excretion in ex-
posed workers appears to vary directly and in proportion to the amount
of benzidine absorbed.  Thus, a safe air concentration of benzidine has
been suggested as 0.2 mg or less of benzidine per cubic meter of air
since this amount, inhaled over an 8-hr period, is calculated to lead to
a urinary output not exceeding 0.26 mg benzidine per liter of urine.
3,3'-Dimethylbenzidine appears to be biotransformed and eliminated in a
manner similar to that of benzidine.  Workers exposed to benzidine yellow
have reportedly excreted 3,3'-dichlorobenzidine in their urine, probably
because of the metabolic reduction of the dye and release of this benzi-
dine derivative.

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     The metabolites of benzidine found in humans are also found in some
experimental animals, along with additional products resulting from sul-
fate and glucuronide conjugations.   Species differences occur among the
test animals in the type of metabolites produced and in the main routes
of elimination.  In comparative tests, the dog was unable to acetylate
benzidine, although this metabolic reaction occurred in the mouse, rat,
rabbit, and guinea pig.  Metabolites of benzidine with available amino
groups were produced in larger amounts by the dog than by the rabbit.
Benzidine was found to be eliminated largely through the urine of the
dog, through the feces of the rat, and in about equal amounts through
the urine and feces of the monkey.  Benzidine metabolites found in bile
appear to be similar to those found in urine but are present in only
about one-third the amount found in urine.

     Monkeys are capable of metabolically reducing a number of benzidine-
based azo dyes and thereby freeing the benzidine molecule.  Substantial
amounts of benzidine and of monoacetylbenzidine were found in the urine
of the animals following single oral doses of the dyes.

     The metabolism and excretion of benzidine derivatives have been less
extensively studied in experimental animals.  In one experiment, admin-
istered doses of 3,3'-dichlorobenzidine in dogs were only partially
accounted for by measured urinary products, some of which were the non-
metabolized parent materials.  No metabolites of 3,3'-dichlorobenzidine
were found, suggesting that this compound, by virtue of the chlorine
substitutions at the 3,3' positions, is more inert to biotransformation
than are the methyl or methoxy substitutions.  A separate study showed
that 3,3'-dichlorobenzidine in dogs is excreted in greater quantity by
the feces than by the urine, in direct contrast to the excretion pattern
of benzidine.  This finding indicated that the route of excretion was
altered by substitution of the benzidine molecule in the 3,3' positions.

     Dogs and monkeys fed 4-aminobiphenyl excreted N-hydroxy products of
this compound more rapidly in their urine than they excreted the parent
compound.  The urinary yield of a 3-sulfuric acid conjugate of 4-amino-
biphenyl varied widely among five species of animals, ranging from 0% in
the guinea pig to 25% to 40% in the dog.

1.6.2  Effects

1.6.2.1  Physiological Effects — A possible relationship was found during
in vitro studies between potential carcinogenicity of benzidine and its
derivatives and their ability to reduce cytochrome o.  4-Aminobiphenyl,
considered to be strongly carcinogenic, did not reduce cytochrome o,
whereas 3,3'-diaminobenzidine, considered to be only weakly carcinogenic,
did reduce this enzyme.  Aminobiphenyls, which are easily oxidized by
mitochondrial systems, may be detoxified in this manner and excreted in
combination with sulfuric or amino acids.

     Exposure to benzidine has been found to alter enzyme activity in
vivo.  The activity of 3-glucuronidase was higher in the urine of exposed
workers than in nonexposed workers.  Cessation of exposure caused a

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decrease in activity to a level more nearly normal.  Blood phenolase
activity in rabbits was decreased by benzidine but not by 3,3'-dimethyl-
benzidine.  Catalase and peroxidase activity was decreased in rats by
benzidine.

1.6.2.2  Toxic Effects — In addition to their carcinogenic potential,
benzidine compounds are known to cause dermatitis, cystitis, and hema-
turia in humans and a number of poisoning symptoms, including glomerulo-
nephritis, in laboratory animals (Section 6.3.2).  Dermatitis has been
reported among workers in dye manufacturing plants.  Benzidine and ben-
zidine-based dyes have been implicated.  Benzidine and 3,3'-dimethylben-
zidine have caused dermatitis among laboratory-exposed chemists.
Individuals appear to vary in sensitivity to these compounds.

     Toxic effects to experimental animals are varied.  For example,
mice fed a daily diet of benzidine lost weight in proportion to the
amount of compound ingested, but the weight of the spleen and thymus
increased.  Morphological changes included a cloudy swelling of the
liver, vascuolar degeneration of renal tubules, and hyperplasia of the
myeloid elements in bone marrow and of the lymphoid cells in the spleen
and thymic cortex.  Several investigators have reported glomerulonephri-
tis in rats exposed to N,N'-diacetylbenzidine.  The nephrotic syndrome
induced resembles glomerulonephritis in humans.  At the high dosage rates
applied to test animals in carcinogenicity studies, liver pathology is
severe and may lead to death prior to any tumor development.

     There is convincing evidence that benzidine and certain other aromatic
amines are responsible for the high rate of occurrence of bladder cancer
among occupationally exposed persons.  It is generally accepted that metab-
olites of these aromatic amines are the actual carcinogens.  Evidence sug-
gests that N-hydroxylation of the parent amine produces the precarcinogen
and that the sulfate or glucuronide conjugates are the carcinogenically
active forms in vivo.  The latter metabolites appear to have an affinity
to and exert a carcinogenic action on certain target organs.   Cancer induc-
tion in humans by benzidine appears to be limited to the bladder.

     Since benzidine and its derivatives are not naturally occuring
chemicals and are not thought to be dispersed in the environment, the
thrust of studies on their carcinogenicity has been directed at groups
of occupationally exposed workers in manufacturing and user industries
of various countries.  Tumor development in these workers has been reported
following exposures to benzidine ranging from 2 to 16 years and averaging
8 years.  The latent period between first exposure and tumor induction
ranges from 8 to 32 years and averages 18 years.  Thus, workers who have
been exposed to benzidine for as little as two years have developed bladder
cancer several years later.  The degree of exposure and the number of years
of survival beyond the exposure period are thought to influence the rate of
occurrence of bladder tumors.  High rates of occurrence averaging 11% to
50% of the exposed workers have been reported from benzidine manufacturing
plants, dyestuff factories, and coal tar dye plants.  Awareness of this
hazard has prompted improved work conditions and work habits, which have
resulted in reduced exposure.  The introduction of closed systems in the

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                                  10
synthesis of benzidine has greatly reduced atmospheric contamination.
Unfortunately, there is a general lack of information on actual exposures
encountered in various plants.  More data should be collected and made
available on air concentrations, on respiratory and dermal absorption, and
on the physical conditions and health of the workers.

     In some earlier studies on the rate of occurrence of bladder cancer
in manufacturing and dyestuff plants, the role of benzidine in the induc-
tion of the cancer was confused by simultaneous exposures to other chem-
icals, particularly to B-naphthylamine, which is considered to be a
potent carcinogen.  Later comparative studies indicated that such dual
exposures may significantly increase the risk of bladder cancer induc-
tion.  One study, for example, showed an increase from 21.3% among
workers exposed only to benzidine to 45.5% among workers exposed addi-
tionally to B-naphthylamine.

     In humans, benzidine has been implicated only in the induction of
bladder cancer.  In contrast, it induces several different types of
cancer in experimental animals.  The evidence of cancer induction by
benzidine and its derivatives suggests that induction by these compounds
depends on both species and compound.

     3,3'-Dichlorobenzidine, unlike benzidine, has not been reported to
have produced bladder tumors in humans, but it has been implicated
recently in the occurrence among exposed workers of tumors of the lung,
bone marrow, rectum, sigmoid colon, prostate, and breast muscle.  These
workers were exposed for 35 years.  Since dichlorobenzidine is nonvola-
tile and poorly absorbed by the skin, respiratory and dermal intake can
be expected to be less than that which would occur with benzidine for an
equivalent period.  Experimentally, a variety of tumors have been induced
by dichlorobenzidine in rats and mice, including bladder tumors in rats.
It is possible that this compound can induce bladder cancer in humans,
but only after a latent period longer than that for benzidine.

     There is no evidence that 3,3'-dimethylbenzidine or 3,3'-dimethoxy-
benzidine induce any type of cancer in humans.  However, both compounds
have been found to be carcinogenic in rats and have induced a variety
of tumors.  They must therefore be considered as potentially carcinogenic
in humans.

     4-Aminobiphenyl is considered to be a potent carcinogen in humans.
Bladder tumors have developed in workers following as little as 133 days
of exposure as well as after more extended exposure periods ranging up
to 19 years.  The latent period appears to range from 5 to 19 years.
This compound causes a variety of tumors in experimental animals, includ-
ing bladder cancer.  However, its production and use in the United States
are believed to have been greatly reduced by the early recognition of
its carcinogenicity.

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                                  11


1.7  THE PROBLEM

     Benzldine presents a serious carcinogenic hazard to exposed indus-
trial workers because of its association with the high rate of occurrence
of bladder cancer among these workers.  It is a potent carcinogen in
experimental animals.  Derivatives of benzidine also cause cancer in
experimental animals, but only 4-aminobiphenyl has been associated with
bladder cancer in humans; usage of this compound is thought to have de-
creased markedly in recent years.  3,3'-Dichlorobenzidine has recently
been implicated in causing cancer other than bladder cancer in humans,
but no reports have implicated either 3,3'-dimethylbenzidine (diortho-
tolidine) or 3,3'-dimethoxybenzidine  (dianisidine).  Nevertheless, these
derivatives must be viewed as potentially hazardous to humans.   The use
of closed systems and better hygiene by workers have resulted in a
decrease in the level of exposure to these compounds and thereby have
reduced the hazard involved.

     Benzidine and its derivatives are not naturally occurring compounds
and are not thought to be dispersed in the environment, although docu-
mentation on this is lacking.  Judging from their toxic effects to
research animals, these compounds, if present in the environment, can be
expected to be hazardous to wildlife.   Recent laboratory information
indicating appreciable bioaccumulation in one species of fish increases
the hazard potential.

1.8  CONCLUSIONS

 1.  Benzidine and its derivatives are not naturally occurring compounds
     and are probably not found in the general environment, although
     adequate documentation is lacking.

 2.  Analysis of benzidine and its derivatives can be performed best by
     use of gas-liquid chromatography or spectrofluorometry;  these
     methods provide needed sensitivity,  selectivity, and versatility.

 3.  The chloramine-T method of analysis is designated as the interim
     method of benzidine analysis by the U.S. Environmental Protection
     Agency, but, unfortunately, it does not adequately identify or
     distinguish between benzidine and its derivatives and the important
     metabolites.

 4.  Benzidine and the derivatives 3,3'-dichlorobenzidine, 3,3'-dimethyl-
     benzidine, and 3,3'-dimethoxybenzidine are manufactured in the
     United States by three major firms which employ closed systems to
     reduce air contamination and exposure by the workers.  There is
     reason to believe that some manufacturing, including limited
     production of 4-aminobiphenyl, is being undertaken by smaller firms
     without the use of the closed-system approach.

 5.  Benzidine, 3,3'-dichlorobenzidine, 3,3'-dimethyIbenzidine, and 3,3'-
     dimethoxybenzidine are used primarily in the production of dyes and
     pigments for the coloring of textiles, paper, leather, rubber,

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                                  12


      plastics,  inks, paints, lacquers, and enamels.  Other less extensive
      uses  of  these  compounds are as reagents in the detection of inorganic
      ions,  organic  molecules, and occult blood, as stains in microscopy,
      and as a curing agent for polyurethane elastomers.  4-Aminobiphenyl
      has been used  as  a rubber antioxidant.

  6.   Data  are not available concerning the distribution of benzidine
      compounds in the  atmosphere or soil.

  7.   Benzidine and  its derivatives are thought to present a hazard in
      water only near factories which use or manufacture these compounds.
      No data  exist  on  benzidine in drinking water.

  8.   No data  are available on accumulation in and movement through food
      chains,  except for a recent radiometric study indicating that blue-
      gill  fish can  bioconcentrate benzidine to a 44-fold increase over
      concentrations in water.

  9.   Toxic effects  to  plants and to wild and domestic animals are not
      known except for  recent laboratory studies on a very limited number
      of species.

 10.   The principal  avenues of benzidine absorption by humans are dermal
      and pulmonary.

 11.   Benzidine does not appear to accumulate in human body tissues, but
      the evidence is indirect and is based on measurements of urinary
      concentrations in exposed workers.

 12.   Benzidine compounds do not accumulate in tissues of the usual
      laboratory animals, although unequal concentrations appear in
      different organs  following administration.  Concentrations tend
      to be  high in  those organs prone to later tumor development.

 13.   Although there is no direct evidence of the placental transfer of
      these  compounds,  studies in mice and rats point to this possibility.

 14.   Benzidine  compounds are believed to become active carcinogens only
      after  metabolic transformations that involve N-hydroxylation to
      produce  the proximate carcinogens, followed by esterification and
      possibly conjugation with sulfate or glucuronate to produce the
      ultimate carcinogens.

15.   Benzidine  compounds and metabolites are eliminated from the animal
     body via the urine, bile, and feces.

16.  Benzidine  compounds cause dermatitis, cystitis, and hematuria in
     humans.

17.  Benzidine  is believed to be carcinogenic in humans  and a major
     cause of bladder  cancer among exposed industrial workers.

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                                  13
18.  A recent report also Implicated 3,3'-dlchlorobenzldine as a cause
     of certain types of cancer among exposed industrial workers, but
     there are no reports of its association with bladder cancer.

19.  Although there are no reports of any associations between cancer
     in humans and exposure to 3,3'-dimethylbenzidine or 3,3'-dimethoxy-
     benzidine, these compounds induce a variety of cancers in experi-
     mental animals and must therefore be considered as potentially
     hazardous to humans.

20.  Although 4-aminobiphenyl is believed to cause bladder cancer in
     humans, its manufacture and use in the United States today are
     considered to be very low.

21.  Areas of research needed include:  (]) epidemiological studies
     designed to determine relative risks and incidence rates of bladder
     cancer and other forms of cancer among adequate numbers of exposed
     and nonexposed workers, with careful consideration of confounding
     factors such as age, smoking history, and exposure to other potenti-
     ally hazardous chemicals; (2) plant monitoring studies to better
     establish the degree of skin and pulmonary involvement in absorp-
     tion; (3) pharmacokinetic studies to better substantiate mechanisms
     and extent of body transport and storage; (4) more extensive moni-
     toring and surveillance of users of these compounds outside of
     large industrial plants, including those who use aerosol formula-
     tions of paints, lacquers, or enamels containing benzidine yellow;
     (5) environmental monitoring studies involving attempts to measure
     these compounds in air, water, sediment, soil, and selected species
     of aquatic and terrestrial life; and (6) laboratory studies aimed
     at determining the extent of toxic effects and possible bioaccumula-
     tion in a variety of aquatic and terrestrial species.

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                               SECTION 2

              PHYSICAL AND CHEMICAL PROPERTIES AND ANALYSIS
 2.1  SUMMARY

      Benzidine is  a  synthetic  aromatic diamine not known  to occur naturally.
 It was first synthesized  in  1845  and has  since become a versatile and  impor-
 tant chemical coupling  agent in the manufacture of commercial azo dyes.
 These dyes form the  largest  and most useful class of all  commercial  dyes;
 many of them are of  great economic importance in the textile industry
 because of their ability  to  dye cotton directly without the use of mordants.
 Benzidine is also  widely  used  in  analytical chemistry and biological lab-
 oratories where its  versatile  chemistry makes it a useful reagent in the
 detection and determination  of many inorganic ions as well as hydrogen
 peroxide, nicotine,  sugars,  occult blood, and bacterial cytochromes.   Benzi-
 dine is sometimes  used  in security printing because it reacts with ink
 erasers to give colored products  which reveal attempted alterations.   About
 680,400 kg of benzidine was  produced in the United States in 1972.

      Despite its versatile chemistry and  widespread use,  benzidine is  a
 hazardous substance  which is believed to  be a potent bladder carcinogen.
 Apparently, a metabolite, rather  than the aromatic amine  per se, is  the
 ultimate carcinogen.  Most investigators  have therefore been concerned with
 identifying and testing the  carcinogenicity of the metabolic products  of
 aromatic amines in various species.  Results from early studies gave rise
 in 1952 to the hypothesis that carcinogenicity is due to  the formation of
 ort/zo-hydroxy metabolites of aromatic amines.  Later results suggested the
 generally held current  theory  that formation of an N-hydroxy metabolite is
 the first step in  the activation  of aromatic amines and amides for carcino-
 genesis.   According  to  this  view, subsequent esterification of the N-hydrox-
 ylated metabolite  produces a highly reactive electrophile, the ultimate
 carcinogen,  that attacks  nucleophilic tissue components such as DNA  and RNA.
 Experimental work  verifying  this  chemical sequence in the metabolism of
 benzidine has not  been  performed, but firm evidence exists for the presence
 of  an  acetyl-N-hydroxy  metabolite in the  urine of persons exposed to
 benzidine.

     Several benzidine  derivatives are also used extensively in the  United
 States.   3,3'-Dichlorobenzidine is employed as a coupling agent in the
manufacture  of  dyes and pigments  which color plastic resins, rubber, print-
 ing inks, metal  finishes,  textiles, and wallpaper prints.  During 1971,
about  1.6 million  kg of this compound was manufactured in the United States
and an  additional  635,000 kg was  imported.  Other widely  used derivatives of
benzidine include  3,3'-dimethylbenzidine  and 3,3'-dimethoxybenzidine.
These compounds  are components of nearly  100 different dyes listed in  the
Colour Index.  More than  44,000 kg of 3,3'-dimethylbenzidine and 122,000 kg
of 3,3'-dimethoxybenzidine were imported  into the United  States during
1970 and 1971 respectively.  Only limited information about the metabolic
chemistry of  these compounds is available.  Other pertinent congeners of
benzidine include  the nitro, alkoxy, sulfonic acid, and carboxylic acid
                                  14

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                                    15
derivatives as well as 4-aminobiphenyl and 4-nitrobiphenyl.  Few metabolic
or carcinogenic studies have been performed with these benzidine deriva-
tives.  4-Aminobiphenyl is an established carcinogen whose large-scale
commercial production in the United States apparently ceased in 1955 when
its carcinogenic character was generally recognized.  4-Nitrobiphenyl is
readily reduced in vitro and in vivo to 4-aminobiphenyl; therefore, it is
as hazardous as 4-aminobiphenyl.  4-Nitrobiphenyl was used chiefly as an
intermediate in the synthesis of 4-aminobiphenyl.  It apparently has not
been produced in large quantities in the United States since the use of
4-aminobiphenyl was discontinued; however, small amounts of both 4-amino-
biphenyl and 4-nitrobiphenyl are still manufactured for research and pilot
plant operations.

     Approved analytical methods for determining benzidine were first estab-
lished by the Association of British Chemical Manufacturers in 1954.  These
colorimetric methods were used with occasional innovations for almost all
of the quantitative analyses of benzidine which were subsequently reported.
Recently, federal legislation in this country provided an impetus for the
development of more sensitive and precise methods for quantifying benzidine
and its congeners; the end results of this stimulation are not yet apparent.
Gas chromatographic and spectrophotofluorometric methods appear to be
attractive alternatives to the older colorimetric procedures, but further
experience will be needed to fully evaluate the new methods.  Meanwhile,
until an adequately tested method is officially sanctioned, the U.S. Environ-
mental Protection Agency has designated a recently revised version of the
older chloramine-T colorimetric technique as the interim method of determin-
ing benzidine.

2.2  PHYSICAL AND CHEMICAL PROPERTIES

     In January 1974, the U.S. Department of Labor issued occupational
safety and health standards for 14 chemical compounds known to cause, or
suspected of causing, human cancer from occupational exposure (federal
Register, 1974).  Benzidine and 3,3'-dichlorobenzidine were included among
these compounds.  Pertinent physical and chemical properties of benzidine
and relevant congeners are discussed in the following sections; established
biotransformation products and urinary metabolites are also characterized.

2.2.1  Benzidine and Salts

     First prepared by Zinin in 1845 (Stecher, 1968), benzidine is now a
versatile and important intermediate in the synthesis of commercial dyes
(International Agency for Research on Cancer, 1972, p. 80).  Its composi-
tion and structure are indicated by the formulas Cl2Hi2N2 and

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                                    16
the Chemical Abstracts identification number of benzidine is 92875; it is
also known as biphenyl, 4,4'-diamino-, 4,4'-biphenyldiamine, 4,4'-diamino-
biphenyl, 4,4'-diphenylenediamine,  4,4'-diaminodiphenyl, p-diaminodiphenyl,
Colour Index (CI) azoic diazo  component 112, benzidine base, and Fast
Corinth Base B  (Christensen and  Luginbyhl, 1974).  The numbering system
commonly used in describing benzidine and its derivatives is indicated in
the following diagram:
 2.2.1.1  Physical Properties — Benzidine is a colorless, crystalline com-
 pound which has a molecular weight of 184.23, a density of 1.250  (20/4°C),
 a melting point of 115°C to 120°C (slow heating) or 128°C  (rapid  heating),
 and a boiling point of about 400°C at 740 torr  (Stecher, 1968).   It is
 soluble in both alcohol and ether but only slightly soluble in water  (0.52
 mg/ml at 25°C) (Bowman, King, and Holder, 1976).  Benzidine forms color-
 less, crystalline salts with hydrochloric acid  (Ci2Hi2N2»2HC1) and sulfu-
 ric acid (Ci2Hi2N2»H2SOi.);  the former is soluble in water  (61.7 mg/ml  at
 25°C) (Bowman, King, and Holder, 1976) and alcohol, but the latter is  only
 slightly soluble in those solvents.

 2.2.1.2  Chemical Properties — Benzidine is both a primary aromatic amine
 and a diphenyl derivative;  it undergoes chemical reactions characteristic
 of each of these classes of compounds as well as some which are peculiar
 to it alone.   Although weakly basic (pK-^ = 12.13), benzidine forms stable
 salts with mineral acids (Karrer, 1950, p. 453); it also forms complexes
 with a large number of metallic salts (Welcher, 1947, p. 277).  Like other
 primary and secondary amines, benzidine is sensitive to oxidation, and
 pure colorless crystals darken with decomposition products during storage
 unless protected from atmospheric oxygen (Fieser and Fieser, 1956, p.  604).
 Benzidine is easily acetylated,
                                    NHCOCHj
            NHCOCH,
                         (CH3CO)20
(CH3CO)20
                     NH2
                  BENZIDINE
                                4-ACETAMIDO-
                               4'-AMINOBIPHENYL
            NHCOCHj
    4,4'-DIACETAMIDOBIPHENYL

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alkylated,
                                      17
                                       NHCH,
                             CH3I
                             NaOH
   CH3I
   NaOH
                       NH2              NHCH3            N(CH3)2
                    BENZIDINE     N,N'-OIMETHYLBENZIDINE      N,N,N',N'-
                                                TETRAMETHYLBENZIDI NE
and  diazotized (International Agency for Research on  Cancer, 1972,  p. 80),
                        NH,
                     BENZIDINE
                                MONO
                                HCI
                                                        2CI
                                      BENZIDINE DIAZONIUM CHLORIDE
The  latter compound,  tetrazotized  benzidine,  couples with many  different
aromatic amines and phenols to yield a wide variety of  commercial dyes
which can be  used to  color cotton  fabrics without the use of mordants.

      When the amino groups of benzidine are protected by acetylation,
benzidine is  also easily nitrated,
                           NHCOCH,
                                      HN03
                           NHCOCHj

                   4, 4'-DIACETAMIDOBIPHENYL
                                                  NHCOCH,
                                                      NO,
        NHCOCHj

    3 ,3'-DINITRO-
4,4'-DIACETAMIDOBIPHENYL

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                                   18
and halogenated,
                         NHCOCH,
                                   CI2
                         NHCOCHj
                  4,4'- DIACETAMIOOBIPHENYL
                                               NHCOCH,
                                               NHCOCH,
    3,3 -DICHLORO-
4, 4'-DIACETAMIDOBIPHENYL
      On treatment with sulfuric acid, benzidine  forms  a variety of sulfonic
 acids, benzidine sulfone, and sulfonic acids  of  the  sulfone, depending on
 the concentration and amount of acid and  the  reaction  temperature.  Other
 benzidine reactions and reaction products have been  reported in the litera-
 ture (Lurie, 1964, p. 408); however, they are mainly of academic interest.

 2.2.1.3  Occurrence, Synthesis, and Use — Benzidine  is a synthetic sub-
 stance not known to occur in nature, although it can occur in waste streams
 of facilities where it is produced or used.   Benzidine can also be formed
 in situ by the introduction of benzidine-based azo dyes into waste streams
 containing hydrogen sulfide or sulfur dioxide (Takemura, Akiyama, and
 Nakajima, 1965); the latter compounds reduce  the azo linkage of the dye,
 liberating the aromatic amine.

      Benzidine is manufactured on a commercial scale by treating an alkaline
 solution of nitrobenzene with a mild reducing agent  —  usually zinc dust.
 The resulting solution contains a mixture of  stepwise  reduction products,
 azoxybenzene and azobenzene, but it consists  primarily of the intermediate
 product, hydrazobenzene:
             NITROBENZENE     AZOXYBENZENE
   01         fO
                \/
 AZOBENZENE    HYDRAZOBENZENE

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                                   19
The addition of mineral acids  to  the  hydrazobenzene  solution causes
spontaneous rearrangement of this compound  into  the  desired  product,
benzidine:
                           ACID
                  HYDRAZOBENZENE    BENZIDINE
                                             DIPHENYLINE
This reaction  is  the well-known  benzidine  rearrangement  (Karrer,  1950,  p.
498).  A small amount,  usually 3%  to  15%,  of  the  o,p'-diaminobiphenyl
(diphenyline)  isomer is usually  formed.  Nitrobenzene  also  can be reduced
with zinc amalgam,  iron powder,  noble metal or  nickel  catalysts,  or  electro-
lytically (Lurie, 1964, p.  411).

     The principal  use  of benzidine and  its salts is in  the manufacture of
dyestuffs based on  the  coupling  of tetrazotized benzidine  (Section 2.2.1.2)
with phenols and  aromatic amines.  More  than  250  commercial dyes  based  on
benzidine have been reported  (ColouT  Index, 1956);  the most important of
these are listed  in Table 2.1.   The composition and color of several impor-
tant benzidine-based cotton dyes are  listed in  Table 2.2.   The symbol -> in
Table 2.2 stands  for "diazotized and  coupled  with"  and is a shorthand des-
ignation commonly used  by dye chemists.  The  chemical  structure of Congo
Red, one of the more important dyes in Table  2.2,  is shown  below  (Johnson,
Zenhauser, and Zollinger, 1963):
                                             H—NH

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                                  20
         TABLE  2.1.   COMMERCIAL DYES DERIVED FROM BENZIDINE
Colour Index name
Mordant Yellow 36
Pigment Red 39
Direct Red 28
Direct Orange 8
Direct Red 10
Direct Red 13
Direct Red 37
Direct Red 1
Direct Brown 2
Direct Orange 1


Direct Violet 1
Direct Blue 2
Co}°ur Colour Index name
Index No .
14135
21080
22120
22130
22145
22155
22240
22310
22311
22370
22375
22430
22570
22590
Direct Blue 6
Direct Brown 1
Direct Brown 1A
Direct Brown 154
Direct Brown 6
Direct Brown 95
Direct Black 38
Direct Black 4
Direct Green 1
Direct Green 6
Direct Green 8
Direct Brown 31
Direct Brown 74

Colour
Index No .
22610
30045
30110
30120
30140
30145
30235
30245
30280
30295
30315
35660
36300

     Source:  Adapted from U.S. Tariff Commission, 1963,  cited  in
Lurie, 1964, Table 1, p. 413.  Reprinted by permission of the publisher.
            TABLE  2.2.   COTTON  DYES  DERIVED  FROM BENZIDINE
                        Composition
Color
   Salicylic  acid -«-  benzidine -> naphthionic  acid             Orange
   Naphthionic  acid  •«- benzidine -> naphthionic acid           Congo Red
   H  acid •«- benzidine -> H  acid                                Blue
   Salicylic  acid «-  benzidine -> gamma acid                   Brown
   Salicylic  acid •*-  benzidine ->• H acid -*- p-nitroaniline      Green
   m-Phenylenediamine •«-> benzidine -»• H acid  -*- aniline        Black
       Source:  Adapted  from Lurie,  1964,  Table 2,  p.  414.  Reprinted
  by permission of  the publisher.

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                                    21
     Although the manufacture of  dyestuffs  accounts for the major portion
of the benzidine consumed in the  United  States,  there are many other uses
for this compound.  Benzidine is  employed  in analytical chemistry to detect
and determine inorganic  ions such as  cadmium,  copper, manganese,  chloride,
fluoride, cyanide, ferricyanide,  ferrocyanide,  phosphate, silica, sulfate,
tungstate, hypohalites,  permanganate,  nitrate,  nitrite, and phosphomolybdate
(Welcher, 1947).  Benzidine is  used as a chromogenic spray reagent in the
thin-layer chromatography of chlorinated organic pesticides (Adamovic,  1966).
It is used as a reagent  for determining  hydrogen peroxide, nicotine, sugars,
occult blood, and bacterial cytochromes.  Benzidine is sometimes  used in
security printing because it reacts with ink erasers to give colored prod-
ucts  (International Agency for  Research  on Cancer,  1972, p. 81).

2.2.1.4  Biochemical Reactions  and Metabolites — The long-held suspicion
that benzidine is a bladder carcinogen (Hueper  and  Conway, 1964,  p.  268)
was established statistically by  Case et al. (1954) and was subsequently
verified by  experiments  with rats, dogs, hamsters,  and mice (Federal Reg-
-ister, 1974).  Benzidine is also  regarded  as mutagenic (Ames et al., 1973).
The specific biochemical reactions responsible  for  these physiological
effects are  not yet known  (Miller and Miller,  1971a, p. 84); some doubt
even remains about the  identity of certain metabolites (Haley, 1975).
Nevertheless, an appreciable store of metabolic  chemistry exists, and the
patterns of  biotransformations  for aromatic amines  pointed out by Williams
(1959, p. 428) probably  are generally applicable to benzidine.  These char-
acteristic reactions will be used as  the basis  of the biochemistry discussed
below.  However, the reader is  cautioned that most  reactions described  in
this  section remain largely unsubstantiated in the  literature since very
little work  has been done to characterize  biochemical reactions of benzidine.

     Unlike  their aliphatic analogues, aromatic  amines are not deaminized
in vivo; instead, the amino group is  conjugated and the aromatic  ring is
hydroxylated.  Conjugates of aromatic amines are more polar and less lipid
soluble than their precursors and consequently  are  more readily excreted in
the urine  (Parke, 1968,  p. 4).  When  a molecule, such as benzidine,  has more
than one functional group, only one group  is usually conjugated.   Double
conjugates are formed in multifunctional substrates only if conjugation of
a single functional group does  not increase the  polarity of the molecule
sufficiently to promote  rapid excretion.  The most  common conjugation of
the amino group is acetylation  (Section  2.2.1.2), a reaction in which the
amino group  is converted to an  acetamido group:

                    NH2              NHCOCH3         NHCOCH,
                       ACETYL COENZYME A
                      ARYL AMINE ACETYL
                         TRANSFERASE
 ACETYL COENZYME A
ARYL AMINE ACETYL
   TRANSFERASE
                  BENZIDINE       4-ACETAMIOO-   4. 4'-DIACETAMIDOBIPHENYL
                              4'-AMINOBIPHENYL

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                                    22
Acetylation  of  benzidine is thought to require the cofactor acetyl coenzyme
A as well  as an enzyme, aryl amine  acetyl transferase.

     The aromatic amino group also  conjugates with glucuronic and sulfuric
acids  to form N-glucuronides,
                      GLUCURONIC ACID
                 BENZIDINE
                                   NH2

                           BENZIDINE N-GLUCURONIDE
           NHC6H906
        BENZIDINE
      N,N'-DIGLUCURONIDE
 and N-hydrogen sulfates,
                                   NH-0-S03H
            NH-0-S03H
                        ARYL AMINE
                        SULFOKINASE

                           PAPS
ARYL AMINE
SULFOKINASE
	»-
   PAPS
                    NH2              NH2             NH-0-S03H

                 BENZIDINE         BENZIDINE          BENZIDINE
                            N-HYDROGEN SULFATE  N, N-DI (HYDROGEN SULFATE)
 Conjugation with glucuronic  acid, the most important conjugation mechanism,
 occurs in all mammals and most vertebrates except fish (Parke, 1968,  p.  77).
 Aryl amine glucuronides  form spontaneously from  glucuronic acid and aryl
 amine, but glucuronides  of phenols, alcohols, and carboxylic acids  (0-
 glucuronides) are formed only with the aid of appropriate enzymes.  Simi-
 larly, formation of  the  benzidine hydrogen sulfates requires the adenosine
 coenzyme 3'-phosphoadenosine-5'-phosphosulfate  (PAPS)  and the appropriate
 aryl amine sulfokinase.

      The second type of  biochemical behavior of  aromatic amines, hydroxyla-
 tion of the ring, occurs extensively unless there is an alternative meta-
 bolic reaction involving another substituent in  the ring.   Usually, the

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                                     23
hydroxyl  group enters OTtho  or para to the amino  groups, depending on  the
presence  of other substituents.  Benzidine hydroxylation occurs ovtho  to
the amino group since the para position is blocked  in the parent compound
(Sciarini and Meigs, 1961a):
MICROSOMAL ARYL
HYDROXYLASE
	 ^.
NADPH2
°2
MICROSOMAL ARYL
HYDROXYLASE
NADPH2
°2
                   BENZIDINE      3-HYDROXYBENZIDINE  3,3'-DIHYDROXYBENZIDINE
A hepatic microsomal enzyme,  oxygen, and reduced  nicotinamide adenine
dinucleotide phosphate  (NADPH2) are required  for  the hydroxylation reaction.
At  least two distinct mechanisms can operate;  the above reaction appears  to
account for the reported metabolites of benzidine (Haley, 1975; Parke,  1968,
p.  40).

      The hydroxybenzidines  shown in the previous  reactions may be excreted
  .changed; however, they are  normally conjugated  with glucuronic acid,
un
                            URIDINE DIPHOSPHATE COENZYME
                               URIOINE DIPHOSPHATE
                               TRANSGLUCURONYLASE
                           NH2

                    3-HYDROXYBENZIDINE
                                                     OCgHgOg
                                                NH2

                                        3-GLUCURONYLBENZIDINE

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                                               24
                                              NH2
                     NH2
                                                                        OC6H906
                                                                        OC6H906
                          NH2
NH2
               3,3'-DIHYDROXYBENZIDINE                   3,3'-DIGLUCURONYLBENZIDINE

                              3-HYDROXY-3'-GLUCURONYLBENZIDINE
or  sulfuric acid,
                                 NH2
                                      OH
                                        SULFOTRANSFERASE
                                        	^-

                                             PAPS
               NH2
                                                                   0-S03H
                                 NH2                         NH2


                        3-HYDROXYBENZIDINE       BENZIDINE 3-HYDROGEN SULFATE
                                             NH2
                    NH2
                                                                       0-SOjH
                                                                       0-S03H
                                              I                    I
                         NH2


               3,3-DIHYDROXYBENZIDINE               BENZIDINE 3,3'-DI (HYDROGEN SULFATE)

                           BENZIDINE 3-HYDROXY-3'-HYDROGEN SULFATE

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                                   25
Conjugation of the hydroxyl groups of hydroxybenzidine with glucuronic
acid is not spontaneous as was the previously described reaction of the
amino groups in benzidine.  Uridine diphosphate coenzyme and uridine diphos-
phate transglucuronylase are required.  An enzyme is also required for forma-
tion of the sulfate esters.  These compounds and the N-hydrogen sulfates
mentioned previously are often identified in the literature as etheral sul-
fates because of their solubility in, and easy extraction into, ether
solvents.

     In 1960, an in vivo biochemical reaction was discovered in which aro-
matic amines are oxidized to hydroxylamines  (Cramer, Miller, and Miller,
1960).  This process, called N-hydroxylation, occurs widely (Hathway, 1970,
p. 271) and is now considered by some investigators to be the first step in
the activation of aromatic amines and amides for carcinogenesis (Miller and
Miller, 1971a):
                                              NHOH
                         OJ                 10

                              MICROSOMAL ENZYME
                                 NADPH2
                                  02
                       BENZIDINE
                                              NH2
                                        N-HYDROXYBENZIDINE
The N-hydroxylating  system requires a microsomal enzyme, NADPH2, and
oxygen; the necessary enzyme occurs in the liver, lungs, and bladder  (Parke,
1968, p. 47).

     Another type of metabolic process, different from those discussed
above, is the in vivo chemical reaction by which benzidine is produced from
a previously ingested source material such as an azo dye.  It has long been
known that humans and other mammals can metabolically reduce certain dyes
to free carcinogenic aromatic amines  (Fuller, 1937; Williams, 1949, pp.
150-154).  Rinde and Troll (1975) established that metabolic reduction of
benzidine-based azo dyes can occur in the monkey.  They found substantial
amounts of benzidine and monoacetylbenzidine in the urine of animals which
were fed single doses of benzidine-based dyes (Direct Red 28, Direct Blue 6,
Direct Black 38, and Direct Brown 95) dissolved in dimethyl sulfoxide.  In
view of their findings, these investigators recommended restricting the pro-
duction of azo dyes to those which could be manufactured from noncarcino-
genic aromatic amines, such as aniline.  Discussions of metabolic transfor-
mations in general and of aromatic amines in particular may be found  in
Arrhenius (1974), Hathway (1970), Parke (1968), and Walker (1970).

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                                   26


     The simple metabolic products indicated in the various biochemical
reactions described above are not necessarily the compounds excreted when
benzidine is ingested by the host; successive operations on a metabolite by
different biochemical processes may result in a complex end product.
Furthermore, use of a particular biotransformation reaction varies among
animal species and with experimental conditions.  It is necessary, therefore,
to identify the metabolites of each animal species experimentally.

2.2.1.5  Chemical Structure Associated with Carcinogenic Activity of
Aromatic Amines — Chemicals were first used to produce experimental tumors
more than 50 years ago  (Yamagiwa and Ichikawa, 1918).  Since then, carcino-
genic activity has been demonstrated for a wide variety of chemical com-
pounds  (Clayson, 1962; Hueper and Conway, 1964; International Agency for
Research on Cancer, 1972, 1973as 1973&, 1974a, 19743).  These compounds
are structurally diverse and have no common metabolic patterns  (Miller and
Miller, 1966); no general explanation for their carcinogenic activity is
available.  Some advances have been made, however, in understanding the
carcinogenic activity of certain classes of compounds.  The following dis-
cussion deals with aromatic amines — the class to which benzidine belongs.

     Not all aromatic amines are potent carcinogens; to qualify, the amino
group apparently must be attached to an aromatic system containing more
than one ring.  Furthermore, the point of attachment of the amino group to
the ring must be such that the position para to the amino group is occupied
by another  substituent  or by part of the conjugated system (Clayson, 1962,
p. 211).  Unlike carcinogenic hydrocarbons, carcinogenic aromatic amines
generally induce tumors at tissue sites distant from the point  of administra-
tion.   This behavior suggests that aromatic amines are not carcinogenic per
se but  acquire  this characteristic only after metabolic activation.

     Since  hydroxylation of the ring occurs extensively in these compounds
 (Section 2.2.1.4), hydroxylated derivatives were among the first metabolites
suspected as carcinogens (Hueper, 1938).  In addition, since the amino group
is an ortho-para director and since the para position in carcinogenic
aromatic amines is usually blocked, hydroxylation of these compounds char-
acteristically occurs in the ortho position.  Early workers thus developed
the ort/zo-hydroxylation hypothesis (Clayson, 1962, p. 219) as a guide to
identifying potentially carcinogenic aromatic amines.  Acceptance of the
theory diminished, however, when some o-hydroxy amines failed to produce
tumors and  others failed to produce neoplasms when administered by a
different route (Miller and Miller, 1966).

     Although strong evidence exists for the carcinogenicity in mice of
o-hydroxyanthranilic acid (Ehrhart, Georgii, and Stanislawski,  1959) and
some o-hydroxyamine metabolites of tryptophan  (Bryan, Brown, and Price,
1964), the ort/zo-hydroxylation hypothesis was largely displaced in 1960 by
the discovery of the in vivo reaction of N-hydroxylation (Section 2.2.1.4)
in which the nitrogen of aromatic amines is oxidized enzymatically to
hydroxylamine (Cramer, Miller, and Miller, 1960).  Troll, Belman, and Rinde
(1963) established that this metabolite of benzidine occurs in humans.
N-Hydroxylation of aromatic amines and amides occurs widely and N-hydroxy
metabolites of carcinogenic aromatic amines are at least as active as the

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                                   27
parent carcinogen  (Boyland, Dukes,  and  Grover,  1963; Miller,  Enomoto,  and
Miller, 1962; Miller, Miller,  and Enomoto,  1964;  Poirier  et al.,  1965).
Also, unlike the o-hydroxy compounds, the N-hydroxy metabolites can  induce
tumors at sites where the parent compounds  are  inactive  (Miller and  Miller,
1966).  As a result of  these  studies, N-hydroxylation  is  now  widely  recog-
nized as the first step  in the activation of  aromatic  amines  and  amides  for
carcinogenesis  (Miller  and Miller,  1971a).

     Although carcinogenic, N-hydroxy aromatic  amines  lack the electrophilic
properties of ultimate  carcinogens  which enable the latter to bind to
nucleophilic sites of proteins and  nucleic  acids  at physiological pH (Miller,
1970).  This deficiency indicates that  N-hydroxy  aromatic amines  are prox-
imate rather than ultimate carcinogens.  The  chemical  reactivity  of  esters
of aromatic hydroxylamines and hydroxamic acids suggests  that esterification
(Section 2.2.1.4) of N-hydroxylated metabolites is the next step  in  the
metabolic sequence leading to  the ultimate  carcinogen  (Miller and Miller,
1972).  No experimental  work  establishing this  chemical sequence  for the
metabolism of benzidine has been performed; however, such experimental
evidence has been obtained for other aromatic amines,  namely, 2-acetylamino-
fluorene  (AAF)  and N-methyl-4-aminoazobenzene (MAB).   Miller  and  Miller
(1972) reported that after treating male rats with AAF, the major reactive
metabolites in  the liver were  sulfuric  acid esters which, when desulfatized,
yielded an aminonium cation that reacted readily  with  nucleophilic tissue
components such as proteins,  RNA, and DNA  (Miller and  Miller, 1971a).  The
principal steps leading to the formation of the reactive  sulfates and  the
aminonium cations of AAF and MAB are shown  in Figure 2.1.
                                       ORNL-DWG 77-13499

                                               MAB
                                                  =\../CH3



                                                  I
                                       \ VM  \
                              lO-Cp-R, 0-£-»0,  0-S-*0, xl-p-D-GLUCURONYL
                              L 0    OH    J
                                         T=S  /COCHjICHjl
     Figure 2.1.  Formation of reactive esters and aminonium cations from
2-acetylaminof luorene  (AAF) and N-methyl-4-aminoazobenzene  (MAB).  Source:
Miller and Miller, 1969a, Figure 5, p. 297.  Reprinted by permission of
S. Karger AG, Basel.


     A variety  of amino  acid  residues in  proteins and bases in nucleic acids
are attacked by electrophilic reactants derived  from aromatic  amine  carcino-
gens.  Among nucleic  acids  and proteins,  the principal targets appear  to be

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                                     28
  guanine, phosphate, methionine, cysteine,  tyrosine,  and histidine (Miller
  and Miller, 1969Z?).  The manner in which two  of  these,  methionine and
  (deoxy)guanosine, react in vitro with N-acetoxy-AAF  is  shown in Figures 2.2
  and 2.3.  In each instance, identical metabolites  are also obtained from
  the liver proteins or hepatic UNA of rats  fed AAF.   As  shown in Figure 2.2,
  the methionine adducts of N-acetoxy-AAF decompose  readily to form 1- and 3-
  methylmercapto-AAF, a process which can result in  cleavage of methionyl
  peptide bonds and in modification of the reacted protein (Miller and Miller,
  1969Z?).  Such reactions could have significant consequences in terms of
  enzymatic activity of alterations in substrate specificity.  The reaction
  of N-esters of AAF with guanine residues,  the major  site of attack in
  nucleic acids  (Miller and Miller, 197l£>),  has obvious implications relative
  to both genetic and epigenetic mechanisms  of  chemical carcinogenesis.  The
  alteration of guanine bases in DNA by insertion  of bulky AAF groups in the
  8-position could impede the progress of this  enzyme  along the double helix
  and lead to deletion mutants.  Indeed, deletion  mutants are the principal
  type observed when Drosophila  is treated with N-acetoxy-AAF (Fahmy and
  Fahmy,  1967).  However, single base pair changes occur  predominantly when
  Bacillus subt-il-is is treated with the same mutagen (Miller and Miller, 1969&)

       From the foregoing discussion it is apparent  that  considerable prog-
  ress has been made in recent years in identifying  proximate and ultimate
  aromatic amine carcinogens and the mechanisms by which  they are formed.
                                            ORNL-DWG 77-12898
                   CH>:
,COO\ =\ ,COCH3
 	>J^>
=\ ,COCH,     ^.-^ ,COCH,
             ^N
                    N-ACETOXY-AAF
                                              —'NH-CH2COOH

                                             NH2
                    N-HYDROXY-AAF
                              + METHIONINE- S
                                     --1C—> HEPATIC PROTEIN-BOUND 'AAF'
                                     L- OJC
     Figure 2.2.   The in vitro reaction of N-acetoxy-AAF  and methionylglycine.
Source:   Miller and Miller, 1969&, Figure 3, p.  244.  Reprinted  by permission
of the publisher.

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                                      29
                                          ORNL-DWG 77-12900
                              =\ /COCH3-citjCOO"
                         *  " /X0 COCHIN—
                         N-ACETOXY-AAF
                       N-(GUANIN-8-YL)-AF
                                                   GUANOSINE
                   N-lGUANOSIN-e-YD-AF
                    C-DERIVATIVE B
-CHjCOO

  OH"

\IDFNTir.AI '
                                                coCHj
   HO OH

N-(GUANOSIN-8-YL)-AAF

 14
  C-DERIVATIVE A
                                             PHOSPHOMONO- AND Dl-
                                                ESTERASES
                                14  R AT
                      N-HYDROXY-AAF-9- C	> HEPATIC RNA-BOUND
     Figure  2.3.   The in vivo reaction  of  N-acetoxy-AAF with guanosine.
Source:  Miller  and Miller, 19692?, Figure  4,  p.  244.   Reprinted by permission
of the publisher.
  Evidence is also accumulating relative to the nucleophilic  targets of
  these compounds; however,  there is no definitive information concerning
  the cellular chemistry  of  the carcinogenic process  itself — no understand-
  ing of the carcinogenic mechanism in molecular terms.   Future work must
  address this difficult  aspect of the problem.  Commonly postulated mecha-
  nisms of chemical carcinogenesis are outlined in Table  2.3.   Chemical
  structures associated with the carcinogenic activity of aromatic amines
  are discussed further by Clayson (1975), Conney and Levin  (1974), and
  Heidelberger (1970).

  2.2.2  3,3'-Dichlorobenzidine and Salts

       3,3"-Dichlorobenzidine is a widely used chemical intermediate which
  has been produced commercially for more than 35 years  (U.S.  Tariff Com-
  mission, 1938, cited in International Agency for Research on Cancer,
  1974cz).  Its composition and structure are indicated by the  formulas
  C12H10C12N2 and
                                          ci

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                                   30
        TABLE  2.3.  POSSIBLE MECHANISMS OF CHEMICAL CARCINOGENESIS
        I.   Genetic mechanisms — heritable changes in DNA  genome
            via:
            1.  Direct modification of existing DNA
            2.  Modification of  RNA which is subsequently  tran-
               scribed  into DNA that becomes integrated into host
               DNA
            3.  Alterations which decrease, at least temporarily,
               the fidelity of  copying of DNA

       II.   Epigenetic mechanisms — nongenomic changes leading to:
            1.  Quasi-permanent  changes in the transcription of DNA
                (including integrated virus genomes and oncogenes)
            2.  The preferential proliferation of previously
               existing preneoplastic or neoplastic cells


            Source:  Miller and  Miller, 197L&, Table 1, p. x.
 The  Chem-Loal Abstracts identification number of 3,3'-dichlorobenzidine is
 91-94-1.  It is also known as CI 23060, DCB, 4,4'-diamino-3,3'-dichloro-
 biphenyl, o,o'-dichlorobenzidine, dichlorobenzidine, dichlorobenzidine base,
 3,3'-dichloro-4,4'-biphenyldiamine, and 3,3'-dichlorobiphenyl-4,4'-diamine.

 2.2.2.1  Physical and Chemical Properties — 3,3'-Dichlorobenzidine is a
 colorless, crystalline compound which has a molecular weight of 253.1 and
 a melting point of 132°C to 133°C,   It is nearly insoluble in cold water,
 slightly soluble in dilute hydrochloric acid, and readily soluble in etha-
 nol, benzene, and glacial acetic acid (International Agency for Research
 on Cancer, 1974a).  3,3'-Dichlorobenzidine forms salts with hydrochloric
 acid.  The principal physical properties of the dihydrochloride salt are
 shown in Table 2.4.

     The chemistry of 3,3'-dichlorobenzidine is similar to that of aromatic
 primary amines in general and benzidine in particular (Section 2.2.1.2).
 Its most important chemical reaction is the formation of the tetrazonium
 compound which couples with aromatic amines and phenols to form a variety
 of dyes and pigments.  In general,  the chlorine atoms of 3,3'-dichloro-
 benzidine are passive and do not participate in these reactions (Gerarde
 and Gerarde, 1974; Karrer, 1950, p.  414).

 2-2.2.2  Occurrence, Synthesis, and Use - 3,3'Dichlorobenzidine is not
 known to occur naturally, although it may be present in the waste streams
 from production facilities where it is manufactured or used (International
Agency for Research on Cancer, 1974a).  There is also evidence that 3,3'-
 dichlorobenzidine is regenerated metabolically in rabbits and humans from
an organic pigment (benzidine yellow) in which it is used as a coupling
agent (Akiyama,  1970).

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                                    31
                  TABLE 2.4.  PHYSICAL PROPERTIES  OF
                3,3'-DICHLOROBENZIDINE DIHYDROCHLORIDE
  Formula
  Molecular weight
  Flash point (Cleveland open cup)

  Auto and ignition temperature

  Corrosiveness

  Physical state


  Solubility


  Odor
  Vapor pressure
  Particle size
C12H10C12N2-2HC1
326.1
No flammable concentration of
  vapors evolved at 200°C
No exothermic reaction recorded
  up to 300°C
Contains free mineral acidity
  or hydrochloric acid

Light grayish semidry powder
  (approx 5% water); white to
  light gray semidry paste
Slightly soluble in water and
  organic solvents; soluble in
  acids
Slightly pungent
Zero at room temperature

Salt crystals; similar to table
  salt
       Source:  Adapted from Gerarde and Gerarde,  1974,  Table  2,
  p.  324.  Reprinted by permission of the publisher.
     3,3'-Dichlorobenzidine is  synthesized  on a commercial scale by chem-
ical reactions similar to those used  for  benzidine,  except that the start-
ing material is o-nitrochlorobenzene  rather than nitrobenzene:
                                    NaOH
                                   Zn DUST
                                                   Cl
                     c-NITROCHLOROBENZENE  2,2'-DICHLOROHYDRAZOBENZENE

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                                   32
On treatment with sulfuric or hydrochloric acid, the intermediate 2,2'-
dichlorohydrazobenzene undergoes the benzidine rearrangement  (Karrer,  1950,
p. 409) to form the 3,3'-dichlorobenzidine salt:
                  2, 2'-DICHLOROHYDRAZOBENZENE 3 ,3'-DICHLOROBENZI DINE
                                         DIHYDROCHLORIDE
     As with benzidine, the principal use of 3,3'-dichlorobenzidine is in
the manufacture of dyestuffs based on the coupling of  the  tetrazotized com-
pound with phenols and aromatic amines;  13 such dyes are described in the
third edition of the Colour Index  (1971).  The 1971 production rates for
six of these dyes are listed in Table 2.5.  These dichlorobenzidine com-
pounds are used chiefly as pigments in plastic resins,  lacquer,  rubber,
printing inks, metal finishes, and textile and wallpaper prints  (Colour
Index, 1971) and in interior grade, lead-free finishes  (paints), toy
enamels, and floor coverings (Martens, 1968, p. 367).

     Dichlorobenzidine is also used as a curing agent  for  liquid-castable
polyurethane elastomers (Woolrich and Rye, 1969).  However,  compared to
dye production, this use of dichlorobenzidine is relatively  minor; it
currently amounts to only a few hundred  thousand kilograms per year in the
United States (International Agency for Research on Cancer,  1974a).
              TABLE 2.5.   SOME DYES OR PIGMENTS MANUFACTURED
                    FROM 3,3'-DICHLOROBENZIDINE IN 1971
Colour
Index No .
21090
21095
21105
21110
21115
21120
Dye or pigment
Pigment Yellow 12
Pigment Yellow 14
Pigment Yellow 17
Pigment Orange 13
Pigment Orange 34
Pigment Red 38
Production
(103 kg)
2547
1034
260
65
55
60
                  Source:   Adapted from U.S. Tariff Commission,
             1972,  cited in International Agency for Research
             on Cancer,  1974a,  p.  51.

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                                    33
2.2.2.3  Biochemical Reactions and Metabolites — On a purely chemical
basis, the biochemistry of 3 ,3'-dichlorobenzidine could be expected to
differ appreciably from that of its parent compound, benzidine.  First,
loss of halogens from the benzene ring apparently does not occur in vivo
(Gerarde and Gerarde, 1974); thus, there is little probability that the
chlorinated compound could form the 3-hydroxy derivatives characteristic of
benzidine metabolites.  Secondly, with the 1, 1', 3, and 3' positions in
the chlorinated compound already blocked, the ortho-para directing influ-
ence of the amino groups should cause any additional substitutions to occur
at the 5 or 5' positions.  Such substitutions would result in metabolites
appreciably different from those of benzidine.

     The metabolism of 3,3'-dichlorobenzidine differs among species (Sciarini
and Meigs , 1961£>).  In most  investigations the excreted chlorinated compound
appeared unchanged from its  administered form.  This apparent inertness of
the chloro derivative may reflect the deactivating influence of halogen sub-
stituents on electrophilic aromatic substitution  (Morrison and Boyd, 1974,
p. 342).

2.2.3  3,3'-Dimethylbenzidine and Salts

     3, 3'-Dimethylbenzidine  is a versatile, widely used dye intermediate;
its elemental and structural composition is indicated by the formulas
Cii.HisNz and
                                   NH
                                   NH,
 The Chemical Abstracts identification number of 3,3'-dimethylbenzidine is
 119937-   It is also known as diorthotolidine, 4,4'-diamino-3,3'-dimethyl-
 biphenyl,  4,4'-diamino-3,3'-dimethyldiphenyl,3,3'-dimethy1-4,4'-biphenyl-
 diamine, 3,3'-dimethyl-4,4'-diphenyldiamine, 3,3'-dimethylbiphenyl-4,4'-
 diamine, 3,3'-dimethyldiphenyl-4,4'-diamine, 3 ,3'-tolidine, 4,4'-bi-o-
 toluidine, 4,4'-di-<9-toluidine, diaminoditolyl, Fast Dark Blue Base R, and
 CI Azoic Diazo Component 113.

 2.2.3.1  Physical and Chemical Properties — 3,3'Dimethylbenzidine is a
 white to reddish crystalline compound which has a molecular weight of
 212.28 and a melting point of 131°C to 132°C.  It is slightly soluble in
 water (1.3 mg/ml at 25°C) (Bowman, King, and Holder, 1976) and very soluble
 in ethanol,  ethyl ether, and acetone (International Agency for Research on
 Cancer, 1972).  3,3'-DimethyIbenzidine is a weak base which readily forms

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                                   34


salts with strong mineral acids such as hydrochloric and sulfuric.  The
monohydrochloride salt is soluble to the extent of 1 part in 112.4 parts
of water at 12°C; the dihydrochloride,  1 part in 17.3 parts.  The monosul-
fate salt is moderately soluble; the disulfate is difficultly soluble in
water.  The monohydrated, monacetyl derivative of 3,3'-dimethylbenzidine
melts at 103°C; the diacetyl and tetraacetyl compounds at 315°C and 211 C
respectively.  3,3'-Dimethylbenzidine forms an intense blue color with chlo-
rine or bromine vapor (Lurie, 1964, p.  414).  Like benzidine, its parent
compound, it can also be hydroxylated,  tetrazotized, and acetylated
(Section 2.2.1.2).

2.2.3.2  Occurrence, Synthesis, and Use - 3,3'-Dimethylbenzidine is a chem-
ical intermediate used in the preparation of more than 95 dyes listed in
the Colour Index  (International Agency for Research on Cancer, 1972, p. 88).
Those manufactured in the United States during 1962 are listed in Table 2.6.

     3,3'-Dimethylbenzidine is prepared in the manner described for benzi-
dine  (Section  2.2.1.3) except that o-nitrotoluene, rather than nitrobenzene,
is the starting material  (Lurie, 1964, p. 414).  In addition to its use in
the dye industry, 3,3'-dimethylbenzidine is also used extensively in quali-
tative and quantitative analyses for the detection and determination of
cobalt, copper, gold, lead, manganese, mercury, silver, tungsten, iodide,
nitrate, nitrite, and sulfate  (Welcher, 1947, p. 462).

2.2.3.3  Biochemical Reactions and Metabolites — Little attention has been
given thus far to the metabolic chemistry of 3,3'-dimethylbenzidine.  In
limited studies of dogs and humans, only the expected metabolic processes
such as ortho  hydroxylation, sulfation, and acetylation have been observed.
                        TABLE 2.6.  COMMERCIAL DYES
                               DERIVED FROM
                          3,3'-DIMETHYLBENZIDINE
                       Colour Index        Colour
                           name           Index No.

                      Direct Red 2          28500
                      Direct Red 39         23630
                      Acid Red 114          23635
                      Direct Blue 25        23790
                      Direct-Blue 14        23850
                      Direct Blue 26        31930
                      Azoic Coupling
                        Component 5         37610


                           Source:  Adapted from
                      U.S. Tariff Commission, 1963,
                      cited in Lurie, 1964, Table 3,
                      p. 415.   Reprinted by permis-
                      sion of the publisher.

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                                    35
     Since aliphatic  side chains attached to a benzene ring are quite sus-
ceptible to oxidation in vitro (Morrison and Boyd, 1974, p. 384), Dieteren
(1966) suggested  that 3,3'-benzidinedicarboxylic acid may be a metabolic
product of 3,3'-dimethylbenzidine:
                     NH2
                                    NH2
NH2
                                                       COOH
                                                    NH2
                                          3, 3'-BENZIDINEDICARBOXYLIC ACID
                       3-METHYL-3-BENZIDINECARBOXYLIC ACID



 However, no experimental evidence exists  to support  this  suggestion.

 2.2.4  3, 3'-Dimethoxybenzidine and Salts

      3,3'-Dimethoxybenzidine is a well-established commercial  dye  inter-
 mediate whose composition and structure are represented by the formulas
 Cii.H16N202 and
                                   NH2
                                       OCH,
                                       OCH,
                                   NH2
 The Chemical Abstracts number of 3,3'-dimethoxybenzidine  is  119-90-4.   The
 compound is also known as bianisidine,  4,4'-diamino-3,3'-dimethoxybenzidine,
 di-p-amino-di-m-methoxydiphenyl, dianisidine,  and  3,3'-dimethoxy-4,4'-
 diaminobiphenyl.

 2.2.4.1  Physical and Chemical Properties — 3,3'-Dimethoxybenzidine is a
 colorless, crystalline compound which turns violet on standing and has a
 molecular weight of 244.3 and a melting point  of 137°C to 138°C.   The  com-
 pound is poorly soluble in water (0.06  mg/ml at 25°C)  (Bowman, King, and

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                                   36
Holder  1976), but it is soluble in ethanol, ethyl ether, acetone, benzene,
chloroform, and probably most organic solvents and lipids (International
Agency for Research on Cancer, 1974a, p. 41).  3,3'-Dimethoxybenzidine is
a weak base and forms salts with mineral acids; it has the chemical char-
acteristics of primary aromatic amines in general and of benzidme in
particular (Section 2.2.1.2).

2.2.4.2  Occurrence, Synthesis, and Use - 3,3'-Dimethoxybenzidine is an
important dye intermediate which has been produced commercially for at
least 50 years; it is not known to occur naturally, although it may some-
times be present  in waste streams from facilities where  it is manufactured
or  used  (International Agency for Research  on Cancer, 1974a, p. 43).

      3,3'-Dimethoxybenzidine is prepared in the manner described  for benzi-
dine (Section 2.2.1.3)  except that the methyl ether of o-nitrophenol is
used as  the  starting material instead of nitrobenzene.   Current U.S.^pro-
duction  data on 3,3'-dimethoxybenzidine are unavailable.  In 1967, five
 domestic producers manufactured 167,000 kg  (U.S. Tariff  Commission, 1968,
 cited in International  Agency for Research  on Cancer, 1974a).  By 1971,
 only two domestic producers  were reported;  imports in that year totaled
 124,000  kg (U.S.  Tariff Commission,  1972, cited in International  Agency
 for Research on Cancer, 1974a).

      3,3'-Dimethoxybenzidine is  the  coupling agent in 89 dyes  listed in
 the Colour Index (1971).   Seven  of  these, for which  1971 U.S.  production
 data are available,  are listed  in  Table 2.7.  In addition, about  87,000  kg
 of a 3,3'-dimethoxybenzidine-based pigment, Pigment Blue 25  (CI  21180),
 was also manufactured in the United States  in  1971  (U.S. Tariff  Commission,
 1972, cited in International Agency for Research on Cancer,  1974a).   3,3'-
 Dimethoxybenzidine-based dyes and  pigments  are  used primarily  to  color
 leather, paper, plastics, rubber,  and textiles.
                   TABLE 2.7.   SOME DYES  MANUFACTURED  FROM
                       3,3'-DIMETHOXYBENZIDINE  IN  1971
Colour
Index No .
24401
21160
24410
24400
24140
24411
23155
Dye
Direct Blue 218
Pigment Orange 16
Direct Blue 1
Direct Blue 15
Direct Blue 8
Direct Blue 76
Direct Blue 98
Production
(103 kg)
479
153
136
94
64
53
39
                   Source:   Adapted from U.S.  Tariff Commission,
              1972, cited in International Agency for Research
              on Cancer, 1974a,  p.  43.

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                                   37


     Smaller quantities of 3,3'-dimethoxybenzidine are used in applications
unrelated to dyes or pigments.  The most important of these is probably the
manufacture of 3,3'-dimethoxy-4,4'-diphenylene diisocyanate, an ingredient
in isocyanate-based adhesive systems and a component of polyurethane elas-
tomers.  3,3'-Dimethoxy-4,4'-diphenylene diisocyanate is prepared by dis-
solving the hydrochloride salt of 3,3'-dimethoxybenzidine in an aromatic
solvent and heating the resulting solution with phosgene (Woolrich and Rye,
1969) .  The annual rate of production for this compound is not known but is
estimated to be less than 500,000 kg (International Agency for Research on
Cancer, 1974a, p. 43).  3,3'-Dimethoxybenzidine is also used in analytical
chemistry to detect and determine cobalt, copper, gold, vanadium, thio-
cyanate, and nitrite  (Welcher, 1947, p. 342).

2.2.4.3  Biochemical Reactions and Metabolites — Laham (1971) fed the mono-
substituted compound 3-methoxybenzidine to rats and detected 3-methoxy-4-
amino-4'-acetamidobenzidine in freshly collected urine.  In vivo acetylation
of this amine in the 4' rather than  the 4 position indicates steric hin-
drance from the methoxy group in the 3 position.

2.2.5  4-Aminobiphenyl

     4-Aminobiphenyl is a derivative of biphenyl rather than benzidine.
It is discussed here because of its  structural and chemical similarities
to benzidine and its established carcinogenicity in animals and humans
(Federal Register, 1974).  The elemental and  structural composition of
4-aminobiphenyl is indicated by the  formulas  C12HnN and
 The  Chemical Abstracts  identification number  of  4-aminobiphenyl is 92671.
 It is  also  known as  4-biphenylamine,  p-aminobiphenyl, p-aminodiphenyl,
 4-aminodiphenyl, p-biphenylamine,  p-phenylaniline,  and xenylamine.

 2.2.5.1   Physical and Chemical  Properties — 4-Aminobiphenyl  is a colorless,
 crystalline compound that  darkens  on  oxidation.  It has a molecular weight
 of 169.2, a boiling  point  of  191°C (15 torr),  and a melting  point of 53°C
 to 54°C  (Weast,  1970).   4-Aminobiphenyl is  very  slightly soluble in cold
 water  and is  soluble in hot water  and nonpolar solvents and  in lipids.
 Like benzidine  (Section 2.2.1.2),  it  forms  salts with mineral acids, is
 oxidized by air, and its amino  group  is diazotized, acetylated, and alkyl-
 ated (International  Agency for  Research on  Cancer,  1972).

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                                    38
 2.2.5.2  Occurrence,  Synthesis,  and Use — 4-Aminobiphenyl does not  occur
 naturally; however, it  can form  inadvertently as an impurity during the
 synthesis of  certain  aromatic amines.   In fact, 4-aminobiphenyl was first
 isolated in 1862  from residues remaining after the distillation of  crude
 aniline  (Hueper and Conway, 1964,  p. 265).  The formation of 4-amino-
 biphenyl in aniline is  probably  due to the reduction of 4-nitrobiphenyl
 produced by the nitration of diphenyl  contained in impure benzene.   Occur-
 rence  of 4-aminobiphenyl in aniline synthesized in modern plants has been
 greatly minimized by  improved distillation techniques (International Agency
 for Research  on Cancer,  1974a, p.  114).

     4-Aminobiphenyl  was produced  on a large scale in the United States
 from 1935 to  1955 for use as a rubber  antioxidant.  It was prepared by
 nitrating diphenyl and  treating  the resulting intermediate with a mild
 reducing agent:
                           HN03
                           H2S04
                    o
                   \/
                  DIPHENYL
                                         REDUCING

                                          AGENT
                               4-NITROBIPHENYL
                                              4-AMINOBIPHENYL
Production of the compound in  the United  States is thought to have ceased
following the general recognition in  1955 of  its carcinogenicity (Inter-
national Agency for Research on Cancer, 1972, p. 74).   However, it still
is being manufactured, but on  a smaller scale than formerly (Haley, 1977).

2.2.5.3  Biochemical Reactions and Metabolites — Studies seeking 4-amino-
biphenyl metabolites have been performed  by several investigators.   Miller
et al. (1961) observed that rats convert  4-diphenylacetamide to the
N-hydroxy derivative:
                        NHCOCH?
                        01                 10
                                            ^^
                  -DIPHENYLYLACETAMIDE  N-HYDROXY-4-DIPHENYLYLACETAMIDE
                                                COCH3

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                                     39
Rabbit  liver microsomes also metabolize 4-acetamidobiphenyl in this manner
(Booth  and Boyland, 1964).  In dogs,  4-aminobiphenyl is metabolized to
4 amino-3-biphenylyl hydrogen sulfate (Bradshaw and Clayson, 1955),
                     4-AMINOBIPHENYL  4-AMINO-3-BIPHENYLYL HYDROGEN SULFATE
and  4-amino-3-biphenylyl glucuronic  acid  (Gorrod,  1971),
                  4-AMINOBIPHENYL   4-AMINO-3-BIPHENYLYL GLUCURONIC ACID
2.2.6  4-Nitrobiphenyl

     4-Nitrobiphenyl is also a derivative of biphenyl  rather than benzidine.
Like 4-aminobiphenyl, it has structural and chemical similarities to benzi-
dine and  is  an established carcinogen in dogs  (Federal Register,  1974).
The composition and structure of 4-nitrobiphenyl  are indicated by the for-
mulas Ci2H9N02 and

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                                    40
 The Chemical  Abstracts  identification number of 4-nitrobiphenyl is 92-93-3.
 Other names  for  the  compound  are p-nitrobiphenyl,  p-nitrodiphenyl, 4-nitro-
 diphenyl,  PNB, 4-phenyl-nitrobenzene, and p-phenyl-nitrobenzene.

 2.2.6.1  Physical and Chemical  Properties — 4-Nitrobiphenyl occurs as
 white to yellow  needles which have  a  molecular  weight of 199.2, a boiling
 point of 340°C,  and  a melting point of 114°C.   It  is almost insoluble in
 water, slightly  soluble in cold alcohol,  and readily soluble in benzene,
 chloroform,  and  ether  (Weast, 1970).   4-Nitrobiphenyl is easily reduced
 both in vitro and in vivo  to  4-aminobiphenyl.   Oyt/zo-hydroxylation occurs
 on prolonged  warming of 4-nitrobiphenyl with powdered potassium hydroxide
 in benzene (International  Agency for  Research on Cancer, 1974cr).

 2.2.6.2  Occurrence, Synthesis, and Use — 4-Nitrobiphenyl does not occur
 naturally.  Prior to 1900,  it formed  inadvertently during the commercial
 preparation of nitrobenzene because of the presence of biphenyl in impure
 benzene.   This source of 4-nitrobiphenyl  has apparently been eliminated by
 improved distillation techniques which completely  remove biphenyl from the
 benzene feedstock (International Agency for Research on Cancer, 1974a).

      Presently,  there appears to be no large-scale industrial production of
 4-nitrobiphenyl  in the  United States.   The only known commercial application
 of the compound  is as a chemical intermediate in the preparation of 4-amino-
 biphenyl (Section 2.2.5).   When use of the latter  material as a rubber  anti-
 oxidant ceased in 1955,  the commercial production  of 4-nitrobiphenyl also
 stopped (Deichmann et al.,  1958); however,  small amounts are still manufac-
 tured for  research and  pilot  plant  use.   The method used to prepare the
 4-nitrobiphenyl  consumed between 1934  and 1955  has not been reported (Inter-
 national Agency  for  Research  on Cancer, 1974a).  An obvious technique
 involves the  nitration  of biphenyl:
                        o,
                                  HN03
                                 CH3OOH
                        o
                       \^-
                      BIPHENYL            4-NITROBIPHENYL
     Synthesis and use of 4-nitrobiphenyl is prohibited in the United
Kingdom under the Carcinogenic Substances Regulations, 1967, Statutory
Instrument No. 487.   The preparation and use of 4-nitrobiphenyl in the
United States is regulated by standards set by the Occupational Safety and
Health Administration (Federal Register, 1974).

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                                    41
fate
          Biochemical Reactions and Metabolites - Rats metabolically reduce
            611!1 to.4~aminobiPheny1 and ^-aminobiphenyl-3-yl hydrogen sul-
                    o
                    ^/
                4-NITROBIPHENYL
                                                       OSO»H
                               4-AMINOBIPHENYL   4-AMINOBIPHENYL-3-YL
                                               HYDROGEN SULFATE
A similar reduction  of  4-nitrobiphenyl  to  4-aminobiphenyl  occurs  in vitro
if rat liver enzymes, the  necessary  cofactors,  and  anaerobic  reaction
conditions are present  (Uehleke  and  Nestel,  1967).

2.2.7  Other Benzidine  Congeners

     In addition  to  the benzidine  compounds  discussed  in the  preceding
sections, many other substituted products  are possible.  Nitro, alkoxy,
sulfonic acid, and carboxylic  acid derivatives  are  the most important.
Few, if any, carcinogenic  or metabolic  studies  have been performed with
these materials.  Their general  characteristics are summarized in Table 2.8.

2.3  ANALYSIS FOR BENZIDINE

     Although alarm  over "aniline  tumors"  was expressed by Rehn as early as
1895, general concern over the carcinogenic  role of benzidine and its con-
geners did not develop  for nearly  half  a century (Spitz, Maguigan, and
Dobriner, 1950).  Approved analytical methods for determining benzidine
were first established  by  the  Association  of British Chemical Manufacturers
in 1954 (Butt and Strafford, 1956).  These colorimetric methods were used,
with innovations, for almost all of  the quantitative analyses of  benzidine
which were subsequently reported.  Recently, the manufacture  and  use of
benzidine and 3,3'-dichlorobenzidine in this country became subject to the
regulations of the Williams-Steiger  Occupational Safety and Health Act of
1970 as amended in the  Federal Register, January 29, 1974.  Analytical
techniques or instruments  for  environmental  monitoring are not specified in
the adopted standards,  but the administration requested the National
Institute for Occupational Safety  and Health to develop qualitative and
quantitative methods for determining the listed carcinogens (Federal Reg-
ister, 1974).  Approved methods  for  determining benzidine  have not yet
been published, but an  interim procedure (Section 2.3.2.3) was suggested
(Federal Register, 1975).  In  the  absence  of formally  sanctioned  analytical
procedures, the discussions which  follow reflect the existing state of the
art as described  in the current  literature.

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                                                   TABLE 2.8.   OTHER BENZIDINE  CONGENERS
_ , Empirical Structural
Compound , . ,.
formula formula
2-Nitrobenzidine C12HuN302 NH,
N02
NH2
3-Nitrobenzidine C12H11N302 NH2
NH2
2,2'-Dinitrobenzidine C12H10N<,0,, NH2
(o^
^S/N02
NH,
Molecular Form and Melting Method of
weight color point (°C) Se preparation
229.2 Red needles 143 Dye intermediate Nitration of ben-
zidine sulfate
in sulfuric
acid
229.2 Red crystals 208-210 Careful reduction
of 4-amino-3,4 '-
dinitrobiphenyl
274.2 Yellow 214 Dye intermediate Nitration of ben-
crystals zidine in exces
sulfuric acid
3,3'-Dinitrobenzidine
274.2
           Red needles
                                                                                          281-282
Dye intermediate
Hydrolysis of its
  N,N'-diacetyl
  or N,N'-di-p-
  toluene sulfonyl
  derivative
                                                                                                                                  (continued)

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                                                           TABLE 2.8 (continued)
      „      j
      Compound
 Empirical
        -
   formula
Structural
  formula
                                                           Molecular
                                                            weight
Form and
  color
  Melting
point (°C)

 Method of
preparation
3-Ethoxybenzidine
                         Ci<.H16N20
4,4'-Diamlno-3-
  biphenylsulfonic
  acid
Benzidine-3,3'-
  disulfonic acid
                         C12H12N203S
C12H12N206S2
                                    228.3
                                                   oc2H5
                             Shiny, flat
                               needles
                                               134-135
                                                             264.3
                                                                             Dye intermediate
                                    344.4
                             Small, white
                               plates
                                                                                                      Dye intermediate
                                                Coupling benzene-
                                                  diazonium chlo-
                                                  ride with phenol-
                                                  4-sulfonic acid,
                                                  followed by
                                                  ethylation of
                                                  the hydroxyl
                                                  group, reduction
                                                  to the hydrazo
                                                  compound, rear-
                                                  rangement with
                                                  mineral acid,
                                                  and desulfona-
                                                  tion with dilute
                                                  acid at 170°C

                                                Heating benzidine
                                                  sulfate to
                                                  170°C for 24 hr,
                                                  extracting the
                                                  product in al-
                                                  kali,  and preci-
                                                  pitating the
                                                  monosulfonic
                                                  acid with acetic
                                                  acid

                                                Baking benzidine
                                                  sulfate with
                                                  excess  sulfuric
                                                  acid at 210°C
                                                  for 36  to 48 hr,
                                                  extracting  the
                                                  product in  alka-
                                                  li,  and precip-
                                                  itating the
                                                  product with
                                                  mineral acid
                                                                                                     -O
                                                                                                     OJ
                                                                                                                                 (continued)

-------
TABLE 2.8 (continued)
Compound
Benzidine-2,2'-
disulfonic acid
Benzidine sulfone
o-Tolidine-6,6'-
disulfonic acid
Empirical Structural
formula formula
C,2H12N206S2 NH,
S03H
S03h
NH2
Ci2H10N202S NH2
Col
y^^soj
X^^S°2
C$J
NH2
Cn1H16N206S2 NH2
H3C^^\
TO!
\x^S03H
/•k^SOjH
foT
ri3c^\|xj
NH2
Molecular Form and Melting Method of
weight color point (°C) preparation
344.4 Prisms Dye intermediate Reducing m-nitro-
benzenesulfonic
acid with zinc
dust and caustic
soda at 70°C,
followed by
neutralization ,
further reduc-
tion with zinc
at 80°C, filtra-
tion, and rear-
rangement in
mineral acid at
20°C
246.3 Light yellow >350 Dye intermediate Treating benzidine
plates sulfate with
excess 20% oleum
100°C
372.4 Needles Dye intermediate Reducing 2-nitro-
toluene-4-
sulfonic acid
with zinc and
caustic soda,
followed by
rearrangement
with mineral
acid
                                                                       (continued)

-------
                                                           TABLE  2.8  (continued)
      Compound
Empirical
 formula
Structural
  formula
Molecular
 weight
Form and
  color
  Melting
point (°C)
                                                                                                             Use
 Method of
preparation
Benzidine-3,3'-
  dicarboxylic acid
                                  272.3
                                             Needles
                                                               275
                                                           Dye intermediate
                                                               Reducing o-nitro-
                                                                 benzoic acid
                                                                 with zinc dust
                                                                 and alkali at
                                                                 100°C to 105°C,
                                                                 precipitating
                                                                 the hydrazo
                                                                 compound with
                                                                 acetic and hydro-
                                                                 chloric acids,
                                                                 and rearranging
                                                                 the product in
                                                                 concentrated
                                                                 hydrochloric
                                                                 acid at 95°C to
                                                                 100°C
     Source:   Compiled from Lurie,  1964,  pp.  416-419.

-------
                                   46
2.3.1  Sampling and Sample Preparation

     The melting points  of benzidine  and  its  common derivatives are well
above ambient environmental temperatures;  consequently,  these compounds
occur in the undissolved state as  aerosols, dusts,  or crystals and in dis-
solved form as aerosols, aqueous  solutions, or organic solutions.   The
principal considerations involved  in  handling the various sample types are
discussed in the following sections.

2.3.1.1  Benzidine in Air — Formerly, benzidine and its  derivatives were
manufactured and used in open systems which permitted loss of the compound
to the atmosphere, the worker, and the work site.  In some operations,
average concentrations in the air  of  2.5  to 17.6 mg/m3 were observed
(Akiyama, 1970; Zavon, Hoegg, and  Bingham, 1973).  Under regulations
adopted in the United States in 1974, only closed .systems are permitted.
Loss of benzidine or other regulated  carcinogens to the  atmosphere is
expected to be reduced to such an extent  that analytical techniques having
a sensitivity at the parts-per-billion level  will be needed for monitoring
(Anonymous, 1974).  However, some  exposure by inhalation can occur when
equipment is being cleaned (Haley, 1975).

     Another source of exposure can occur in  the use by  the general public
of pressurized spray containers of paints, lacquers, and enamels containing
benzidine yellow, an azo dye derived  from 3,3'-dichlorobenzidine.   The
various uses of this derivative of benzidine  are noted in Section 2.2.2.2.
The amount of air contamination and dispersion of benzidine yellow afforded
by the use of aerosol products is  not known.

     Benzidine in the air has previously  been collected  with standard
Greenburg-Smith impingers (Figure  2.4) containing hydrochloric acid (Inter-
national Union of Pure and Applied Chemistry, 1962; Zavon, Hoegg,  and Bing-
ham, 1973) or water (Classman and  Meigs,  1951) and  with  high-volume vacuum
samplers equipped with fiberglass  filters (Akiyama, 1970; Zavon, Hoegg, and
Bingham, 1973).  When necessary,  the  collected sample was dissolved in
hydrochloric acid or extracted with diethyl ether in preparation for analy-
sis by spectrophotometry.  Under the  new  federal regulations, highly effi-
cient samplers will be required in many instances since  the level of
contamination will be greatly reduced relative to previously existing con-
ditions.  In this case,  countercurrent scrubbers, spray  columns, and multi-
stage impingers can be used.  Some examples of dry, cascade impingers are
shown in Figure 2.5.  Sampling devices and procedures for collecting dusts
from the air are further discussed in the Air Pollution  Manual (American
Industrial Hygiene Association, 1972) and by  Hendrickson (1967).

2.3.1.2  Benzidine in Wastewaters  — Wastewaters can be contaminated with
benzidine or its congeners not only by direct addition of these substances
through careless or accidental operating  procedures during manufacture, but
also by the discharge of benzidine-coupled dyes. These  dyes are subsequently
converted to the parent  amine by reductants such as sulfur dioxide or hydro-
gen sulfide which are present in,  or  are  later added to, the wastewater
(Takemura, Akiyama, and  Nakajima,  1965).   Samples are normally taken in
glass or polyethylene bottles.  No data are available concerning storage

-------
                                     47
                                                     ORNL-DWG 77-9689
                                                      -mm HOLE
                                         WATER OR HYDROCHLORIC ACID

     Figure 2.4.  Early version of all glass Greenburg-Smith and midget
impingers.  Source:  Adapted  from American Industrial Hygiene Association,
1972, Figure 9-22, p.  133.  Reprinted by permission of the publisher.

-------
                                   48
                                                            ORNL-DWG 77-(2899
                                                 SMALL
                                                 'PARTICLE
                                IM FACTION
                                  SLIDE
     Figure 2.5.  Types of dry, cascade  impingers.   Source:  American  Indus-
trial Hygiene Association, 1972, Figure  9-23,  p.  134.   Reprinted by per-
mission of the publisher.

-------
                                  49


 losses.  Samples of raw sewage, secondary effluents, rivers, and industrial
 waste streams usually require pretreatment prior to analysis for benzidine
 figure 2.6).  Typically, the sample  is adjusted to pH 11 by addition of
 sodium hydroxide,  filtered to remove  suspended solids, and extracted with
 diethyl ether.   For colorimetric analyses, the resulting solution is extrac-
 ted with hydrochloric acid, followed  by neutralization with sodium hydroxide.
 it the sample is to be analyzed chromatographically, a second ether extrac-
 tion and a concentration step are performed.  Jenkins and Baird (1975)
 reported photodecomposition of benzidine during concentration of the final
 ether phase but observed that this can be prevented by the addition of
 methanol.
                                             ORNL-OWG  77-H647
                     SAMPLE  PRETREATMENT
            RAW  SEWAGES, SECONDARY
            EFFLUENTS. RIVERS	
            ADJUSTMENT OF pH?ll
            WITH 10/y NoOH/FILTRATlON
            EXTRACTION OF  FILTRATE
            WITH DIETHYL ETHER
                               DISCARD  AQUEOUS PHASE
            EXTRACTION OF ETHER
            PHASE  WITH  2 /VHCI
            NEUTRALIZATION  OF  ACID
            PHASE WITH  10/VNaOH	
DISCARD  ETHER  PHASE

             COLORIMETRIC
             ANALYSIS
            EXTRACTION OF AQUEOUS
            PHASE WITH DIETHYL  ETHER
            CONCENTRATION OF ETHER
            PHASE
DISCARD  AQUEOUS PHASE
             GLC AND/OR TLC
             ANALYSIS
     Figure 2.6.  Procedure for pretreatment of sample prior  to analysis by
gas-liquid chromatography  (GLC), thin-layer chromatography (TLC), or colorim-
etry.  Source:  Jenkins and Baird, 1975,  Figure 2, p. 441. Reprinted by
permission of the publisher.

-------
                                   50
2.3.1.3  Benzidine in Biological Media — Since benzidine is primarily a
bladder carcinogen, urine is by far the most common biological medium in
which benzidine is sought; however, tissue and fecal samples are also occa-
sionally analyzed.  Urine samples should be freshly voided.  If immediate
analysis is not feasible, the samples should be refrigerated or frozen to
avoid loss of benzidine, which occurs after only a few hours at room tem-
perature (Sciarini and Mahew, 1955).   Typically, urine samples are alka-
lized with sodium hydroxide to pH 8.5 to 11, filtered or centrifuged, and
extracted one or more times with diethyl ether or an ethyl acetate-acetone
mixture.  When concentration of the sample is necessary, the organic phase
is evaporated.  The resulting organic extract can be used directly in deter-
mining benzidine by chromatographic techniques or it can be treated with an
aqueous mineral acid solution for colorimetric analysis (Classman and Meigs,
1951; Sciarini and Mahew, 1955).  Tissues are usually homogenized and ex-
tracted with acetone.  After evaporation of the solvent, the residues are
washed with hot glacial acetic acid and the resulting solution is cooled
and filtered.  This liquid is then analyzed for benzidine by the preferred
colorimetric or chromatographic technique.  Typically, fecal, samples are
homogenized and extracted with water.  After centrifugation, the aqueous
phase is extracted with ether; the latter is washed with aqueous sodium
hydroxide, concentrated, and back-extracted with hydrochloric acid.  The
resulting aqueous solution is then analyzed for benzidine by the preferred
method  (Sciarini and Meigs, 1961a).

2.3.2  Methods of Analysis

     Benzidine, its congeners, and their metabolites can be determined in
environmental and biological media by a variety of procedures.  Those which
are currently important or which show promise of future usefulness are
described in this section.  The performance and limitations of each method
are emphasized rather than minute operational details.  The methods are
summarized in Table 2.9.  Sensitivity, precision, and accuracy vary not
only among different methods, but also among various models of analytical
instruments and among different operators  (Karasek, 1975); the tabulated
data should therefore be considered representative rather  than definitive.
Performance data obtained from laboratories concerned with developing a new
method usually reflect optimized conditions.  Interlaboratory comparisons,
when they exist, offer more realistic evaluations of the various methods.

2.3.2.1  Gas-Liquid Chromatography — Gas-liquid chromatography is an analyt-
ical process in which components of the sample are physically partitioned
between  two phases — a stationary bed of large surface area and a gas which
percolates through and along the stationary bed.  Typically, the stationary
bed is  a finely divided column packing which is covered with a suitable
liquid  sorbent.  An inert gas, such as helium, argon, or nitrogen, is
usually  used as the carrier for the volatile phase.  When  the sample is
introduced into the chromatographic column, the unadsorbed carrier gas moves
the various constituents of the sample through the column  at a rate deter-
mined by the interaction of each constituent with the liquid sorbent.
Since each constituent of the sample has a slightly different affinity for
the sorbent, each  fraction of the sample usually emerges from a well-
designed column completely resolved from other components  after the passage

-------
                                                   TABLE 2.9.  METHODS FOR DETERMINING BENZIDINE

Analytical
method

Gas-liquid
chromatography






Thin-layer
chromatography

Important
applications

Air, water, urine,
blood






Simple, inexpen-
sive method of
Precision
T . • ^ n / -i • Accuracy
Limit of (relative , .
detection standard
j . . s error)
deviation)
2-3 yg/liter
(waste-
water)12





0.4-0.5 yg
(5-yl spot)a

Interfering .
. Selectivity
substances

Substituted benzidine
compounds which in-
terfere in other
methods can usually
be separated and
quantized if pro-
grammed- temperature
operation is used.
Selective for benzi-
dine

Comments

Method of choice
for determining
benzidine and
its congeners




Often used to
identify the
Spectrophotometry
  (chloramine-T
  method)
Spectrophotometry
  (diazo dye
  method)
  separating com-
  plex mixtures
  of benzidine,
  its metabolites,
  and congeners;
  basically a
  qualitative
  procedure

Air, water, urine,
  blood
Air, water, bio-
  logical samples
0.2 yg/liter
  (1-liter
  sample of
  wastewater)
5 ppb (waste-
  water^
100 ppb
  (natural
  waters)0
5.1% (1.8
  yg/liter of
  river water)'
31% (1.8
  yg/liter
  of river
  water)b
Organic bases
0.5%-6%
  (20-100 yg
  amine)
5%-30%
  (unchlorinated
  wastewater)
Hypochlorous
  acid (from
  chlorinated
  wastewaters)
Compounds similar to
  benzidine (e.g.,
  dichlorobenzidine,
  o—tolidine,  and
  dianisidine) inter-
  fere with quantifi-
  cation.

Selective for  aromatic
  amines in general
  but does not dis-
  tinguish benzidine
  from its derivatives
  or many other aro-
  matic amines
                                                                                                                                  metabolites of
                                                                                                                                  benzidine and
                                                                                                                                  its congeners
                                                                                                                                  but only infre-
                                                                                                                                  quently to
                                                                                                                                  quantify such
                                                                                                                                  results
Sample color fades;
  must be measured
  rapidly and repro-
  ducibly for con-
  sistent results;
  nevertheless,
  popular procedure

Frequently used
                                                                                                                                       (continued)

-------
TABLE 2.9  (continued)

Analytical Important Limit of
method applications detection

Spectrophoto- Trace analysis of 2 ng/ml (as
fluorometry benzidine, 3,3'- amine)<^
dimethoxybenzi- 10 ng/ml (as
dine and their salt)^
dihydrochloride
salts in micro-
biological
growth media,
potable water
and waste-
waters , human
urine, and rat
blood













^Jenkins and Baird, 1975.
Longbottom, 1974.
°El-Dib, 1971.
"T> 	 IT- -: — „ ,-. ~ J u ^ "1 ^ ^ -^ 1 Q "7 f.
Precision
(relative
standard
deviation)
0.0%-5.0%
(0.10 ppm) ,
biomedia"
0.0%-1.2%
(1.0 ppm),
biomedia"
0.0%-5.. 0%
(20 ppb),
wastewater"
l%-25%
(10 ppm),
rat blood"
5%-18% (20
ppb ) human
urine"















Accuracy interfering
(relative substances
error)
32% (0.10 ppm), None reported
biomedia"
20% (1.0 ppm),
I 1
biomedia"
25% (20 ppb),
(wastewater)"
86% (10 ppm) ,
rat blood
without
hydrolysis"
81% (10 ppm) ,
rat blood with
alkaline
hydrolysis"
37% (10 ppm),
rat blood
with acid
hydrolysis"
10% (20 ppb),
human urine
without
hydrolysis"
32% (20 ppb),
human urine
with alkaline
hydrolysis"




Selectivity Comments

Good for benzidine, Although not ade-
3, 3 '-dimethyl- quately tested
benzidine, 3,3'- under field con-
dimethoxybenzidine, ditions, appears^
and their salts when attractive for
present singly analysis of trace
levels of these
compounds in
wastewater, pota-
ble waters,
urine, blood,
and selected bio-
logical media
















                                                                                            Ul
                                                                                            to

-------
                                    53
 of  a characteristic volume of carrier gas.  Under standardized operating
 conditions, each component can be identified by its characteristic elution
 time.   The composition of the original sample is determined by identifying
 and measuring each component.  Various kinds of detectors are available for
 quantifying the fractions; electron capture, flame ionization, and thermal
 conductivity types are commonly used.  A schematic diagram of a typical sys-
 tem is shown in Figure 2.7.

      Unlike colorimetric methods, gas-liquid chromatography readily distin-
 guishes individual components of aromatic amine mixtures, including closely
 related derivatives.  For example, Jenkins and Baird (1975) used gas-liquid
 chromatography to analyze samples of wastewater containing benzidine, 3,3'-
 dimethoxybenzidine, diphenylamine, and 1-napthylamine in the parts-per-
 billion concentration range.  Their analytical system consisted of a Perkin-
 Elmer Model 900 gas chromatograph equipped with dual 6 ft x 1/8 in. inside
 diameter glass columns packed with a mixture of OV-17  (4.7%), QF-1  (5%),
 and DC-200(0.5%) on 80/100 mesh Gas-chrom Q.  Dual flame ionization detec-
 tors were  operated in the reference/sample mode and nitrogen was used as
 the carrier gas.  Ten microliters of prepared sample (Section 2.3.1.2) were
 analyzed either isothermally at 200°C or programmed from 150°C to  250°C.
 Detection  limits for benzidine were  0.1 mg/liter with  the  former method and
 0.5 mg/liter with the latter mode of operation.  Although  programmed ther-
 mal operation  gave decreased sensitivity  for benzidine when compared with
 isothermal analysis, resolution was  improved and complete  separation of
 benzidine, 3,3'-dimethoxybenzidine,  diphenylamine, and 1-napthylamine was
 obtained  (Figure 2.8).
                                                  ORNL-DWG 77-9690
                                        VENT
            INJECTION
              PORT
          GAS
          FLOW
               ' 11 ITU ITT
               HEATER
COLUMN
OVEN
/


Pi





<
\





^
1 	
^-









MANI-
FOLD












DETECTOR












0
o
o
o
0
0




AMPLIFIER


^
0
o
o
o
0
0
COLUMN RECORDER
     Figure 2.7.  Schematic diagram of a gas chromatograph.
from Environmental Instrumentation Group, 1973.
Source:   Adapted

-------
                                    54
                                                ORNL-DWG 77-9691
             Q
             M
             UJ
             03
             X
             o
             I
                                                    LJ
            55
50
45
40
10
0
                                TIME (min)
     Figure 2.8.  Resolution of four aromatic amines by the column mixture
OV-17 (4.7%), QF-1 (5.0%), and DC-200 (0.5%)  on 80- to 100-mesh Gas-chrom Q,
using PTGC (150-250°C at 3°/min, holding 12 min at 150°C) .   Source:  Adapted
from Jenkins and Baird, 1975, Figure 1,  p.  440.  Reprinted by permission of
the publisher.
       Published  data  concerning  the chromatographic determination  of  benzi-
  dine  and  its  congeners  are  thus  far very  limited.  Standardized procedures
  have  not  been established and statistics  by which the  precision and  accu-
  racy  of the method can  be evaluated are unavailable.   Nevertheless,  the
  superior  sensitivity and selectivity  of the gas  chromatographic method make
  it very attractive;  it  seems likely to become  the method  of  choice for
  determining mixtures of benzidine and its congeners  in the parts-per-billion
  concentration range.  The method is suitable for all types of samples if
  prescribed preliminary  preparations are performed.   The principles and ana-
  lytical applications of gas chromatography are discussed  extensively by
  Pauschmann and  Bayer (1974, pp.  143-165)  and by  Krugers (1968).

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                                    55


2.3.2.2  Thin-Layer Chromatography — Thin-layer chromatography (TLC) is a
separation technique in which the solution to be analyzed is deposited on
a sorbent surface along which it is caused to migrate by a mobile liquid
phase.  As the sample moves, the various components of the sample interact
with the sorbent surface in a characteristic manner and usually fractionate
into distinct spots or zones which can be identified by comparison with
standard chromatograms.  For analysis of benzidine, a typical sorbent sur-
face is Silica Gel G (0.25-mm thickness) or a sheet of prepared paper such
as Whatman No. 1.  After the sample is deposited, the chromatogram is devel-
oped by enclosing the sorbent layer in a cylindrical or sandwich-type chro-
matographic tank and allowing a prepared solvent to diffuse through the
sorbent surface by capillary action.  Usually, the direction of diffusion
is upward.  The solvent is a liquid or, more frequently, a mixture of
liquids chosen on the basis of a trial performance.  For a given sample,
the more polar the solvent, the greater will be the distance of migration.
After components of the sample have migrated sufficiently, usually about
10 cm above the spot origin, development is stopped and the spots are made
visible by irridation with ultraviolet light or by spraying with a suitable
reagent.  For a given system, identification of particular compounds is
given by characteristic retardation factor (R-p) values, the ratio of the
distances traveled by the component and the solvent.  Frequently, more
positive identification is obtained by spraying the separated components
with reagents which give characteristic identifying colors.

     In a recent application of TLC to the determination of benzidine in
wastewaters, Jenkins and Baird (1975) used 0.25-mm-thick Silica Gel G for
the adsorbent, benzene-methanol (95/5) for the solvent, and ultraviolet
light or 0.01% ethanolic fluorescein dye for visualization.  They observed
the following Rf values: diphenylamine, 85; 1-napthylamine, 70; 3,3'-dimeth-
ylbenzidine, 51; and benzidine, 37.  Detection limits were 0.4 to 0.5 yg
when an initial 5-yl spot was used.  A similar TLC system also was described
by Jakovljevic, Zynger, and Bishara (1975) for the determination of trace
amounts of 4-aminodiphenyl present in 2-aminodiphenyl.  The free amines
were isolated by TLC, extracted from the plates, and determined fluorometri-
cally.  More recently, Holder, King, and Bowman (1976) utilized Silica Gel
GF (0.25-mm-thick) to obtain TLC Rf values in ten different solvent systems.
Diphenyl was used as the reference compound.  The TLC system used by these
authors is thus sufficiently selective to isolate benzidine from the other
components of the sample, but the overall sensitivity of the method is poor.

     Laham, Farant, and Potvin (1970) studied a variety of TLC systems to
isolate benzidine, 4,4'-dinitrobiphenyl, and the most important biotrans-
formation products of these compounds from human and animal urine.  They
used Whatman No. 1 paper sheets, ten different solvents (Table 2.10), and
five different detection reagents (Table 2.11) in their work.  The char-
acteristic identifying colors of benzidine, 4,4'-dinitrobiphenyl, and their
metabolites are shown in Table 2.12; the Rf values for each compound and
each solvent are given in Table 2.13.  The results show that the chromato-
graphic behavior of the various compounds is related to their structure and
that the migration trends of the various compounds in the selected solvents
can be used to identify the biotransformation products of benzidine and
4,4'-dinitrobiphenyl.

-------
                                       56
        TABLE  2.10.   SOLVENTS USED FOR CHROMATOGRAPHIC SEPARATION OF
                  4,4'-DINITROBIPHENYL, BENZIDINE,  AND THEIR
                         RESPECTIVE METABOLIC PRODUCTS
                       Solvent  system
                                  Volume to
                                volume  ratio
        n-Butanol,  water
        n-Butanol,  acetic acid,  water
        n-Butanol,  ethanol, N NHAOH
        see-Butanol, 3% NHAOH  (in water)
        Toluene,  methanol, water
        Cyclohexane, tert-butanol, pyridine, water
        Ligroine, toluene, methanol, N NH<,OH
        Ligroine, benzene, methanol, N NH<,OH
        Ligroine, methanol, water
        Ligroine, methanol, water
                                1:1
                                4:1:5
                                2:1:1
                                3:1
                                4:3:1
                                16:2:2:1
                                33:17:30:20
                                33:17:40:20
                                9:2:1
                                20:17:3
              Source:  Adapted  from Laham, Farant,  and Potvin,  1970,
        Table 1,  p.  17.  Reprinted by permission of the publisher.
       TABLE 2.11.  COMPOSITION OF SPRAYING REAGENTS USED FOR CHROMATOGRAPHIC
                SEPARATION OF 4,4'-DINITROBIPHENYL, BENZIDINE, AND
                        THEIR RESPECTIVE METABOLIC PRODUCTS
No.
             Name
                                    Reagent composition
                                          Group(s)
                                          detected
       Ehrlich
       Gibbs
       3-Resorcylaldehyde
       Folin ciocalteu
       FeCl3
p-Dimethylaminobenzaldehyde, 2 w/v %
  in 95% EtOH - 8 vol
  HC1,  6 N - 2 vol

First spray:  sodium carbonate, 0.125 M
Second  spray:  N-2,6-trichloro-p-quinone
  imine in 100 w/v % EtOH — 0.4%

6-Resorcylaldehyde — 1  g
Glacial acetic acid — 1 ml
Ethanol (100%) - 100 ml

First spray:  Folin ciocalteu
Second  spray:  sodium carbonate, 20 w/v %

Potassium ferricyanide, w/v %
Ferric  chloride, 1 w/v  %
                                                                   NH2, NHCOCHa
                                                                   OH
                                                                   NHS03H, OS03H
                                                                   OH
                                                                    OH
     Source:  Adapted  from Laham,  Farant, and Potvin,  1970, Table 2,  p.  18.
Reprinted by permission of the publisher.

-------
                        TABLE 2.12.  CHROMATOGRAPHIC BEHAVIOR OF 4,4'-DINITROBIPHENYL,  BENZIDINE,  AND THEIR METABOLITES
Identifying
Chemical
4,4' -Dinitrobiphenyl
4-Amino-4 '-nitrobiphenyl
4-Acetamido-4 '-nitrobiphenyl
4-Amino-4 ' -nitro-3-hydroxybiphenyl
4-Amino-4 '-nitro-3-biphenylyl potassium sulfate
4-Acetamido-4 '-nitro-3-biphenylyl potassium sulfate
4 ,4 '-Diaminobiphenyl
4-Acetamido-4 •' -aminobiphenyl
4,4 '-Diacetamidobiphenyl
4,4'-Diamino-3-biphenylyl sodium sulfate
Untreated
paper
DLfc
NC
Y
FtY
Y
Y
FtY
NC
NC
NC
NC
UV°
DB1
FY
FtPi
Br
Br
Pi
FBI
NC
NC
FBI
colors





With spray reagents
Ehrlich
DL
NC
Or
FtOr
Or
Or
FtOr
R-Or
Or
NC
Pi
UV
NC
G-Br
Br-Pi
Br
FtBr
Br
FOr
FY
NC
FtBr
Gibbs
DL
NC
Y
NC
G
NC
NC
NC
NC
NC
NC
UV
DB1
Br-Pi
NC
DB1
Br
Br
DB1
FBI
NC
DB1
g-Resorcylal-
dehyde
DL
NC
Y
NC
Y
FtY
NC
Y
FtY
NC
Y
UV
NC
DG
Pi
Br
G
Pi
FGr
FGr
NC
FGr
Folin
ciocalteu
DL
NC
Y
NC
01
Y
NC
Gr
Gr
NC
Gr
UV
NC
Br
FY
FGr
FtBr
FY
DB1
FGr
NC
DB1
FeCl3
DL
NC
G
NC
Gr
G
NC
G
Bl
NC
Bl
UV
DB1
Br
FY
Br
Br
Br
FBI
FBI
NC
FBI
      Bl — blue; Br — brown; G — green; Gr — grey; Or — orange; Pi — pink; R — red;  Y — yellow;  01 — olive;  Tu — turquoise;  F — fluorescent;
NC — no colour; D — dark; Ft — faint.
     ^Examined in daylight.
     ^Examined under ultraviolet light  (2540 nm).
      Llarkened after exposure to ultraviolet light.
     Source:  Adapted from Laham, Farant, and Potvin, 1970, Table 4, p. 20.  Reprinted by permission of  the  publisher.

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                      TABLE 2.13.  RETARDATION FACTOR VALUES OF 4,4'-DINITROBIPHENYL,  BENZIDINE,
                                         AND THEIR MOST IMPORTANT METABOLITES

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Rf x 100 in solvent
123456789 10
4,4 '-Dinitroblphenyl o2N-/Q\ — /O/-N°2 91 90 8S 85
4-Amino-4 '-nitrobiphenyl 02N— /Q/ 	 (O/~NH2 91 S9 88 86
4-Acetamido-4' -nitrobiphenyl o2N— (O/ — /O/-NHCOCH3 90 90 86 86
	 /OH
4-Amino-4'-nitro-3-hydroxybiphenyl 02N-(O/ 	 (O)-NH2 S6 86 78 79
\ 	 / \ 	 /
,OS03K
/ \ / \
4-Amino-4 '-nitro-3-biphenylyl °ZN— \O ) — ( O)~NH2
potassium sulfate — — 60 62 77 70
4-Acetamido-4 '-nitro-3-biphenylyl o2N— \Q} — \O/ NHC°CH3
potassium sulfate \ — ' ^ — ' 72 77 77 80
4,4'-Diaminobiphenyl HjN-/O/ — (O/-NH2 84 70 79 78
4-Acetamido-4 '-aminobiphenyl H2N— ^O/ — \ O/~NHCOCH3 89 83 83 82
4-4'-Diacetamidobiphenyl HJCOCHN— (O^> — ^OVNHCOCH3 83 85 83 84
88 80 88 89 57 48
88 58 59 57 9 9
63 39 24 15 3 0
37 34 7 4 0 0
000000
000000
43 10 2 35 4 0
16 6 2 2 1 0
22 5 0 4 0 0
4,4 '-Diamino-3-biphenylyl ri2™— \O/ — \O/~NH2
sodium sulfate N — ' N — ' 38 40 59 40 0 0 0 0 0 0
Ln
00
Source:  Adapted from Laham, Farant, and Potvin, 1970, Table 3, p. 19.  Reprinted by permission of the publisher.

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                                    59


     From these examples, it is apparent that TLC is a convenient separa-
tion procedure which is readily adapted to the qualitative analysis of
benzidine and its metabolites in environmental and biological samples.
Semiquantitative estimates of sample components can also be made from thin-
layer chromatograms by comparing sample spots with those on previously pre-
pared standard chromatograms.  Although convenient, this technique is not
as sensitive or dependable as other methods.  Better data can usually be
obtained by removing identified spots from thin-layer chromatograms for
quantitative determination by an appropriate conventional analytical tech-
nique.  An extensive discussion of recent chromatographic developments is
available in Ckpomatography  (1974).

2.3.2.3  Spectrophotometry:  Chloramine-T Method — The chloramine-T variant
of the spectrophotometric method for determining benzidine depends on the
formation of a yellow oxidation product when an acid solution of benzidine
is treated with toluene-p-sulphonchloroamide (chloramine-T).  The quantity
of benzidine in the sample is determined by extracting the yellow oxidation
product with an organic solvent and measuring the amount of light it absorbs
under standardized conditions  (Butt and Strafford, 1956; Classman and Meigs,
1951).  The color reaction is not  specific for benzidine; all p,p'-diamino-
diphenyl derivatives form the yellow oxidation product to some degree.
Furthermore, the yellow oxidation  product is not permanent; it is photo-
sensitive and gradually fades to a colorless state, possibly a quinone
complex, over a 2-hr interval.  The light absorption of the sample must
therefore be measured immediately  after the color is developed.

      In spite of these inadequacies, the chloramine-T method is convenient,
and  it is frequently used to determine benzidine and its derivatives.  In
the  most recent and sensitive version of the method (Longbottom, 1974),
aqueous samples are adjusted to pH 8.5 to 9.0 with sodium hydroxide or
hydrochloric acid and extracted with ethyl acetate.  The latter is back-
extracted with hydrochloric  acid and the resulting aqueous solution is
refrigerated in the dark until the remaining steps of the procedure can be
performed rapidly on one sample at a time.  Chloramine-T is then added to
the  aqueous solution, with shaking, to develop the yellow oxidation product.
The  product is extracted with ethyl acetate, filtered, and scanned with a
double-beam spectrophotometer over the spectral range of 510 to 370 nm.
Benzidine is identified by its absorbance maximum at 436 nm (Figure 2.9).
The  spectrum of dichlorobenzidine  is similar, but it has an absorbance
maximum at 445 nm.  The detection  limit of the method is 0.2 yg/liter if
1-liter samples are used.  The average relative standard deviation (n = 8)
is 5.1% for analyses of 1-liter samples of river water containing 1.8 yg
benzidine.  The relative error under these conditions is large — 31.1%.
Organic bases interfere with the analysis, as do compounds having a struc-
ture very similar to benzidine, such as dichlorobenzidine, 3,3'-dimethyl-
benzidine, and 3,3'-dimethoxybenzidine.  This method can also be applied to
benzidine or its derivatives in samples of air, urine, feces, and blood if
suitable sample preparation  steps  are taken.

2.3.2.4  Spectrophotometry:  Diazo Dye Method — This analytical method is
based on the conversion of benzidine to its diazo salt and subsequent
coupling to an aromatic phenol to  produce a diazo dye which absorbs light

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                                     60
                                                     ORNL-DWG 77-9692

                                                          —I 50
                                                             100
           500     480     460     440     420
                              WAVELENGTH (nm)
                                                400
                                                       380
     Figure 2.9.   Spectrum of  benzidine  oxidation product.
from Longbottom,  1974,  Figure  1.
Source:  Adapted
  in  the  visible portion of the electromagnetic spectrum.  The amount of ab-
  sorbed  light  is related to the benzidine concentration in the sample by
  comparison with a previously determined calibration plot.

       In a typical spectrophotometric analysis of benzidine in wastewater
  (Jenkins and  Baird, 1975), the sample is adjusted to pH 11 by addition of
  10 M  sodium hydroxide solution, filtered to remove suspended solids,
  diazotized with sodium nitrite and hydrochloric acid, treated with sulfamic
  acid  to destroy excess nitrite, and coupled with resorcinol.  Absorption
  of the  resulting diazo dye is determined at 550 nm with a double-beam
  spectrophotometer.  When 10-cm absorption cells are used, the detection
  limit for benzidine is about 5 ppb.  For unchlorinated wastewaters, the
  relative error of spiked samples varies from 5% to 30%.  Recovery of benzi-
  dine from chlorinated wastewater is poor, however, apparently because hypo-
  chlorous acid reacts with benzidine to yield a chloramine-type compound
 which does not give a positive benzidine test.  Although this procedure
 readily distinguishes between aromatic and alkyl amines, it is not selective
 for benzidine in the presence of other aromatic amines; accordingly, the
 method is unsuitable for samples containing mixed aromatic amines.  Despite
 these shortcomings,  the diazo dye technique is a useful analytical method
 for determining benzidine in the absence of other aromatic amines and is
 frequently used for  all types of samples when this condition is satisfied.

 2.3.2.5   Spectrophotofluorometry — Spectrophotofluorometry is based on the
 measurement  of fluorescence  radiation emitted by a sample previously ex-
 cited  by ultraviolet or visible light.   The emitted radiation results  from

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                                    61


the transition of the excited molecule from the first excited singlet state
to the ground state; the frequency of the emitted light is therefore char-
acteristic of the analyte.  The intensity of the emission is proportional
to the concentration of the analyte as well as the intensity of the excit-
ing radiation.  Because of the latter relationship, spectrophotofluorometry
is inherently very sensitive; under favorable conditions, it can be four
orders of magnitude more sensitive than molecular absorption spectrophotom-
etry  (Mancy, 1971, p. 70).  In a typical application of spectrophotoflu-
orometry to the determination of benzidine in environmental or biological
media, samples are prepared as described in Section 2.3.1.2 or 2.3.1.3
except that methanol, rather than ether, is used as the final solvent.   The
prepared sample is then irradiated with monochromatic light from mercury or
xenon lamps and a selected wavelength of the resulting fluoresence is meas-
ured with a photodetector tube.  The intensity of the measured fluoresence
is then related to the amount of benzidine in the original sample by means
of a predetermined calibration curve.  Bowman, King, and Holder (1976)
determined benzidine, 3,3'-dimethylbenzidine, 3,3'-dimethoxybenzidine,  and
their dihydrochloride salts in a variety of matrices with a spectrophoto-
fluorometer equipped with a xenon lamp, a 1P28 photodetector, and 1-cm
square cells.  The frequencies of the incident (XEx) and emitted (XEm)
radiations varied for each compound and are shown in Table 2.14.   The
relative intensities of the fluorescence of each compound are also listed.
The detection limits of the amines and their salts were 2 ng/ml and 10 ng/ml
respectively.  Good precision was obtained in a variety of sample types;
relative standard deviations of 0.0% to 5.0% were reported for trypticase
soy dextrose and brain heart infusion medium containing 0.1 ppm and 1.0 ppm
benzidine (Table 2.15) and wastewater containing 20 ppb benzidine (Table
2.16).  Somewhat poorer results (1% to 25%) were obtained with human urine
(20 ppb) and rat blood (10 ppm).  The relative errors in the above analyses
varied from 10% to 35%, except for the samples of rat blood, which averaged
about 85%.  This level of accuracy is generally adequate for all samples
mentioned other than rat blood.
      TABLE  2.14.  WAVELENGTHS USED AND RELATIVE INTENSITIES OBSERVED
             DURING ANALYSIS OF BENZIDINE AND ITS CONGENERS
Compound
Benzidine
Benzidine- 2HC1
3,3' -Dimethylbenzidine
3,3' -Dimethylbenzidine • 2HC1
3,3' -Dimethoxybenzidine
3,3' -Dimethoxybenzidine* 2HC1
XEx
(nm)
295
302
300
310
312
318
X_ Relative intensity
Em , J
(nm) Per yg Per ml
396
410
384
410
380
422
33.5
7.45
51.8
12.2
64.3
8.25
        Source:  Adapted from Bowman, King, and Holder, 1976, p. 211.
   Reprinted by permission of the publisher.

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                                           62
      TABLE 2.15.   ANALYSIS  OF  TWO  BIOLOGICAL  GROWTH MEDIA SPIKED WITH BENZIDINE,
                 TWO  CONGENERS, AND THEIR  SALTS AT 0, 0.10, and 1.0 ppm

Compound
Benzidine








Benzidine-2HCl





3





3










, 3 ' -Dime thy Ibenzidine





, 3'-Dimethylbenzidine«2HCl





3, 3 '-Dimethoxybenzidine





3,










3 ' -Dimethoxybenzidine • 2HC1





„ , . a
Medium
BHI

TSD


BHI


TSD


BHI


TSD


BHI


TSD


BHI


TSD


BHI


TSD


Amount
added*
(ppm)
0
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
0.00
0.10
1.00
(yg)
0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
0.0
1.0
10.0
Amount
(x
recovered
± SE)e
(ppm) (%)
0.040
0.070
0.780
0.019
0.075
0.787
0.040
0.073
0.795
0.019
0.073
0.778
0.037
0.074
0.839
0.029
0.073
0.902
0.045
0.070
0.777
0.036
0.064
0.710
0.031
0.078
0.923
0.019
0.055
0.829
0.030
0.057
0.715
0.027
0.052
0.770
± 0.000
± 0.000
± 0.004
± 0.000
± 0.000
± 0.012
± 0.000
± 0.002
± 0.000
± 0.002
± 0.001
± 0.004
+ 0.001
+ 0.005
± 0.010
+ 0.004
± 0.002
+ 0.009
+ 0.004
± 0.002
+ 0.006
± 0.003
± 0.001
± 0.003
+ 0.003
± 0.001
+ 0.007
± 0.001
± 0.000
± 0.008
+ 0.003
± 0.005
± 0.002
± 0.003
± 0.001
± 0.006
70.0
78.0

75.0
78.7

73.0
79.5

73.0
77.8

74.0
83.9

73.0
90.2

70.0
77.7

64.0
71.0

78.0
92.3

55.0
82.9

57.0
71.5

52.0
77.0
± 0.0
± 0.4

± 0.0
± 1.2

± 2.0
± 0.0

± 1.0
± 0.4

± 5.0
± 1.0

± 2.0
±0.9

± 2.0
± 0.6

± 1.0
± 0.3

± 1.0
± 0.7

± 0.0
± 0.8

± 5.0
± 0.2

± 1.0
± 0.6
     ,BHI — brain heart infusion; TSD — trypticase soy dextrose.
      Per 10 ml of sample.
      Mean and standard error from triplicate assays; spiked samples are corrected for
controls.  Controls and 0.10-ppm samples contained 1-g equivalent of medium per milli-
liter for spectrophotofluorometric reading; the 1.0-ppm samples contained 0.2-g
equivalents per milliliter.
     Source:  Adapted from Bowman, King, and Holder, 1976, Table I,
by permission of the publisher.
216.   Reprinted

-------
                                   63
      TABLE 2.16.  ANALYSIS OF WASTEWATER SPIKED WITH BENZIDINE,
            TWO CONGENERS, AND THEIR SALTS AT 0 AND 20 ppb
                                                        Amount
                                       Amount                   ,
                                            a          recovered
              Compound                 added           (Zc ±
                                     (ppb)     (yg)    (ppb)
Benzidine

Benzidine* 2HC1

3,3' -Dimethylbenzidine

3,3' -Dimethylbenzidine»2HCl

3,3' -Dimethoxybenzidine

3,3' -Dimethoxybenzidine* 2HC1

0
20
0
20
0
20
0
20
0
20
0
20
0.0
2.0
0.0
2.0
0.0
2.0
0.0
2.0
0.0
2.0
0.0
2.0
4 + 1
17 ± 0
4 ± 1
15 ± 1
4 ± 1
15 ± 0
3 ± 1
13 ± 1
3 ± 0
16 ± 0
3 + 0
14 + 1

85

75

75

65

80

70
          ,Per  100 ml of sample.
          Mean and  standard error from triplicate assays; spiked
     samples are  corrected for controls.  Samples contained 10-g
     equivalents  of  water per milliliter for spectrophotofluoro-
     metric reading.
          Source:  Bowman, King, and Holder, 1976, Table II, p. 217,
     Reprinted  by permission of the publisher.
     In continued research in the same laboratory (Holder, King, and Bowman,
1976), 4-aminobiphenyl was determined utilizing the same substrates and
techniques.  Recovery rates ranged from 81% to 95% in biological growth
media and wastewater, from 45% to 95% in human urine, and from 6% to 76% in
mouse whole blood.  Best recovery from urine occurred without prior hydroly-
sis, and acid hydrolysis led to an unsuitable purple discoloration.  However,
best recovery from blood occurred after acid hydrolysis  (67% to 72%).

     Although the spectrophotofluorometric method is very specific for indi-
vidual benzidine compounds because of the particular wavelengths involved,
an effort by Bowman, King, and Holder (1976) to determine three amines or
their three salts in admixture by measuring the relative intensities at
each excitation and emission maxima was unsuccessful because of large dif-
ferences in the specific responses and extensive overlap of the spectra.
Further experience is needed to define the useful limits of this application,
but the method appears attractive for the determination  of trace levels of
benzidine and its congeners in a variety of environmental samples.

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                                   64


2.3.3  Comparison of Analytical Procedures

     Although benzidine has been known since 1845 and has been used exten-
sively in analytical chemistry to determine other substances, relatively
little attention has been given to analytical procedures by which the rea-
gent itself can be determined, particularly at the low concentrations
which are of current interest.  Indeed, the International Union Against
Cancer concluded that "present analytical methods are satisfactory for the
assessment of gross aromatic amine contamination of the human environment"
but that "new techniques will have to be designed for the measurement of
lower degrees of contamination" (Shubik, Clayson, and Terracini, 1970,
p. 16).  More recently, the U.S. Environmental Protection Agency stated,
"Adequately tested methods for benzidine are not available," and recommended
the chloramine-T method described in Section 2.3.2.3 as an interim method
 (Federal Eegi-ster, 1975).  Thus, there are no officially sanctioned analyt-
ical procedures for determining low levels of benzidine in environmental
and biological samples.

     The most likely candidate for official sanction appears to be gas
 (or gas-liquid) chromatography.  Although only a limited number of gas
chromatographic analyses of benzidine have been performed, the technique
has already demonstrated a high degree of sensitivity, selectivity, versatil-
 ity, and speed, and better performance can be expected with further use.
Gas chromatography is the only analytical technique available which readily
determines benzidine in the presence of its congeners.  The chief dis-
advantages of the gas chromatographic method are its relatively high capital
 investment and maintenance costs and the somewhat higher level of sophis-
 tication required in the operating and maintenance personnel compared with
other methods of analysis.

     The determination of benzidine by spectrophotofluorometry has been even
more limited than the use of gas chromatography.  Nevertheless, spectro-
photofluorometry is potentially important as an analytical method for benzi-
dine and its congeners.  These compounds emit distinctive fluorescent
spectra by which each can be identified and quantified.  The method is char-
acterized by inherent sensitivity, simplicity, and speed.  However, quanti-
tative determinations of mixed benzidine congeners are not yet feasible
because of spectral overlap and large differences in relative intensities
 (Bowman, King, and Holder, 1976).  The importance of this deficiency depends
on the composition and type of sample to be analyzed — in many instances it
is not significant.  In any event, marked improvement in the sensitivity and
selectivity of this technique may be expected with continued use.

     The diazo and chloramine-T spectrophotometric methods of analyzing
benzidine and its derivatives are the oldest, most widely used methods
described.   Each method has benefited from a series of improvements over
the years;  recent versions of each method have sensitivities in the parts-
per-billion range, good precision, and moderate accuracy.  However, neither
method distinguishes between benzidine and its congeners; the diazo tech-
nique is responsive to aromatic amines in general and the chloramine-T
method responds generally to p,p'-diaminodiphenyl derivatives.  In addition,
the chloramine-T method is photosensitive, requiring rapid reading of the
samples to  prevent inaccurate results (Butt and Strafford, 1956).  Despite

-------
                                   65


these shortcomings, both spectrophotometric procedures are useful.  For
example, a modern variation of the chloramine-T method was designated by
the U.S. Environmental Protection Agency as the interim method of determin-
ing benzidine (Federal Register, 1975).

     The thin-layer chromatographic technique is a simple, frequently used
qualitative procedure for separating and identifying benzidine, its congeners.
and their metabolites.  Although the procedure can be applied to the quanti-
tative determination of these compounds by comparing the area or fluorescence
of separated spots with that of standard chromatograms, it is relatively in-
sensitive and is not the method of choice.

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                                   66


                                SECTION  2

                                REFERENCES
 1.   Adamovic, V. M.   1966.  Aromatic Amines as  Spray  Reagents  in the
     Thin-Layer  Chromatography  of Chlorinated Organic  Pesticides.
     J.  Chromatogr.  (Netherlands) 23:274-279.

 2.   Akiyama,  T.   1970.   The Investigation  on the Manufacturing Plant
     of  Organic  Pigment.   Jikeikai Med.  J.  (Japan)  17(1):l-9.

 3.   American  Industrial  Hygiene Association.  1972.   Air  Pollution
     Manual, Part  1 — Evaluation, 2nd ed.   Westmont, N.J.   259  pp.

 4.   Ames,  B.  N., W.  E. Durston, E. Yamasaki, and F. D. Lee.   1973.
     Carcinogens Are  Mutagens:  A Simple Test System Combining  Liver
     Homogenates for  Activation and Bacteria for Detection.  Proc.
     Natl.  Acad. Sci. U.S.A. 70(8)=2281-2285.

 5.   Anonymous.   1974.  Final Rules Set  for Exposure to Carcinogens.
     Chem.  Eng.  News  52:12-13.

 6.   Arrhenius,  E.   1974.   Comparative Metabolism of Aromatic Amines.
     In:  Chemical  Carcinogenesis Essays, R. Montesano and L. Tomatis,
     eds.   International  Agency for Research on  Cancer, Lyon, France.
     pp. 25-37.

 7-   Booth, J.,  and E.  Boyland.  1964.   The Biochemistry of Aromatic
     Amines:   10.   Enzymic /If-Hydroxylation  of Arylamines and Conversion
     of  Arylhydroxylamines into o-Aminophenols.  Biochem.  J.  (Great
     Britain)  91:362-369.

 8.   Bowman, M.  C.,  J.  R.  King, and C. L. Holder.   1976.   Benzidine and
     Congeners:  Analytical Chemical Properties  and Trace  Analyses  in
     Five  Substrates.  Int. J.  Environ.  Anal. Chem.  (Great Britain)
     4(3)=205-223.

 9.   Boyland,  E., C.  E. Dukes,  and P. L. Grover.  1963.  Carcinogenicity
     of  2-Napthylhydroxylamine  and 2-Naphthylamine.  Br. J. Cancer
     (Great Britain)  17:79-84.

10.   Bradshaw, L.,  and  D.  B. Clayson.  1955.  Metabolism of Two Aromatic
     Amines in the  Dog.   Nature (Great Britain)  176(4490):974-975.

11.   Bryan, G. T.,  R. R.  Brown, and J. M. Price.  1964.  Mouse  Bladder
     Carcinogenicity  of Certain Tryptophan  Metabolites and Other
     Aromatic  Nitrogen  Compounds Suspended  in Cholesterol. Cancer  Res.
     24:596-602.

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                                    67


12.   Butt, L. T., and N. Strafford.  1956.  Papilloma of the Bladder in
     the Chemical Industry.  Analytical Methods for the Determination
     of Benzidine and g-Naphthylamine, Recommended by A.B.C.M.  Sub-
     committee.  J. Appl. Chem. (Great Britain) 6:525-539.

13.   Case, R.A.M., M. E. Hosker, D. B. McDonald, and J. T.  Pearson.  1954.
     Tumours of the Urinary Bladder in Workmen Engaged in the Manufacture
     and Use of Certain Dyestuff Intermediates in the British Chemical
     Industry.  Br. J. Ind. Med. (Great Britain) 11:75-104.

14.   Christensen, H. E., and T. T.  Luginbyhl, eds.  1974.  The  Toxic
     Substances List.  U.S. Department of Health, Education, and Welfare,
     Rockville, Md.  pp. 108-109.

15.   Chromatography.  1974.  Laboratory Instrumentation, Series 1,  Vol.  1.
     International Scientific Communications, Inc., Green Farms, Conn.
     308 pp.

16.   Clayson, D. B.  1962.  Chemical Carcinogenesis.  Little, Brown, and
     Company, Boston.  467 pp.

17.   Clayson, D. B.  1975.  The Chemical Induction of Cancer.  In:   Biology
     of Cancer, 2nd ed., E. J. Ambrose and F.J.C. Roe, eds.  Ellis  Horwood
     Limited, Chichester, England,   pp. 163-179.

18.   Colour Index.  1957.  2nd ed., Vol. 3.  The Society of Dyers and
     Colourists, Bradford, England, and the American Association of
     Textile Chemists and Colorists, Lowell, Mass.  3824 pp.

19.   Conney, A. H., and W. Levin.  1974.  Carcinogen Metabolism in  Experi-
     mental Animals and Man.  In:  Chemical Carcinogenesis Essays,  R.
     Montesano and L. Tomatis, eds.  International Agency for Research on
     Cancer, Lyon, France,  pp. 3-22.

20.   Cramer, J. W., J. A. Miller, and E. C. Miller.  1960.   ./17-Hydroxyla-
     tion:  A New Metabolic Reaction Observed in the Rat with the
     Carcinogen 2-Acetylaminofluorene.  J. Biol. Chem. 235(3):885-888.

21.   Deichmann, W. B., W. M. MacDonald, M. M. Coplan, F. M. Woods,  and
     W.A.D. Anderson.  1958.  Para Nitrobiphenyl, a New Bladder Carcinogen
     in the Dog.  Ind. Med. Surg. 27:634-637.

22.   Dieteren, H.M.L.  1966.  The Biotransformation of o-Tolidine.   Arch.
     Environ. Health 12:30-32.

23.   Ehrhart, H. , A. Georgii, and K. Stanislawski.  1959.  Untersuchungen
     uber Experimentelle Leukamien.  Uber die Leukamogene Wirkung von
     3-Hydroxy-anthranilsaure bei RFH-Mausen (Investigations of Experi-
     mental Leukemia.  On the Leukemogenic Action of 3-Hydroxy-
     anthranilic Acid in RFH-Mice).  Klin. Wochenschr.  (West Germany)
     37:1053-1059.

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                                    68
24.  El-Dib, M. A.  1971.   Colorimetric Determination of Aniline Deriva-
     tives in Natural Waters.  J.  Assoc. Off.  Anal. Chem. 54(6):1383-1387.

25.  Environmental Instrumentation Group.  1973.   Instrumentation for
     Environmental Monitoring — Water.   Lawrence Berkeley Laboratory,
     Berkeley, Calif.

26.  Fahmy, 0. G., and M.  J. Fahmy.  1967-   Inactivity of Hydroxylamine
     and Hydroxyamic Acid Derivatives in the Induction of Gene Mutations.
     In:  British Empire Cancer Campaign, 45th Annual Report,   p. 81.

27.  Federal Register.  1974.  39(20):3756-3779.

28.  Federal Register.  1975.  40:24539.

29.  Fieser, L. F., and M. Fieser.   1956.  Organic Chemistry.   Reinhold
     Publishing Corporation, New York.   1112 pp.

30.  Fuller, A. T.  1937.   Is p-Aminobenzenesulphonamide the Active
     Agent in Prontosil Therapy?  Lancet (Great Britain) 232:194-198.

31.  Gerarde, H. W., and D. F. Gerarde.  1974.  Industrial Experience
     with 3,3'-Dichlorobenzidine:   An Epidemiological Study of a
     Chemical Manufacturing Plant.   J.  Occup.  Med. 16(5):322-343.

32.  Classman, J. M., and J. W. Meigs.   1951.   Benzidine (4,4'-Diamino-
     biphenyl) and Substituted Benzidines.   Arch. Ind.  Hyg. Occup.  Med.
     4(6):519-532.

33.  Gorrod, J. W.  1971.   Species Differences in the Formation of
     4-Amino-3-biphenyl 3-D-Glucosiduronate in vitro.  Biochem. J.
     (Great Britain) 121:29P-30P.

34.  Haley, T. J.  1975.  Benzidine Revisited:  A Review of the Literature
     and Problems Associated with the Use of Benzidine and Its Congeners.
     Clin. Toxicol. 8(l):13-42.

35.  Haley, T. J.  1977.  Personal Communication.

36.  Hathway, D. E.   1970.  Biotransformations.  In:  Foreign Compound
     Metabolism in Mammals, Vol. 1.  The Chemical Society, London.
     455 pp.

37.  Heidelberger, C.  1970.  Chemical  Carcinogenesis,  Chemotherapy:
     Cancer's Continuing Core Challenges — G.H.A. Clowes Memorial Lecture.
     Cancer Res. 30:1549-1569.

38.  Hendrickson, E.  R.   1967.  Air Sampling and Quantity Measurement.
     In:  Air Pollution, 2nd ed.,  Vol.  II,  Analysis, Monitoring, and
     Surveying, A. C. Stern, ed.  Academic Press, New York.  pp. 3-52.

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                                    69
39.   Holder, C. L. , J. R. King, and M. C. Bowman.  1976.  4-Amino-
     biphenyl, 2-Naphthylamine, and Analogs:  Analytical Properties
     and Trace Analysis in Five Substrates.  J. Toxicol. Environ.
     Health 2:111-129.

40.   Hueper, W. C.  1938.  "Aniline Tumors" of the Bladder.  Arch.
     Pathol. 25:856-899.

41.   Hueper, W. C., and W. D. Conway.  1964.  Chemical Carcinogenesis
     and Cancers.  Charles C. Thomas, Springfield, 111.  744 pp.

42.   International Agency for Research on Cancer.  1972.  IARC Monographs
     on the Evaluation of Carcinogenic Risk of Chemicals to Man, Vol. 1.
     Lyon, France.  184 pp.

43.   International Agency for Research on Cancer.  1973(2.  IARC Mono-
     graphs on the Evaluation of Carcinogenic Risk of Chemicals to Man,
     Vol. 2, Some Inorganic and Organometallic Compounds.  Lyon,
     France.   181 pp.

44.   International Agency for Research on Cancer.  1973£>.  IARC Mono-
     graphs on the Evaluation of Carcinogenic Risk of Chemicals to Man,
     Vol. 3, Certain Polycylic Aromatic Hydrocarbons and Heterocyclic
     Compounds.  Lyon, France.  271 pp.

45.   International Agency for Research on Cancer.  1974a.  IARC Mono-
     graphs on the Evaluation of Carcinogenic Risk of Chemicals to Man,
     Vol. 4, Some Aromatic Amines, Hydrazine and Related Substances,
     N-Nitroso Compounds and Miscellaneous Alkylating Agents.  Lyon,
     France.   286 pp.

46.   International Agency for Research on Cancer.  1974&.  IARC Mono-
     graphs on the Evaluation of Carcinogenic Risk of Chemicals to Man,
     Vol. 5, Some Organochlorine Pesticides.  Lyon, France.  241 pp.

47.   International Union of Pure and Applied Chemistry.  1962.  Methods
     for the Determination of Toxic Substances in Air.  Butterworths,
     London.  pp. 0.1-0.12, 23.1-23.3.

48.   Jakovljevic, I. M., J. Zynger, and R. H. Bishara.  1975.  Thin
     Layer Chromatographic Separation and Fluorometric Determination
     of 4-Aminobiphenyl in 2-Aminobiphenyl.  Anal. Chem. 47:2045-2046.

49.   Jenkins, R. L., and R. B. Baird.  1975.  The Determination of
     Benzidine in Wastewaters.  Bull. Environ. Contam. Toxicol. 13(4):
     436-442.

50.   Johnson, R. F., A. Zenhauser, and H. Zollinger.  1963.  Azo Dyes.
     In:  Kirk-Othmer Encyclopedia of Chemical Technology, 2nd ed.,
     Vol. 2, R. E. Kirk and D. F. Othmer, eds.  Interscience Publishers,
     New York.  pp. 868-898.

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                                   70
51.   Karasek, F.  W.   1975.   Detection Limits  in Instrumental Analysis.
     Res.  Dev.  26:20-24.

52.   Karrer,  P.   1950.   Organic Chemistry,  4th ed.   Elsevier Publishing
     Company, Inc.,  New York.   983 pp.

53.   Krugers, J.   1968.  System Components.   In:   Instrumentation in
     Gas Chromatography, J.  Krugers,  ed.   Centrex Publishing Company,
     Eindhoven, Netherlands.  245 pp.

54.   Laham, S.  1960.  Biological Conversion  of 4-Nitrobiphenyl to an
     Active Carcinogen.  Can.  J. Biochem.  Physiol.  (Canada)  38:1383-1386.

55.   Laham, S.  1971.  Metabolism of  a New Carcinogen Related to
     Benzidine (abstract).   Toxicol.  Appl.  Pharmacol.  19:368-369.

56.   Laham, S., J. P- Farant,  and M.  Potvin.   1970.   Biochemical Deter-
     mination of Urinary Bladder Carcinogens  in Human Urine.  Occup.
     Health Rev.  21(3-4):14-23.

57.   Longbottom,  J.  E.   1974.   Method for  Benzidine  and Its  Salts in
     Wastewaters  (personal communication;  method authorized  in Federal
     Register 40:24535).

58.   Lurie, A. P-  1964.  Benzidine and Related Diaminobiphenyls.  In:
     Kirk-Othmer Encyclopedia  of Chemical  Technology,  2nd ed., Vol.  3,
     R. E. Kirk and D.  F.  Othmer, eds.  Interscience Publishers, New York.
     pp. 408-420.

59.   Mancy, K. H.  1971.  Elements of Instrumental Analysis.  In:
     Instrumental Analysis for Water  Pollution Control, K. H. Mancy, ed.
     Ann Arbor Science Publishers, Inc., Ann  Arbor,  Mich. p. 70.

60.   Martens, C.  R. , ed.  1968.  Technology of Paints, Varnishes, and
     Lacquers.  Reinhold Book Corporation, New York.

61.   Miller, E. C.,  and J.  A.  Miller.  1966.   Mechanisms of  Chemical
     Carcinogenesis:  Nature of Proximate  Carcinogens and Interactions
     with Macromolecules.   Pharmacol. Rev.  18:805-838.

62.   Miller, E. C.,  and J.  A.  Miller.  1971a.  The Mutagenicity of
     Chemical Carcinogens:   Correlations,  Problems,  and Interpretations.
     In:  Chemical Mutagens, Vol. 1,  A. Hollaender,  ed.  Plenum Press,
     New York.  pp.  83-119.

63.   Miller, E. C.,  and J.  A.  Miller.  1972.   Approaches to  the Mechanisms
     and Control of Chemical Carcinogenesis.   In:  Environment and Cancer.
     The Williams and Wilkins  Company, Baltimore,  pp. 5-39.

64.   Miller, E. C.,  J.  A.  Miller, and M. Enomoto.  1964.  The Comparative
     Carcinogenicities  of 2-Acetylaminofluorene and  Its N-Hydroxy
     Metabolite in Mice, Hamsters, and Guinea Pigs.   Cancer  Res.
     24:2018-2031.

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                                   71


65.   Miller, J. A.  1970.  Carcinogenesls by Chemicals:  An Overview—
     G.H.A. Clowes Memorial Lecture.   Cancer Res. 30(3):559-576.

66.   Miller, J. A., M. Enomoto, and E. C. Miller.  1962.   The Carcino-
     genicity of Small Amounts of N-Hydroxy-2-acetylaminofluorene and
     Its Cupric Chelate in the Rat.  Cancer Res. 22:1381-1391.

67.   Miller, J. A., and E. C. Miller.  1969a.  The Metabolic Activation
     of Carcinogenic Aromatic Amines and Amides.  In:  Progress in Experi-
     mental Tumor Research, Vol. 11,  F. Homburger, ed.   S. Kargar AG,
     Basel, Switzerland,  pp. 273-301.

68.   Miller, J. A., and E. C. Miller.  1969&.  Metabolic  Activation of
     Carcinogenic Aromatic Amines and Amides via N-Hydroxylation and
     N-Hydroxy-Esterification and Its Relationship to Ultimate  Car-
     cinogens as Electrophilic Reactants.  In:   Physico-Chemical
     Mechanisms of Carcinogenesis, E. D.  Bergmann and B.  Pullman, eds.
     The Israel Academy of Sciences and Humanities, Jerusalem,   pp.  237-
     261.

69.   Miller, J. A., and E. C. Miller.  1971b.  Chemical Carcinogenesis:
     Mechanisms and Approaches to Its Control.   J. Natl.  Cancer Inst.
     47(3):v-xiv.

70.   Miller, J. A., C. S. Wyatt, E. C. Miller,  and H. A.  Hartmann.   1961.
     The N-Hydroxylation of 4-Acetylaminobiphenyl by the  Rat and Dog and
     the Strong Carcinogenicity of N-Hydroxy-4-acetylaminobiphenyl  in the
     Rat.  Cancer Res. 21:1465-1473.

71.   Morrison, R. T., and R. N. Boyd.  1974.  Organic Chemistry,  3rd ed.
     Allyn and Bacon, Inc., Boston.  1258 pp.

72.   Parke, D. V.  1968.  The Biochemistry of Foreign Compounds.
     Pergamon Press, New York.  269 pp.

73.   Pauschmann, H., and E. Bayer.  1974.  Gas Chromatography.   In:
     Methodicum Chimicum, Vol. 1, Analytical Methods, F.  Korte, ed.
     Academic Press, New York.  pp. 143-165.

74.   Porier, M. M., J. A. Miller, and E.  C. Miller.  1965.  The Car-
     cinogenic Activities of N-Hydroxy-2-acetylaminofluorene and Its
     Metal Chelates as a Function of Retention at the Injection Site.
     Cancer Res. 25:527-533.

75.   Rinde, E., and W. Troll.  1975.   Metabolic Reduction of Benzidine
     Azo Dyes to Benzidine in the Rhesus Monkey.  J. Natl. Cancer Inst.
     55U):181-182.

76.   Sciarini, L. J., and J. A. Mahew.  1955.  A Rapid Technique for
     Estimating Benzidines in Industrial Exposure.  AMA Arch. Ind.
     Health 11:420-421.

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                                   72
 77.  Sciarini, L. J., and J. W. Meigs.  1961a.  The Biotransformation
     of Benzidine:  II.  Studies in Mouse and Man.  Arch. Environ.
     Health 2:423-428.

 78.  Sciarini, L. J., and J. W. Meigs.  1961&.  Biotransformation of
     the Benzidines:  III.  Studies on Diorthotolidine, Dianisidine,
     and Dichlorobenzidine:  3,3' Disubstituted Congeners of Benzidine
      (4,4'-Diaminobiphenyl).  Arch. Environ. Health 2:584-588.

 79.  Shubik, P., D. B. Clayson, and B. Terracini, eds.  1970.  The
     Quantification of Environmental Carcinogens.  Union Internationale
     Contre le Cancer, Geneva, Switzerland.  33 pp.

 80.  Spitz, S., W. H. Maguigan, and K. Dobriner.  1950.  The Carcino-
     genic Action of Benzidine.  Cancer 3:789-804.

 81.  Stecher, P. G. , ed.  1968.  The Merck Index, 8th ed.  Merck and
     Company, Inc., Rahway, N.J.  1713 pp.

 82.  Takemura, N., T. Akiyama, and C. Nakajima.  1965.  A Survey of the
     Pollution of the Sumida River, Especially on the Aromatic Amines
     in the Water.  Int. J. Air Water Pollut.  (Great Britain) 9:665-670

 83.  Troll, W., S. Belman,  and E. Rinde.  1963.  717-Hydroxy Acetyl Amino
     Compounds, Urinary Metabolities of Aromatic Amines in Man
      (abstract).  Proc. Am. Assoc. Cancer Res. 4:68.

 84.  Uehleke, H., and K. Nestel.  1967.  Hydroxylamino- und Nitroso-
     biphenyl:  Biologische Oxydationsprodukte von 4-Aminobiphenyl
     und Zwischenprodukte der Reduktion von 4-Nitrobiphenyl (Hydro-
     xylamino- and Nitrosobiphenyl:  Biological Oxidation Products of
     4-Aminobiphenyl and Reduction Metabolites of 4-Nitrobiphenyl).
     Naunyn-Schmiedebergs Arch. Pharmakol. Exp. Pathol. (West Germany)
     257:151-171.

 85.  Walker, R.  1970.  The Metabolism of Azo Compounds:  A Review of
     the Literature.  Food Cosmet. Toxicol. (Great Britain) 8:659-676.

 86.  Weast, R. C., ed.  1970.  Handbook of Chemistry and Physics, 51st
     ed.  The Chemical Rubber Company, Cleveland, Ohio.

 87.  Welcher, F.  J.   1947-  Organic Analytical Reagents, Vol. II.
     D. Van Nostrand Company, Inc., New York.  530 pp.

 88.  Williams, R.  T.  1949.  Detoxication Mechanisms.  John Wiley and
     Sons,  Inc.,  New York.  288 pp.

89.  Williams, R.  T.  1959.  Detoxication Mechanisms, 2nd ed.   John
     Wiley and Sons, Inc., New York.  796 pp.

90.  Woolrich, P.  F. , and W. A. Rye.  1969.  Urethanes.  J.  Occup. Med.
     11(4):184-190.

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                                   73
91.   Yamagiwa, K.,  and K.  Ichikawa.   1918.   Experimental Study of the
     Pathogenesis  of Carcinoma.   J.  Cancer  Res.  3(1):1-21.

92.   Zavon, M. R.,  U. Hoegg, and E.  Bingham.  1973.   Benzidine Exposure
     as a Cause of  Bladder Tumors.  Arch. Environ.  Health 27:1-7-

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                               SECTION 3

                  BIOLOGICAL ASPECTS IN MICROORGANISMS
     No data were found on the metabolism of benzidine in microorganisms.
However, some duodenal bacteria, soil bacteria, and Esoheviohia aoli can
reduce the azo linkage of benzidine-based azo dyes to liberate benzidine
(Yoshida and Miyakawa, 1973).

     Antiviral activity has been demonstrated among benzidine-based dyes.
Of 36 such dyes tested, 5 showed antiviral activity and 26 showed hemag-
glutinating activity (Dettori, 1964).  No relationship occurred between
the intensities of the hemagglutinating and antiviral activities.  Congo
Red (derived from benzidine) and benzopurpurin (derived from 3,3'-dimeth-
ylbenzidine) inhibited TI and T7 phage production in a strain of Escheriehia
aoli (Dettori and Neri, 1964).  In this study, the dyes showed no bacteri-
cidal activity and did not inhibit respiration or anaerobic glycolysis.

     Congo Red has been used as a bacteriostatic agent in the isolation of
the tubercle bacillus from sputum (Frobisher, 1946) and as an indicator dye
in the mixed culture growth of Rhizobiwn and related species of bacteria
(Vincent, 1970).

     The Federal Register (1976) noted that benzidine inhibited biooxida-
tion in activated sludges at 500 mg/liter, caused some inhibition at 1 to
5 mg/liter, and was thought to be oxidized at 0.1 mg/liter or less.  Howard
and Saxena  (1976), in reporting on work done by the Synthetic Organic Chem-
ical Manufacturers Association in 1975, noted that Warburg tests showed
benzidine inhibition of oxygen uptake at concentrations of 40 to 80 mg/liter
in unacclimated sludge and at concentrations of 60 to 120 mg/liter in accli-
mated sludge.

     Benzidine and some of its congeners have been found to be mutagenic
to strains  of Salmonella typhimuriym through the use of an assay method
recently developed for the testing of the mutagenic and carcinogenic
potential of a wide variety of chemicals (McCann and Ames, 1976).  Ames
et al.  (1973) first showed that benzidine was mutagenic to this bacte-
rium, although only after it had been activated by a rat liver homogenate.
Since the assay involved the detection of reversals of frameshift muta-
tions,  it was suggested that benzidine could cause frameshift mutations.
More recently, Garner, Walpole, and Rose (1975) have used tester strain
TA 1538 of  Salmonella typhimuriwn in determining the mutagenic capability
of benzidine and a number of congeners in the presence and absence of a
preparation of liver mixed function oxidase.  The assay measured the
production  of histidine prototrophs  (revertants).  As noted in Table 3.1,
3,3'-dichlorobenzidine and 3,3'-dichlorobenzidine sulfate (technical
grade)  were the only compounds which exhibited weak mutagenic activity
in the  absence of the liver preparation.  3,3',5,5'-Tetramethylbenzidine
produced no mutagenic activity even in the presence of the liver prepara-
tion.   The  presence of the liver preparation caused weak mutagenic activity
by 3,3'-dianisidine and strong mutagenic activity by 3,3',5,5'-tetrafluoro-
benzidine,  3,3'-dichlorobenzidine, and 3,3'-dichlorobenzidine sulfate.
                                    74

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                                        75
 TABLE 3.1.  MUTAGENIC ACTIVITY OF BENZIDINE ANALOGUES TO SALMONELLA TYPHIMURIUM
           IN THE PRESENCE OR ABSENCE OF LIVER MIXED FUNCTION OXIDASE
_ , Amount added Liver
Compound / / -, \ .a
(yg/plate) preparation
Benzidine



3,3' ,5,5' -Tetraf luorobenzidine



3,3' ,5,5'-Tetramethylbenzidine



3,3' -Dichlorobenzidine



3,3 '-Dichlorobenzidine sulfate
(technical grade)


3,3' -Dianisidine
(3, 3'-dimethoxybenzidine)


Dimethylsulfoxide (control)

50 +
100 +
50
100 -
50 +
100 +
50
100 -
50 +
100 +
50 -
100 -
50 +
100 +
50 -
100 -
50 +
100 +
50 -
100 -
50 +
100 +
50 -
100 -
+

Mutagenic
activity
(His+ revertants
per plate)
430
640
5
15
560
1040
20
29
15
15
5
9
3360
7520
114
131
5490
8350
127
129
63
82
6
11
16
8
     a
      '+ indicates liver homogenate present; — indicates liver homogenate absent.

     Source:  Adapted from Garner, Walpole, and Rose, 1975,  Table 1,  p.  41.
Reprinted by permission of the publisher.

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                                   76


                                SECTION 3

                                REFERENCES
 1.  Ames, B. N.,  W.  E.  Durston,  E.  Yamasaki,  and F.  D.  Lee.   1973.
     Carcinogens  Are  Mutagens:  A Simple Test  System Combining Liver
     Homogenates  for  Activation and  Bacteria for Detection.   Proc. Natl.
     Acad. Sci. U.S.A.  70:2281-2285.

 2.  Dettori, R.   1964.   Attivita Antivirale di Coloranti Azoici:  I.
     Correlazione Tra Attivita Emoagglutinate  e Attivita Antivirale
     (Antiviral Activity of Dyes:  I.   Correlation between Haemoaggluti-
     nating and Antiviral Activities).   G.  Microbiol.  (Italy) 12:135-144.

 3.  Dettori, R., and M. G. Neri.  1964. Attivita Antivirale di Coloranti
     Azioci:  II.  Azione di Alcuni  Derivati Benzidinici sul  Sistema
     Batteriofago-Cellula Batterica  (Antiviral Activity  of Dyes:  II.
     Action of a  Group of Benzidine  Derivatives on a Series of Phage-
     Bacterium Systems).  G. Microbiol.  (Italy) 12:145-152.

 4.  Federal Register.   1976.  41:27012-27017.

 5.  Frobisher, M.  1946.  Fundamentals of  Bacteriology, 3rd  ed.
     W. B. Saunders Company, Philadelphia,   pp. 126-127.

 6.  Garner, R. C., A.  L. Walpole, and F. L. Rose.  1975.  Testing of
     Some Benzidine Analogues for Microsomal Activation  to Bacterial
     Mutagens.  Cancer Lett. (Netherlands)  1:39-42.

 7.  Howard, P- H., and  J. Saxena.  1976.   Persistence and Degradability
     Testing of Benzidine and Other  Carcinogenic Compounds.   EPA
     560/5-76-005, U.S.  Environmental  Protection Agency, Washington, D.C.
     p. 14.

 8.  McCann, J.,  and  B.  N. Ames.   1976.   A  Simple Method for  Detecting
     Environmental Carcinogens as Mutagens. Ann. N.Y. Acad.  Sci.
     271:5-13.

 9.  Vincent, J.  M.   1970.  A Manual for the Practical Study  of Root
     Nodule Bacteria.  Blackwell  Scientific Publishers,  Oxford, England.
     pp.  4-5.

10.  Yoshida, 0.,  and M. Miyakawa.  1973.   Etiology of Bladder Cancer:
     "Metabolic"  Aspects.  In:  Analytic and Experimental Epidemiology
     of Cancer, W. Nakahara, T. Hirayama, K. Nishioka, and H. Sugano,
     eds.   University Park Press, Baltimore,  pp. 31-39.

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                               SECTION 4

                     BIOLOGICAL ASPECTS IN PLANTS
     The only reference found in the literature concerning benzidine metab-
olism in higher plants involved the in vitro oxidation of 3,3'-diamino-
benzidine by a commercial preparation of horseradish peroxidase (Barbotin
and Thomas, 1974).  The oxidative activity occurred when the peroxidase
was in solution or immobilized in an artificial membrane.  Oxidation has
also been shown to occur with peroxidase from a variety of green algae,
but not with peroxidases from varieties of red and brown algae (Siegel
and Siegel, 1970).  Diaminobenzidine oxidation in blue-green algae occurs
via the respiratory and photosynthetic electron transport systems
(Lauritis et al., 1975).

     Diaminobenzidine is used in electron microscopy as a histochemical
stain.  It apparently is oxidized by the cytochromes of the mitochondrial
electron transport chain, polymerizes and remains tightly bound to the
oxidizing heme protein, and reacts with osmium tetroxide to give an
electron-dense deposit  (Opik, 1975).  Diaminobenzidine can also be used
to localize sites of peroxidase and catalase activity (Nougarede, 1971;
Silverberg, 1975).

     No information was found in the literature on any effects to higher
plants produced by benzidine exposure.  However, Boney (1974) has noted
that benzidine  (0.3 rag/liter) provided a 12% stimulation in growth over
control culture conditions in the growth of the red alga Antithamnion
plwrrula.
                                   11

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                                  78


                               SECTION 4

                               REFERENCES
1.   Barbotin,  J.  N.,  and D.  Thomas.   1974.   Electron Microscopic and
    Kinetic Studies Dealing  with an  Artifical Enzyme Membrane; Applica-
    tion to a  Cytochemical Model with the Horseradish Peroxidase-3,3'-
    Diaminobenzidine  System.   J. Histochem.  Cytochem. 22(11):1048-1059.

2.   Boney, A.  D.   1974.   Aromatic Hydrocarbons and the Growth  of Marine
    Algae.  Mar.  Pollut. Bull. (Great Britain) 5:185-186.

3.   Lauritis,  J.  A.,  E.  L. Vigil, L.  Sherman, and H. Swift.   1975.
    Photosynthetically-Linked Oxidation of Diaminobenzidine  in Blue-
    Green Algae.   J.  Ultrastruct. Res.  53:331-344.

4.   Nougarede, A.  1971.  Observations Nouvelles sur les Lieux de
    Peroxydation de  la 3,3'-Diaminobenzidine (DAB)  dans les  Gals et
    les Suspensions  Cellulaires d'un Mutant Chlorophyllien Obtenu a
    partir de  la Souche  Sauvage de iMcer pseudoplatanus L.  C.  R.
    Seances Acad. Sci. (France) 273:864-867.

5.   Opik, H.  1975.   The Reaction of Mitochondria in the Coleoptiles of
    Rice (Ovyza sativa L.) with Diaminobenzidine.   J. Cell Sci.  (Great
    Britain) 17:43-55.

6.   Siegel, B. Z., and S. M.  Siegel.   1970.   Anomalous Substrate Spe-
    cificities among  the Algal Peroxidases.   Am.  J.  Bot.  57(3):285-287.

7.   Silverberg,  B. A.  1975.   3,3'-Diaminobenzidine (DAB)  Ultra-
    structural Cytochemistry of Microbodies in Chlorogonium  elongatum.
    Protoplasma (Austria) 85:373-376.

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                               SECTION 5

            BIOLOGICAL ASPECTS IN WILD AND DOMESTIC ANIMALS
     No data were found concerning the metabolism of benzidine or its
derivatives by wild or domestic animals.  Metabolism by research animals
is discussed in Section 6; there are differences among species of animals.
Therefore, it is reasonable to expect some variation among diverse aquatic
and terrestrial fauna.

     Apparently, the only information available on the toxicity of benzi-
dine or its derivatives to wild or domestic animals is that which has been
obtained through laboratory research on a limited number of species,
including the commonly used research animals.  Most of this information
is covered in Section 6 since it provides comparative data useful in deter-
mining the toxicity potential of these compounds to humans, including their
carcinogenic potential.  Some of the data are also useful in projecting the
toxicity potential among wild and domestic animals, should they be exposed
in their natural environment.  Thus, recent bioassays of benzidine in fish
have shown TL50 values ranging from 2.5 mg/liter for red shiner to 20
mg/liter for the fathead minnow (Federal Register, 1976).  Pliss and
Khudoley (1975) found liver damage in guppies fed 30 mg benzidine per 100
g of dry diet material.  At two to four weeks of exposure, liver tissue
developed foci of necrosis and fatty dystrophy.  Hyperplasia of the hepa-
tocytes occured by four to eight weeks.  None of the fish had developed
tumors by the 56-week termination of the experiment.

     Benzidine has not been found to occur in the aquatic environment of
the United States (Federal Register, 1976), although it has been detected
in the Sumida River of Japan  (Takemura, Akiyama, and Nakajima, 1965).
Should contamination occur, the possibility exists for heightened toxicity
among some species because of the potential of bioaccumulation within food
chains.  The Federal Register (1976) reported that bioaccumulation occurred
in bluegill fish in a radiometric study using 14C-benzidine.  Edible
tissues contained a 44-fold increase in concentration over that in water.

     Benzidine injected into the blastoderm of early chick embryos at 18
to 24 hr of incubation was found by Noto (1967) to cause morphological
abnormalities.  The closure of the cephalic neural tube was inhibited.
                                   79

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                                  80


                               SECTION 5

                               REFERENCES


1.    Federal Register.   1976.   41:27012-27017-

2.    Noto,  T.   1967.   The Effects  of Some  Carcinogens on the Morphogenesis
     and Differentiation in the Early Chick Embryo.   Sci.  Rep.  Tohoku
     Univ.  Ser.  4 (Japan) 33:65-69.

3.    Pliss, G.  B.,  and V. V.  Khudoley.   1975.   Tumor Induction by Carcino-
     genic Agents in Aquarium Fish.   J.  Natl.  Cancer Inst.  55(1):129-136.

4.    Takemura,  N.,  T. Akiyama, and C.  Nakajima.   1976.   A  Survey  of the
     Pollution  of the Sumida River,  Especially on the Aromatic Amines
     in the Water.   Int.  J.  Air Water Pollut.  (Great Britain) 9:665-670.

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                               SECTION 6

                     BIOLOGICAL ASPECTS IN HUMANS
6.1  SUMMARY

     Benzidine exposure is primarily an industrial problem among workers
in plants which manufacture or use benzidine and its derivatives.  Uptake
of these compounds is by skin absorption, inhalation, and ingestion.  Skin
absorption and inhalation are the major uptake routes; ingestion adds an
insignificant portion, except for Japanese kimono painters who use their
lips to moisten brushes dipped in benzidine dyes.  Uptake is positively
correlated with industrial hygiene and the particular benzidine compound
to which the worker has been exposed.  Volatile compounds, compounds of
small particle size, and bases easily penetrate the skin.  High air tem-
perature and relative humidity also aid skin penetration.

     Benzidine does not appear to accumulate in human blood or other tis-
sues for any appreciable length of time.  Studies made with warm-blooded
experimental animals also showed no significant accumulation by benzidine
or its derivatives.  However, there appears to be rapid distribution by
the blood to other tissues and temporarily increased concentrations in
some organs, notably the liver, lung, and kidney, although this is not a
consistent finding; findings vary with the compound tested and the test
animal used.  Although the usual experimental animal does not appear to
accumulate benzidine in its tissues, a recent study has demonstrated a
44-fold accumulation of this compound in bluegill fish.

     Benzidine and its derivatives are biotransformed into several metab-
olites in the animal body; the metabolites produced are species dependent.
The dog differs from other animal species in that it cannot acetylate ben-
zidine.  The major benzidine metabolite in both humans and dogs appears
to be 3-hydroxybenzidine.  In humans, benzidine and 3,3'-dimethylbenzidine
(diorthotolidine) seem to be metabolized similarly since hydroxylation of
diorthotolidine occurs in the ortho position with respect to the amino
group.

     Benzidine, its derivatives, and metabolites are eliminated in the
urine and feces.  Biliary secretion contributes to fecal excretion.  Uri-
nary excretion in humans increases with increased exposure.  There is
evidence that urinary excretion in exposed workers is higher in warmer
periods of the year because of increased uptake.  Excretion in experi-
mental animals varies with the compound administered and the species used.
The rat, for example, excretes benzidine primarily in the feces, whereas
benzidine is excreted primarily in the urine by the dog and monkey.  In
contrast, 3,3'-dichlorobenzidine is excreted primarily in the feces by
all three animals.  Bile appears to contain the same metabolites as urine,
but in only one-third the quantity.

     Benzidine and its derivatives produce toxic effects in humans and
test animals, including the induction of cancer.  In humans, strong
                                   81

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                                   82
evidence implicates benzidine and the related compound 4-aminobiphenyl as
a cause of bladder cancer among workers occupationally exposed to these
compounds.  Although exposure to 3,3'-dimethylbenzidine, 3,S'-dimethoxy-
benzidine, or 3,3'-dichlorobenzidine remain suspect, there is no present
evidence that bladder cancer is induced in humans.  However, a recent
report has suggested that 3,3'-dichlorobenzidine may be responsible for
other types of tumor production in humans other than bladder cancer, and
all three compounds, as well as benzidine and 4-aminobiphenyl, have pro-
duced various tumors in experimental animals.  Interestingly, evidence for
the induction of bladder cancer in test animals is very meager for all of
these compounds except 4-aminobiphenyl.  It is generally accepted that the
actual carcinogenic compounds are metabolites of the parent aromatic amines.
There is mounting evidence that the precarcinogen may be produced through
N-hydroxylation of the parent compound, but esterification may be required
as a further activation step.  The sulfate and glucuronidate conjugation
products of the aromatic amines may also be carcinogenic.  Benzidine and
its derivatives cause dermatitis, cystitis, nephritis, and hematuria in
humans and various effects in test animals.

     Benzidine and its derivatives also influence the activity of some
enzymes.  Workers exposed to benzidine had higher levels of 3-glucuronidase
in their urine than unexposed workers.  Cessation of exposure led to more
nearly normal urinary levels.  Benzidine also has been shown to decrease
blood phenolase activity in rabbits and catalase and peroxidase activity
in rats.  In vitro studies have shown that benzidine, its derivatives, and
related compounds exert differing degrees of ability to reduce cytochrome
o.  This reducing power appears to relate inversely with the strength of
the compounds as carcinogens.  Thus, a compound such as diaminobenzidine,
believed to be a weak carcinogen, displays strong reducing power, whereas
a potent carcinogen such as p-aminobiphenyl displays weak reducing power.

6.2  METABOLISM

6.2.1  Uptake

     Exposure to benzidine and benzidine derivatives is of concern mainly
to employees in factories which manufacture and use these compounds.  Ben-
zidine uptake by exposed persons may be through the respiratory tract, from
the air, by contaminated food into the gastrointestinal tract, and by pene-
tration of the skin through direct contact or from contaminated clothing
(Meigs, Brown, and Sciarini, 1951).  All steps in benzidine synthesis as
carried out by large manufacturers in the United States are now conducted
in closed systems.  Even under such conditions, some exposure can occur
when equipment is being cleaned (Haley, 1975).  There is also a question
as to whether closed systems are being used by firms within the dye industry
who may be manufacturing their own benzidine and derivatives (Haley, 1977).

     Ingestion of benzidine or its derivatives has not been reported as a
significant source of exposure with the exception of painters of silk
kimonos in Japan who "point" or moisten their brushes with their lips and
thereby ingest some of the benzidine dyes on the brushes (Yoshida and
Miyakawa,  1973).

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                                     83
       Skin penetration is the most important avenue of entry into the body.
  Both benzidine and 3,3'-dimethylbenzidine readily penetrate intact skin
  (Meigs,  Brown, and Sciarini, 1951).  3,3'-Dichlorobenzidine, which is non-
  volatile and has a large particle size, presents little inhalation hazard
  and less skin absorption hazard than benzidine (Gerarde and Gerarde, 1974;
  Rye, Woolrich, and Zanes, 1970).  Barsotti and Vigliani (1952) pointed out
  that workers occupationally exposed in the manufacture of benzidine risk
  development of tumor lesions because the light, fluffy, powdery composition
  of the benzidine base provides for ready skin contact and absorption.  The
  order of acute toxicity of benzidine and some of its derivatives appears
  to follow the order of ease of skin penetration:  benzidine, 3,3'-dimethoxy-
  benzidine, and 3,3'-dichlorobenzidine (Rye, Woolrich, and Zanes, 1970).

       Meigs, Sciarini, and Van Sandt (1954) suggested that environmental
  conditions of high air temperature and high relative humidity influence
  the quantity of benzidine, 3,3'-dimethoxybenzidine, 3,3'-dichlorobenzidine,
  and 3,3'-dimethylbenzidine which penetrates the skin.  Men who perspired
  freely,  thus having wet skin, had higher amounts of benzidine in their urine,
  indicating a more rapid skin penetration, than men whose skin was  less wet.
  Benzidine skin penetration was higher on hot days than on cool days, as
  indicated by increased benzidine urine concentrations during high  temper-
  atures (Table 6.1).

  6.2.2  Distribution and Accumulation

       No  information was found on direct measurements made to determine the
  distribution and accumulation in human tissue of benzidine or its  deriva-
  tives.  However, indirect evidence afforded by the measurements of benzi-
  dine in  urine samples from occupationally exposed people (Meigs, Brown,
  and Sciarini, 1951)  indicates that no appreciable accumulation occurs with
  this compound.
    TABLE 6.1.  RELATIONSHIP BETWEEN ENVIRONMENTAL CONDITIONS AND BENZIDINE
               CONCENTRATIONS IN URINE  OF SIX PRESSROOM WORKERS


Environmental
conditions


Cool, dry days

Hot, humid days


Mean
temperature


23
21
34
25

Mean
relative
humidity


63
58
85
78


Mean urinary
specific gravity


1.026
1.024
1.027
1.025
Mean
quinonizable
substance
expressed as
benzidine
(mg/liter)
0.313
0.362
0.668
0.895
     Source:   Adapted from Meigs,  Sciarini, and Van Sandt,  Arch.  Ind. Hyg.
Occup.  Med.,  Vol.  9, Table 6, p.  129.   Copyright 1954, American Medical
Association.

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                                   84
     Studies made with experimental animals, discussed below, suggest that
benzidine and its derivatives are distributed fairly rapidly into various
tissues following uptake but do not remain for any great length of time
before elimination.  Prior to elimination, these compounds or their metab-
olites appear to concentrate in some tissues more than others.

     According to Solimskaya (1968), benzidine was rapidly absorbed within
1 hr of injection into rats.  Maximum concentrations of free and bound ben-
zidine were detected at 2 and 3 hr, respectively, after injection.  In
tissues other than blood, concentrations were higher in liver and kidney
than in spleen, heart, and lung.

     Kellner, Christ, and Lotzsch  (1973) followed the disappearance of
^C-labeled benzidine and 3,3'-dichlorobenzidine in the blood of rats and
dogs after single, intravenous injections of each compound at the rate of
0.2 mg/kg body weight.  Half-lives of the labeled compounds in blood were:
benzidine, 65 hr in the rat, 88 hr in the dog; dichlorobenzidine, 68 hr in
the rat, 86 hr in the dog.  As shown in Figures 6.1 and 6.2, blood concen-
trations of both compounds decreased relatively steadily, but the most
rapid decreases occurred during the first 24 hr after injection.

     In the same study, several measurements were made of the concentra-
tions of the two compounds in various tissues of the dog, rat, and monkey.
                                                   ORNL-DWG 77-9684
                 i  BENZIDINE           (n = 8)
                 $  3,3'-DICHLOROBENZIDINE (n = 8)
                      1234567
                                   TIME (days)

     Figure 6.1.  Concentration in blood after intravenous administration  of
0.2 mg of 1AC-labeled 3,3'-dichlorobenzidine  or benzidine per  kilogram body
weight to rats.  Mean values and 95%  confidence intervals.   Source:   Adapted
from Kellner, Christ, and Lotzsch, 1973, Figure 1, p.  65.  Reprinted  by
permission of the publisher.

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                                     85
                                                  ORNL-DWG  77-9685
                  J BENZIDINE             (n = 3)
                  5 3,3'-DICHLOROBENZIDINE (n = 3)
                               23456
                                    TIME (doys)

     Figure 6.2.  Concentration in blood after intravenous administration of
0.2 mg of li'C-labeled 3,3'-dichlorobenzidine or benzidine per kilogram body
weight to dogs.  Mean values and 95% confidence intervals.  Source:  Adapted
from Kellner, Christ, and Lotzsch, 1973, Figure 2, p. 65.  Reprinted by
permission of the publisher.
 The  results  obtained  are  summarized  in  Tables  6.2  and  6.3.   The  only  sig-
 nificant  difference between the  tissue  concentrations  of  benzidine  and
 dichlorobenzidine was in  the urinary bladder wall  of dogs at 4 hr after
 administration;  this  difference  was  thought to be  caused  by  contamination
 of the wall  with urine.   At 4 hr after  administration,  concentrations of
 both compounds  tended to  be elevated in lung tissue of  rats  and  in  liver
 tissue of dogs.  At 7 to  14 days after  administration,  elevated  concentra-
 tions of  benzidine were found in liver  tissue  of the rat, dog, and  monkey
 and  in lung  tissue of the monkey.  A somewhat  similar  pattern of distri-
 bution was found for  dichlorobenzidine;  elevated concentrations  occurred
 in liver  tissue  of the rat,  dog,  and monkey and in lung tissue of the dog
 and  monkey.

      Baker and Deighton  (1953) gave  rats intraperitoneal  injections of
 benzidine, 100 mg/kg  body weight,  and measured the concentrations found
 in various tissues and urine at  4  and 12 hr after  injection.  Concentra-
 tions, expressed as diazotizable amino  groups,  are given  in  Table 6.4.
 Highest concentrations of total  diazotizable material were found in the
 stomach,  stomach contents,  and small intestine at  4 hr  and in the small
 intestine and small intestine contents  at 12 hr.   Lowest  concentrations

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                                                86
     TABLE 6.2.  DISTRIBUTION PATTERN 1 AND 4 hr AFTER INTRAVENOUS ADMINISTRATION OF 0.2 mg OF
     "C-LABELED 3,3'-DICHLOROBENZIDINE OR BENZIDINE PER KILOGRAM BODY WEIGHT TO RATS AND DOGS
Concentration in rat tissues
Tissue

Stomach
Small intestine
Large intestine
Kidney
Ureter
Urinary bladder
Liver
Bile
Pancreas
Spleen
Adrenals
Gonads , male
Lung
Heart
Skeletal muscle
Retroperitoneal fat
Subcutaneous fat
Brain
Mesentery lymph nodes
Blood
Plasma

Mean
value

0.13
0.26
0.13
0.27
0.005
0.22
0.81

0.13
0.14
0.24
0.088
0.91
0.14
0.093
0.061
0.070
0.033
0.10
0.16
0.22
1 hr
95%
confidence
interval

0.02
0.11
0.02
0.03
to 0.088
0.11
0.22

0.02
0.02
0.05
0.012
0.18
0.03
0.019
0.010
0.015
0.005
0.03
0.06
0.07

Mean
value
Benzidine
0.050
0.26
0.26
0.13
0.001
0.18
0.53

0.044
0.067
0.086
0.030
0.90
0.053
0.030
0.021
0.024
0.011
0.036
0.066
0.092
4 hr
95%
confidence
interval

0.010
0.05
0.12
0.03
to 0.035
0.08
0.11

0.011
0.017
0.024
0.011
0.29
0.017
0.006
0.008
0.006
0.004
0.013
0.027
0.031
Concen
tissue
No. 4

0.094
0.20
0.46
0.24
0.32
2.2
0.79
30
0.036
0.12
0.081
0.031
0.11
0.044
0.030
0.044
0.060
0.013
0.061
0.076
0.12
tration
s, 4 hr
No. 5

0.15
0.23
0.24
0.32
0.28
2.3
0.78
19
0.053
0.16
0.096
0.041
0.12
0.046
0.026
0.088
0.076
0.015
0.068
0.10
0.16
in dog
(yg/g)
No. 6

0.057
0.080
0.22
0.21
0.24
3.3
0.56
7.9
0.043
0.11
0.080
0.063
0.068
0.043
0.054
0.085
0.043
0.013
0.053
0.058
0.094
3,3'-Dichlorobenzidine
Stomach
Small intestine
Large intestine
Kidney
Ureter
Urinary bladder
Liver
Bile
Pancreas
Spleen
Adrenals
Gonads , male
Lung
Heart
Skeletal muscle
Retroperitoneal fat
Subcutaneous fat
Brain
Mesentery lymph nodes
Blood
Plasma
0.020
0.55
0.032
0.096
0.11
0.030
0.20

0.045
0.024
0.24
0.037
0.41
0.032
0.016
0.12
0.12
0.014
0.057
0.025
0.041
0.006
0.18
0.008
0.024
0.02
0.007
0.05

0.018
0.005
0.13
0.010
0.16
0.010
0.002
0.05
0.04
0.005
0.012
0.004
0.007
0.015
1.1
0.33
0.078
0.04
0.049
0.22

0.013
0.012
0.086
0.018
0.28
0.014
0.007
0.018
0.017
0.005
0.014
0.016
0.028
0.006
0.8
0.29
0.011
0.02
0.043
0.09

0.004
0.002
0.037
0.003
0.10
0.004
0.003
0.012
0.008
0.003
0.003
0.005
0.008
0.025
0.087
1.0
0.078
0.072
0.068
0.35
38
0.018
0.013
0.050
0.018
0.073
0.017
0.017
0.093
0.092

0.035
0.013
0.026
0.096
0.56
0.80
0.046
0.074
0.081
0.28
36
0.032
0.022
0.032
0.020
0.044
0.015
0.016
0.056
0.044
0.013
0.049
0.016
0.031
0.024
0.23
0.49
0.041
0.089
0.032
0.23
68
0.070
0.014
0.045
0.017
0.057
0.021
0.013
0.18
0.089
0.012
0.12
0.010
0.019
     Source:   Adapted from Kellner,  Christ,  and  Lotzsch,  1973,  Table 4,  pp.  75-76.   Reprinted by
permission of the publisher.

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        TABLE 6.3.  DISTRIBUTION PATTERN 7 AND 14 DAYS AFTER INTRAVENOUS ADMINISTRATION OF 0.2 mg OF ^C-LABELED
                 3,3'-DICHLOROBENZIDINE OR BENZIDINE PER KILOGRAM BODY WEIGHT TO RATS, DOGS, AND MONKEYS
Concentration in wet tissues (pg/g)
Rat
Tissue
7
Mean
value
days
95%
confidence
interval

Mean
value
14 days
Dog, 7 days
95%
confidence
interval
No. 1
No. 2
No. 3

Monkey
7 days
No. 1
No. 2

14 days,
No. 3
Benzidine
Kidney
Ureter
Urinary bladder
Liver
Bile
Spleen
Adrenals
Gonads , male
Lung

Kidney
Ureter
Urinary bladder
Liver
Bile
Spleen
Adrenals
Gonads , male
Lung
0.009
0.001
0.005
0.042

0.005
0.004
<0.001
0.005

0.006

0.004
0.013

0.004
0.015
0.002
0.004
<0.001
<0.001
<0.001
0.002

<0.001
<0.001

<0.001

<0.001

<0.001
<0.001

<0.001
0.003
<0.001
<0.001
0.006
0.002
0.006
0.022

0.010
0.003
0.001
0.005
3
0.002

0.002
0.004

0.003
0.006
<0.001
0.002
<0
<0
<0
0

0
<0

<0
.001
.001
.001
.004

.001
.001

.001
0.012
0.001
0.007
0.12
0.086
0.029
0.016
0.002
0.007
0.013
0.002
0.007
0.19
0.13
0.029
0.010
0.002
0.010
0.020
0.003
0.007
0.087
0.13
0.030
0.016
0.008
0.011
0.007


0.027

0.003


0.012
0.008
0.001
0.003
0.010
0.007
0.002
0.002
0.005a
0.010
0.004
0.002
0.002
0.011
0.004
0.003
0.003
0.001
0.011
, 3 ' -Dichlorobenzidine
0

<0
<0

<0
<0

<0
.001

.001
.001

.001
.001

.001
0.014
0.004
0.005
0.062
0.60
0.004
0.004
0.002
0.036
0.010
0.003
0.003
0.040
0.18
0.005
0.005
0.002
0.023
0.007
0.003
0.003
0.044
0.13
0.004
0.005
0.002
0.031
0.018
0.011
0.015
0.042
0.055
0.012
0.016
0.006
0.012
0.009
0.003
0.018
0.032
0.019
0.006
0.004
0.001
0.013









       a.
        Female.

       Source:  Adapted  from Kellner, Christ, and LStzsch, 1973, Table 2, pp. 72-73.  Reprinted by permission of the
publisher.
                                                                                                                             oo

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    TABLE 6.4.  THE CONCENTRATION AND DISTRIBUTION OF FREE AND TOTAL DIAZOTIZABLE MATERIAL IN RAT TISSUES FOLLOWING

                  A SINGLE INTRAPERITONEAL INJECTION OF 100 mg BENZIDINE PER KILOGRAM OF BODY WEIGHT
Concentration after 4
Tissue
Whole blood
Plasma
Blood cells
Liver
Spleen
Kidney
Stomach
Stomach contents
Small intestine
Small intestine contents
Caecum
Caecum contents
Colon
Urine
Miscellaneous
Carcass
Total

(ug/g)
16.2
32.5
8.7
16.2
21.2
21.2
275.8
310.0
81.2

2.5
2.0
3.7
5.4
1.7
81.2

Free
(% of total)

0.3
1.1
1.7
0.2
0.2
8.3
15.6
13.0

0.1
0.1
0.2
0.3
0.3
28.8
69.2

(ug/g)
35.0
70.0
11.2
45.0
46.2
46.2
310.0
315.0
157.5

21.2
11.4
21.2
10.2
21.2
82.5

hr
Total
(% of total)

0.7
0.1
4.8
0.5
0.5
9.3
15.8
25.2

0.6
0.6
1.6
0.5
3.8
29.3
93.3
Concentration after 12

(Pg/g)
<1.0
<1.0
3.8
11.3
6.3
2.5
20.0
54.0
26.3
134.0
13.8
0.1
1.0
28.0
1.0
8.8

Free
(% of total)

<0.1
<0.1
1.6
0.1
0.1
0.6
2.7
2.2
6.7
0.3
<0.1
0.1
1.4
0.2
3.2
19.20

(yg/g)
17.5
15.0
5.0
25.0
17.5
11.2
80.0
85.0
135.0
560.0
75.0
15.0
25.0
50.0
11.2
36.2

hr
Total
(% of total)

0.2
0.1
3.5
0.2
0.2
2.4
4.3
11.5
28.0
1.9
0.8
1.3
2.5
2.0
13.5
72.4
 The miscellaneous sample consisted of brain, diaphragm, bladder, gonads,  esophagus, heart, thymus, lungs, and adrenals.


Source:   Adapted from Baker and Deighton, 1953, Table 1, p. 531.  Reprinted by permission of the publisher.
                                                                                                                                oo
                                                                                                                                oo

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                                   89
were found in the red blood cells at both times.  The measured, total diaz-
otizable material accounted for 93% of the administered dose at 4 hr and
72% at 12 hr.  Conjugated forms of the diazotizable material rose from 24%
at 4 hr to 53% at 12 hr, indicating the formation of appreciable levels of
metabolites.  The content of total diazotizable material in urine was con-
siderably higher at 12 hr than at 4 hr, with proportionately higher amounts
of conjugated amines present.  It was suggested that the difference between
the amount of material injected and that measured during the 12-hr period
was caused by in vivo oxidation to products not detectable by the method of
measurement used.  Since there is evidence that benzidine causes tumors in
the liver of some animals, it may be of importance that measured concentra-
tions in the liver were relatively high and remained fairly constant over
the 12-hr period.

     Pliss and Zabezhinsky (1970) reported on the distribution of free and
bound amines in the tissues of rats given 20 mg of 3,3'-dimethylbenzidine
subcutaneously once per week for eight weeks.   Three days after the final
injection the highest amine content was found in the Zymbal's gland with
lesser amounts found in the kidney, omentum, spleen, and liver.  A higher
incidence of tumor development in the Zymbal's gland was observed in rats
administered 3,3'-dimethyIbenzidine.

     Although no data that directly concern placental transfer of benzi-
dine or its derivatives were found, studies made by Golub (1969) and Shabad
et al. (1972) indicated transplacental effects of 3,3'-dichlorobenzidine
and 3,3'-dimethyIbenzidine on cultured embryonic kidney tissue.  The tis-
sue was obtained from pregnant mice treated with the benzidine derivatives
at concentrations of 8 to 10 mg.  Both derivatives promoted a longer sur-
vival rate of tissue and induced epithelial cell hyperplasia.

     Although there is no evidence in the literature of any significant
bioaccumulation of benzidine or its derivatives in human tissue or in
tissues of the usual experimental animals, the Federal Register1 (1976)
recently reported that edible portions of bluegill fish contained a 44-
fold increase in residues of 14C-benzidine over those present in water
during a radiometric study.

6.2.3  Biotransformation and Elimination

     Benzidine and its derivatives are wholly or partly transformed in
humans and experimental animals to a number of metabolites, some of which
are thought to act as proximate carcinogens in the induction of tumor
formation.  The metabolites, as well as the nontransformed parent
compounds, are eliminated from the animal body via the urine and feces.

     A summary of the biotransformation products of benzidine and its
derivatives is provided in Table 6.5.   The closely related compounds 4-
aminobiphenyl and 4-nitrobiphenyl are included because of their structural
and chemical similarities to benzidine and similar carcinogenic behavior
in humans and animals.  The specific chemistries of benzidine, its deriva-
tives, and related compounds are covered in Section 2.2.

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                                                  90
TABLE 6.5.  METABOLITES FORMED BY BIOTRANSFOKMATION OF BENZIDINE AND BENZIDINE DERIVATIVES IN ANIMALS
 Compound
Species
                                               Metabolite
                                                                                      Reference
Benzidine
                   Human         Acetyl N-hydroxy compound
                   Human         N-Hydroxy acetylaminobenzidine
                   Human         Monoacetylbenzidine and
                                   diacetylbenzidine
                   Human         3-Hydroxybenzidine
                   Human         3,3'-Dihydroxybenzidine
                   Monkey        Monoacetylbenzidine
                   Dog           3-Hydroxybenzidine sulfate
                                   and glucuronide
                   Dog           3-Hydroxybenzidine hydrogen sulfate
                   Dog           3-Hydroxybenzidine

                   Dog           4,4'-Diamino-3-diphenylyl hydrogen
                                   sulfate
                   Dog           4-Amino-4-hydroxybiphenyl
                   Dog           Monoacetylbenzidine and
                                   diacetylbenzidine
                   Guinea pig    4'-Acetamido-4-aminodiphenyl
                   Guinea pig    4'-Acetamido-4-amino-3-diphenylyl
                                   hydrogen sulfate
                   Guinea pig    4'-Amino-4-diphenylyl sulfamic acid
                   Guinea pig    N-Glucuronides
                   Guinea pig    4'-Acetamldo-4-diphenylyl sulfamic
                                   acid
                   Rabbit        3-Hydroxybenzidine sulfate and
                                   glucuronide
                   Rabbit        4'-Acetamido-4-aminodiphenyl
                   Rabbit        3-Hydroxybenzidine
                   Rabbit        4'-Acetamido-4-amino-3-diphenylyl
                                   hydrogen sulfate
                   Rabbit        4'-Amino-4-diphenylyl sulfamic acid
                   Rabbit        4'-Acetamido-4-diphenylyl sulfamic
                                   acid
                   Rabbit        N-Glucuronides
                   Rat           3,3'-Dihydroxybenzidine
                   Rat           N-Glucuronides
                    Rat           4'-Acetamido-4-aminodiphenyl
                    Rat           3-Hydroxybenzidine
                    Rat           4,4'-Diamino-3-diphenylyl hydrogen
                                    sulfate
                    Rat           4'-Acetamido-4-amino-3-diphenylyl
                                    hydrogen sulfate
                    Rat           4'-Amino-4-diphenylyl sulfamic acid
                    Rat           4'-Acetamido-4-diphenylyl sulfamic
                                    acid
                    Mouse          Monoacetylbenzidine and
                                    diacetylbenzidine
                    Mouse          Monoacetylated  3-hydroxybenzidine
                                    glucuronide and/or ethereal sulfate
                    Mouse          N-Hydrogen sulfate and/or glucuronide
                    Mouse          3-Hydroxybenzidine glucuronide
                    Mouse          4'-Acetamido-4-aminodiphenyl
                    Mouse          4,4'-Diamino-3-diphenylyl hydrogen
                                    sulfate
                    Mouse          4'-Acetamido-4-amino-3-diphenylyl
                                    hydrogen sulfate
                    Mouse          N-Glucuronides
                                                      Troll, Belman, and Rinde, 1963
                                                      Haley, 1975
                                                      Haley, 1975

                                                      Haley, 1975
                                                      Haley, 1975
                                                      Rinde and Troll, 1975
                                                      Troll and Nelson, 1958

                                                      Sciarini and Meigs, 1958
                                                      Bradshaw and Clayson, 1955
                                                      Sciarini, 1957
                                                      Clayson, Ward, and Ward, 1959

                                                      Haley, 1975
                                                      Haley, 1975

                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Troll and Nelson, 1958

                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959
                                                      Haley, 1975
                                                      Elson, Goulden, and Warren,
                                                        1958
                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Sciarini and Meigs, 1961<2

                                                      Sciarini and Meigs, 1961a

                                                      Sciarini and Meigs, 1961a
                                                      Sciarini and Meigs, 1961a
                                                      Clayson, Ward, and Ward, 1959
                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959

                                                      Clayson, Ward, and Ward, 1959
                                                                                                (continued)

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          91
TABLE 6.5  (continued)
Compound
3,3'-dimethyl-
benzidine
(orthotolldine)

3,3'-Dimethoxy-
benzidine
(dianisidlne)
3-Methoxybenzidine
(mono-substituted
dianisidine)
4-Aminobiphenyl









4-Diphenylacet amide


4-Nitrobiphenyl



Species
Human
Human
Human
Dog
Dog


Rat


Monkey
Monkey
Monkey

Dog
Dog
Dog
Dog


Rat


Monkey
Monkey
Dog
Dog
Metabolite
Diacetyl-o-tolidine
5-Hydroxy-o-tolidine
Monoacetyl-o-tolidine
5-Ethereal sulfate of o-tolidine
Unidentified diamine metabolite


4-Amino-4 '~acetamido-3-methoxybiphenyl


N-Hydroxy-4-aminobiphenyl
4-Nitrosobiphenyl
N-Hydroxy-4-acetylaminobiphenyl
glucuronide
4-Amino-3-diphenylyl hydrogen sulfate
N-Hydroxy-4-aminobiphenyl
4-Nitrosobiphenyl
4-Amino-3-biphenylyl glucuronic acid


N-Hydroxy-4-diphenylacetamide


N-Hydroxy-4-aminobiphenyl
4-Nitrosobiphenyl
N-Hydroxy-4-aminobiphenyl
4-Nitrosobiphenyl
Reference
Dieteren, 1966
Dieteren, 1966
Dieteren, 1966
Sciarini and Meigs , 196L&
Sciarini and Meigs, 1961&


Laham, 1971


Radomski et al. , 1973
Radomski et al., 1973
Radomski et al. , 1973

Bradshaw and Clayson, 1955
Radomski et al . , 1973
Radomski et al., 1973
Gorrod, 1971, as cited in
International Agency for
Research on Cancer, 1972
Miller et al., 1961, as cited
in International Agency for
Research on Cancer, 1972
Radomski et al . , 1973
Radomski et al., 1973
Radomski et al. , 1973
Radomski et al. , 1973

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                                    92
6.2.3.1  Human Studies — Englebertz and Babel  (1953, as cited by Haley,
1975) identified free benzidine and its monoacetylated and diacetylated
metabolites in the urine of a person receiving a single oral dose of
100 mg of benzidine.  Not all of the dose received was recovered in the
urine, indicating some additional fecal excretion or body accumulation.
Troll, Belman, and Rinde (1963) identified free benzidine and N-hydroxy
acetyl amino benzidine in the urine of persons receiving 200 mg of benzi-
dine orally.  In the analysis of urine from plant workers exposed to
benzidine, Sciarini and Meigs (1961a) also found free benzidine and the
monoacetylated and diacetylated derivatives and, in addition, found 3-
hydroxybenzidine.  The latter metabolite was the major excretion product,
amounting to 78.5% to 89.7% of the total.

     Total urinary excretion in the study by Sciarini and Meigs (1961a)
was greater in August than in March, indicating greater uptake of benzi-
dine by the workers during the warmer month of August.  These results con-
firmed an earlier study made by Meigs, Brown, and Sciarini (1951) of plant
workers exposed to benzidine.  As shown in Figure 6.3, urinary excretion in
this study was higher in June (mean for 12 men was 1.48 mg/liter) than in
December (mean for 12 men was 0.433 mg/liter).  Control urine from univer-
sity or plant personnel entirely away from benzidine operations contained
       LJ
       z
       Q
       N
       Z
       iLJ
       03
       co
       co
       co
       UJ
       cr
       Q.
       X
                                     ORNL-OWG 77-9686
•s -
CO
CD
CO
Id
CD

z
o
z
o
   1.5
~  1.0
            0.5
 	JUNE 1950
	MEAN
                                         / \
                  	DECEMBER 1950   /  \
                 6:30 AM
                     NOON      4 PM
                        TIME OF DAY
                                       PM
      Figure 6.3.  Trends of mean urinary concentration of quinonizable
 substance (expressed as benzidine) at different times of day over two-
 week periods in June and December 1950.  Source:  Adapted from Meigs,
 Brown, and Sciarini, Arch. Ind. Hyg. Occup. Med. , Vol. 4, Figure 4,
 p. 539.  Copyright 1951, American Medical Association.

-------
                                   93
no detectable benzidine.  The higher urinary concentrations detected in
June possibly were caused by greater concentrations of benzidine in the
work area air.  In a later study, Meigs, Sciarini, and Van Sandt (1954)
suggested that air contaminated with 0.018 mg of benzidine compounds per
cubic meter would lead, if inhaled for 8 hr, to a urinary concentration of
not more than 0.026 mg/liter of diamines in urine voided at the end of a
work shift.  Hence, the authors concluded that a safe level of air expo-
sure was probably 0.02 mg or less of benzidine per cubic meter of air.

     Workers exposed to benzidine in a dyestuff factory were found by
Vigliani and Barsotti  (1962) to excrete, via the urine, benzidine and
smaller amounts of 4-amino-4-oxybiphenyl and monoacetylbenzidine.  No
significant differences in urinary excretion were found between summer
and winter periods of exposure.

     Dieteren (1966) analyzed urine from chemical plant workers exposed
to 3,3'-dimethylbenzidine (diorthotolidine) indicated the presence of free
diorthotolidine, diacetyl-o-tolidine, and a hydroxyamino compound thought
to be 5-hydroxy-o-tolidine.  Although monoacetyl-o-tolidine could not be
identified, there remained the possibility of its presence.  These results
indicate that in humans hydroxylation of diorthotolidine occurs in the
ortho position with respect to the amino group and that, in this respect,
the metabolisms of diorthotolidine and benzidine are similar.

     Akiyama  (1970) reported that workers handling benzidine yellow excreted
3,3'-dichlorobenzidine in their urine.  This derivative of benzidine is part
of the benzidine yellow molecule and presumably is liberated upon reductive
metabolism of the dye.

6.2.3.2  Comparative Experimental Animal Studies — The biotransformation
of benzidine to 3-hydroxybenzidine and to monoacetylated and diacetylated
derivatives, as found in humans, also occurs in some experimental animals.
Sciarini and Meigs  (1961a) found that mice given benzidine intraperitone-
ally (100 mg/kg body weight) excreted in their urine the free benzidine,
the monoacetylated and diacetylated metabolites, and, at somewhat higher
concentrations, the ethereal sulfates and glucuronates of 3-hydroxybenzi-
dine.  Earlier, Sciarini (1957) found that dogs given benzidine intraperi-
toneally (100 mg/kg body weight) excreted free benzidine and conjugated
3-hydroxybenzidine.  Sciarini and Meigs (1958) identified the conjugated
metabolite as the ethereal sulfate of 3-hydroxybenzidine, which was recov-
ered from the urine of dogs at rates of 25% to 50% of the intraperitoneal
dose.  Troll and Nelson (1958) reported that the major metabolites of ben-
zidine in the dog and rabbit were the sulfate and glucuronide of 3-hydroxy-
benzidine.  No unesterified hydroxy derivatives were found in dogs injected
intraperitoneally with 1 g benzidine dihydrochloride or in rabbits given
100 to 300 mg of this compound.  The metabolites were thought to result
largely from ortho oxidation.

     Differences appear among species of experimental animals in the metab-
olism and excretion of benzidine and its derivatives.  Clayson, Ward, and
Ward (1959) gave benzidine and 4'-acetamido-4-aminodiphenyl orally to dogs
and rabbits and intraperitoneally to rats, mice, and guinea pigs.  A sum-
mary of the metabolites produced by these species is given in Table 6.6.

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                                        94
         TABLE 6.6.  THE URINARY AND BILIARY METABOLITES OF BENZIDINE PRODUCED
                          BY VARIOUS EXPERIMENTAL ANIMALS
               Compound
   Dog
Dog
                                                      Rat
                                                            Mouse
                                                                    Rabbit
                                        Cavy
                                     Urinary
Benzidine
4'-Acetamido-4-aminodiphenyl
3-Hydroxybenzidine (ether extracts)
4,4'-Diamino-3-diphenylyl hydrog-en sulfate
4'-Acetamido-4-amino-3-diphenylyl hydrogen
  sulfate
4'-Amino-4-diphenylyl sulfamic acid
4'-Acetamido-4-diphenylyl sulfamic acid-
N-Glucuronides
Acid stable unknowns

Benzidine
4'-Acetamido-4-aminodiphenyl
4,4'-Diamino-3-diphenylyl hydrogen sulfate
4'-Acetamido-4-amino-3-diphenylyl hydrogen
  sulfate
4'-Amino-4-diphenylyl sulfamic acid
4'-Acetamido-4-diphenylyl sulfamic acid
N-Glucuronides
Acid stable unknowns
Biliary
                  +
                  +
                       +
                       +
      4'-Acetamido-4-aminodiphenyl administered.
     Source:  Adapted from Clayson, Ward, and Ward, 1959, Tables I and II,  pp. 582-583.
Reprinted by permission of the publisher.
  Dog urine contained free benzidine, 3-hydroxybenzidine, 4,4'-diamino-3-
  diphenylyl hydrogen sulfate,  and N-glucuronides.   Rat urine  contained  the
  same metabolites as well as  4?-acetamido-4-aminodiphenyl, 4'-acetamido-4-
  amino-3-diphenylyl hydrogen  sulfate,  4'-amino-4-diphenylyl sulfamic acid,
  and three acid  stable unknowns.   Mouse  urine contained only  free benzidine
  and 4'-acetamido-4-amino-3-diphenylyl hydrogen  sulfate.  Rabbit urine  con-
  tained the latter compound as well as 4'-amino-4-diphenylyl  sulfamic acid,
  4'-acetamido-4-diphenylyl sulfamic acid,  and N-glucuronides.   Guinea pig
  urine contained only 4'-acetamido-4-amino-3-diphenylyl hydrogen sulfate
  and N-glucuronides.  These results suggest two major differences in benzi-
  dine metabolism among the species tested:   (1)  the dog was the only species
  tested unable to acetylate benzidine, and (2) the  rabbit, rat, and guinea
  pig could convert benzidine  to 4'-amino-  and 4'-acetamido-4-diphenylyl
  sulfamic acid,  whereas the dog and mouse  could not.

-------
                                    95
     Troll and Nelson (1958) found differences between dogs and rabbits
in the excretion of amine metabolites of benzidine following intraperi-
toneal injection of benzidine.  Dogs excreted 80% or more of the dose as
compounds with an available aromatic amino group, whereas rabbits excreted
only 50% of the dose as the same compounds.  Also, dogs excreted relatively
more of the sulfate conjugate and an unidentified amine fraction that was
ether extractable.

     Some differences in the amounts of excretion products found may result
from varying periods of in vivo oxidation following administration.  Thus,
Baker and Deighton (1953) gave rats 100 mg benzidine per kilogram of body
weight by intraperitoneal injection and, by analysis of the diazotizable
material in tissues and urine 4 and 12 hr later, found that recovered amino
groups rose from 24% to 49% in tissues over the 8-hr period and from 0.5%
to 2.5% in urine over the same period.  Sciarini and Meigs (1958) found
that with decreasing dosage levels of benzidine given intraperitoneally
to dogs the detection time in urine was comparatively decreased.  A dose
of 100 mg/kg body weight was detected in the urine for as long as seven
days, whereas a dose of 20 yg/kg body weight was detected only in the
first morning void.

     Differences appear in the type and quantity of metabolites eliminated
by different routes (i.e., urine, feces, and bile).  In the work discussed
above by Clayson, Ward, and Ward (1959), dog bile contained qualitatively
the same metabolites as urine but in one-third the amount.  Dog feces did
not contain 3-hydroxybenzidine or the N-glucuronides present in the urine
and bile.

     Kellner, Christ, and Lb'tzsch (1973) determined that substitution of
benzidine in the 3,3' positions affects the route of excretion in several
animal species.  Rats, dogs, and monkeys were injected intravenously with
^C-labeled benzidine and 3,3'-dichlorobenzidine (2 mg/kg body weight).  As
shown in Table 6.7, differences in the main route of excretion were more
apparent for benzidine than for dichlorobenzidine.  In the rat, both benzi-
dine and dichlorobenzidine were excreted in greater quantities in the feces
than in the urine.  In the dog, fecal excretion of dichlorobenzidine was
again greater than urinary excretion, but fecal excretion of benzidine was
much less than urinary excretion.  In the monkey, neither route decisively
excreted more of either compound, although there was a trend toward greater
excretion of both compounds via the urine.  Sciarini and Meigs (1961&) also
found that dichlorobenzidine excretion by dogs was greater (by some ten
times) in feces than in urine, and, in an earlier study (Sciarini and Meigs,
1958), they found just the opposite pattern for benzidine (i.e., some ten-
fold greater amounts excreted via the urine).

     Biliary secretion is an important route of elimination.  A portion of
the products of benzidine metabolism in rats given intraperitoneal injec-
tions, 100 mg/kg body weight, was excreted by the bile to the stomach and
intestinal tract (Baker and Deighton, 1953).  As shown in Table 6.6, Clayson,
Ward, and Ward (1959) detected some six metabolites of benzidine in bile of
several animal species, but in only one-third the quantity found in urine.
Kellner, Christ, and Lb'tzsch (1973) found benzidine and dichlorobenzidine
in the bile of dogs and monkeys seven days after intravenous injection,

-------
TABLE 6.7.  EXCRETION  IN THE FIRST  SEVEN DAYS AFTER INTRAVENOUS ADMINISTRATION OF 0.2 mg OF  1;
-------
                                    97


but not in the bile of rats after an identical administration.  However,
the biliary concentrations found were low as compared with those found in
urine or feces.

     Rinde and Troll  (1975) reported that the rhesus monkey can metabol-
ically reduce a number of benzidine-based azo dyes to free the amine.  They
found substantial amounts of benzidine and monoacetylbenzidine in the urine
of animals fed single doses of these dyes.  This finding is in agreement
with the finding by Akiyama (1970)  (Section 6.2.3.1) that workers occupa-
tionally exposed to benzidine yellow (derived from 3,3'-dichlorobenzidine)
excreted dichlorobenzidine in their urine, presumably through metabolic
reduction of this dye.

     The metabolism and  excretion of benzidine derivatives and related
compounds have been less extensively studied than  that of benzidine.
Sciarini and Meigs  (19612?) injected dogs  intraperitoneally with 3,3'-
dimethylbenzidine  (diorthotolidine), 3,3'-dimethoxybenzidine  (dianisidine),
and  3,3'-dichlorobenzidine.  Administered levels of  these compounds were
only partly accounted for by measured, urinary excretory products.  All
three diamines were recovered partly in their nonmetabolized  form.  A
metabolite of  diorthotolidine, thought to be the 5-ethereal sulfate, was
recovered at concentrations ranging from  15% to 40%  of the administered
dose.  A metabolite of dianisidine  was also recovered, but at a relatively
lower percentage yield.   However, no metabolite of dichlorobenzidine was
found.  Laham  (1971)  detected an acetyl derivative,  4-amino-4'-acetamido-
3-methoxybiphenyl, in the urine of  rats following  injection of 3-methoxy-
benzidine, the mono-substitute of dianisidine.  Radomski et al. (1973)
found 4-nitrosobiphenyl  and N-hydroxy-4-aminobiphenyl in the urine of dogs
and  rhesus monkeys fed 5 mg of 4-aminobiphenyl per kilogram body weight.
Monkey urine contained a third metabolite, N-hydroxy-4-acetylaminobiphenyl
glucuronide.  Urinary excretion of  the N-hydroxy metabolites was more rapid
in both animals than  that of the administered 4-aminobiphenyl, with the max-
imum excretion occurring at 4 to 6  hr  (Figure 6.4).  Bradshaw and Clayson
(1955) fed dogs 200 mg/day of 4-aminobiphenyl and  recovered the parent com-
pound and a metabolite,  3-hydroxy-4-aminobiphenyl  from the urine.  Bradshaw
(1959) calculated recoveries in the urine of several species of animals fed
4-aminobiphenyl.  The yield of the  3-sulfuric acid conjugate measured in
the  urine was 25% to  40% in dogs, 3% to 7% in rats,  1% to 2% in hamsters,
1% in mice, and 0% in guinea pigs.

6.3  EFFECTS

     As noted by Clayson (1976) , there is convincing evidence that benzi-
dine is a bladder carcinogen in humans and that benzidine and several deriv-
atives are carcinogenic  in experimental animals.   In addition to their
carcinogenic potential,  there is also evidence that  these compounds cause
dermatitis, cystitis, and hematuria in humans and  a number of additional
effects in experimental  animals.  A summary of these effects  is provided
in Table 6.8.

-------
                                      98
                                            ORNL-DWG 77-9687
            2  -
          en
          E
         Q
         LU
         H
         iLl
         o:
         o
         x
o
s
<
            1   -
            0
                                      N-HYDROXY-4-

                                      AMINOBIPHENYL

                                  	 N-HYDROXY-4-

                                      ACETYLAMINOBIPHENYL
              0
                                           10
12
                                  TIME  ( hr!
     Figure 6.4.   Comparative excretion of N-oxidation products of  4-amino-
biphenyl by monkeys and dogs.  Source:   Adapted from Radomski et al.,  1973,
Figure 2, p. 992.

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                                   99
           TABLE 6.8.  EFFECTS OF BENZIDINE, ITS CONGENERS,
               AND METABOLITES ON VARIOUS ANIMAL SPECIES
Species
       Carcinogen
            Effect
Mouse      Benzidine

           3,3'-Dihydroxybenzidine
Rat
Hamster
Rabbit
Dog
Benzidine and its sulfate
           3,3'-Dihydroxybenzidine
           Dianisidine
           o-Ditoluidine
3,3'-Benzininedioxyacetic

3,3'-Dichlorobenzidine
N,N'-Diacetylbenzidine

Benzidine
           O-Ditoluidine
Benzidine
Benzidine
Monkey     Benzidine

Human      Benzidine
Hepatoma, lymphoma, bile duct
  proliferation

Hepatoma, lymphoma, bile duct
  proliferation, benign blad-
  der papilloma

Cirrhosis of liver, hepatomas,
  carcinoma of Zymbal's gland,
  adenocarcinoma, degeneration
  of bile ducts, sarcoma, mam-
  mary gland carcinoma
Hepatoma, adenocarcinoma of
  colon, carcinoma of fore-
  stomach, Zymbal's gland
  carcinoma, bladder carcinoma
Zymbal's gland carcinoma,
  ovarian tumor
Papilloma of stomach, Zymbal's
  gland carcinoma, mammary
  tumor, leukemia
Papilloma of bladder, hepatic
  sarcoma
Extensive cancer
Chronic glomerulonephritis

Hepatoma, liver carcinoma,
  cholangiomas

Bladder cancer

Proteinuria, hematuria, liver
  cirrhosis, myocardial atro-
  phy, bladder tumor, gall
  bladder tumor

Recurrent cystitis, bladder
  tumor, convulsions, liver
  cirrhosis, hematuria

No pathological changes

Bladder tumor, papilloma,
  chronic cystitis, hematuria
     a
      ,3,3'-Dimethoxybenzidine.
       3,3'-Dimethylbenzidine.
      Source:   Adapted  from Haley,  1975,  Table  5,  p.  24.
 permission  of  the  publisher.
                                              Reprinted by

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                                   100
6.3.1  Physiological Effects

     During in vitro studies on benzidine, its derivatives, and related
compounds, Hirai and Yasuhira (1972) found a possible relationship between
the potential carcinogenicity of these compounds and their ability to reduce
cytochrome o.  3,3'-Dichlorobenzidine and p-aminobiphenyl failed to reduce
cytochrome o; benzidine,  3,3'-dimethylbenzidine, and 3,3'-dimethoxybenzidine
were moderate reductants;  and 3,3'-diaminobenzidine was a strong reductant.
Gammer and Moore (1973) also reported that 3,3'-diaminobenzidine markedly
reduced cytochrome o.  Thus, a compound such as p-aminobiphenyl, considered
to be strongly carcinogenic, displayed weak reducing power, whereas 3,3'-
diaminobenzidine,  considered to be weakly carcinogenic, displayed strong
reducing power.  The authors suggested that aminobiphenyls which are easily
oxidizable by mitochondrial systems may be detoxified in this manner and
excreted in combination with sulfuric and amino acids.

     Exposure to benzidine alters the activity of several enzymes.  The
activity of 3-glucuronidase in urine of exposed workers is significantly
increased when compared with activity levels in healthy unexposed workers
(Kleinbauer et al. , 1969;  Popler, Selucky, and Vlasak,  1964).  Removal of
workers from benzidine exposure decreased the enzyme activity; however,
the decrease did not reach the level in unexposed workers.

     Exposure to benzidine also decreases enzyme activity.  Subcutaneous
administration of benzidine to rabbits caused a decrease in blood pheno-
lase activity (Nakajima,  1955), whereas diorthotolidine did not cause this
decrease.  Since blood phenolase activity decreases prior to the appear-
ance of anemia, phenolase activity may be a means of early diagnosis of
poisoning by aromatic derivatives.  Catalase and peroxidase activity was
decreased in rats injected with benzidine (Soloimskaya, 1968).  Along with
the decreased enzyme activity, there was a decrease in erythrocytes and
thrombocytes and an increase in leucocytes.

     Along with decreasing enzyme activity in rats, an increase in male
rat liver glutathione occurred with exposure to benzidine (Neish, 1967).
The compound was injected intraperitoneally at a dose of 12.7 mg/100 g
body weight.  The control glutathione value was 182 mg %, whereas the
value 24 hr following benzidine injection was 272 mg %.

6.3.2  Toxicity

6.3.2.1  General Toxicity — Benzidine and benzidine derivatives cause poi-
soning in laboratory animals resulting in glomerulonephritis and nephrotic
syndrome.  Indirect evidence of transplacental effects on embryonic tissues
also has been observed.  In humans, benzidine compounds have been associ-
ated with dermatitis, cystitis, and hematuria.

6.3.2.1.1  Dermatitis — Schwartz, Tulipan, and Peck (1947) reported cases of
dermatitis among workers  in several dye manufacturing plants and attributed
a portion of these cases  to benzidine.  Both benzidine and 3,3'-dimethylben-
zidine have caused dermatitis in chemists who work in laboratories.  Various
benzidine color dyes have been implicated as causing dermatitis; however,
not all exposed workers are irritated by these compounds.  Individual sensi-
tivity plays a role in determining dermatitis development.

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                                   101
6.3.2.1.2  Glomerulonephritis and nephrotic syndrome — N,N'-Diacetylbenzi-
dine has been used to produce a nephrotic syndrome in rats which morpholog-
ically resembles a rapidly progressive human glomerulonephritis  (Harman et
al., 1952; Harman, 1971).  Both sexes of Sprague-Dawley rats were fed a
grain diet containing 0.043% N,N'-diacetylbenzidine.  Proteinuria developed
in both sexes within three to four weeks.  In females, proteinuria rapidly
became severe until as much as 0.1 g of protein was excreted within a 24-hr
period following two months on the diet.  Severe anemia in females appeared
following proteinuria (Table 6.9), whereas in the male rats anemia was rare
and never severe.  Females, after developing proteinuria, displayed hypo-
proteinemia, hyperlipemia, generalized edema, and, as previously mentioned,
anemia.  Glomerular lesions which consisted of florid epithelial crescents,
progressive sclerosis, and obliteration of many glomeruli appeared in
females.  Similar renal lesions developed in males; however, their appear-
ance was slower and less extensive.  Only a mild nephrotic syndrome was
found in male rats.  Atrophy of the testes developed in all males which
showed the syndrome.  Morphological similarities between the nephrotic
syndrome produced in rats by N,N'-diacetylbenzidine and the human syndrome
included extracapillary cell proliferation, formation of luxuriant cres-
cents in 80% of the glomeruli, intact tufts in almost all glomeruli,  and
the prevalence of many normal glomeruli in advanced grades of the syndrome.
     Rats fed N,N'-diacetylbenzidine and 4,4,4',4'-tetramethylbenzidine
at equal molar levels of 0.25% and 0.27%, respectively, developed lipemia
and glomerular lesions consisting of fat-filled spaces in the glomerular
tuft from 2 to 4.5 months after beginning of treatment (Dunn, Morris,  and
Wagner, 1956).  No difference in the effects of the two compounds was
observed.  Two groups of inbred mice fed these compounds at the same con-
centration showed no effects.  N,N'-Diacetylbenzidine introduced by sub-
cutaneous (100 mg) or intraperitoneal (100 or 200 mg) injection produced
severe glomerulonephritis in 5 rats and mild lesions in 12 rats (Bremner
and Tange, 1966).  Renal lesion severity may have varied with the dose of
        TABLE 6.9.  DEVELOPMENT OF PROTEINURIA AND ANEMIA IN FOUR
                    FEMALE RATS FED A DIET CONTAINING
                         N,N'-DIACETYLBENZIDINE


                                       Mean value after feeding

            Observation
                                 0-3       4-8      9-10       11
                                weeks     weeks     weeks     weeks
      Red cell count, 106/yl    8.23     7.69      6.81      3.51

      Daily protein loss in
        urine, mg               16.54    378.67    314.38    250.63
           Source:  Adapted from Harman,  1971,  Table III,  p.  123.
      Reprinted by permission of the publisher.

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                                   102


the compound.  In another study, Christopher and Jairam  (1970) reported a
low-grade type of glomerulonephritis present in white rats fed 4,4'-
diaminobiphenyl.

6.3.2.1.3  Subacute toxicity — Mice daily fed 0.01% to 0.08% benzidine
dihydrochloride exhibited various toxic symptoms (Rao et al., 1971).  The
mice lost weight in proportion to the dose of benzidine received, with
males losing up to 20% and females up to 7% of their body weight.  The
weights of the carcass, liver, and kidney decreased with an increase in
dose, whereas the spleen and thymus weights increased with dose increases.
Among morphological effects were cloudy swelling of the liver, vacuolar
degeneration of renal tubules, and hyperplasia of the myeloid elements in
bone marrow and of lymphoid cells in the spleen and thymic cortex.  Male
mice appeared more sensitive to benzidine than did female mice.  This find-
ing seems to be in disagreement with that of Harman (1971) , who reported
female rats more sensitive than male rats.  However, this difference may
be a species difference, a difference in benzidine compounds, or a combi-
nation of these two possibilities.

6.3.2.1.4  Indirect evidence of transplacental effects — Golub (1969) and
Shabad et al.  (1972) found that 3,3'-dichlorobenzidine and 3,3'-dimethyl-
benzidine increased survival time of embryonic mouse kidney tissue cultures
and produced hyperplastic changes in the epithelium.  Eight to 10 mg of
either compound injected subcutaneously into pregnant mice produced hyper-
plastic growth that was nodular or diffuse or that formed solid, compact
areas in explanted embryonic kidney tissue five to six days after adminis-
tration (Table 6.10).  Longer survival of the explanted kidneys was pro-
moted by treatment with these two compounds during pregnancy.  Administration
of a total dose of 8 to 10 mg per mouse of 3,3'-dimethylbenzidine by subcu-
taneous injection to BALB/c mice during the last week of pregnancy produced
an increased incidence of tumors in the progeny (Golub, Kolesnichenko, and
Shabad, 1974).  Eight of 16 mice had tumors; 6 with adenomas of the lungs
and 5 with tumors of the mammary gland.  The tumors found in the progeny
could have been induced by transplacental action or by transmission of
3,3'-dimethylbenzidine through milk of the lactating mothers.

6.3.2.2  Carcinogenicity — Benzidine and several other aromatic amines
have been implicated as carcinogens of the urogenous organs, particularly
the bladder (Hueper, 1954).   However, it is generally accepted that metab-
olites of these aromatic amines, referred to as proximate carcinogens, are
the active compounds (Clayson, 1969).  The metabolites are formed by con-
version of the aromatic amines to ring hydroxylated compounds which then
are N-hydroxylated,  acylated and deacylated, and conjugated with sulfate
and glucuronic acid (Haley,  1975).  Evidence suggests that the N-hydroxyl-
ation produces the precarcinogen and that the sulfate or glucuronidate
conjugates are the carcinogenically active forms in vivo.  Metabolites
produced by experimental animals apparently have an affinity to and exert
a carcinogenic action on organs other than the bladder (Hueper, 1961).
The carcinogen apparently must be administered to the animal a consider-
able time before tumors are produced.

     There is strong experimental evidence that benzidine and related com-
pounds  induce various tumors in laboratory animals.   As noted in Table 6.8,

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    TABLE 6.10.  SURVIVAL AND HYPERPLASTIC CHANGES OF EPITHELIUM IN EMBRYONIC KIDNEY TISSUE CULTURES TREATED
                     TRANSPLACENTALLY WITH 3,3'-DICHLOROBENZIDINE AND 3,3'-DIMETHYLBENZIDINE
3,3' -Dichlorobenzidine-treated
Duration of
experiment
(days)
3-4
6-7
14-15
18-20
Total
Total survival, %
Total percentage
of hyperplastic
growth

Number of
surviving explants
in control
cultures /total
13/13
12/12
0/23
0/7
25/55
45.5




Number of
surviving
explants /total
3/3
6/6
48/56
9/13
68/78
84.9



culture

Hyperplastic
changes
(outgrowths)
2
15
3

20



30.4
3,3 '-Dimethylbenzidine-treated

Number of
surviving
explants /total
6/6
8/8
12/16

26/30
86.9




Hyperplastic
Hyperplasia
of tubules
2
1


3



11.5
culture

changes
Outgrowths
1
1
4

6



23.1
 Control cultures did not reveal any hyperplastic changes.

Source:  Adapted from Shabad et al., 1972, Table 6, p. 621.  Reprinted by permission of the publisher.

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                                   104


many of these are located in the liver.  In single experiments without con-
firmation, bladder cancer induction in experimental animals was limited to
the dog and rabbit.

     As pointed out by Haley (1975), a serious problem exists with the
animal experimentation so far accomplished in that experiments have always
been carried out at toxic doses that resulted in liver failure and death of
the majority of the animals prior to tumor development.  He suggested that
one means of correcting this problem would be the performance of a 90-day
subacute study in several species at dosage levels below those known to
produce liver pathology.
     Despite the substantial evidence accumulated indicating a strong
association between occupational exposure to benzidine and the develop-
ment of bladder cancer in humans, a cause-effect relationship has not
been established in the epidemiological sense.  (See MacMahon and Pugh,
1970,  for epidemiological procedure and meaning.)  A note of caution,
therefore, seems warranted.  In the following discussion of a number of
studies made on occupationally exposed workers, the proportions of per-
sons with cancer are noted for specific periods.  Such proportional rates
do not express the real magnitude of the risk associated with the expo-
sures  encountered.  However, this magnitude can be determined by compar-
ing the rate of bladder cancer among the exposed workers with the rate of
bladder cancer among the unexposed population at large.  This concept of
risk is useful in identifying high-risk groups.  For example, Case et al.
(1954) reported that the risk of developing bladder cancer was 14 times
greater among workers exposed to benzidine than in persons without such
exposure.

6.3.2.2.1  Benzidine — Benzidine has been associated with a high occur-
rence of bladder cancer in exposed industrial workers (International Agency
for Research on Cancer, 1972; Riches, 1972; Sax, 1975).  Malignancies have
been reported following only a few weeks of exposure and a latent period
of several years (Deichmann and Gerarde, 1969).  Hamblin (1963) reported
an average latent period of 18.6 years for bladder tumors.  The develop-
ment of tumors from benzidine exposure seems to be related to the degree
of control of exposure afforded by work habit and personal hygiene pro-
grams  (Rye et al., 1970).   The occurrence of tumor formation is affected
by initial exposure concentration, exposure duration, and years of sur-
vival following exposure.   However, there is a lack of data on the benzi-
dine concentrations to which workers have been exposed.

     Zavon,  Hoegg, and Bingham (1973) reported 13 of 25 exposed men devel-
oped tumors  of the bladder.  This unusually high occurrence rate may have
been due to  the long exposure period.  The workers were exposed to other
chemicals; however, benzidine was the chemical common to all and was indi-
cated as the carcinogen.  Those who developed tumors were exposed to ben-
zidine more  than 13 years,  whereas the nontumor group was exposed less than
9  years.   The tumor recurrence rate was 62% (Wendel, Hoegg, and Zavon,
1974).   Samples of benzidine atmospheric concentrations taken from vari-
ous locations in the benzidine manufacturing plant ranged from less than
0.005  to 0.415 mg/m ,  except in one location where the concentration was
17.6 mg/m3.

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                                   105
     Bladder tumors in benzldine-exposed workers are found in all coun-
tries in which this chemical is manufactured and used.  In France, 85
cases of bladder tumors in men working in aromatic amine manufacturing
plants were found before 1960 (Billiard-Duchesne, 1960).  Fifty-one cases
originated in a factory in Normandy; 17 cases from this factory occurred
prior to 1947 and 34 subsequent to 1947-  Eighteen of those 34 had symp-
toms of hematuria and stranguria.  Seven of the 18 were not directly
exposed to the amines, but they had worked in the factory an average of
25 years.  Kuzelova, Kunor, and Hurt (1969) reported positive findings
in 17%  of those examined for urinary system tumors in workers employed
in benzidine production.  The average length of exposure was eight years;
the highest rate of positive findings was among those with six to ten
years of exposure.

     Gehrman (1936) reported occurrence of bladder tumors among workers
in the American dye industry.  A total of 24 cases of carcinoma appeared
in workers exposed to aromatic amines,  including benzidine.  The average
exposure time necessary to produce tumors was 12 years.   Case et al.  (1954)
found that workmen exposed to benzidine in the dyestuff industry in England
had more bladder tumors than unexposed workers.  The induction period aver-
aged 16 years; however, some tumors appeared in less than 2 years.  Report-
ing on the occurrence of bladder tumors in a British dyestuff factory,  Scott
(1952) found 66 cases of bladder tumors in which 30 were of workers exposed
to benzidine.  The latent period averaged 15.9 years and ranged from 8  to
32 years (Figure 6.5).  The intensity of exposure in the benzidine manufac-
turing was thought to be a factor in producing earlier tumors among these
workers than among workers engaged in benzidine handling.   Of 23 cases  of
bladder tumors in benzidine-exposed workers in manufacturing, 14 had papil-
loma, 7 had carcinoma, and 2 had papilloma which recurred as carcinoma.

     Studies on the occurrence of bladder tumors among workers in Italian
dyestuff factories indicated a higher proportion among benzidine-exposed
workers than among unexposed workers.  Vigliani and Barsotti (1962) found
24 cases of bladder tumors in a total of 109 workers exposed to benzidine
or benzidine and g-naphthylamine.  From 1931 to 1960, 47 bladder tumors
were found in workers exposed to benzidine.  Of these, 21 were carcinomas
and 16 were papillomas.  From 1931 to 1948, 13 cases of carcinoma of the
bladder were detected in 83 workers exposed to benzidine in a dyestuff
plant (Barsotti and Vigliani, 1952).  Men working in filtration, pressing,
drying, and milling in the benzidine processing had the greatest exposure.
Workers with tumors had been exposed to benzidine from 5 to 16 years with
an average exposure of 8 years.  The maximum time between cessation of
benzidine contact and tumor development was 16 years.  Over a period of
six years (1964 to 1970), Forni, Ghetti, and Armeli  (1972) examined 858
workers in five dyestuff factories and found 17 cases of bladder tumor.
Of these, ten were papillomas and seven were carcinomas.

     Tsuchiya, Okubo, and Ishizu (1975) studied 100 cases of occupational
bladder cancer reported from 1949 to 1970 by dye-producing companies in
Japan.  Only a few of these cases were reported prior to 1955 because  of
the long latent period involved.  The proportion of bladder tumors was
11.25% among workers involved in benzidine production and 1.45% among

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                                    106
                                             ORNL-DWG 77-9688
                           10     15     20     25

                             LATENT PERIOD  (years)
30
35
     Figure 6.5.   Graph of time from initial exposure to benzidine to
diagnosis of tumors.   Source:   Adapted from Scott,  1952, Figure 3, p. 129,
Reprinted by permission of the  publisher.
 those concerned with benzidine use.   Eight  of  the 100 cases developed
 tumors in the upper urinary tract  that  did  not involve the bladder.   The
 average latent period for those exposed to  benzidine was 16.25 years with
 a standard deviation of  7.38 years.   A  high risk of  bladder tumors among
 silk kimono painters in  Kyoto was  reported  by  Yoshida and Miyakawa (1973).
 These painters moistened brushes with the tongue and accidentally ingested
 benzidine dyes, probably causing the  bladder tumors.

      Workers in the coal tar dye industry also have  a high occurrence of
 bladder tumors.  Goldwater,  Rosso, and  Kleinfeld (1965)  reported 21.3% of
 employees exposed to benzidine contracted malignant  bladder tumors in a
 coal tar dye plant.   Those  exposed to benzidine plus 3-naphthylamine had a
 higher rate of 45.5%.  The  average latent period until tumor development
 was  18.4 years for papillomas and  18.7  years for malignancies.   In a later
 report,  Kleinfeld,  Rosso, and Goldwater (1966) also  reported a higher pro-
 portion of bladder tumors in coal  tar dye plant workers  exposed to benzi-
 dine plus 3-naphthylamine than among  workers exposed to  only benzidine.

      Mancuso and  El-Attar  (1966, 1967)  found a higher proportion of  blad-
 der  and  kidney cancer  in benzidine-exposed  workers in a.  plant manufactur-
 ing  benzidine and g-naphthylamine  than  that found among  unexposed workers.

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                                   107


Of 171 deaths among the exposed workers, 18 were reportedly due to bladder
and kidney cancers.  There was also a higher rate of malignant neoplasms
of the digestive system.  Exposure to benzidine plus 3-naphthylamine was
apparently more potent than exposure to benzidine alone.

     In a report of carcinogenic hazards in microbiology laboratories,
Wood and Spencer (1972) suggested that benzidine exposure in the labora-
tory could cause bladder cancer.  Benzidine is used in clinical biochemi-
cal laboratories and presents a carcinogenic hazard to technicians (Collier,
1974; Veys, 1972).  Congo Red, a benzidine-based azo dye, has been used as
a bacteriostatic agent in the isolation of tubercle bacilli from sputum
(Frobisher, 1946) and is still employed as an indicator dye in the mixed
culture of Rhizobi-ivn species and related species of bacteria (Vincent,
1970, pp. 4-5).

     Occupational tumors of the bladder from benzidine exposure have a
long latent period averaging 18 years.  Age is not considered a factor in
disease development  (Hamilton and Hardy, 1974).  These occupational blad-
der tumors appear to be similar to bladder tumors found in the general
public and have a tendency for high recurrence.

     Benzidine is carcinogenic in several animal species under varying
conditions (Casarett and Doull, 1975).  There appears to be, however, some
controversy about the induction of bladder tumors by benzidine in dogs.
Haley (1975) stated that benzidine does in fact produce bladder tumors in
dogs.  Spitz, Maguigan, and Dobriner  (1950) found a papillary carcinoma
of the urinary bladder in one of seven dogs fed benzidine for five years.
The tumor was found seven and one-half years after the start of the exper-
iment.  Benzidine administered orally to dogs has not produced bladder
cancer (Marhold et al., 1968).  Deichman et al. (1965) fed female beagle
dogs 1 mg/kg of benzidine per dog five times a week for three years;  no
tumors were found.  The carcinogenic actions of 2-naphthylamine, benzi-
dine, 4-aminobiphenyl, and 4-nitrobiphenyl were not additive when the
compounds were fed together.

     Saffiotti et al. (1967) failed to induce bladder tumors in 30 male
and female Syrian golden hamsters fed benzidine at 0.1% of the diet through-
out their life spans.  Carcinogenic effects were produced in other organs;
extensive bile duct proliferations and cysts appeared, with cholangiofi-
brosis and liver cell carcinoma and hepatomas.

     Benzidine injected subcutaneously into rats at 15 mg/week produced
hepatic injury followed by cirrhosis  (Spitz, Maguigan, and Dobriner,  1950).
Sebaceous gland carcinomas were found as well as hepatomas and adenocar-
cinomas of the rectum.  No bladder tumors were produced.  Baker (1950)
subcutaneously injected Albino Delph mice with 300 mg benzidine or 300 mg
dihydroxybenzidine, a suspected benzidine metabolite produced in humans.
Both bladder and liver changes were found, including benign papillomas of
the bladder.  Table 6.11 summarizes these effects.  Dihydroxybenzidine
produced benign papillomas in the bladders of the mice, whereas mice re-
ceiving benzidine did not show these effects.  Later, Baker (1953) found
changes in the liver, including cirrhosis and hepatomas, adenocarcinoma

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                      TABLE 6.11.
                                   BLADDER AND LIVER CHANGES PRODUCED IN ALBINO DELPH MICE ADMINISTERED BENZIDINE
                                            OR DIHYDROXYBENZIDINE BY SUBCUTANEOUS INJECTION

Group

Al
A2

Bl, B2
Cl, C2

Chemical
administered

300 mg benzidine base
300 mg 3,3'-dihydroxy-
4,4 '-diaminodiphenyl
Olive oil
Untreated

surviving
45 weeks

9

9
19
17

.. . Papillomas
Normal TT .,
bladder . ,. n .
Benign Malignant

9

215
17 2
17




„ -, T, • n j Hepatomas
Normal Bile duct
liver

1

5
13
12
proliferation
Benign

3 4

1 3
3 3
3
Malignant

I



2 ?


1— '
o
00



Source:   Adapted from Baker, 1950, Tables II and III, p. 49.  Reprinted by permission of the publisher.

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                                    109
of the colon, carcinoma of the sebaceous gland next to the external audi-
tory canal (Zymbal's gland), and squamous-cell carcinoma of the stomach
in rats fed 5 to 8 g/day of dihydroxybenzidine (0.125% of a normal basic
diet).  In three of the seven surviving animals, one sessile papilloma
and two keratinized squamous-cell carcinomas of the bladder wall appeared.
Wistar rats injected intraperitoneally or subcutaneously with 100 or 200
mg of N,N'-diacetylbenzidine developed tumors primarily in the external
auditory canals and mammary glands 6 to 15 months following injection.
Twenty-four tumors were formed in 14 of 30 rats.  Severe glomerulonephri-
tis was found in 5, and mild lesions were found in 12 animals.  Renal
lesion severity probably varied  in relation  to the size of the dose.
Griswold et  al.  (1968)  also  reported  carcinomas of the mammary gland in
female Sprague-Dawley  rats given 12  to 50 mg of benzidine per rat orally.
One  fibroadenoma was also found  in the mammary gland.  However, Marhold
et al.  (1967, 1968) found no  tumors  in Wistar rats fed 2 mg of benzidine
per  rat per  day for their life spans.

      Rats  given benzidine  (the amount of dose was not specified) by sub-
cutaneous  injection for six months developed cirrhosis early in the study
 (Pliss, 1963).  Hepatomas, tumors of  the Zymbal's gland, and sarcomas at
the  injection site were found.   These tumors made up 70% of those found
in the rats  (Pliss, 1964).   Benzidine was more toxic to female rats than
to male rats.   Injection of  3,3'-benzidine dicarboxylic acid in mice and
rats  over  a  period of  a year  produced tumors of the Zymbal's gland and
the  liver  (Pliss,  1969).  Four of 28  rats injected weekly with 5 mg ben-
zidine developed intestinal  tumors, and 4 of 37 rats injected weekly with
5 mg  benzidine  plus 10  mg orthotolidine had  intestinal tumors (Pliss,
Volfson, and Jogannsen, 1973).   The activity of benzidine plus orthotol-
idine did  not appear to be additive.

      Of 22 rats given  an accumulative dose of 0.75 g/kg body weight of
benzidine  for 15 days,  20 rats developed tumors, including 19 hepatomas,
18 cholangiomas, 7 intestinal tumors, and 4  carcinomas of the sebaceous
gland (Holland  et  al.,  1974).  Tetramethylbenzidine  (4.15 to 8.3 g/kg
body  weight) given subcutaneously produced only benign tumors at the injec-
tion  site  and, hence, was not considered carcinogenic.

      Bonser, Clayson,  and Jull  (1956) subcutaneously administered benzi-
dine  or 3,3'-dihydroxybenzidine  in weekly doses of 6 mg for 52 weeks to
mice  until exitus.  Benzidine induced hepatomas and lymphomas, whereas
3,3'-dihydroxybenzidine induced  lymphomas and benign intestinal polyps.
Induction  periods  were  70 weeks.  One-third  of the control animals devel-
oped  spontaneous lymphomas, which made significant interpretation diffi-
cult.  3,3'-Dihydroxybenzidine was a weak carcinogen in mice, causing
tumors of  the liver and mammary  gland and also causing leucosis when it
was given  subcutaneously (Pliss, 1961).  When 3,3'-dihydroxybenzidine was
applied to the skin, the mice developed tumors of inner organs.  Benzi-
dine  administered  subcutaneously in weekly doses of 6 mg to mice of line
C3HA  produced hepatomas in 31 of 46 mice (Prokofjeva, 1971).  One mouse
had a pulmonary adenocarcinoma.  The  first tumors appeared 15 to 16 months
following  the beginning of benzidine administration.

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                                   110


     N,N'-Diacetylbenzidine produced tumors in female Wistar rats given
a single intraperitoneal (100 or 200 ing) or subcutaneous (100 mg) injec-
tion (Bremner and Tange, 1966).  In 14 of 30 rats, 24 tumors developed
principally in the external auditory canals and mammary glands 6 to 15
months after injection.   Interestingly, tumors did not develop in the 6
animals given 200 mg intraperitoneally, whereas they did develop in 11
out of 18 animals given 100 mg by the same route.

 6.3.2.2.2   3,3'-Dimethylbenzidine  (Diorthotolidine) — There  is no evi-
 dence  that  diorthotolidine is  carcinogenic in humans  (Rye, Woolrich, and
 Zanes, 1970).  It is a weaker  carcinogen than benzidine in animals  (Sax,
 1975), and  this difference may carry over to humans.  Transient hematuria
 is  a common symptom in workers exposed to diorthotolidine  (Hamblin, as
 cited  in Rye, Woolrich, and Zanes, 1970).  Since diorthotolidine follows
 a metabolic pathway similar to benzidine (Rye, Woolrich, and Zanes, 1970),
 it  should be treated as a potential industrial carcinogen  (Sax, 1975).

     The only data concerning  diorthotolidine carcinogenicity are obtained
 from studies dealing with rats and mice.  Rats treated with an accumula-
 tive dose of 5.4 g/kg body weight of diorthotolidine for 241 days devel-
 oped 11 gastrointestinal tract tumors, 7 hepatomas, 4 tumors of bone and
 associated  tissues, and 4 carcinomas of the Zymbal's gland.  Twenty female
 Sprague-Dawley rats were given diorthotolidine orally up to a total dose
 of  500 mg per rat.  At  the end of nine months, 3 of 16 surviving rats had
 a total of  four mammary carcinomas  (Griswold et al., 1968).  The method
 of  administration seems to influence where tumors develop.  Pliss and
 Zabezhinsky (1970) administered diorthotolidine to rats either by subcu-
 taneous injection (20 mg per rat) or by subcutaneous implantation of pel-
 lets  (20 mg per rat) for 13 to 14 months.  Tumors, mainly of the skin,
 large  sebaceous glands, and mammary glands, developed in 60% to 70% of the
 rats  (Table 6.12).  Implantation of pellets of diorthotolidine induced
 subcutaneous sarcomas in 2 of  68 rats and hepatocellular carcinomas in 4;
 this effect was not found when diorthotolidine was injected.

 6.3.2.2.3   3,3'-Dimethoxybenzidine  (Dianisidine) — Dianisidine is another
benzidine derivative in which  there is no evidence of carcinogenicity in
humans (Rye,  Woolrich, and Zanes, 1970).  However, several studies have
provided evidence that it is carcinogenic to rats.  Dianisidine adminis-
 tered by subcutaneous injection induced tumors of the Zymbal's gland in two
rats and an ovarian tumor and  fibroadenoma of the mammary glands in another
rat (Pliss,  1963).  The incidence rate was low since only 3 of 18 rats
developed tumors.  After 260 doses of dianisidine (10 mg per dose) given
orally, both male and female Fischer rats developed tumors in the gastro-
intestinal  tract, skin, breast, and ear duct  (Weisburger et al. , 1967).
Tumors developed as early as 293 days after the first administration.

6.3.2.2.4   3,3'-Dichlorobenzidine — No cases of bladder cancer in humans
attributable to dichlorobenzidine have been reported  (Rye, Woolrich, and
Zanes, 1970).  However, tumor  induction by this compound has been demon-
strated in  rats and mice, and  there is some evidence for its complicity
in  the occurrence of nonbladder tumors in humans.

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                  TABLE 6.12.   TUMORS INDUCED IN RATS RECEIVING 20 mg OF DIORTHOTOLIDINE EITHER BY SUBCUTANEOUS INJECTION
                                                   OR SUBCUTANEOUS IMPLANTATION OF PELLETS
, r- m. r Number of rats , , . . . , . . a
Number of Time of Number of rats with tumors at specific sites

IXLetnoa ot rats at iirst tumor . .. 	
, . . ,_ . ... . Survived , , . ,
administration beginning of appearance . ,. With Zymbal s
/ , , to time or , ,
experiment (months) tumors gland
v first tumor &
Injection 27 males 8 25 17 14
(8-22)
26 females 8 25 13 6
(8-20)
Total 53 8 50 30 20
Implantation 24 males 12 16 11 6
(12-18)
24 females 12 20 12 5
(12-18)
Total 48 12 36 23 11

Mammary
gland


5
(13-22)
5


7
(12-23)
7

Skin
2
(18-23)
1
(16)
3
1
(17)
1
(18)
2

Preputial T . Fore—
, , Liver , i
gland stomach
213
(20-22) (23) (21-25)
1
(13)
313
3
(15-20)


3

at site of Other
mplantation
S6

1°

6
3d
(20)
I8
(20)
1 4
     ^Numbers in parentheses indicate time of tumor appearance in months.
      In one rat, tumor of small intestine; in two rats, tumors of hematopoietic system (in 12 and 23 months respectively);  in one rat,
thyroid tumor (in 25 months); in one rat, lung tumor (in 22 months).
      JJterine tumor.
      In one rat, angiosarcoma in area of anterior extremity (in 14 months); in one rat,  neurosarcoma in area of the ear (in 15 months); in
one rat, tumor of hematopoietic system (20 months).
      Lymphangioma in neck region.

     Source:  Adapted from Pliss and Zabezhinsky, 1970, Tables 1 and 2, p. 285.

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                                    112


     Gerarde and Gerarde (1974) found no bladder tumors in employees at
a New York plant of Hercules, Inc.  The workers were exposed to dichloro-
benzidine for 35 years.  However, 17 workers developed neoplasms in other
locations:  2 in the lung,  1 in bone marrow, 6 lipomas, 3 papillomas of
the rectum, 2 carcinomas of the sigmoid colon, 1 prostate carcinoma, 1
myoblastoma of the breast muscle, and 1 basal cell epithelioma.  At a
British plant using dichlorobenzidine for 30 years, no cases of bladder
cancer were found among more than 200 exposed employees (Maclntyre, 1975).
Most of the exposed workers had been exposed for less than 16 years, which
indicates that the latent period may not have been reached.

     A comparison of tumor incidence was made between workers exposed to
dichlorobenzidine and those exposed to both benzidine and dichlorobenzidine
at a Clayton Aniline plant (Gadian, 1975).  Workers exposed to benzidine
plus dichlorobenzidine developed three bladder tumors, whereas those exposed
to dichlorobenzidine alone did not develop any bladder tumors (Table 6.13).
The employees had been exposed to dichlorobenzidine for 10 to 15 years,
during which time occasional bladder tumor cases should have appeared if
the latent period were similar to benzidine.  It is possible, however, that
the latent period is longer.   If dichlorobenzidine is a human carcinogen,
it would appear to be weaker than benzidine.

     Dichlorobenzidine is carcinogenic to several animal species.  Pliss
(1963) injected 3,3'-dichlorobenzidine subcutaneously into rats and found
tumors in 74% of the animals.  Tumors developed in the skin, sebaceous and
mammary glands, intestines, bones, and urinary bladder.  Tumors developed
in 48 of 64 D-line mice that survived to the appearance of the first tumor
after receiving dichlorobenzidine by ingestion or injection into the under-
lying fat (Pliss, 1959).  Sarcomas were found at the injection site in
seven rats.  Two rats ingesting the compound had adenocarcinomas of the
small intestine.  Tumors were found also in the mammary and sebaceous
glands, and three rats had papillomas of the bladder.

     Griswold et al. (1968) did not find any tumors in rats given dichlo-
robenzidine dihydrochloride (300 mg per rat total dose) by oral feeding.
There was a significant increase in tumor number in progeny of BALB/c mice
given dichlorobenzidine (8 to 10 mg per mouse total dose)  by subcutaneous
injection (Golub, Kolesnichenka, and Shabad, 1974).  Tumors developed in
13 of 24 mice:   4 mice had adenocarcinomas of the mammary gland, 5 had
adenomas of the lung, and 7 had lymphatic leukemia.  Rats  receiving 1000
ppm dichlorobenzidine in the diet had tumors of the mammary gland in both
males and females and tumors in the Zymbal's gland and hematopoietic tumors
in males (Stula, Sherman,  and Zapp, 1971; Stula et al., 1975).

6-3.2.2.5  4-Aminobiphenyl — Melick et al. (1955) studied the workers in a
plant manufacturing 4-aminobiphenyl from 1935 to 1955.  Of the 171 exposed
employees, 11.1% had developed bladder tumors from 5 to 19 years after ini-
tial exposure.   The duration of exposure was 1.25 to 19 years.  A metabo-
lite of 4-aminobiphenyl was suspected as being the carcinogen.  In a follow-
up study to the Melick et al. (1955) study, bladder tumors were found in
workers exposed to 4-aminobiphenyl in two plants manufacturing this com-
pound (Melick,  Naryka,  and Kelly, 1971).  The minimum exposure time to

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           TABLE 6.13.
COMPARISON OF TUMOR INCIDENCE BETWEEN WORKERS EXPOSED TO DICHLOROBENZIDINE
    AND THOSE EXPOSED TO DICHLOROBENZIDINE PLUS BENZIDINE
Number
Group of
men

(hr)
Tumor incidence
Urinary Other
tract
Deaths from
other causes
Segregated dichloro-
  benzidine workers

Mixed benzidine and
  dichlorobenzidine
  workers
  35
  14
68,505
16,200'
                 a
None
One papilloma
  of bladder, two
  carcinomas of
  bladder
None
One carcinoma
  of bronchus
One coronary thrombosis,
  one cerebral hemorrhage

One coronary thrombosis
     a.
      Exposure to approximately 60% benzidine and 40% dichlorobenzidine.

     Source:  Adapted from Gadian, 1975, Table 1, p. 828.  Reprinted by permission of the publisher.

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                                    114


tumor induction was 133 days; the longest time interval for tumor develop-
ment to date was 35 years.  The incidence rate of bladder tumors between
1957 and 1970 increased from 2.3% to 18.5% in one plant, probably because
of workers reaching the latent period required for tumor development.  A
strong association may exist between bladder cancer and occupational expo-
sure to 4-aminobiphenyl (International Agency for Research on Cancer, 1972).

     Bladder tumors have been induced in dogs given 4-aminobiphenyl.  Two
beagle dogs administered 4-aminobiphenyl (30 to 34 g total) by mouth devel-
oped advanced bladder tumors and were killed 33 months after first dosing
(Walpole, Williams, and Roberts, 1954).  Since the tumors appeared early
in the treatment relative to tumor induction time of benzidine, 4-amino-
biphenyl was more effective than benzidine as a bladder carcinogen in dogs.
All female beagle dogs fed 4-aminobiphenyl (0.66 to 0.74 g/kg body weight)
for three years developed from one to several papillomas or carcinomas of
the bladder (Deichmann et al., 1965).  4-Nitrobiphenyl was fed to beagle
dogs at the same dose level, and at the end of the three-year period the
bladders of all treated dogs were normal.   4-Aminobiphenyl was more car-
cinogenic than 4-nitrobiphenyl in the urinary bladder of dogs.  Deichmann
and MacDonald (1968) found that a single dose of 50 mg 4-aminobiphenyl per
kilogram body weight administered by mouth to beagle dogs did not induce
precancerous lesions of the bladder mucosa or tumors in the urinary blad-
der.  Since the dose size was much smaller than that used by others in
producing tumors, tumor development would not necessarily be expected.

     4-Aminobiphenyl is carcinogenic in rats and mice, although the effec-
tive carcinogen is probably an o-hydroxyamine formed in the body's metabolic
hydroxylation (Walpole, Williams, and Roberts, 1952).  Rats subcutaneously
injected with 4-aminobiphenyl at total dose levels of 5.8, 4.4, 4.2, and
3.6 g/kg body weight developed tumors of the liver, intestines, mammary
glands, kidney, and uterus.  Newborn male and female Swiss mice were given
200 yg of 4-aminobiphenyl by subcutaneous injection during the first three
days of life (Gorrod, Carter, and Roe, 1968).  At the termination of the
study, 48 to 52 weeks after injection, greater than 90% of the male mice
and about 18% of the females developed hepatomas.  One pulmonary adenoma,
one thymic lymphoma, and one lymphosarcoma of the spleen also were found.
Testing three hydroxylated derivatives of 4-aminobiphenyl (4-amino-3-
hydroxybiphenyl, 4-hydroxylaminobiphenyl,  and 4-amino-4'-hydroxybiphenyl)
in the same manner produced a significant increase of hepatomas in males
above the controls and a probable significant increase of hepatomas in
females in response to three of the compounds, but not to 4-amino-3-
hydroxybiphenyl.

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                                  115


                               SECTION 6

                               REFERENCES
 1.  Aklyama, T.  1970.  The Investigation on the Manufacturing Plant of
     Organic Pigment.  Jikeikai Med. J. (Japan) 17:1-9.

 2.  Baker, R. K.  1950.  The Carcinogenic Activity of Dihydroxy Benzi-
     dine  (3:3' Dihydroxy 4:4' Diamino Diphenyl?).   Acta Unio Int. Contra
     Cancrum  (Belgium) 7(1):46-51.

 3.  Baker, R. K.  1953.  The Carcinogenic Activity of Dihydroxybenzidine,
     Further Investigations.  Cancer Res. 13:137-141.

 4.  Baker, R. K., and J. G. Deighton.  1953.  The Metabolism of Benzi-
     dine in the Rat.  Cancer Res. 13:529-531.

 5.  Barsotti, M., and E. C. Vigliani.  1952.  Bladder Lesions from Aro-
     matic Amines.  Arch. Ind. Hyg. Occup. Med. 5:234-241.

 6.  Billiard-Duchesne, J. L.  1960.  Cas Francais  de Tumeurs Profes-
     sionnelles de la Vessie (French Cases of Occupational Tumors in the
     Bladder).  Acta Unio Int. Contra Cancrum (Belgium) 16:284-288.

 7.  Bonser, G. M., D. B. Clayson, and J. W. Jull.   1956.  The Induction
     of Tumours of the Subcutaneous Tissues, Liver  and Intestine in the
     Mouse by Certain Dyestuffs and Their Intermediates.   Br. J. Cancer
     (Great Britain) 10(4)=653-667.

 8.  Bradshaw, L.  1959.  The Metabolism of the Carcinogen 4-Aminodiphenyl
     and Related Compounds.   Acta Unio Int. Contra  Cancrum (Belgium)
     15:137-141.

 9.  Bradshaw, L., and D. B. Clayson.  1955.  Metabolism of Two Aromatic
     Amines in the Dog.  Nature (Great Britain) 176(4490):974-975.

10.  Bremner, D. A., and J.  D. Tange.  1966.  Renal and Neoplastic Lesions
     after Injection of N-N'-Diacetylbenzidine.  Arch. Pathol. 81:146-151.

11.  Gammer, W., and C. L. Moore.   1973.  Oxidation of 3,3'-Diaminobenzi-
     dine by Rat Liver Mitochondria.  Biochemistry  12(13):2502-2509.

12.  Casarett, L. J., and J. Doull, eds.  1975.  Toxicology.   Macmillan
     Publishing Company, Inc., New York.  p. 340.

13.  Case, R.A.M., M. E. Hosker, D. B. McDonald, and J. T. Pearson.   1954.
     Tumours of the Urinary Bladder in Workmen Engaged in the Manufacture
     and Use of Certain Dyestuff Intermediates in the British Chemical
     Industry:  Part I.  The Role of Aniline, Benzidine,  Alpha-Naphthyl-
     amine, and Beta-Naphthylamine.  Br. J. Ind. Med. (Great Britain)
     11:75-104.

-------
                                  116
14.   Christopher,  K.  J.,  and B.  T.  Jairam.   1970.   Benzidine (H2N
     C6H4C6Hi.NH2)  Poisoning in White Rats.   Sci.  Cult.  (India)  36(19):
     511-512.

15.   Clayson,  D.  B.   1969.   Some Problems in Bladder Carcinogenesis.
     In:  Physico-Chemical  Mechanisms of Carcinogenesis,  E. D.  Bergmann
     and B.  Pullman,  eds.   The Israel Academy of  Sciences and Humanities,
     Jerusalem,   pp.  284-297.

16.   Clayson,  D.  B.   1976.   Case Study 2:  Benzidine and  2-Naphthylamine -
     Voluntary Substitution or Technological Alternatives.   Ann.  N.Y.
     Acad. Sci.  271:170-175.

17.   Clayson,  D.  B.,  E. Ward, and L. Ward.   1959.   The  Fate of  Benzidine
     in Various  Species.  Acta Unio Int. Contra Cancrum (Belgium) 15:581-
     586.

18.   Collier,  H.  B.   1974.   Are  Orthotolidine and  Dianisidine Health Haz-
     ards to Laboratory Workers?  Clin.  Biochem.  (Canada) 7:3-4.

19.   Deichmann,  W. B., and  H. W. Gerarde.  1969.   Toxicology of Drugs
     and Chemicals.   Academic Press, New York.  p.  90.

20.   Deichmann,  W. B., and  W. E. MacDonald.   1968.   The Non-carcinogenic-
     ity of a  Single Dose of 4-Aminobiphenyl in the Dog.   Food  Cosmet.
     Toxicol.  (Great Britain) 6:143-146.

21.   Deichmann,  W. B., J. Radomski, E. Glass, W.A.D. Anderson,  M. Coplan,
     and F.  Woods.  1965.   Synergism among Oral Carcinogens III,  Simul-
     taneous Feeding of Four Bladder Carcinogens  to Dogs.  Ind. Med. Surg,
     34:640-649.

22.   Dieteren, H.M.L.  1966.  The Biotransformation of  0-Tolidine.  Arch.
     Environ.  Health 12:30-32.

23.   Dunn, T.  B.,  H.  P. Morris,  and B. P. Wagner.   1956.   Lipemia and
     Glomerular  Lesions in  Rats  Fed Diets Containing N-N'-Diacetyl-
     and 4,4-4',4'-Tetramethylbenzidine.  Proc. Soc. Exp. Biol. Med.
     91:105-107.

24.   Elson,  L. A., F. Goulden, and F. L. Warren.   1958.  The Metabolism
     of Aromatic  Amines in  Relation to Carcinogenesis.  Br. J.  Cancer
     (Great  Britain)  12:108-115.

25.   Federal Register.  1976.  41:27012-27017-

26.   Forni,  A.,  G. Ghetti,  and G. Armeli.  1972.   Urinary Cytology in
     Workers Exposed  to Carcinogenic Aromatic Amines:  A  Six-Year Study.
     Acta Cytol.  16(2) :142-145 .

27.   Frobisher, M.  1946.   Fundamentals  of Bacteriology,  3rd ed.   W. B.
     Saunders  Company, Philadelphia,  pp. 126-127.

-------
                                  117
28.  Gadian, T.  1975.  Carcinogens in Industry, with Special Reference
     to Dichlorobenzidine.  Chem. Ind. (Great Britain) 19:821-831.

29.  Gehrmann, G. H.  1936.  Papilloma and Carcinoma of the Bladder in
     Dye Workers.  J. Am. Med. Assoc. 107(18):1436-1439.

30.  Gerarde, H. W., and D. F. Gerarde.  1974.  Industrial Experience
     with 3,3'-Dichlorobenzidine:  An Epidemiological Study of a Chemi-
     cal Manufacturing Plant.  J. Occup.  Med. 16(5):322-344.

31.  Goldwater, L. J., A. J. Rosso, and M. Kleinfeld.  1965.  Bladder
     Tumors in a Coal Tar Dye Plant.  Arch. Environ. Health 11:814-817.

32.  Golub, N. I.  1969.  Transplacental Action of 3,3'-Dichlorobenzidine
     and Orthotolidine on Organ Cultures of Embryonic Mouse Kidney Tissue.
     Bull. Exp. Biol. Med.  (U.S.S.R.) 68:1280-1283.

33.  Golub, N. I., T. S. Kolesnichenko, and L. M.  Shabad.  1974.  Onco-
     genic Action of Some Nitrogen Compounds on the Progeny of Experi-
     mental Mice.  Bull. Exp. Biol. Med.  (U.S.S.R.) 78:1402-1404.

34.  Gorrod, J. W., R. L. Carter, and F.J.C. Roe.   1968.  Induction of
     Hepatomas by 4-Aminobiphenyl and Three of Its Hydroxylated Deriva-
     tives Administered to Newborn Mice.   J. Natl. Cancer Inst. 41:403-410.

35.  Griswold, D. P., Jr., A. E. Casey, E. K. Weisburger, and J. H.
     Weisburger.  1968.  The Carcinogenicity of Multiple Intragastric
     Doses of Aromatic and Heterocyclic Nitro or Amino Derivatives in
     Young Female Sprague-Dawley Rats.  Cancer Res. 28:924-933.

36.  Haley, T. J.  1975.  Benzidine Revisited:  A Review of the Litera-
     ture and Problems Associated with the Use of Benzidine and Its
     Congeners.  Clin. Toxicol. 8(l):13-42.

37.  Haley, T. J.  1977.  Personal Communication.

38.  Hamblin, D. 0.  1963.  Aromatic Nitro and Amino Compounds.  In:
     Industrial Hygiene and Toxicology, Vol. II, D. W. Fassett and D. D.
     Irish, eds.  Interscience Publishers, New York.  pp. 2105-2171.

39.  Hamilton, A., and H. L. Hardy.  1974.  Aromatic Nitro and Amino
     Compounds.  In:  Industrial Toxicology, 3rd ed.  Publishing Sciences
     Group, Inc., Acton, Mass.  pp. 309-310.

40.  Harman, J. W.  1971.  Chronic Glomerulonephritis and the Nephrotic
     Syndrome Induced in Rats with N,N'-Diacetylbenzidine.  J. Pathol.
     (Scotland) 104:119-128.

41.  Harman, J. W., E. C. Miller, and J.  A. Miller.  1952.  Chronic
     Glomerulonephritis and Nephrotic Syndrome Induced in Rats by
     N,N'-Diacetyl-Benzidine (abstract).   Am. J. Pathol. 28:529-530.

-------
                                  118
42.  Hirai,  K.,  and K.  Yasuhira.   1972.   Mitochondrial Oxidation of
     3 3'-Diaminobenzidine and Related Compounds, and Their Possible
     Relation to Carcinogenesis.   Gann (Japan)  63(6):665-673.

43.  Holland, V. R.,  B. C. Saunders,  F.  L.  Rose,  and  A.  L.  Walpole.
     1974.   A Safer Substitute for Benzidine in the Detection of Blood.
     Tetrahedron (Great Britain)  30:3299-3302.

44.  Hueper, W.  C.   1954.   Recent Developments  in Environmental Cancer.
     Arch.  Pathol.  58:475-523.

45.  Hueper, W.  C.   1961.   Environmental Carcinogenesis  and Cancers.
     Cancer Res. 21:842-857.

46.  International  Agency  for Research on Cancer.  1972.  IARC Monographs
     on the Evaluation  of  Carcinogenic Risk of  Chemicals to Man, Vol.  I.
     Lyon,  France,   pp. 74-86.

47-  Kellner, H. M.,  0. E. Christ, and K. Lbtzsch.  1973.   Animal Studies
     on the Kinetics  of Benzidine and 3,3'-Dichlorobenzidine.  Arch.
     Toxicol. (West Germany)  31:61-79.

48.  Kleinbauer, V.,  V. Kunor, A. Popler, and R.  Vlasak.  1969.  Sledovani
     Expozice Zamestnancu  Pri Vyrobe  Benzidinu  (Observation of Personnel
     Exposure in Benzidine Production).   Cesk.  Hyg. (Czechoslovakia)
     14:150-154.

49.  Kleinfeld,  M., A.  J.  Rosso,  and  L.  J.  Goldwater.   1966.  Bladder
     Tumors in a Coal Tar  Dye Plant.   Ind.  Med.  Surg.  35:570.

50.  Kuzelova,  M.,  V. Kunor,  and  K. Hurt.  1969.   Sledovani Pracovniku
     Zamestnanych Pri Vyrobe  Benzidinu (Investigation of Workers Employed
     in Benzidine Production). Prac. Lek.  (Czechoslovakia) 21(7):310-314.

51.  Laham,  S.   1971.  Metabolism of  a New Carcinogen Related to Benzidine
     (abstract). Toxicol. Appl.  Pharmacol.  19:368-369.

52.  Maclntyre,  I.   1975.   Experience of Tumors in a  British Plant Hand-
     ling 3 3'-Dichlorobenzidine.  J. Occup.  Med. 17(1):23-26.

53.  MacMahon,  B.,  and  T.  Pugh.   1970.   Epidemiology:   Principles and
     Methods.  Little and  Brown,  Boston,  pp. 17-72.

54.  Mancuso, T. F.,  and A. A. El-Attar.  1966.   Cohort  Studies of Workers
     Exposed to  Betanaphthylamine and Benzidine.   Ind. Med. Surg. 35:571.

55.  Mancuso, T. F.,  and A. A. El-Attar.  1967.   Cohort  Study of Workers
     Exposed to  Betanaphthylamine and Benzidine.   J.  Occup. Med. 9(6):277-
     285.

56.  Marhold, J., M.  Hub,  F.  Ruffer,  and M.  Matrka.  1967.   Possible Com-
     plicity of  Diphenyline in the Origin of Tumors in the Manufacture of
     Benzidine (abstract). Toxicol.  Appl.  Pharmacol.  10:397.

-------
                                  119


57.  Marhold, J., M. Matrka, M. Hub, and F. Ruffer.  1968.  The Possi-
     ble Complicity of Diphenyline in the Origine of Tumours in the
     Manufacture of Benzidine.  Neoplasma (Czechoslovakia) 15(1):3-8.

58.  Meigs, J. W., R. M. Brown, and L. J. Sciarini.  1951.  A Study of
     Exposure to Benzidine and Substituted Benzidines in a Chemical
     Plant.  Arch. Ind. Hyg. Occup. Med. 4:533-540.

59.  Meigs, J. W., L. J. Sciarini, and W. A. Van Sandt.  1954.  Skin
     Penetration by Diamines of the Benzidine Group.  Arch. Ind. Hyg.
     Occup. Med. 9:122-132.

60.  Melick, W. F., H. M. Escue, J. J. Naryka, R. A. Mezera, and E. P.
     Wheeler.  1955.  The First Reported Cases of Human Bladder Tumors
     Due to a New Carcinogen — Xenylamine.  J. Urol. 74 (6):760-766.

61.  Melick, W. F., J. J. Naryka, and R. E.  Kelly.   1971.  Bladder Can-
     cer Due to Exposure to Para-Aminobiphenyl:  A 17-Year Followup.
     J. Urol. 106:220-226.

62.  Nakajima, T.  1955.  On the Influence of the Aromatic Nitro- and
     Amino-Derivatives on the Blood Phenolase Activity.  Rodo Kagaku
     Kiho (Japan) 4:22-25.

63.  Neish, W.J.P.  1967.  Liver Glutathione and Polyamines in Hepato-
     carcinogen-treated Rats.  Biochem.  Pharmacol.  (Great Britain)
     16:163-173.

64.  Pliss, G. B.  1959.  The Blastomogenic Action of Dichlorobenzidine.
     Vopr. Onkol. (U.S.S.R.) 5:524-533.

65.  Pliss, G. B.  1961.  On the Cancerogenic Action of 3,3'-Dioxy-
     benzidine (Is 3,3'-Dioxybenzidine a Basic Cancerogenic Metabolite
     of Benzidine?)  Vopr. Onkol. (U.S.S.R.) 7(2):33-41.

66.  Pliss, G. B.  1963.  On Some Regular Relationships between Carcino-
     genicity of Aminodiphenyl Derivatives and the Structure of Substance.
     Acta Unio Int. Contra Cancrum (Belgium) 19:499-501.

67.  Pliss, G. B.  1964.  On the Cancerogenic Properties of Benzidine.
     Vopr. Onkol. (U.S.S.R.) 10 (5):50-55.

68.  Pliss, G. B.  1969.  On Peculiarities of Carcinogenic Effect of
     3,3'-Benzidine Bicarboxylic Acid.  Vopr. Onkol. (U.S.S.R.) 15(5):
     60-64.

69.  Pliss, G. B., N. J. Volfson, and M. I.  Jogannsen.  1973.  On Intes-
     tinal Tumors Induced by Benzidine in Rats.  Vopr. Onkol. (U.S.S.R.)
     19(6):75-79.

70.  Pliss, G. B., and M. A. Zabezhinsky.  1970.  Carcinogenic Properties
     of Orthotolidine (3,3'-Dimethylbenzidine).  J. Natl. Cancer Inst.
     45(2):283-295.

-------
                                 120
71.  Popler, A.,  M.  Selucky,  and R.  Vlasak.   1964.   Follow-up of Exposure
     in People Working in the Production of  Benzidine.   Prac. Lek.
     (Czechoslovkia)  16(4):147-152.

72.  Prokofjeva,  0.  G.  1971.  Induction of  Hepatic Tumors in Mice  by
     Benzidine.  Vopr. Onkol. (U.S.S.R.) 17(5):61-64.

73.  Radomski, J. L.,  G.  M. Conzelman,  Jr.,  A.  A. Rey,  and E. Brill.
     1973.   N-Oxidation of Certain Aromatic  Amines, Acetamides,  and
     Nitro  Compounds  by Monkeys and  Dogs.  J.  Natl. Cancer Inst. 50(4):
     989-995.

74.  Rao, K.V.N., J.  H. Rust, N.  Mihailovich,  S.  D. Vesselinovitch,
     and J. M. Rice.   1971.   Subacute Toxicity of Benzidine in the
     Young  Adult  Mice (abstract).  Fed.  Proc.  Fed.  Am.  Soc. Exp. Biol.
     30:444.

75.  Riches, E.  1972.  Industrial Cancers.  Nurs.  Mirror (Great Britain)
     134(16):21-25.

76.  Rinde, E., and W. Troll.  1975.   Metabolic Reduction of Benzidine
     Azo Dyes to  Benzidine in the Rhesus Monkey-  J. Natl.  Cancer Inst.
     55(1)=181-182.

77.  Rye, W. A.,  P. F. Woolrich,  and R.  P. Zanes.   1970.   Facts  and Myths
     concerning Aromatic Diamine Curing  Agents.   J. Occup.  Med.  12(6):
     211-215.

78.  Saffiotti, U., F. Cefis, R.  Montesano,  and A.  R. Sellakumar.  1967.
     Induction of Bladder Cancer in  Hamsters Fed  Aromatic Amines.  In:
     Bladder Cancer;  a Symposium,  W.  Deichmann and  K. F.  Lampe,  eds.
     Aesculapis,  Birmingham,  Ala.  pp.  129-135.

79.  Sax, N. I.  1975.  Dangerous Properties of Industrial Materials,
     4th ed.  Van Nostrand Reinhold  Company, New  York.   pp. 281, 442.

80.  Schwartz, L., L.  Tulipan,  and S.  M. Peck.  1947.   Dermatitis in
     Synthetic Dye Manufacture.   In:   Occupational  Diseases of the  Skin.
     Lea and Febiger,  Philadelphia,   pp. 268-280.

81.  Sciarini, L. J.   1957-   3-Hydroxybenzidine,  a  Metabolite of Benzi-
     dine.   Arch. Biochem. Biophys.  71:437-441.

82.  Sciarini, L. J.,  and J.  W.  Meigs.   1958.   The  Biotransformation  of
     Benzidine (4,4'-Diaminobiphenyl),  an Industrial Carcinogen, in the
     Dog:  I.  AMA Arch.  Ind. Health 18:521-530.

83.  Sciarini, L. J.,  and J.  W.  Meigs.   1961a.  The Biotransformation
     of Benzidine:  II.  Studies in  Mouse and  Man.   Arch. Environ.
     Health 2:423-428.

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                                  121
84.  Sciarini, L. J., and J. W. Meigs.  1961&.  Biotransformation of the
     Benzidines:  III.  Studies on Diorthotolidine, Dianisidine, and
     Dichlorobenzidine:  3,3' Disubstituted Congeners of Benzidine  (4,4'-
     Diaminobiphenyl).  Arch. Environ. Health 2:584-588.

85.  Scott, T. S.  1952.  The Incidence of Bladder Tumours in a Dyestuffs
     Factory.  Br. J. Ind. Med. (Great Britain) 9:127-132.

86.  Shabad, L. M., J. D. Sorokina, N. I. Golub, and S. P- Bogovski.
     1972.  Transplacental Effect of Some Chemical Compounds on Organ
     Cultures of Embryonic Kidney Tissue.  Cancer Res. 32:617-627.

87.  Soloimskaya, E. A.  1968.  The Distribution of Benzidine in Rat
     Organs and Its Effect on the Peripheral Blood.  Vopr. Onkol.  (U.S.S.R.)
     14(7):51-53.

88.  Spitz, S., W. H. Maguigan, and K. Dobriner.  1950.  The Carcinogenic
     Action of Benzidine.  Cancer 3:789-804.

89.  Stula, E. F., H. Sherman, and J. A. Zapp, Jr.  1971.   Experimental
     Neoplasia in ChR-CD Rats with the Oral Administration of 3,3'-
     Dichlorobenzidine, 4,4'-Methylenebis(2-chloroaniline),  and 4,4'-
     Methylenebis(2-methylaniline) (abstract).  Toxicol.  Appl.  Pharmacol.
     19:380-381.

90.  Stula, E. F., H. Sherman, J.  A.  Zapp,  Jr.,  and J. W.  Clayton,  Jr.
     1975.  Experimental Neoplasia in Rats  from Oral Administration of
     3,3'-Dichlorobenzidine, 4,4'-Methylene-bis(2-chloroaniline),  and
     4,4'-Methylene-bis(2-methylaniline).  Toxicol. Appl.  Pharmacol.
     31:159-176.

91.  Troll, W., S. Belman, and F.  Mukai.  1969.   Studies  on  the Nature
     of the Proximal Bladder Carcinogens.  J.  Natl. Cancer Inst.  43(1):
     283-286.

92.  Troll, W., S. Belman, and E.  Rinde.  1963.   N-Hydroxy Acetyl  Amino
     Compounds, Urinary Metabolites of Aromatic Amines in Man (abstract).
     Proc. Am. Assoc. Cancer Res.  4(1):68.

93.  Troll, W., and N. Nelson.  1958.  Studies on Aromatic Amines:   I.
     Preliminary Observations on Benzidine  Metabolism.  Am.  Ind.  Hyg.
     Assoc. J. 19:499-503.

94.  Tsuchiya, K., T. Okubo, and S. Ishizu.  1975.  An Epidemiological
     Study of Occupational Bladder Tumours  in the Dye Industry of Japan.
     Br. J. Ind. Med. (Great Britain) 32:203-209.

95.  Veys, C. A.  1972.  Aromatic  Amines:  The Present Status of the
     Problem.  Ann. Occup. Hyg. (Great Britain)  15(1):11-15.

96.  Vigliani, E. C., and M. Barsotti.  1962.   Environmental Tumors of
     the Bladder in Some Italian Dye-stuff  Factories.   Acta Unio Int.
     Contra Cancrum (Belgium) 18:669-675.

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                                   122


 97.   Vincent,  J.  M.   1970.   A Manual for the Practical Study of Root
      Nodule Bacteria.   Blackwell  Scientific Publishers,  Oxford, England.
      pp.  4-5.

 98.   Walpole,  A.  L.,  M.H.C.  Williams,  and D.  C.  Roberts.   1952.  The
      Carcinogenic Action of  4-Aminodiphenyl and  3:2'-Dimethyl-4-amino-
      diphenyl.   Br. J.  Ind.  Med.  (Great  Britain)  9:255-263.

 99.   Walpole,  A.  L.,  M.H.C.  Williams,  and D.  C.  Roberts.   1954.  Tumours
      of the Urinary Bladder  in Dogs  after Ingestion of 4-Aminodiphenyl.
      Br.  J. Ind.  Med.  (Great Britain)  11:105-109.

100.   Weisburger,  J. H.,  N. Mantel, E.  K.  Weisburger,  Z.  Hadidian, and
      T. Fredrickson.    1967.   New Carcinogenic Naphthalene and Biphenyl
      Derivatives.  Nature (Great  Britain)  213:930-931.

101.   Wendel, R.  G., U.  R. Hoegg,  and M.  R.  Zavon.   1974.   Benzidine:   A
      Bladder Carcinogen.  J.  Urol. 111:607-610.

102.   Wood,  J.  M.,  and R.  Spencer.  1972.   Carcinogenic Hazards in the
      Microbiology Laboratory.   In:   Safety in Microbiology,  D. A. Shapton
      and R. G.  Boards,  eds.   Academic  Press,  London,   pp.  185-189.

103.   Yoshida,  0.,  and M.  Miyakawa.   1973.   Etiology of Bladder Cancer:
      "Metabolic"  Aspects.  In:  Analytical and Experimental  Epidemiology
      of Cancer,  W. Nakahara,  T. Hirayama,  K.  Nishioka, and H.  Sugano,
      eds.   University Park Press,  Baltimore,  pp.  31-39.

104.   Zavon, M.  R., U. Hoegg,  and  E.  Bingham.  1973.   Benzidine Exposure
      As a Cause of Bladder Tumors.   Arch.  Environ.  Health  27:1-7.

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                               SECTION 7

             ENVIRONMENTAL DISTRIBUTION AND TRANSFORMATION
7.1  SUMMARY

     Benzidine and its related compounds (3,3'-dichlorobenzidine, 3,3'-
dimethylbenzidine, and 3,3'-dimethoxybenzidine) are used primarily as
intermediates in the production of azo dyes.  Additionally, they are used
in polyurethane production and in chemical analyses.

     Benzidine is not thought to be commonly distributed in the environ-
ment.  In water, it is a probable hazard only near dye factories.  Water
samples collected below Japanese dye factories have contained up to 0.233
ppm benzidine.  No data concerning benzidine in air and soil were found.

     Information regarding degradation of benzidine under normal environ-
mental conditions is not available, except for one survey of the Buffalo
and Niagara river areas.  Laboratory studies indicated that benzidine
tends to resist biological and physical degradation.  Estimated half-lives
for benzidine are 1 day for reaction with OH or 03 in air and 100 days for
reaction with R02 in water.

     Based on its solubility in water and various organics, benzidine is
suspected to accumulate within food chains.  However, no specific data
are available other than a laboratory study indicating bioaccumulation in
bluegill fish to a factor of 44 times the level in water.

7.2  PRODUCTION AND USE

7.2.1  Benzidine

     Benzidine is used primarily as an intermediate in the production of
azo dyes.  It is also used as a hardener for polyurethane, in qualitative
and quantitative chemical analyses, in the detection of occult blood, as
a microscopy stain, and as an agent to reveal bank check alteration
(International Agency for Research on Cancer, 1972; Lurie, 1963; Sciarini,
1969; Welcher, 1947).  Benzidine production in the United States was 680.9
metric tons (750 tons) in 1972 (Anonymous, 1974).

7.2.2  3,3'-Dichlorobenzidine

     3,3'-Dichlorobenzidine, a dye intermediate and curing agent for poly-
urethane, gives azo dyes which are bluer and more stable to acids than
those from benzidine (Radding et al., 1975).  More than 95 dyes are derived
from 3,3'-dichlorobenzidine (Colour- Index, 1957); the primary one is benzi-
dine yellow (Hancock, 1975).  United States production of 3,3'-dichloro-
benzidine and its salts was 1,600,000 kg (3,500,000 Ib) in 1971  (U.S.
Tariff Commission, 1973, cited in International Agency for Research on
Cancer, 1974).  Imports in 1971 were 658,000 kg  (1,450,890 Ib)  (Interna-
tional Agency for Research on Cancer, 1974).
                                   123

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                                   124
 7.2.3   3,3'-Dimethylbenzidine

     More  than 90 dyes are derived from 3,3'-dimethylbenzidine  (diortho-
 tolidine)  (Colour Index,  1957).  Additionally, diorthotolidine  is  used
 in  detection of various ions (Welcher, 1947).  United  States  production
 was approximately 110,200 kg (243,000 Ib) in 1962  (Lurie,  1964).   In  1969
 and 1970, U.S. imports amounted to 36,600 kg (80,600 Ib) and  44,400 kg
 (97,800  Ib) respectively  (International Agency for Research on  Cancer,
 1972).

 7.2.4   3,3'-Dimethoxybenzidine

     3,S'-Dimethoxybenzidine (dianisidine) is used primarily  in dye pro-
 duction, with 88 dyes derived from this chemical (Colour Index, 1957).
 It  is also used to detect copper, cobalt, gold, thiocyanate,  and vanadium
 (Welcher, 1947).  The United States produced 163,000 kg (360,000 Ib)  of
 dianisidine in 1960  (U.S. Tariff Commission, cited in Lurie,  1964).

 7.3 DISTRIBUTION IN THE ENVIRONMENT

 7.3.1  Distribution in Soils

     No  data concerning benzidine measurements in soils were  located  in
 the literature.  Due to its physical properties, benzidine probably is
 immobilized rapidly in soils and sediments (Radding et al. , 1975).
 Furukawa and Brindley (1973) found that benzidine was adsorbed  to some
 clays.

 7.3.2  Distribution in Water

     Benzidine in water is probably a hazard only in the vicinity of  dye
 and pigment factories from which wastes escape or are discharged.   Gener-
 ally, processes in azo dye production are conducted within a closed
 system.  Contamination can occur, however, during cleanup  (Haley,  1975).

     Howard and Saxena (1976, pp. 16-17)  reported on a field survey made
 by  the Synthetic Organic Chemical Manufacturers Association Task Force on
 Benzidine.   The survey was made to determine whether benzidine could be
 detected in the Buffalo and Niagara river areas, where some benzidine
 release by upriver plants had been thought to occur.   No benzidine was
 detected in either water or sediment samples when they were analyzed by
 the chloramine-T method, which had a limit of detection of 0.2 yg/ml
 (for 1-liter  water samples).   As pointed  out by the authors, lack of
 detection of  benzidine in these samples may have resulted either from
 dilution to below the limit of  detection  or from oxidative degradation
 into compounds  not detectable by this method of analysis.

     Benzidine  was detected (samples containing 0.082,  0.140,  and  0.233
ppm) in the Sumida River (Japan)  below dye factories (Takemura,  Akiyama,
and Nakajima,  1965).   These authors speculated, however, that  the  benzi-
dine may not  have  been discharged as such but was produced by  reduction
of azo  dyes in  the wastes  by H2S  or S02 present in the  river.

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                                  125
7.3.3  Distribution in Air

     Although benzidlne in closed air systems is potentially hazardous
(Zavon, Hoegg, and Bingham, 1973), no data were located concerning its
distribution in the atmosphere.  The azo dye benzidine yellow, derived
from 3,3'-dichlorobenzidine, is used in various paints, enamels, and
lacquers and has been found in pressurized containers designed for the
hobbyist and householder market.  Such usage in the home and work environ-
ment may pose a hazard to the user as well as provide an avenue of air
contamination and dispersion.

7.4  ENVIRONMENTAL FATE

7.4.1  Mobility and Persistence

     Benzidine is volatile and soluble enough to have a potential for
wide dispersion.  According to several authors, benzidine resists physical
and biological decomposition (Lutin et al., 1965; Malaney et al., 1967;
Radding et al. , 1975) and probably persists for a time in the environ-
ment.  The principal chemical reaction of benzidine in air and water is
oxidative degradation by free radical, enzymatic, or photochemical pro-
cesses (Radding et al. , 1975).  Data concerning the reaction rate of
benzidine with radicals and ozone and on photochemical reactions under
normal environmental conditions are not available.  However, estimated
half-lives are 1 day for reaction with OH or 03 in air and 100 days for
reaction with R02 in water (Radding et al., 1975).

     In a study of benzidine degradation under experimental water treat-
ment conditions, Howard and Saxena (1976, pp. 16-17) noted that air
oxidation of benzidine seemed to have occurred readily and that some
biological oxidation may also have occurred.

     3,3'-Dichlorobenzidine is thought to be bound tightly to humic mate-
rials  (Radding et al. , 1975).  Due to the halogen substitution, 3,3'-
dichlorobenzidine probably degrades more slowly than benzidine.  Its
estimated half-lives are 1 day with OH radicals, 1 to 10 days with 03,
and 100 days with R02 radicals.

7.4.2  Accumulation in Food Chains

     Benzidine and 3,3'-dichlorobenzidine are more soluble than DDT in
water and are quite soluble in many organics (Sections 2.2.1.1 and
2.2.2.1).  Therefore, it is suspected that these chemicals can move with-
in the food chain.  Accumulation is expected to occur, and recent labora-
tory findings indicated that bluegill fish concentrate residues of
14C-benzidine to a level 44 times that present in water (Federal Register,
1976).

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                                  126


                               SECTION 7

                               REFERENCES
 1.  Anonymous.  1974.  Final Rules Set for Exposure to Carcinogens.
    Chem. Eng. News 52:12-13.

 2.  Colour Index.  1957.  2nd ed. , Vol. 3.  The Society of Dyers and
    Colourists, Bradford, England, and The American Association of
    Textile Chemists and Colorists, Lowell, Mass.  3824 pp.

 3.  Federal Register.  1976.  41:27012-27017.

 4.  Furukawa, T., and G. M. Brindley.  1973.  Adsorption and Oxida-
    tion  of Benzidine and Analine by Montmorillonite and Hectrite.
    Clay  Miner. 21:279-288.

 5.  Haley, T. J.  1975.  Benzidine Revisited:  A Review of the Litera-
    ture  and Problems Associated with the Use of Benzidine and Its
    Congeners.  Clin. Toxicol. 8(1):13-42.

 6.  Hancock, E. G.  1975.  Benzidine and Its Industrial Derivatives.
    John  Wiley and Sons, New York.  p. 516.

 7-  Howard, P. H., and J. Saxena.   1976.  Persistence and Degradability
    Testing of Benzidine and Other Carcinogenic Compounds.  EPA 560/5-
    76-005, U.S.  Environmental Protection Agency, Washington, D.C.
    pp.  16-17.

 8.  International Agency for Research on Cancer.  1972.  Benzidine.
    In:   IARC Monographs on the Evaluation of Carcinogenic Risk of
    Chemicals to  Man, Vol. 1.  Lyon, France.  pp. 80-91.

 9.  International Agency for Research on Cancer.  1974.  3,3'-Dichloro-
    benzidine.  In:  IARC Monographs on the Evaluation of Carcinogenic
    Risk  of Chemicals to Man, Vol.  4.  Lyon, France,  pp. 49-55.

10.  Lurie, A. P.  1964.  Benzidine  and Related Diaminobiphenyls.  In:
    Encyclopedia  of Chemical Technology, R. E. Kirk and D. T. Othmer,
    eds.  John Wiley and Sons, Inc., New York.  pp. 408-420.

11.  Lutin, P. A., J. J. Cibulka,  and G. W. Malaney.  1965.  Oxidation
    of  Selected Carcinogenic Compounds by Activated Sludge.  Proc.  Ind.
    Waste Conf.  20:131-145.

12.  Malaney, G. W., P. A. Lutin,  J. J. Cibulka, and L. H. Hickerson.
    1967. Resistance of Carcinogenic Organic Compounds to Oxidation
    by  Activated  Sludge.  J. Water  Pollut. Control Fed. 39(12):2020-2029.

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                                   127
13.   Radding, S.  B., B. R.  Holt,  J.  L.  Jones,  D.  H.  Liu,  T.  Mill,  and
     D.  G.  Hendry.  1975.   Review of the Environmental Fate  of  Selected
     Chemicals.   EPA 560/5-75-001, U.S. Environmental Protection Agency,
     Washington,  B.C.  37  pp.

14.   Sciarini, L. J.  1969.  Benzidine.  In:   Industrial  Toxicology,
     L.  T.  Fairhall, ed.  Hafner Publishing Company, New  York.
     pp. 165-166.

15.   Takemura, N., T. Akiyama, and C. Nakajima.   1965. A Survey of  the
     Pollution of the Sumida River, Especially on the Aromatic  Amines
     in the Water.  Int. J. Air Water Pollut.  (Great Britain)  9:665-670.

16.   Welcher, F.  J.  1947.   Organic Analytical Reagents,  Vol.  2.   D. Van
     Nostrand Company, Inc., New York.   p. 275.

17.   Zavon, M. R., U. Hoegg, and E. Bingham.   1973.   Benzidine  Exposure
     as a Cause of Bladder Tumors.  Arch. Environ.  Health 27:1-7-

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                               SECTION 8

                       ENVIRONMENTAL ASSESSMENT


8.1  PRODUCTION,  USES,  AND POTENTIAL ENVIRONMENTAL CONTAMINATION

8.1.1  Production

     Although exact figures for current U.S.  production and importation of
benzidine and benzidine compounds are unavailable, an examination of records
of the U.S.  Tariff Commission for past years  indicates that U.S. production
and importation of these substances may exceed 3.5 million kilograms per
year.  In 1972, benzidine production was 680,000 kg, while that of dichloro-
benzidine was 2,300,000 kg in 1971.  Records  for the 1960s indicate that
total production and importation of 3,3'-dimethylbenzidine and 3,3'-dimethoxy-
benzidine ranged from 200,000 to 500,000 kg per year.

8.1.2  Uses

     Benzidine and its  congeners are used in  industry primarily for the
synthesis of azo dyes.   More than 250 dyes are derived from benzidine, 95
from dichlorobenzidine, 90 from 3,3'-dimethylbenzidine, and 88 from 3,3'-
dimethoxybenzidine.  The leather, paper, and  textile industries utilize more
than 10 million kilograms of such dyes every  year.  In addition, benzidine,
3,3'-dimethylbenzidine, and 3,3'-dimethoxybenzidine are widely used in chem-
ical and biochemical laboratories as analytical reagents.  Dichlorobenzidine
and 3,3'-dimethoxybenzidine are also important in the polyurethane industry—
the latter compound for the production of 3,3'-dimethoxy-diisocyanates and
the former as a curing  agent.

8.1.3  Losses to the Environment

     There is little published information available to indicate the extent
to which benzidine, benzidine congeners, and  benzidine-based dyes are inad-
vertently released into the environment.  The manufacturing and processing
operations for benzidine salts and azo dyes are now contained within closed
systems; however, some  losses to the environment undoubtedly still occur,
especially during cleaning operations.

     In the past, in the absence of evidence  that any of these compounds
might be health hazards, routine sampling for air or water contamination
was not practiced.  As  epidemiological data began to suggest that benzidine
might be a human carcinogen, a greater effort was made to determine levels
of atmospheric contamination at benzidine manufacturing plants.  Several
studies revealed that atmospheric concentrations of benzidine in such
plants normally ranged  from 0.002 to 0.152 mg/m3 (Meigs, Sciarini, and Van
Sandt, 1954; Zavon, Hoegg, and Bingham, 1973) and could reach as high as
17 mg/m3 (Zavon,  Hoegg, and Bingham, 1973).
                                  128

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                                  129


     Since 1974, when more stringent industrial standards were instituted
by the Occupational Safety and Health Administration  (OSHA) of the U.S.
Department of Labor (Federal Register,  1974), the risk of cancer from indus-
trial exposure to benzidine has been substantially reduced.  Although the
OSHA standards did not recognize a maximum safe level of exposure, they did
attempt to reduce exposure "to the maximum extent possible consistent with
continued use."  Mixtures of compounds  containing less than 0.1% of benzidine
or its salts were excluded from the regulation in an attempt to avoid hinder-
ing scientific research on these substances.  However, this exclusion clause
in effect permitted a 0.1% level of contamination in compounds, such as vari-
ous azo dyes, which are produced from benzidine.  Currently, dye manufacturers
warrant their products to contain not more than a certain level of free benzi-
dine.  This level (in one case 20 ppm)  is generally much lower than the OSHA
standard; however, it still represents  a potential source of environmental
contamination.  Consequently, traces of benzidine salts probably occur in the
wastewater effluents of the textile, paper,  and leather manufacturing plants
using azo dyes.  Such manufacturing plants generally use several gallons of
dye per pound of fabric processed, and  the total amount of wastewater gener-
ated is often more than one million gallons  per day.

     There is increasing evidence that  azo dyes, some of which may be toxic
themselves, are capable of being reconverted by chemical or biological mech-
anisms into the toxic parent compounds  (Rinde and Troll, 1975; Takemura,
Akiyama, and Nakajima, 1965; Yoshida and Miyakawa, 1973).  It may therefore
be very important to determine the extent of environmental contamination by
azo dyes.  Published information on this subject is, however, quite limited.

     In the azo dye plants themselves,  removal of benzidine contaminants
from wastewater effluents is sometimes  accomplished by tetrazotization.
Whether this process leads to a safe degradable end product or whether benzi-
dine or some other toxic substance might be  resynthesized by later chemical
or microbial processes has not been fully examined.  However, the question
is important in light of the fact that benzidine wastes are often piped
directly into municipal sewage systems.

8.2  ENVIRONMENTAL PERSISTENCE

8.2.1  Physical and Chemical Degradation

     Very little information is currently available on the environmental
fate of benzidine, its congeners, or benzidine-based dyes.  Although benzi-
dine is a moderately volatile substance, naturally occurring photochemical
and chemical processes would probably reduce atmospheric concentrations to
insignificant levels; however, the rates of  such reactions are not well
known.  Benzidine is sensitive to various oxidative processes.  With 03 or
HO radicals the half-life of benzidine  in a  gaseous state has been calculated
to be about one day (Radding et al., 1975),  and that of dichlorobenzidine is
about ten days.

     If there should prove to be any environmental accumulation of benzidine
or its congeners, it might be expected  that  this would occur in natural
bodies of water receiving effluents from manufacturing and processing plants.

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                                  130


According to Radding et al.  (1975),  the half-lives of benzidine and dichloro-
benzidine in an aqueous state would  be about 100 days if the compounds reacted
primarily with R02 radicals.   However, because the R02 rate constants used for
these calculations were only estimates, the actual half-lives may be as little
as 10 days or as much as 1000 days.   With a relatively long half-life, the
processes of biological degradation  may be more important in reducing benzi-
dine levels in aquatic environments.  Because of its halogen substitution,
dichlorobenzidine may be more resistant to biodegradation (Radding et al.,
1975).

     The solubility of the benzidine compounds would also have a significant
effect on their environmental fate.   Although benzidine is only slightly
soluble in water (0.52 mg/ml at 25 ± 2°C) , its chloride salts, which are used
quite extensively in the azo dye industry, are very soluble in water (61.7
mg/ml) (Bowman, King, and Holder, 1976).  In a similar manner, the benzidine
congeners 3,3'-dimethylbenzidine and 3,3'-dimethoxybenzidine are much less
soluble (1.3 and 0.06 mg/ml respectively) than their corresponding chloride
salts (76.7 mg/ml and 41.4 mg/ml).

     The chloride salt of benzidine  has also been reported to be more resist-
ant to degradation than the free amine.  Bowman, King, and Holder (1976)
found that over a 16-day period, the concentration of an aqueous solution of
benzidine declined 11% while that of its salt declined only 2%.  The con-
centration of both 3,3'-dimethylbenzidine and its salt declined 9% during
the test period, and that of 3,3'-dimethoxybenzidine and its salt declined
64% and 9% respectively.

8.2.2  Biodegradation

     It is known that benzidine and  its congeners undergo in vivo oxidation
in higher organisms; however, there  is also evidence that benzidine is
resistant to decomposition by microorganisms.  Lutin, Cibulka, and Malaney
(1965) and Malaney et al. (1967) found that benzidine at concentrations of
500 mg/liter was usually inhibitory  or even toxic to sludge microorganisms,
thus preventing normal biodegradative processes.  The studies of Jenkins
and Baird (1975) suggest that the toxic substance may not have been benzi-
dine itself, but a reaction product  resulting from chlorination.  These
investigators found that in unchlorinated wastewater samples spiked with
benzidine 70% to 95% of the chemical could be removed analytically, but in
chlorinated samples only a very small amount could be recovered.  This sug-
gested that benzidine reacted with hypochlorous acid to produce a chloramine-
type compound.  Chloramines are known to be toxic to a great number of
aquatic organisms.

     It has been reported by several investigators that some azo dyes can
be reduced to free benzidine by soil and intestinal bacteria (Yoshida and
Miyakawa, 1973).  Presumably, similar biochemical transformations occur in
bacteria in aquatic systems.

     Numerous nonbenzidine azo food  dyes are known to undergo reduction to
various metabolites by way of the hepato-azo reductase system of higher
organisms (see Walker, 1970, for a recent review).  Metabolic reduction of

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                                  131


benzidine dyes to benzidine has recently been demonstrated In the rhesus
monkey (Rinde and Troll, 1975), and benzidine dyes have been implicated as
carcinogenic agents in painters accidently ingesting these dyes (Yoshida
and Miyakawa, 1973).

8.3  EFFECTS ON AQUATIC AND TERRESTRIAL ORGANISMS

8.3.1  Nonlaboratory Organisms

     Although there is a substantial amount of information on the effects
of benzidine on standard laboratory research animals such as rats, mice,
and dogs, very little is known about the toxicity of benzidine to other
kinds of organisms.  That benzidine can be toxic to some plants and wild
animals is shown by the studies of Fitzgerald, Gerloff, and Skoog (1952)
and Pliss and Khudoley (1975).  In analyzing the toxicity of several organic
compounds to the blue-green alga MicTOoystis aerug-inosa, Fitzgerald,
Gerloff, and Skoog  (1952) found that benzidine, at concentrations of 20
mg/liter, was lethal to 50% of five-day algal cultures.  Pliss and Khudoley
(1975) examined the effects of benzidine on the freshwater guppy.  They
found that although the chemical did not produce tumors in the fish, its
toxic effects included extensive liver damage.  Since the benzidine dosage
used by these investigators was calculated in terms of food intake (30 mg of
benzidine per 100 g of dry food), there is no way to correlate these results
with potential benzidine concentrations in natural bodies of water.

8.3.2  Laboratory Animals

     The toxic effects of benzidine and its congeners have been found to
depend on several factors:  (1) physiochemical form of the compound admin-
istered, (2) size of the dose, (3) mode of administration, (4)  length of
exposure, and (5) species of animal undergoing the tests.  In most species
tested these substances tended to cause the greatest damage to the liver,
kidney, and urinary bladder.  The gall bladder, intestines, and lymph glands
can also be affected to a lesser extent.  Toxic levels of benzidine often
lead to extensive liver damage.  In many laboratory studies, excessive deaths
due to the poisoning have obscured the carcinogenic potential of these com-
pounds.  However, following administration of sublethal doses tumors have
formed in almost all species studied.  In various species of rodents, hepato-
mas, lymphomas, and adenocarcinomas have resulted from exposure to benzidine
and 3,3'-dihydroxybenzidine.  In contrast, in hamsters, rabbits, and dogs the
carcinogenic activity of benzidine is centered almost solely in the bladder.
The benzidine congeners are also known to be carcinogenic in rats and mice;
the target organs depend considerably on the mode of administration and con-
centration of the compound.  Tumors have been produced in the rat and mouse
in the skin, gastrointestinal tract, liver, bone, ovaries, Zymbal's gland,
sebaceous glands, mammary glands, and urinary bladder.

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                                  132


8.4  EFFECTS ON HUMAN HEALTH

8.4.1  Toxic Effects

     Schwartz, Tulipan, and Peck  (1947) have reported on the occurrence of
dermatitis among workers in azo dye manufacturing plants.  In several
instances it was found that the dermatitis resulted from exposure to benzi-
dine or benzidine-based dyes.  Laboratory exposure to 3,3'-dimethylbenzidine,
as well as to benzidine, has also been known to cause dermatitis among chem-
ists.  Hematuria occasionally occurs in workers exposed to 3,3'-dimethyl-
benzidine or benzidine, and the latter compound is also known to cause
chronic cystitis.

8.4.2  Teratogenic Effects

     There is no evidence that benzidine or its congeners act as human
teratogens.  In one of the few laboratory studies having any possible rele-
vance to this subject, Noto (1967) found that albumen suspensions of benzi-
dine (3 mg) injected into a chicken egg resulted in morphological abnormalities
in the developing embryo.  The chemical was thought to inhibit morphogenetic
movements, thus causing the unclosure of the neural tube.  Other known carcino-
gens such as 4-nitroquinoline-N-oxide and o-aminoazotoluene caused similar
abnormalities.

8.4.3  Mutagenic Effects

     Ames et al. (1973) proposed that many known carcinogens, including
benzidine, owe their carcinogenic activity to the fact that they cause
somatic mutations.   In tests using mutant strains of the bacteria Salmonella
typh-i.mur"ium and a rat or human liver homogenate to provide the necessary
enzyme systems responsible for activating the carcinogen, these workers
found that benzidine caused a significant increase in the number of revertant
bacteria colonies.   The carcinogen was thought to have caused frameshift
mutations involving addition or depletion of DNA base pairs.  Such a change
in the structure of DNA might produce an inheritable change in cell regula-
tion which could thereby lead to the formation of a tumor.

8.4.4  Carcinogenic Effects

     Epidemiological evidence leaves no doubt that exposure to benzidine can
lead to bladder cancer in humans.  Although there is no evidence to indicate
that the benzidine congeners 3,3'-dimethylbenzidine, 3,3'-dimethoxybenzidine,
°r 3,3'-dichlorobenzidine can cause bladder cancer in humans, all three com-
pounds have been implicated as carcinogens in animal studies.  Tumors of other
human organ systems (intestinal tract, lungs, bone, and muscles) have been
found in some dichlorobenzidine workers (Gerarde and Gerarde, 1974), but the
significance of this finding has not yet been established.

     Various studies have shown that the actual chemical substance causing
bladder cancer following benzidine exposure is not benzidine itself but a
metabolic by-product of the compound.  Enzyme systems that are found pri-
marily in the liver presumably convert benzidine into N-hydroxylated

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                                   133


derivatives which may then require esterfication  to become further activated.
The ultimate carcinogens may be sulfate or glucuronidate conjugates of the
metabolically altered parent compound  (see Section 2.2.1.5).

     An exact quantitative relationship between the degree of exposure to
benzidine, the length of the exposure period, and the incidence of bladder
cancer has not been established.  Studies with laboratory animals are not
very indicative in this regard; there appears to  be species-specific differ-
ences in the relative toxicity and carcinogenicity of the compounds, rate
and route of uptake and excretion, and metabolic  pathways.  Studies at benzi-
dine manufacturing plants indicated  that workers  had been exposed to atmos-
pheric concentrations of benzidine from 0.002 to  17.3 mg/m3 (Meigs, Sciarini,
and Van Sandt, 1954; Zavon, Hoegg, and Bingham, 1973), yet there is no way
of accurately estimating the level of exposure and the amount taken up by
individual workers.  Laboratory studies on animals led Meigs, Sciarini, and
Van Sandt (1954) to speculate that approximately  5% of the amount of benzi-
dine taken up is excreted as the  free amine.  Presumably the remaining 95%
undergoes metabolic transformation.  Whether all  the by-products are excreted
or whether some might be stored in tissues has not been shown.  The degree to
which in vivo oxidation renders the  compounds harmless is also unknown.

     According to Zavon, Hoegg, and  Bingham (1973) there is a nonlinear
relationship among exposure levels,  exposure periods, and incidence of
bladder tumors.  Supposedly, a minimum exposure will be followed by a pro-
longed latent period, but increased  exposure will not necessarily result in
decreased latency or increased incidence of the disease (Scott, cited in
Zavon, Hoegg, and Bingham, 1973).  This hypothesis would seem to be con-
firmed by the fact that the latent period is quite prolonged (average time
16 to 20 years) in benzidine workers developing bladder tumors, regardless
of exposure histories.

     Meigs, Sciarini, and Van Sandt  (1954) calculated that an atmospheric
concentration of 0.02 mg/m3 might be safe for industrial workers.   They based
this assumption on the fact that workers exposed  to this level of benzidine
(estimated from the concentration of benzidine in their urine, which was
thought to be 5% of the amount taken up) were reportedly unlikely to develop
bladder tumors, whereas workers with higher exposures were more susceptible.
The validity of these calculations has not been verified by other investigators.

8.5  POTENTIAL HEALTH HAZARDS

8.5.1  Industrial Workers

     Since the late 1950s when it was definitely  established that benzidine
was carcinogenic, there has been  a general effort to reduce the levels of
exposure to which benzidine workers  are subjected.  In 1974 the U.S. Depart-
ment of Labor announced specific  regulations governing the conditions under
which benzidine and the benzidine congeners could be manufactured and pro-
cessed (Federal Register, 1974).  Presumably, these regulations have reduced
benzidine concentrations in industrial environments to safe levels; however,
these regulations do not recognize maximum permissible levels of contamination.
In the absence of published information on the current monitoring practices

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                                   134


 in the  benzidine  industry, of data regarding current  levels  of  exposure,
 and of  a  proven minimum exposure threshold, it is difficult  to  evaluate
 current health hazards in industry; however, the reduction in tumor  inci-
 dence would  suggest  that the risks for benzidine workers have been sub-
 stantially reduced in recent years.

 8.5.2   Laboratory Workers

     A  number of  reports have emphasized the potential dangers  of benzidine
 and the benzidine congeners in chemical, biochemical, and microbiological
 laboratories where these compounds are often used as  analytical reagents
 (Collier, 1974; Veys, 1972; Wood and Spencer, 1972).  Levels of contamination
 would undoubtedly vary from laboratory to laboratory, and it is very likely
 that a  broad epidemiological study of laboratory workers would be necessary
 to determine if laboratory exposure to these compounds constitutes a signif-
 icant hazard.  In view of the potential danger, suitable alternative analyti-
 cal reagents should be recommended, and if no such alternatives exist, users
 of these  compounds should be adequately warned of their potential
 carcinogenicity.

 8.5.3   General Population

     There is no  evidence that benzidine or any of its congeners represent
 a  health hazard to the general public.  The little information that is
 available suggests that any benzidine released into the atmosphere would
 undergo rapid physiochemical degradation.  It is more likely that if danger-
 ous environmental levels of benzidine are found, these would be restricted
 to water supplies near manufacturing and processing plants.   However, these
 compounds have not been reported in any natural bodies of water in the
 United  States.   Whether this negative evidence is due to a lack of adequate
 monitoring data or to a real absence of these substances is unknown.   It is
 quite possible that biological decomposition in water may proceed at a rapid
 rate; however,  it has also been shown that benzidine is resistant to bio-
 degradation in water treatment plants — possibly due to the formation of
 toxic chloramines.  The contamination of potential water supplies is a
 distinct possibility as is indicated by a Japanese study showing that benzi-
 dine levels were quite high in a river downstream from a series of benzidine
 dye plants (Takemura, Akiyama, and Nakajima, 1965).   This also raises the
 question as to  whether environmental contamination by benzidine-based dyes
 is  a greater potential hazard than that associated with benzidine alone.
 It has been reported that such dyes can be broken down into benzidine by soil
 and intestinal  bacteria (Yoshida and Miyakawa,  1973);  it is very likely that
bacteria normally found in natural bodies of water would have the same capa-
bility.   Benzidine dyes are used in a wide variety of  commercial products,
but as in the case of benzidine,  there is very little  information on the
amounts  being released into the environment.

 8.6  POTENTIAL  ENVIRONMENTAL HAZARDS

     It  has been shown that benzidine is potentially toxic to microorganisms,
a species of  blue-green algae,  one species of freshwater fish, and various
laboratory animals.   Although the data are not  very extensive, they lead to

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                                   135


the conclusion that sufficiently high concentrations of benzidine may prove
to be disruptive to the environment.  In view of the fact that the most
likely route of entry into the environment would be through industrial
effluents, aquatic systems may be the most susceptible to damage.  There is,
however, no evidence that toxic levels of benzidine or any benzidine compound
are present in any natural bodies of water in the United States.   This lack
of evidence may be due to an insufficient amount of environmental monitoring
data resulting from the general assumption that these substances  are not
environmental hazards.  More refined analytical techniques are currently
available to detect levels of contamination as low as 0.2 yg/liter and these
should be used to determine whether any significant environmental contamina-
tion is occurring.

     Although it would appear that benzidine lacks the physiochemical charac-
teristics — such as resistance to chemical and biological degradation — to
make it a major long-range environmental problem, its toxicity and carcino-
genicity are sufficient to require that a continuing effort be made to
evaluate its effects on the environment.

8.7  REGULATIONS AND STANDARDS

     The industrial standards instituted by OSHA in 1974 excluded from
regulation any compounds containing less than 0.1% benzidine.  These stan-
dards did not recognize a safe level of air or water contamination, nor were
any provisions made for environmental monitoring.

     In 1973 the Environmental Protection Agency proposed a toxic pollutant
standard for benzidine which was based primarily on an extrapolation of
animal test data (Federal Register, 1973).  The standard proposed limited
the amount of benzidine discharged into navigable waters to 1.8 yg/liter
provided there was an immediate 1:10 rate of diffusion or to 0.18 yg/liter
in situations where there was a slower rate of diffusion.  Because of the
limited data base, these standards were not promulgated.

     In 1976 EPA proposed new standards for benzidine discharges  (Federal
Register, 1976).  These standards were supported by evidence presented in
Criteria Document:  Benzidine (U.S. Environmental Protection Agency, 1976),
which contained information on toxicological and environmental effects and
fate of benzidine.  These standards, which were promulgated in 1977  (Fed-
eral Register, 1977) , establish an ambient water criterion for benzidine of
0.1 yg/liter.  Effluent standards were set at 10 yg/liter  (daily  average)
with a maximum for any single day of 50 yg/liter.  Based on a monthly
average, daily loading was limited to 0.130 kg per 1000 kg of benzidine
produced.  The standards set for users of benzidine-based dyes were  the
same except that the maximum daily effluent concentration of benzidine was
limited to 25 yg/liter.

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                                  136


                               SECTION  8

                               REFERENCES
 1.   Ames,  B.  N.,  W.  E.  Durston,  E. Yamasaki,  and  F.  D.  Lee.   1973.   Car-
     cinogens  Are  Mutagens:   A Simple  Test  System  Combining Liver Homog-
     enates for Activation and Bacteria  for Detection.   Proc.  Natl.  Acad.
     Sci. U.S.A.  70(8):2281-2285.

 2.   Bowman, M. C.,  J. R. King,  and C. L. Holder.   1976.   Benzidine  and
     Congeners:  Analytical  Chemical Properties  and Trace Analysis in Five
     Substrates.   Int. J. Environ. Anal.  Chem.  (Great Britain)  4:205-223.

 3.   Collier,  H. B.   1974.   Are Orthotolidine  and  Dianisidine  Health Hazards
     to Laboratory Workers?   Clin. Biochem.  (Canada)  7:3-4.

 4.   Federal Register.   1973.   Proposed  Toxic  Pollutant  Effluent  Standards.
     30(247):35388-35392.

 5.   Federal Register.   1974.   Occupational Health and Safety  Standards,
     Carcinogens.   39(20):3756-3781.

 6.   Federal Register.   1976.   Benzidine:   Proposed Toxic Pollutant
     Effluent  Standards.  41(127) :27012-27017.

 7.   Federal Register.   1977.   Toxic Pollutant Effluent  Standards.
     42(8):2617-2621.

 8.   Fitzgerald,  G.  P-,  G. C.  Gerloff, and  F.  Skoog.   1952.  Studies on
     Chemicals with  Selective Toxicity to Blue-Green  Algae.  Sewage  Ind.
     Wastes 24(7) :888-896.

 9.   Gerarde,  H. W.,  and D.  F.  Gerarde.   1974.   Industrial Experience with
     3, 3'-Dichlorobenzidine:  An Epidemiological Study of a Chemical
     Manufacturing Plant.  J.  Occup. Med. 16:322-344.

10.   Jenkins,  R. L.,  and R.  B.  Baird.  1975.   The  Determination of Benzidine
     in Wastewaters.   Bull.  Environ. Contam. Toxicol.  13(4):436-442.

11.   Lutin, P. A., J.  J. Cibulka,  and  G.  W.  Malaney.   1965.  Oxidation of
     Selected  Carcinogenic Compounds by  Activated  Sludge.  Proc.  Ind. Waste
     Conf.  20:131-145.

12.   Malaney,  G. W.,  P-  A. Lutin,  J. J.  Cibulka, and  L.  H. Hickerson.  1967.
     Resistance of Carcinogenic Organic  Compounds  to  Oxidation by Activated
     Sludge.   J. Water Pollut.  Control Fed.  39(12):2020-2029.

13.   Meigs, J. W., L.  J. Sciarini, and W. A. Van Sandt.   1954.   Skin Penetra-
     tion by Diamines of the Benzidine Group.  Arch.  Ind. Hyg.  Occup. Med.
     9:122-132.

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                                  137
14.   Noto, T.   1967.  The Effects of Some Carcinogens on the Morphogenesis
     and Differentiation in the Early Chick Embryo.   Sci.  Rep.  Tohoku  Univ.
     Ser. 4 (Japan) 33:65-69.

15.   Pliss, G. B., and V- V- Khudoley.  1975.   Tumor Induction  by Carcino-
     genic Agents in Aquarium Fish.  J. Natl.  Cancer Inst.  55(1):129-136.

16.   Radding,  S. B., B. R. Holt, J. L. Jones,  D.  H.  Liu, T.  Mill, and
     D. G. Hendry.  1975.  Review of the Environmental Fate of  Selected
     Chemicals.  EPA 560/5-75-001, U.S. Environmental Protection  Agency,
     Washington, D.C.  37 pp.

17.   Rinde, E., and W. Troll.  1975.  Metabolic Reduction of Benzidine
     Azo Dyes to Benzidine in the Rhesus Monkey.   J. Natl.  Cancer Inst.
     55(1):181-182.

18.   Schwartz, L., L. Tulipan, and S. M. Peck.  1947.  Dermatitis in Synthetic
     Dye Manufacture.  In:  Occupational Diseases of the Skin.  Lea and
     Febiger,  Philadelphia.  pp. 268-280.

19.   Takemura, N., T. Akiyama, and C. Nakajima.  1965.  A Survey  of the
     Pollution of the Sumida River, Especially on the Aromatic  Amines  in
     the Water.  Int. J. Air Water Pollut. (Great Britain)  9:665-670.

20.   U.S. Environmental Protection Agency.  1976.  Criteria Document:
     Benzidine.  EPA-440/9-76-017, Washington, D.C.   74 pp.

21.   Walker, R.  1970.  The Metabolism of Azo  Compounds:  A Review of  the
     Literature.  Food Cosmet. Toxicol. (Great Britain) 8:659-676.

22.   Wood, J.  M., and R. Spencer.  1972.  Carcinogenic Hazards  in the
     Microbiology Laboratory.  In:  Safety in Microbiology, D.  A. Shapton
     and R. G. Board, eds.  Academic Press, London,   pp. 185-189.

23.   Veys, C.  A.  1972.  Aromatic Amines:  The Present Status of  the
     Problem.   Ann. Occup. Hyg.  (Great Britain)  15:11-15.

24.   Yoshida, 0., and M. Miyakawa.  1973.  Etiology of Bladder Cancer:
     "Metabolic" Aspects.  In:  Analytic and Experimental Epidemiology
     of Cancer, W. Nakahara, T. Hirayama, K. Nishioka, and H. Sugano,  eds.
     University Park Press, Baltimore,  pp. 31-39.

25.   Zavon, M. R., U. Hoegg, and E. Bingham.   1973.  Benzidine Exposure
     As a Cause of Bladder Tumors.  Arch. Environ. Health 27:1-7-

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                                  139
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                                140
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     U.S. Environmental Protection Agency,  Cincinnati, Ohio  45268.
47.  A.  F.  Bartsch,  Environmental Research  Laboratory, U.S. Environ-
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48.  William Bishop,  U.S.  Environmental Protection Agency,  Region IX,
     100 California  Street,  San Francisco,  California  94111.
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67.  A.  Freiberger,  R&D Representative, U.S. Environmental Protection
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            .Suggested Format for the Human Effects  Section
                         of Criteria Documents
  I.  Exposure (Route of Entry)

     A.   Ingestion
          1.  Water  \
          2.  Food (including food chain magnification)
     B.   Inhalation
     C.   Dermal
          1.  Some statement as to relative contributions to total dose.

 'II.  Pharnacokinetics Human Data. Supplemented by Other Mammalian '
     Species Where Pertinent.  This section should be short but  briefly
     address each of the following and include citations of important  papers.

     A.   Absorption
     B.   Distribution
     C.   Metabolism
     D.   Excretion (including body burden and half-life data)

III.  Effects (including clinical, occupational, epideiniologic and pertinent
     animal studies).  The emphasis is to be upon E.   Animal and human data
     on cancer is the major item and should be as complete as possible.

     A.   Acute, Subacute, and Chronic Toxicity (Target Organs)
     B.   Synergistic or Antagonistic Compounds
     C*   Teratogenicity
     D.   Mutagenicity
     E.   Carcinogenicity
          1.  Animal data.  This data, should where possible, be presented in
              tabular form, i.e. describe species, route of administration,
              sex, affected organ(s), time to tumor,  reference,  etc. as
              well as dose response data.  See Example.
          2.  Human data, case reports, etc.

 IV-  Criterion Rational

     A.   Existing Standards
     B.   Current Levels of Human Exposure
     C.   Special Groups at Risk
     D.   Basis for the Standard
          1.  Extrapolation - use the linear, non-threshold model.  We will
              supply method and assistance.

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                                  141
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        Carolina  27711.
   87.   Librarian, Institute for Research on Land and Water Resources,
        Pennsylvania State University, University Park, Pennsylvania
        16802.
   88.   Librarian, U.S. Environmental Protection Agency, Office of Research
        and Development, 9311 Groh Road, Grosse  He, Michigan   48138.
   89.   Library, Eastern Environmental Radiation Facility, P.O. Box  3009,
        Montgomery, Alabama  36109.
90-93.   Library of Congress, Exchange and Gifts  Division, Washington,
        D.C.  20540.
   94.   Library, Office of Noise Abatement and  Control  (AW-471), U.S.
        Environmental Protection Agency; Washington, D.C.  20460.

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                                   142
     95.  Library, U.S. Environmental Protection Agency, Environmental
          Research Laboratory, Sabine Island, Gulf Breeze, Florida  32561,
     96.  E. Linde, Science Advisory Board (A-101),  U.S. Environmental
          Protection Agency, Washington,  B.C.  20460.
     97.  E. Lomasney, R&D Representative, U.S. Environmental Protection
          Agency, Region IV, 345 Courtland Street NE,  Atlanta, Georgia
          30308.
     98.  H. Luger, Librarian, U.S. Environmental Protection Agency
          Technical Library, Edison, New Jersey  08817.
     99.  H. Luger, U.S. Environmental Protection Agency, Region II
          Library, 26 Federal Plaza, New York, New York  10007
    100.  K. Mackenthun, Director, Criteria and Standards Division,
          Office of Water Planning and Standards, U.S. Environmental
          Protection Agency (WH-585), Washington, D.C.  20460.
    101.  C. McKenzie, U.S. Environmental Protection Agency, Region VII
          Library, 1735 Baltimore Avenue, Kansas City, Missouri  64108.
    102.  G. Marinenko, National Bureau of Standards,  Washington,  D.C.
          20234.
    103.  R. Mason, R&D Representative, U.S.  Environmental Protection
          Agency, Region II, 26 Federal Plaza, New York, New York  10007-
    104.  F. T.  Mayo, Water Laboratory, U.S.  Environmental Protection
          Agency, Cincinnati,  Ohio  45268.
105-107.  A. Montague, R&D Representative, U.S. Environmental Protection
          Agency, Region III,  6th and Walnut  Streets,  Philadelphia,
          Pennsylvania  19106.
    108.  J. E.  Moss, Attn:  Richard Heller,  Room 3304,  House Annex No.
          2, 2nd and D Streets SW, Washington, D.C.   20515.
    109.  D. I.  Mount, Environmental Research Laboratory, U.S. Environ-
          mental Protection Agency, Duluth, Minnesota  55804.
    110.  M. Munro, Annapolis Field Office, U.S. Environmental Protection
          Agency, Region III,  Annapolis Science Center,  Annapolis,  Mary-
          land  21401.
    111.  T. Murphy; U.S. Environmental Protection Agency (RD-682),
          Washington, D.C.  20460.
    112.  Robert Olson, U.S. Environmental Protection Agency, Region II,
          26 Federal Plaza, New York, New York  10017.
    113.  John Osborn, U.S. Environmental Protection Agency, Region X,
          1200 6th Avenue, Seattle, Washington  98101.
114-124.  Lynn Pretty, Technical Information  Staff,  Office of Research
          and Development, U.S. Environmental Protection Agency,
          Cincinnati, Ohio  45268.
    125.  M. Reece, U.S. Environmental Protection Agency (WH-548),  Office
          of Water Programs EEB Library,  Washington, D.C.  20460.
    126.  Registration Division Library,  Ecological Effects Branch, U.S.
          Environmental Protection Agency, Attn:  Mark Segal  (WH-567),
          Washington, D.C.  20460.
    127.  R&D Representative,  U.S. Environmental Protection Agency,
          Region I, 2203 J. F. Kennedy Federal Building, Boston,
          Massachusetts  02203.
    128.  C. Risley, R&D Representative,  U.S. Environmental Protection
          Agency, Region V, 230 South Dearborn, Chicago, Illinois  60604.

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                                   143
    129.  W. A. Rosenkranz, U.S. Environmental Protection Agency (RD-682),
          Washington, D.C.  20460.
    130.  A. Schadel, Librarian, Air Quality Planning and Standards, U.S.
          Environmental Protection Agency (mail stop 16), 826 Mutual Plaza,
          Research Triangle Park, North Carolina  27711.
    131.  S. M. Schatz, Headquarters Library, Room 2404 WSM, U.S. Environ-
          mental Protection Agency, 401 M Street SW, Washington, D.C.
          20460.
    132.  E. D. Schneider, Environmental Research Laboratory, U.S.  Environ-
          mental Protection Agency, Narragansett, Rhode Island  02882.
    133.  R. Seidman, Region I Library, U.S. Environmental Protection
          Agency, Room 2211-B, J. F. Kennedy Federal Building, Boston,
          Massachusetts  02203.
    134.  S. D. Shearer, Environmental Monitoring Support Laboratory,
          U.S. Environmental Protection Agency, Research Triangle Park,
          North Carolina  27711.
    135.  L. Smith, Library Services Branch, Office of Administration,
          U.S. Environmental Protection Agency (mail stop 35), Research
          Triangle Park, North Carolina  27711.
    136.  L. K. Smith, U.S. Environmental Protection Agency, Technical
          Information (RD-680), Washington,  D.C.   20460.
    137.  M. Smith, R&D Representative, U.S. Environmental Protection
          Agency, Region VI, First 'International Building, 1201 Elm
          Street, Dallas, Texas  75270.
138-286.  Jerry F. Stara, Office of Program Operations, Health Effects
          Research Laboratory, U.S. Environmental Protection Agency,
          Cincinnati, Ohio  45268.
    287.  D. G. Stephan, Director, U.S. Environmental Protection Agency,
          Industrial Environmental Research Laboratory, Cincinnati, Ohio
          45268.
288-289.  E. Stokes, U.S. Environmental Protection Agency, Region VI
          Library, 345 Courtland Street NE,  Atlanta, Georgia  30308.
    290.  Lester Sutton, U.S. Environmental Protection Agency, Region 1,
          J. F. Kennedy Federal Building, Room 2304, Boston, Massachusetts
          02203.
    291.  H. Sykes, Office of Pesticide Programs, Technical Information
          Center, Room 42-B, U.S. Environmental Protection Agency,
          Washington, D.C.  20460.
    292.  V. Tenney, R&D Representative, U.S. Environmental Protection
          Agency, Region IX, 100 California Street, San Francisco,
          California  94111.
    293.  L. Tilley, U.S. Environmental Protection Agency, Region V
          Library, 230 South Dearborn, Chicago, Illinois  60604.
    294.  U.S. Environmental Protection Agency, Office  of Research  and
          Development, Health Effects Division (RD-683), Washington,
          D.C.  20460.
    295.  U.S. Environmental Protection Agency, Region  1, New England
          Regional Laboratory, 60 Westview Street, Lexington, Massachusetts
          02173.
    296.  U.S. Geological Survey Library, National Center  (mail  stop  950),
          12201 Sunrise Valley Drive, Reston, Virginia   22092.
    297.  A. Weir, U.S. Environmental Protection Agency, Region  X  Library,
          1200 Sixth Avenue, Seattle, Washington  98101.

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                              144
298.  Wheeling Field Office,  U.S.  Environmental Protection Labora-
      tory Director, 303 Methodist Building,  Wheeling,  West Virginia
      26003.
299.  H.  Wiser, Principal Science  Advisor (RD-676),  U.S.  Environmental
      Protection Agency, Washington,  D.C.  20460.
300.  E.  A. Young,  U.S.  Environmental Protection Agency,  Field Studies
      Section, P.O. Box  219,  Wenatchee,  Washington   98801.

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                                   TECHNICAL REPORT DATA
                            (Please read Instructions on the reverse before completing)
1. REPORT NO.
                                                           3. RECIPIENT'S ACCESSION-NO.
4. TITLE AND SUBTITLE
                                                           5. REPORT DATE
 Reviews  of the Environmental Effects of Pollutants:
 II.   Benzidine
             6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
  Carole R. Shriner, John S.  Drury, Anna S. Hammons,
  Leigh E.  Towill, Eric  B.  Lewis, and Dennis M.  Opresko
             8. PERFORMING ORGANIZATION REPORT NO.
9. PERFORMING ORGANIZATION NAME AND ADDRESS
  Information Center  Complex, Information Division
  Oak Ridge National  Laboratory
  Oak Ridge, Tennessee   37830
             10. PROGRAM ELEMENT NO.
                1HA616
             11. CONTRACT/GRANT NO.

                IAG D5-0403
12. SPONSORING AGENCY NAME AND ADDRESS
  Health Effects  Research Laboratory, Cin-OH
  Office of Research and Development
  U.S. Environmental Protection Agency
  Cincinnati, Ohio   45268
             13. TYPE OF REPORT AND PERIOD COVERED
                Final October 1977
             14. SPONSORING AGENCY CODE
                EPA/600/10
15. SUPPLEMENTARY NOTES
16. ABSTRACT

       This report  is  a review of the scientific literature on the biological
  and environmental effects of benzidine.   Included in the review are a general
  summary and a comprehensive discussion of the  following topics as related to
  benzidine and specific benzidine compounds:  physical and chemical properties;
  occurrence; synthesis and use; analytical methodology; biological aspects in
  microorganisms, plants, wild and domestic animals,  and humans; distribution,
  mobility, and persistence in the environment;  assessment of present and
  potential health  and environmental hazards;  and review of standards and
  governmental regulations.  More than 200  references are cited.
17.
                                KEY WORDS AND DOCUMENT ANALYSIS
                  DESCRIPTORS
                                              b.IDENTIFIERS/OPEN ENDEDTERMS
                                                                         c.  COSATI Field/Group
  ^Pollutants
    Benzidine
    Toxicology
  Health Effects
     06F

     06T
13. DISTRIBUTION STATEMENT

  Release to public
19. SECURITY CLASS (This Report)
  Unclassified	
!1. NO. OF PAGES
     160
                                              20. SECURITY CLASS (This page)
                                                Unclassified
                                                                         22. PRICE

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