EPA/600/8-87/055F
                              November 1987
Summary Review of Health Effects
   Associated with Naphthalene

      Health Issue Assessment
ENVIRONMENTAL CRITERIA AND ASSESSMENT
               OFFICE
  OFFICE OF HEALTH AND ENVIRONMENTAL
            ASSESSMENT
  OFFICE OF RESEARCH AND DEVELOPMENT
U. S. ENVIRONMENTAL PROTECTION AGENCY
   RESEARCH TRIANGLE PARK, NC 27711

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                           Disclaimer

    This document has been reviewed in accordance with U.S. Environmental
Protection  Agency policy and approved for publication.  Mention of trade
names or commercial  products  does not constitute endorsement  or
recommendation for use.

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                                Preface

     The Office of Health and Environmental Assessment has prepared this
 summary health assessment to serve as a source document for EPA use  The
 summary  health assessment was  developed for  use by the Office of Air
 Quality Planning  and Standards to support  decision making regarding
 possible regulation of naphthalene as a hazardous air pollutant
     In the development of  the summary health assessment document the
 scientific literature has been inventoried  through October, 1987  key studies
 have been evaluated, and summary/conclusions have been prepared so that
 the chemicals' toxicity and  related characteristics are qualitatively identified
 Observed  effect levels  and other measures  of dose-response relationships
 are discussed, where appropriate, so that the  nature of the  adverse health
 responses  is placed in perspective with observed environmental levels
    Any  information  regarding  sources,  emissions,  ambient  air
 concentrations,  and  public  exposure has  been included only to give the
 reader a preliminary indication of the potential presence of this substance in
 the ambient air. While the available information is presented as accurately as
 possible, it is acknowledged to be limited and dependent in many instances
 on assumption  rather than specific data. This information is not intended  nor
 should it be used, to support any conclusions regarding risk to public health
    it a review  of the health information  indicates  that the  Agency  should
 consider regulatory action for this substance, a considerable effort  will be
 undertaken to obtain appropriate information regarding  sources, emissions
and ambient air concentrations. Such data will provide additional  information
for drawing regulatory conclusions regarding the extent and significance of
public exposure to this substance.

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                              Abstract

    Naphthalene, a white crystalline solid that is nearly insoluble in water, is
released into ambient air via  industrial gaseous and  paniculate emissions
tobacco  use,  and  through  consumer use. Naphthalene is the  principal
inqredient of mothballs.                                   .             ,
    The data base concerning exposure of humans via  inhalation and
associated health  effects  is virtually nonexistent.  Human  data consist
principally of accidental  overexposure  and occupational  case  reports.
Overexposure often  results  in  acute hemolytic  anemia  and  has been
associated with  cataract formation.  There are no  available  dose-response
    'ln laboratory animals, two principal target tissues have been identified:
nonciliated bronchiolar epithelial (Clara) cells and eye tissue. Effects on Clara
cells  appear to correlate with the degree  of covalent binding of  reactive
metabolites. The absence of such effects in some studies suggest that strain
and/or  exposure  variables may play  a role.  The metabol.te(s)  that  is
responsible for Clara cell damage is unknown. There are no  published studies
involving inhalation exposure.                          .
    Administration of naphthalene by routes other than inhalation has  been
shown  to produce cataracts in rats, rabbits, and one mouse strain. Animal
strains  with pigmented eyes develop cataracts faster and more severely than
albino strains. The likely causative agent is polyphenol oxidase, found only in
 pigmented eyes,  that catalyzes  the formation of 1 ,2-naphthoqumone which
 binds to lens tissue.                                                    .
     Only a limited number of mutagenicity studies have  been conducted.
 Negative results  have  been  reported  for  gene  mutations  (Salmonella),
 unscheduled  DNA synthesis  in  rat hepatocytes and  micronuclei  in mouse
 bone marrow. Limited teratology studies in rats and rabbits  reported no gross
 abnormalities. In a single dose (300 mg/kg) study in mice, both maternal and
 fetal toxicity were reported.
     The effects of chronic inhalation exposure of mice to 10 and 30 ppm have
 been examined in a lifetime study by  the National  Toxicology  Program.
 Results are not expected to  be published until the latter part of 1988. This
 study  should provide for a more definitive judgment of the toxicologic and
 carcinogenic potential of naphthalene..
                                     IV

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                        Table of Contents
 Preface   	             ,-jj
 Abstract  	'.'.'.'.'.	   jv
 List of Tables 	'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'."   vii
 List of Figures  	'.'.'.'.'.'.'.'.'.'"  viii
 Authors, Contributors, and Reviewers	              jx
 1. Summary	   1

 2. Background Information  	    5
    2.1   Chemical Characterization  	'.'.'.'.'.'.'.'.'.'.  5
    2.2   Environmental Release and  Exposure  	'.'.'.'.'.'"'  5
    2.3   Environmental Fate and Effects	  7

 3. Metabolism  	         11
    3.1   Pharmacokinetics and Metabolism	  11
          3.1.1 Absorption	  11
          3.1.2 In Vivo Metabolism  	'  11
             3.1.2.1  Oral Administration  	  11
             3.1.2.2 Intraperitoneal Administration  	        15
          3.1.3 In Vitro Metabolism  	  16
    3.2   Mechanisms of Metabolite-Induced Toxicities             21
          3.2.1 Ocular Toxicity	 '.  21
          3.2.2 Pulmonary Toxicity  	  22

4.  Health Effects  	  25
    4.1   Acute Toxicity  	                                25
         4.1.1 Oral	'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.'.  25
         4.1.2 Dermal	'.'.'.'.'.'.'.'.  26
         4.1.3 Inhalation  	'.'.'.'.'.'.'.  26
         4.1.4 Intraperitoneal  	'  26
         4.1.5 Subcutaneous  	'//_  27
         4.1.6 Eye Irritation  	  27
         4.1.7 Dermal Irritation and Sensitization  	        27
    4.2   Subchronic  Toxicity  	                       27
         4,2.1 Oral   	'.'.'.'.'.'.'.'.','.'.'.'.'.  27
    4,3   Chronic Toxicity  	'.'.'.'.'.'.  30
    4.4   Carcinogenicity	'.'.'.'.'.'.  30
    4.5   Mutagenicity   	     32
    4.6   Teratogenicity and Reproductive Effects	  32
    4.7   Neurotoxicity  	    33

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    4.8  Effects on Humans	   33
         4.8.1  Hemotoxicity  	   33
         4.8.2 Skin Sensitization 	   36
         4.8.3 Ocular Toxicity	   36
         4.8.4 Carcinogenicity  	   37
5.  References
                                                                 39
                                     VI

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No.

2-1

3-1

3-2
4-1
4-2
                           List of Tables
Current domestic manufacturers of naphthalene and their
production capacities
Metabolism of p4C]Naphthalene in control'and bile-duct-'
cahnulated rates  	
Naphthalene metabolites in urine
Acute toxicity values of naphthalene in laboratory animals
Tumor incidence in female A/J strain mice exposed to
naphthalene via inhalation for 6 months   	   31
 6

13
17
25
                                 VII

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                         List of Figures
No.
                                                           Page
3-1     Proposed in vitro and in vivo pathways for the metabolism of
       naphthalene by rats  	   14
3-2    In vitro metabolism of naphthalene  	   18
                                   VIII

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            Authors, Contributors, and Reviewers

    The following personnel of Dynamac Corporation  were involved in  the
 preparation  of earlier  drafts  of  this document: Nicolas P. Hajjar Ph D
 (Department Manager); Finis Cavender, Ph.D. (Department  Director/Principal
 Author); Louis Borghi, Dana Cazzulino, Guillermo Millicovsky, Ph D  William
 Richards, Ph.D.,  and  Patricia Turck  (Authors); William McLellan  Ph D
 (Reviewer);  Anne Gardner  (Technical  Editor); and  Gloria Fine  (Information
 Specialist).
    The final report was prepared by Mark Greenberg, Environmental Criteria
 and Assessment Office, U.S. Environmental Protection Agency.
    Drafts of this document have been reviewed for scientific and technical
 merit by the following scientists: Professor Alan Buckpitt, School of Veterinary
 Medicine, Department of Veterinary Pharmacology and Toxicology University
 of California, Davis, California; Professor Marjorie G.  Horning  Institute  for
 Lipid  Research, Baylor  College of Medicine, Houston, Texas; and Dr.  George
 M.  Shopp,  Jr., Inhalation Toxicology Research Institute,  Albuquerque, New
 Mexico.  This document has  also been  reviewed  by scientists  in  the
 Carcinogen  Assessment  Group (CAG),  Reproductive  Effects  Assessment
 Group (REAG), and the Exposure Assessment Group (EAG) of the Office of
 Health and Environmental Assessment (OHEA), U.S. EPA, Washington  DC as
 well as scientists from the Environmental Criteria and Assessment Office
 Cincinnati, OH. Special acknowledgement is  made  to  Fred Hauchman  the
 Office of Air Quality Planning and Standards, for his many  helpful scientific
and editorial suggestions throughout the preparation of this document.
                                  IX

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                             1.  Summary
  in wran h/ ±te> TV*0 £rystalline solid tha* * nearly insoluble
  £J£ i  i            released  to  ambient air via  industrial gaseous and
  part.culate  emissions, aqueous wastestreams,  tobacco  use  and  throuah
  consumer use into indoor environments                            mrougn
  EPA^nn^T"4;5,?! 'tis tconMati™  ^ ambient air are limited. One U.S
  EPA report indicated levels are in the range of 0.03 to 0.10 ng/rr.3 Levels are
  known to be  considerably higher  (in the low ppb  range) in The vfcS* of
  industrial sources  of naphthalene. In  air,  naphthalene is subfeSSd  to
  photochemical degradation. During sunlight hours,  naphthalene reacts wih
  SnhSfV raKICa'S  and  has a half-|ife  of  8 nours  During  darkness
  SL raS'T^nf r^H ^IHife °f 15 h°urs  as a result °f reacSS
  nitrate radicals.  Thus,  naphthalene is not expected to be persistent in the

  ftTsTubiect TSr ' "fPhtha'ene  levels are generally no hig'he? San 2%/L
  n^vf^J       de9radatlon  by microorganisms  and  is  known to sorb  to
  particulates  in aqueous environments.
  «ir Jneadata btasf co^n'nQ naphthalene exposure of humans via ambient
  D  ncioaNv 0fCS  ? * ^^ * Virtua"y nonexistent. Human data conS
  ina2nSly nf h £     overexposure and occupational case reports. In these
  instances of human overexposure, acute hemolytic anemia has  been  a
  frequen  finding and  there is  suggestive evidence that Overexposure  is
  af ocjated with cataract formation.  One factor identified as increasing risk for
  SSve d^Ztr 'S ,9|ucose-6-Pnosphate  dehydrogenase  deficiency
 n^rLlr  derrnatt'salso can result upon direct  contact  with naphthalene
 There are no available dose-response data

 effeSsShaSeShPPneHinf°rr!lati0n -ela,?n9  naPnthalene to adverse health
 effects  has been derived  principally  from  limited  laboratory  animal
 experimentation.  Data available from inhalation exposures are minimal
 eDithenalS^fr.^9^ !jsfuesHhave been identified: nonciliated bronchiolar
 epithelial  cells (Clara cells) and eye tissue.  In mice, single intraperitoneal
 £2 TVf^'  '" a dose-dePendent necrosis of Clara cells.  The eS and
 severity of this les.on appears to correlate with the degree of covalent bindinq
         6 metab°"tes of  naphthalene in the lung. The nature  of the react ve
            h-and 'ts,?ource (whether the Clara cell or liver) have not been
         . While naphthols have been identified as being partially responsible
 to hP a ,T   I0?'"? °bServed in Clara cells' they have n°l been demonstrated
 Sine    fh    t0r '"  Producm9 Pulmonary necrosis. The absence of such
 lesions ,n other mouse studies, including  subchronic studies, suggests strain
 ™t  Si""6 !fKable! may P'ay a role- The data base for o^er species (eg
 rat, rabbt, and hamster) is limited but there are indications that the mouse is

                      '                           neCr°SiS haS not been
           jre an  extensive number of metabolites (>30)  that have been
         in the rat and mouse. The metabolic profile differs between these
species.  In hmitedI studies with humans, only 1- and 2-naphthol have beln
conclus,vely ,dent,fied. Most metabolites excreted in the urine are conjugates

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of qlucuronides or mercapturic acids. The metabolic profile between rodents
•wd Sates' suggests interspecies differences.  In  rodents .conjugation of
naphSne with glutathione (GSH) appears.to be the principal mechanism o
exCretion.  In  primates, conjugation  with GSH may ^ <**"£**"**
metabolic  pathway. It  is not  known whether this metabolic  d«erenf®. 1S
Sgniticant in eliciting differences in adverse responses between the species.
The metabolism of naphthalene in primates has been studied only with acute
oral  exposure.  Information  from  oral studies suggests that  reactive
mf abolites are produced in a stereoselective manner ,n the liver and have a
 sufficiently long half-life  that enables  them  to  reach the lung  and eye,
       eacuo50 values for mice and rats indicate that naphthalene is
 not particularly toxic.  For mice, LD50 values are in the range of 500 to 700
 mg/kg while for rats, the range is 2,009 to 3,310 mg/kg.  It is not known what
 the comparable inhalation LC5o values are.              . u  . t-   K   h^^n
     Administration of naphthalene by routes other than  inhalation has been
 shown to produce cataracts in  rats, rabbits, and one mouse strain. IT irate. jaye
 pigmentation is an  important factor in cataract formation. P'gmentec Is  ams
 develop cataracts faster and more severely  than albino  strains. A I ke y
 causative factor  is the occurrence of  polyphenol  oxidase, found  only in
 pigmented tissue, that catalyzes formation of 1 -2-naP/lth^TtonfJr°^q1l'J"
 dihydroxynaphthalene. 1 ,2-naphthoquinone is  known to  bind to tens tissue.
 In rabbits, depletion of antioxidants is believed to be the  critical step  because
 the reserve of antioxidants is considerably less than ,n rate. Cataract forma ,on
 and other damage  to the  eye have been reported in C57BL/6J  mice  in
                          s, some naphthalene is likely to enter the systemic
  circulation. In this event, metabolism by the liver may result in the formation
  of reactive metabolites similar  to those identified  in non-inhalation  studies
  and associated with pulmonary cell damage and cataract formation. However
  there are insufficient  dose-response and pharmacokinetic data to estimate
  likely effect levels via the inhalation route.              ..-•»•      ^  /o
      Naphthalene  was found to cause a  statistically significant increase  (p
   <005) in the  number of  adenomas per tumor-bearing mouse lung but not in
  the number of adenomas per mouse in female A/J strain mice after • € i months
  of inhalation exposure. These  results are inconclusive with  regard to  the
  carcinogenic potential of  naphthalene.  Effects  of chronic exposure of mice (to
   10 and  30 ppm  naphthalene)  have been  examined in a 2-year inhalation
  study  by the National Toxicology Program. Results  have  not  yet been
  published. This study should provide information with which one can evaluate
  ihe carcinogenic  potential of naphthalene.  According to U.S. Environmental
   Protection Agency Guidelines for Carcinogen Risk Assessment naphthalene
   is classified as a Group D carcinogen. The evidence is inadequate to  evaluate
   the carcinogenic potential of naphthalene for man.              ,,,,<•«,
       Only a limited number of mutagenicity studies have been conducted with
   naphthalene.  Negative results  have  been reported for gene mutations  in
   Salmonella, unscheduled DNA  synthesis in rat  hepatocytes, and micronuclei

   10 TnTsingle dose (300 mg/kg) teratology study in mice, both maternal and
   fetal toxicity  were reported. Limited  teratology studies in rats and rabbits
   reported no gross abnormalities from naphthalene exposure.
       A more definitive judgment  of the impact of  naphthalene exposure via
   ambient air on  human  health can only  be made after completion of  the
   National Toxicology Program (NTP) chronic  bioassay  and additional studies

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on  selected  biological  endpoints. A reassessment  of  naphthalene effects
associated with inhalation  exposure should  be carried out  once the NTP
results become available.

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                   2.  Background Information

  2.1  Chemical Characterization

      Naphthalene  (CAS No. 91-20-3) has the empirical formula C10H8.  It is
  a white  crystaline sohd with a molecular weight of  128.16. Naphthatene is

  Ha T^r?/rle'" ,Watern(3° mg/L) and has a low vaP°r Pressure <1  mm
  mg/m3         (Toxicology Data Bank). At 25°C, 1  part per million  = 5.2

      Domestic  production capacity of naphthalene was  estimated to be  660
  million pounds annually as of January 1, 1984. Six manufacturers produce the

  3°UN  ^h"',06  Plant Sites as shown in Table  2'1 ' and use as a moth repellant
 (2 percent) (Chemical Economics Handbook, 1981).

 2.2 Environmental  Release and Exposure

    Naphthalene is released into the environment via  industrial gaseous and
 particulate emissions  aqueous waste streams, and through consumer  uses
 MNIiamT^,  To«lfn deteCted in aerosols from a coal gasification  plani
  Williams et al  1982), gaseous  emissions from aluminum  manufacturing
  Hung and Bermer 1983), rendering plant  emissions (Van Langenhove et al
 1982), spent pulp  bleaching liquor (Kringstad  et  al.,  1984), and wastewater
 from  oil and gas fields (Middleditch, 1982). Oil spills  are another important
 source of naphthalene release into the aquatic environment (U.S EPA 1980)
 The compound  is also released into the atmosphere via the combustion gases
 of coal-fired boHers (Warman, 1983), residential wood stoves (Jaasma and
 mt™ 't   ^' ,Chfnotaw e"9'nes 
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Table 2-1  Current Domestic Manufacturers of Naphthalene and Their
          Production Capacities (million pounds)            •;
                     Manufacturer
                                                       Annual Capacity
  Allied Corporation, Allied Chemical, Ironton, OH

  Ashland Oil, Inc., Ashland Chemical Company Division,
   Petrochemicals Division,
   Catlettsburg, KY

  El. du Pont de Nemours & Company, Inc., Conoco Inc.,
   subsidiary, Conoco Chemicals Company Division,
   Chocolate Bayou, TX

  Getty Oil Company, Getty Refining and Marketing
   Company, subsidiary, Delaware City, DE

  Koppers Company, Inc., Organic Materials Group,
   Cicero, IL
   Follansbee, WV
   Fontana,  CA

  United States Steel Corporation, USS Chemicals Division,
   Clairton,  PA
   Gary, IN

               Total
                                                            75"
660
 aFrom petroleum; naphthalene is sold on the merchant market.
 t>From petroleum (ethylene coproduct); naphthalene is used used captively.
 cFrom coal tar; naphthalene is used captively and sold on the merchant market.
 dFrom coal tar; naphthalene is used captively.
 Source: SRI International (1984)
 coal gasification sites at concentrations of 380 to 1,800 ppb 15 months after
 gasification activity had ended. Pankow et al. (1984) reported mean dissolved
 naphthalene concentrations of 11 and 72 ng/L in rainwater samples collected
 in semirural and residential locations, respectively, in Oregon.
      Naphthalene was  detected  in ambient air samples collected in  Denver,
 CO (Hutte et al  1984), and near abandoned chemical waste dumps (Durchm
 and Pendleton, 1983). In 1977, ambient air concentrations were reported to
 range from  0.03  to 0.10 ng/m3 (for vapor) and  0.003  to 0.25  ng/rr.3  (for
 particulates) (U.S. EPA, 1980). In a field study of mobile homes, Connor et al.
 (1985) reported naphthalene levels have been 0.3 and 11.8 ppb. Naphthalene
 has also been detected in fly-ash samples from municipal waste incinerators
 in  Canada and Norway  at concentrations of  130 to 760  ng/g  (Viau et al.,
  1984)  The  compound  has been  found to be adsorbed  to the particulate
  matter emitted in diesel  engine exhaust; Yergey et al. (1982) determined an
  average emission rate of 329 iig/g of particle.
      Estimates of occupational exposures to naphthalene  have been reported
  in  industrial  hygiene  surveys performed by  the National Institute for
  Occupational Safety  and  Health  (NIOSH).  According  to  the  National

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  Occupational  Hazard Survey  (NOHS), 121,977  workers were  potentially
  exposed  to naphthalene  in domestic workplace environments in  1970
  SS'Sffi-  f th°* in9r^in  the  Nati°nal Optional Exposure  Survey
  to the com ouffd           *    rS' includin9 1'535 women, were exposed

    „ J,h6K Occupational Safety and Health Administration (OSHA   1983)
  nS^f fn nan  8£nUr time-wei9nted ^erage (TWA) permissible exposure
  limit of 10 ppm (50 mg/m3) for naphthalene; the American Conference of
  Governmenta  Industnal Hygienists (ACGIH, 1984) recommended an 8-hour
  TWA threshold  Hm* value (TLV) of 10 ppm and a 15-minute  short-term
  exposure limit-TLV of 15 ppm (75 mg/m3)
     Van Langenhove  et al.  (1982) detected naphthalene in the  workplace
  atmosphere of a rendering plant. Bjorseth et al. (1978a) reported naphthalene
  vapor concentrations  of 0.7 to 60  ppb (4 to 311 ug/m3) in  atmospheric
  samples and 0.01 to 0.7 ppb (0.09 to 4 .g/mS) (as SSJuSsff^SSS
  samples taken at an aluminum reduction plant. Atmospheric samples at a
  coke plant showed mean naphthalene concentrations  of 0.2 ppb (12 uq/m3)
         1   } 1^1 1f/Pb (646  t0  653 *9/m3> <9aseous> (Bjorseth  et al.
       '"               y> naPhtna|ene vapor concentrations  up to 230 ppm

                     ^EpX, x>place atmospheres  where m™en
     A 1977 report (U.S. EPA, 1980) listed groups of workers that were among
 those having potential exposure to naphthalene. These workers were involved
 in the use or manufacture of beta naphthol, celluloid, coal tar, dye chemicals
 fungicides, hydronaphthalene, lampblack, moth repellants, phthalic anhydride'
 reduction3 ^^  ta"nery products'  textile chemicals,  and  aluminum

     Gas chromatography (GC) coupled with mass  spectrometry (MS)  is the
 method  most commonly used to characterize naphthalene in environmental
 media and workplace atmospheres; flame ionization detection has been used
 "1 TS10? With GC/MS  to obtain quantitative concentration data (Pankow
 P * " IOAO: I0"9 ^la'" 1984: Viau et al" 1984: Dernier et al., 1982 Yergey
 et al., 1982; Bjorseth et al., 1978a).

 2.3  Environmental Fate  and Effects

    Naphthalene  is expected to be released  into the atmosphere  from
 sources  that include  petroleum fuel combustion (Biermann et al., 1985) and
 mothball subl.mation. In the atmosphere, the compound exists predominantly
 "]  ioa3?0,! P    u: as ^Pared to being bound to particulates (Biermann et
 al., 1985). It is subject to various photo-oxidative or  oxidative reactions
    beveral recent articles suggest that  naphthalene may be  subject  to
 hydroxy  (OH) radical attack during the daytime and to nitrate (N03) radical
 f^fnCH tt  I"9  iJT3"" et al" 1985: Atkinson et al- 1984>- Biermann et al.
 found that naphthalene reacts rapidly  with OH radicals at room temperature-
 they determined a rate constant  of 2.35 x 10-" cm3/mo|-sec, which gives a
 ftmnTrfh  a  ot°f approximately 8 hours (lifetime of 12 hours), assuming an
 atmosphenc OH radical concentration of 1 x 106  mol/crr.3. Atkinson et al
 presumably provided  the first direct evidence for the gas phase reaction of  .
 NOs radicals with  naphthalene and determined a rate constant of 64 x 10-15
cmJ/mol-sec.  Recent evidence suggests  that N03  radicals  may be a
common  constituent of nighttime air over many U.S. continental areas  with
maximum concentrations in excess of 10 pot and probably close to 100 ppt in
populated areas (Platt et al., 1984). Assuming an  atmospheric N03 radical

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concentration  of 80  ppt, the  nighttime  half-life  for  naphthalene is
approximately 15 hours.                               .               	
    Atkinson et al. (1987) observed that gas-phase  reactions of naphthalene
with OH radicals in the presence of nitrogen oxides resulted in the production
of 1- and 2-nitronaphthalenes and  1-  and  2-naphthols.  Nitronaphthalenes
have been detected in ambient air (Arey et al., 1987).
    The  mechanisms and products of these reactions have not been  fully
elucidated. These reactions are likely to proceed via initial radical addition to
the aromatic ring, but subsequent reaction mechanisms and products under
atmospheric conditions are not known (Biermann et al., 1985; Atkinson et al.,
1984)  For  the  OH radical,  analogies  can  be  made with  monocyclic
hydrocarbons. Initially, the aromatic ring would stay  intact, with products such
as hydroxynaphthalene and nitronaphthalene  expected to form. However it is
possible that the aromatic ring could cleave, leading to products such as
dibenzaldehyde (Biermann et al., 1985).
    Naphthalene is  expected to enter the aqueous environment from  botn
natural and anthropogenic sources (U.S.  EPA, 1979).  The  initial fate of the
compound is determined by three competing physical  processes: sorption to
particulates, evaporation, and water solubility. Sorption to organic  matter is
linearly related to the log octanol/water partition coefficient for naphthalene
concentrations  up  to  60  to  70 percent of its water solubility  (30  mg/L),
whereas increased sorption occurs at higher concentrations (Kanckhoff et aL,
 1979)  Given  naphthalene's  log octanol/water partition  coefficient of  3.37
 adsorption  to particulates would seem to be moderately strong; however at
 low naphthalene concentrations, this may not be true. At a concentration  of 25
 up/L  Lee et al.  (1978)  found that only 2 percent of  naphthalene  bound to
 suspended particulates  in seawater following a 3-hour incubation period. No
 data on the organic content  or the concentrations of  the  particulates  in the
 seawater were reported.
     Southworth  (1979)  calculated  volatilization rates of naphthalene  from a
 model stream with a depth  of 1.0 m.  The  half-life for volatilization  varied
 from about 80 hours for a stream with a velocity of  0.1 m/sec and  a wind
 velocity of 0.25 m/sec,  to about 3 hours for a stream with a velocity of 1.0
 m/sec and a wind velocity  of 4  m/sec.  He concluded  that the rate of
 volatilization would  be low in relatively deep, slow-moving rivers but that it
 may be competitive with other removal processes such as adsorption in clear,
 rapidly flowing shallow streams.                                .
      Lee and  Anderson  (1977) studied  the  fate of naphthalene in a  model
 ecosystem. When 2 g of naphthalene were added  to the ecosystem to make
 a  concentration of  34 ng/L,  220  mg were detected in the sediment after 4
 days Thus  about 11 percent of the naphthalene settled to the  sediment,
 approximately 44 percent remained in the water  column,  and the  remaining
 45 percent was unaccounted  for. The naphthalene  may have evaporated,
 photo-oxidized, or  adsorbed to the sides  of the  container, but the  authors
 suggested that biodegradation played the major role.
      A laboratory method for measuring the volatilization rate of naphthalene
 and other  low volatility chemicals from water has been described by Smith et
 al. (1981). The use of  XAD-2 resin as an  adsorbent for trace quantities of
 naphthalene in water was described by Wigilius et  al. (1987).
      Many microorganisms found  in the environment are capable of degrading
  naphthalene. These include  algae  (Cerniglia et al., 1979), fungi (Cerniglia et
  al   1978)  and bacteria (Gibson,  1972; Davies and Evans, 1964). In addition,
  treatment of wastewater effluents has been shown to effectively degrade
  naphthalene (Tabak et  al., 1981;  Malaney et al., 1967). At concentrations of 5

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  and 10 mg/L, complete primary degradation of naphthalene was observed in a

  Sabak ^ ai°U Qft^*^ Hith  d,°meStiC wastewater "sed *>  an inoculum
  (Tabak et al.,  981). Biodegradation of naphthalene  to CO2  has been
                                3CtiVated Slud9e system where'2,500 mg/L
                                hem'ICa* °xygen demand ran9ing from 32.8
               /(l oxygen demand (Malaney et al.  1967)  Lee
               (197?) dettermined the biodegradation ratesof naphthalene by
                 present in  marine water at depths of  5  to 10  m   These
  andhH^^  14C-"aPntha'ene at a concentration oTso^/L
  and incubated for  3 days.  Rapid adaptation to naphthalene as a  carbon
               ^/^ the ^adation rates Banged from 0.1  yg/L/day  on
               l-9/L/day on  day 3. Under  anaerobic conditions  however,
         dation pf naphthalene is not likely. Delaune et al. (1980)  found tha
           f H °fhS hi bi°de9rade under  a"aerobic conditions that  are
  prevalent at depths below 2 cm in sediments
  bePnS£iMriHiHhepmiCr°bial  biode9radative pathways of naphthalene have
  been eluadated. For pseudomonads and most other bacteria, naphthalene is
  broken down  to catechol as shown below.                        "wiene is>
                                     OH
                                                            HO
                                                                COOH

                                                                  : o
                OH
                                        COOH
                                                               CHO
Catechol is further degraded by  these  microorganisms  to  CO2 and HoO
Chough the metabolic  pathways vary among differing  species (Barnslev'
H^h I  i°o Jr?81 bacteria-  the initl'a' metabolite of naphthalene is  c/s-1 2-
dihydro-1,2-dihydroxynaphthalene,  in contrast to naphthalene-1 2-oxide
wh.ch is thought to be the initial  metabolite for fungi,  eukaryotes, and other
bacteria (Cern.glia et al., 1984). This arene oxide is very unstable  and can
undergo other reactions,  predominantly to  1-naphthol.  It rearranges
probably nonenzymatically,  to 1-naphthol; some 2-naphthol is also formed'
I he oxide also will react nonenzymatically or enzymatically with water to form

-------
1,2-dihydroxy-1,2-dihydronaphthalene  with  glutathione to  form  the
glutathione analog of the dihydrodiol.
                                    10

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                           3.  Metabolism

  3.1  Pharmacokinetics and Metabolism

      With  the  exception  of one study (Mackell et  al.,  1951), there  is  no
  information concerning the metabolism  of  naphthalene in man There are
  however, a number of studies that have investigated the in vitro and in vivo
  metabolism  of naphthalene pertinent to laboratory animals, particularly the
  rabbit and rat. These data, coupled with limited information from subhuman
  primates,  appear sufficient to enable  one to  draw relevant conclusions for
  msn.

  3.1.1 Absorption

     The few case reports available in the literature suggest that ingestion of
  naphthalene results in absorption and subsequent acute toxicity (Gidron and
  ^f' 1956: Chusid and Fried- 1955=  Macke" et al- 1951; Zuelzer and Apt
  1949) A recent case report identified naphthalene ingestion as the cause of
 death (Ijiri et al., 1987). Dermal absorption also is likely based on the reports
 by Dawson et al. (1958), Cock (1957), and Schafer (1951). Only one inhalation
 case report associated with toxicity has been identified (Valaes et al., 1963)
     Bock et al. (1979) studied the absorption and metabolism of naphthalene
 in the rat jejunum in situ.  i^C-naphthalene was  injected into  the isolated
 intestinal loop, and the  concentrations  of naphthalene and its  metabolites  in
 M  IT?" and portal blood were  determined  after a 30-minute incubation
 Naphthalene was rapidly  absorbed and found mostly unchanged (about 84
 percent  of the dose) in portal blood.  The  major ether-soluble metabolites
 were identified  as naphthalene-1,2-dihydrodiol  and  1-naphthol
 Conjugates comprised about 40 percent of the metabolites and were mostly
 glucuronides of the dihydrodiol and 1-naphthol. This  study  indicates that
 metabolism can occur prior to first-pass through the liver.

 3.1.2 In Vivo Metabolism

 3.1.2.1  Oral Administration
    Recently,  Bakke  et  al.  (1985)  studied  the  metabolism of  14<>
 naphthalene in male Sprague-Dawley  rats  in  an effort to determine the
 catabohsm of premercapturic  acid  pathway metabolites  of naphthalene to
 napnthols and  methylthio-containing metabolites. Mercapturic acids are n-
 acetyl cysteinyl thioethers of the form:

                           R-S-CH2-CH-COOH
                                       I
                             CH3-CO-NH

 R represents an aryl radical.
    14C-naphthalene (2 mg/0.5  nCi  in 0.5  ml  ethanol) was  administered
orally to two groups of control rats, 4 groups of bile duct-cannulated rats and
                                  11

-------
to 4 germ-free rats (2 mg/1.0 nCi). Bile, urine, and feces from control and
cannulated rats were  collected for 72 hr (urine and bile samples from each
group were separately pooled for metabolite identification). In control rats, the
recovered dose in urine was 77 to 93 percent and 6 to 7 percent in feces; in
cannulated rats, urine represented 25 to 43 percent while bile represented 49
to 76 percent (feces contained < 1 percent).
    Urinary naphthols and naphthol glucuronides represented 4.6 percent of
the dose administered (methylthioglucuronide also represented  4.6 percent)
in control rats. In  contrast, bile and urine from cannulated rats and urine from
germ-free rats contained no labeled  methylthio  derivative and only trace
amounts of labeled  naphthols  or conjugates. The principal  metabolites in
control urine were  identified as 1,2-dihydro-1-hydroxy-2-S-(N-acetyl)
cysteinyl   naphthalene  (38  percent)   and   1,2-dihydro-1,2-
dihydroxynaphthalene glucuronide (24 percent). In germ-free rats, the major
urinary  metabolite  was  1,2-dihydro-1-hydroxyl-2-S(N-acetyl)-
cysteinyl 14C-naphthalene (89 percent). Identified  metabolites are  shown in
Table  3-1.
     Figure 3-1 highlights the proposed in vitro and in vivo  pathways, with a
focus  on  the pre-mercapturic acid pathway. As  shown in  Figure  3-1, it is
likely that  naphthol formation in  rats  is derived  from  pre-mercapturic acid
metabolites,  possibly  from the  action  of intestinal microflora.  Oral
administrations of compounds I or II to control rats resulted in the formation of
both naphthols and the methylthio derivatives; elimination of  acid hydrolysis in
the stomach as a mechanism was confirmed when compounds  I and II were
injected intracecally.  Both naphthol  and methylthio derivative  increased
significantly above oral values.
     Rozman et al. (1982) determined the urinary, fecal, and biliary excretion
of thioethers and hepatic GSH content (by  liver biopsy)  in rhesus monkeys
following administration of a single oral dose of naphthalene  (in sesame oil) at
0, 30,  75, or 200 mg/kg. Naphthalene had no significant effect on the urinary
and fecal excretion of thioethers or the hepatic GSH content. Bile excretion of
thioethers  increased  from 6.4 to  14.6 iimol/kg/24 hours,  but the amount
corresponded to only 0.5 percent of the  administered  dose.  Bakke et al.
(1985) found that methylthio derivatives were about 5 percent of administered
dose to rats. The  data of Rozman et al.  (1982) suggest  that naphthalene
conjugation with  GSH is apparently not a major metabolic pathway in rhesus
monkeys. Similarly, a single dose of naphthalene in sesame or corn oil at 200
mg/kg did  not increase the urinary excretion of  mercapturic acids in  four
chimpanzees (Summer  et al.,  1979).  However when SPF  Wister  rats were
administered naphthalene (0, 30, 75 or 200 mg/kg), up to  39 percent of the
dose (30 mg/kg) was excreted in the urine as mercapturic acids (Summer et
al., 1979).
     There were no GSH conjugates of naphthalene in the bile and only trace
amounts were found  in the urine of humans receiving a single oral dose of 0.5
g naphthalene (Boyland and Sims, 1958). These data are consistent with the
 hypothesis that primates do not conjugate naphthalene with  GSH to the extent
that rodents do (Rozman et al., 1982; Summer et al., 1979),  possibly because
 of a  slow  rate  of  naphthalene-epoxide  formation  or a higher epoxide
 hydrolase activity  in primates (Rozman  et al.,  1982).  Increased epoxide
 hydrolase activity would result  in increased formation of  naphthols at the
 expense  of mercapturic acids.  Lower activities of GSH transferases  in
 primates, as suggested  by the studies of Chasseaud (1973), also may be an
 additional  factor. It  also is known  that  a variety of  isozymes of GSH
 transferases exist and which  may differ among species (Ketterer, 1986).
                                    12

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  Table 3-1.  Metabolism of [14C]Naphthalene in Control and Bile-Duct-
             Cannulated Rates
                                                    % of 14C dose
                Metabolite(s)
               Bile duct
Control        cannulated
 Urine
                                                         Urine
                                                                   Bile
   1,2-Dihydro-1 -hydroxy-2-S-cysteinyl-
   naphthalene (1)'

   1,2-Dihydro-l-hydroxy-2-S-(N-acetyl)
   cysteinylnaphthalene (II)'
   1,2-Dihydro-1-hydroxy-2-S-
   cysteinylglycine-
   naphthalene'

  Dihydroxynaphthalene
  Dihydrodihydroxylnaphthalene
  l,2-Dihydro-1,2-dihydroxynaphthalene
   glucuronide(lll)

  1,2-Dihydro-1-hydroxy-2-
   methylthionaphthalene
   glucuronide*
  Naphthols
  Naphthol glucuronides
  Uncharacterized""
 38.1





 4.9


 23.9


 4.6



 1.6
 3.0

 2.4
14.1
1.5
14.5
16.9


0.7


9.6
 6.4

26.8
                                                        3.0(4)     6.0(5)
 Urine from control rats and urine and bile from bile-duct-cannulated rats were
 collected for 24 hr after dosing; these contained 75.6, 29.9, and 66.8% of the 14C
 dose, respectively, —not detected (limit of detection was  <0.5% of the 14C
 dose).
 "Assumed to have the 1,2-dihydro-l-hydroxy structure as deducted by Jefferv
 and Jerina (1975).
 "Numbers in parentheses indicate the number of chromatographic fractions.
 Source: Bakke (1985).
    In a study by Corner and Young (1954) the comparative metabolism of
naphthalene  in male rabbits, male  guinea pigs, hooded male rats, and male
white mice was assessed by paper chromatographic identification of urinary
metabolites. All animals were given a single dose of naphthalene in arachis oil
at 500 mg/kg. Rabbits were dosed by stomach tube; guinea pigs and mice
were  dosed  by  intraperitoneal injection; and rats were dosed  by both
intraperitoneal injection and stomach tube. The same metabolites were found
in the urine of rats dosed with naphthalene intraperitoneally or orally. All four
species  converted   naphthalene  to  1-  and  2-naphthol,  1  2-
dihydronaphthalene-1,2-diol,   1-naphthyl-sulfuric  acid,   and  '1-
naphthylmercapturic acid.  In addition, rabbits  and  rats excreted  1-
naphthylglucuronic  acid and  1,2-dihydronapthalene-1,2-diol  glucuronic
acid;  mice excreted  1-naphthylglucuronic acid; and  guinea pigs  excreted
1,2-dihydroxynaphthalene.  Chromatographic  analyses  suggested
                                   13

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                                     -glutathione

                                     -cysteinylglycine

                                     -cysteine (I)

                                     -(h-acetyl)cysteine (II)
                           preMAP-metabolites
                                                                  SCH3
 Figure 3-1  Proposed in vitro (••••
 metabolism of naphthalene by rats.
 Source: Bakke et al. (1985).
•) and in vivo (•
••) pathways for the
interspecies difference  in  the amounts of 1- and 2-naphthol  produced.
Hooded rats were found to secrete glucuronic acid conjugates of both levo-
and  dextro-rotary  forms  of  1,2-dihydronaphthalene-1,2-diol.  In  rabbits,
the glucuronic acid conjugate (Corner et al., 1954) was found. No evidence
was  found for  the occurrence of the  glucuronic  acid conjugates in either
guinea pigs or mice (Corner and Young,  1954).
    Boy land  and Sims (1958) detected 1-naphthyl-mercapturic  acid  in the
acidified urine of rabbits dosed with naphthalene in arachis oil (5 ml of 20%,
w/v).  Acidification of urine also resulted  in the  concomitant production of
naphthols and indications that N-acetylcysteine may have been formed. The
precursor of 1-naphthylmercapturic acid  was  suggested  to be N-acetyl-
S-(1,2-dihydro-2-hydroxynaphthyl)-L-cysteine.  Other  species  shown
to form this precursor included both male and female rats, mouse, hamster,
guinea  pig,  and  man.  Bourne  and Young  (1934) detected a-
naphthylmercapturic acid in  urine of  rabbits administered  naphthalene in
warm paraffin.
    In a  study designed  to  elucidate  the impaired metabolic step  in an
inherited disorder, Kodama et al. (1974) found high concentrations of cystine,
N-monoacetylcystine,  and  S-(2-hydroxy-2-carboxyethylthio)cysteine in
the urine of rabbits dosed  orally with 3 g of naphthalene (approximately 1.2
g/kg) daily for 3 weeks.
                                   14

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 3.1.2.2 Intraperitoneal Administration

     In a study with female Sprague-Dawley rats, 24 and 60 percent of the
 l-T*C-napnthalene dose  (100  mg/kg) administered intraperitoneally, was
 found  in the urine 24 and 72 hours after dosing,  respectively (Chen and
 Dorough, 1979).  In addition, about 14 percent of the dose was found in the
 feces  72  hours  after   dosing.  1,2-Dihydro-1,2-dihydroxynaphthalene
 (naphthalene-1,2-dihydrodiol) and 1-naphthol  were  the major ether-
 extractable metabolites in the urine, accounting  for about 6 percent of the
 administered dose. This is similar to the amount formed by control rats in the
 oral dosing  study  by Bakke et al. (1985). Four  water-soluble radiolabeled
 metabolites were found in the urine of rats after 72 hours. These metabolites
 were  tentatively  identified as 1-naphthol,  1,2-dihydro-1,2-dihydroxy-1-
 naphthyl sulfate  (most  probably  the  1,2-dihydro-2-hydroxy-1-naphthyl
 sulfate),  N-acetyl-S-(1,2-dihydro-2-hydroxy-1-naphthyl)cysteine
 (most    probably     N-acetyl-S-(1,2-dihydro-1 -hydroxyl-2-
 naphthyl)cysteine  or possibly  N-acetyl-S-(2-naphthyl)cysteine),  and
 1,2-dihydro-2-hydroxy-1-naphthyl glucuronide,  and accounted  for 5.0
 8.0, 65.0, and 16.8 percent, respectively, of the total radiolabel found in the
 water-soluble fraction. It was concluded that in rats, glutathione (QSH) and
 mercapturic acid  derivatives were the major conjugates in the metabolism  of
 naphthalene.

     Several  studies  were conducted  on  the metabolism  of  1-14C-
 naphthalene  in male  Sprague-Dawley rats following  intraperitoneal injection
 at a dosage of 100 mg/kg  in 0.5 ml corn oil (Horning et al., 1980a; Horning  et
 al., 1980b; Stillwell et al., 1978). Of the administered radiolabeled dose, 20  to
 30 and 3 to  11 percent was excreted in  the urine in 0  to 24 and  24 to 48
 hours,  respectively.  Unconjugated  (neutral) and conjugated  (acidic)
 metabolites accounted for  5 to 20 and 80 to 95 percent,  respectively, of the
 total  metabolites excreted in urine.  Of the radioactivity excreted  as
 conjugates, 20 to 40  percent was liberated  after glucuronide and  sulfate
 hydrolysis;  the  remainder was  accounted  for  as  mercapturic and
 premercapturic  acids (Horning  et al.,  1980b).  Twenty-one suggested
 metabolites were  isolated  and characterized by GC and  GC/MS. The major
 metabolites  were  1-naphthol,  2-naphthol, frans-1,2-dihydrodiol  (1f32a-
 dihydroxy-1,2-dihydronaphthalene), ?rans-1,4-dihydrodiol  (rac-trans-
 1,4-dihydroxy-1,4-dihydronaphthalene),  and 1,2-,  1,7-,  and  26-
 dihydroxynaphthalene.  Other metabolites  included O-methylcatech'ol
 trihydroxy naphthalenes,    trihydroxydihydronaphthalenes'
 tetrahydroxynaphthalenes,  and  tetrahydroxy-tetrahydronaphthalenes. The
 authors also  suggested that in addition  to naphthalene-1,2-oxide,  several
 other epoxides,  including two  naphthalene dihydrodiol epoxides one
 diepoxide, and a cyclic peroxide, were intermediates in the in vivo metabolism
 of naphthalene. These epoxides and the cyclic peroxide, in turn, lead to the
formation of the di,  tri-, and tetrahydroxynaphthalenes, dihydronaphthalenes
and  tetrahydronaphthalenes as  urinary excretion  products (Horning  et al.,
 1980a; Horning et al.,  1980b).  In  addition, 10 methylthio metabolites were
isolated (Horning et al., 1980a; Stillwell et al., 1978). These metabolites were
identified as  1-methyl-thionaphthalene, methylthiohydroxynaphthalene and
methylthio derivatives  with  a dihydronaphthalene or a tetrahydronaphthalene
structure. The methylthio derivatives accounted for only a minor part of the
metabolites  excreted.   The  two  major  methylthio  metabolites
(methylthiodihydrodiol  and  dimethylthiotetrahydrodiol) accounted for 02  to
                                 15

-------
1.0 percent of the administered dose (Stillwell et al., 1978). This finding is in
contrast to that of Summer et al. (1979) in which Wistar rats converted about
39 percent of the dose to thioethers.
    Stillwell  et al.  (1982)  conducted a similar study with male Swiss mice
dosed  intraperitoneally with naphthalene dissolved in corn oil at 100 or 150
mg/kg. Approximately 65 percent of the administered dose  was excreted in
the urine  after 24  hours and 3 percent between 24 and 48 hours. Neutral
metabolites accounted  for only 4 percent of the metabolites excreted in  the
urine, whereas 96 percent were excreted as conjugates with approximately 20
percent of these as glucuronides or sulfates. Three major neutral metabolites
were identified in the urine after  enzyme hydrolysis; these  were 1-naphthol
(I), frans-1-hydroxy-2-methylthio-1,2-dihydronaphthalene  (II), and
1fj,2a-dihydroxy-1,2-dihydro-naphthalene (III). In  addition,  eight  minor
sulfur-containing metabolites  were isolated.
    Most  of  the neutral metabolites isolated from  mouse  urine also were
present in rat urine, but the profiles of the urinary  metabolites were quite
different for  the two species.  1-Naphthol was the major neutral metabolite in
hydrolyzed urine from mice (8 to  10 percent of the dose), whereas the trans-
1,2-dihydrodiol was the major metabolite in hydrolyzed urine from rats (18 to
24 percent of the dose).  In mice,  the order of excretion of the five major
metabolites  was  l>ll>lll>1-methylthionaphthalene>2-naphthol. In rats,
the order of excretion  of  the four  major  metabolites was  ll>l>2-
naphthol > 1,7-dihydroxynaphthalene (III  is a minor metabolite). It  was
suggested that these differences between mice and rats were associated with
differences  in mono-oxygenase and epoxide  hydrolase activities  for each
species.
    Seven acidic  sulfur-containing metabolites  were also  identified. A
product   identified as  N-acetyl-S-(l-hydroxy-1,2-dihydro-2-
naphthalenyl)-cysteine  was  the major  metabolite  and accounted for 38
percent of the administered dose of naphthalene. A number of other sulfur-
containing metabolites, accounting for approximately 1  percent of the dose,
were isolated.
    A variety of naphthalene metabolites also has been identified in the  bile
of  cannulated rats dosed i.p.  (until  rats  became  ill) with solutions of
naphthalene  (75  mg), 1,2-dihydro-naphthalene  (50  mg), or  1,2-epoxy-
1:2:3:4 tetrahydronaphthalene (25 mg) in 0.5 ml arachis oil (Boyland et al.,
1961).  The   bile  of rats  treated with  naphthalene contained  1- and 2-
naphthol, 1-naphthylglucuronic  acid,  1,2-dihydroxynaphthalene  and  1-
and 2-glucuronic acid  conjugates of trans  naphthalene. Sulfuric esters  1,2-
dihydrodiol  were not  detected. In  rats treated with 1,2-dihydronapthalene,
bile contained all metabolites seen upon naphthalene administration as well
as S-(1:2:3:4-tetrahydro-2-hydroxy-1-naphthyl)  glutathione.  Large
amounts  of  2-naphthol were produced.  Detection was   made  by paper
chromatography.
    The metabolites identified in the in vivo studies are presented in Table
3-2.
3.1.3  In Vitro Metabolism

    The in  vitro metabolism  of  naphthalene has  been studied by several
investigators (Booth et al., 1960; Jerina et al., 1968, 1970; Chen and Dorough,
1979;  Holtzman et al.,  1967a,b; Oesch and Daly, 1972;  Bock et al., 1976; van
Bladeren  et  al.,  1984,  1985;  Hesse and Mezger,  1979; Hesse et al., 1982).
Jerina et  al.  (1970, 1968) demonstrated, in radioisotope trapping experiments
                                   16

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  Table 3-2. Naphthalene Metabolites in Urine

Metabolite Rab-
bit
1-naphthol 1>7
2-naphthot 7,7
1-naphthyl sulfate ij
1-naphthyl glucuronic acid 1,7
S-(1 -naphthyl)-L-cysteine
1-naphthyl mercapturic acid 1,7
l,2-dihydro-1,2-dihydroxy 1,7
naphthalene
l,2-dihydro-2-hydroxy- 1,7
1-naphthyl -
glucuronic acid
1,2-dihydro- 1 -hydroxy-
2-naphthyl-
glucuronic acid
N-acetyl-S-(l,2-dihydro- 1
2-hydroxy-l -naphthyl)-
L-cysteine
2-hydroxy-l-naphthyl t
sulfate
l-hydroxy-2-naphthyl z
sulfate
1 ,2-dihydroxynaphthalene
l,2-dihydro-1-hydroxy-
2-methylthiono-
naphthalene
glucuronide
1 ,2-dihydro-2-hydmxy-
1-naphthyl sulfate
1 ,4-dihydrodiol, naphthalene
1 ,7-dihydrodiol, naphthalene
2,6-dihydrodiol, naphthalene
0-methy catechol
trihydroxynaphthalene
trihydroxydihydro-
naphthalene
tetrahydroxynaphthalene
tetrahydroxytetrahydro-
naphthalene
1,2-dihydro-1-hydroxy-
2-methylthio-
naphthalene
1 -methylthiononaphthalene
S-(2-hydroxy-2- g
carboxvethylthio)cysteine
Found in:
pin Mouse Rat "af" Man
7 5,7 2,3,7 8
7 727 8
777
7 7

1,7 1,7 1.7 1
7 5,7 3,4,7
2,3,7


2


1 1,5 1,2,3





7 2
2



3

4
4
4
4

4
4
4


5


5


References: 1. Boyland and Sims (1958); 2. Bakke et a/. C7985,); 3. Chen and


Sf« (197^); 4' H°r?'"9 et al' <1980a'b): still»e" ^ al.(1978); 5. Stillwell et al.

>!of?,   Kodama et al (1974>: 7- c°™er and Young (1954); and 8. Mackell et al.
(1951).
                                    17

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and  by  direct  isolation, the  formation  of 1,2-naphthalene oxide  from
naphthalene following incubation  with  rat liver microsomes.  Incubations  of
rabbit liver microsomes with the oxide resulted in the formation of the trans-
dihydrodiol with a 35 to 40 percent yield (see Figure 3-2). The formation of
                                                           RS H
                                                   Glutathione conjugate

                                                            OH
   Naphthalene
                                                   1,2-Dihdro-1,2-
                                                   dihydroxynaphthalene


  Figure 3-2 In vitro metabolism of naphthalene. Source: Jerina et al. (1968).
 small amounts  of naphthol  is  apparently  a result of a  nonenzymatic
 isomerization of the oxide  during  incubation. When the GSH-conjugating
 system  and  GSH were  added  to  the  microsomal  preparations, the GSH
 conjugate increased at the expense of the other two metabolites. Thus, 1,2-
 naphthalene  oxide appears to be  obligatory in the  formation of  all three
 metabolites.  When racemic  1,2-naphthalene  oxide was incubated  with
 microsomes, an optically active diol identical with the diol from naphthalene
 with respect to  stereochemistry  and  source of the oxygen  atom  in the  2
 position, was produced (Jerina et al., 1970). Inhibition  of epoxide  hydrase
 increased the yield of naphthol at the expense of  the diol. Small amounts of
 2-naphthol were  shown  to  be formed  during  non-enzymatic isomerization
 of  1,2-naphthalene oxide.                                         .
      Similar results were reported by Chen and Dorough  (1979). Formation ot
 water-soluble products from the metabolism of  1-14C-naphthalene  in  vitro
 was increased from 34 to 61 and  74 percent upon addition of 300 and 600 yg
 of  GSH,  respectively. Buckpitt  (1985) has  suggested that 2-glutathione
                                    18

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 conjugates formed in vitro upon incubation of naphthalene with lung and liver
 microsomes  from  mice were stereoisomers of  1-hydroxy-1 2-dihydro-
 2-s-glutathionyl-naphthalene.
     Holtzman  et al.  (1967a; 1967b) utilized  i8Q-enriched  air and
 demonstrated that the enzymatic conversion  of naphthalene to naphthalene
 dihydrodiol proceeds  with  the incorporation of one  oxygen  atom  from
 molecular oxygen; the second oxygen atom is derived from water. The initial
 attack on  naphthalene occurs at the  1-position, and the  product formed is
 the frans-diequatorial diol as shown by  nuclear magnetic resonance (NMR)
 spectroscopy.
     Oesch and  Daly (1972) studied the in  vitro metabolism  of naphthalene
 with liver preparations from  male guinea pigs, utilizing naphthalene and 1,2-
 naphthalene  oxide as substrates and a variety of biochemical (metabolic
 inhibitors and inducers) and radiolabel tracing techniques.  They reported the
 presence of a coupled monooxygenase-hydrase system in liver microsomal
 preparations  that  catalyzes  the overall  conversions  of naphthalene to the
 dihydrodiol. Bock et al.  (1976) studied  the glucuronidation of naphthalene
 1,2-dihydrodiol in isolated hepatocytes  and liver  microsomal fraction  from
 male Sprague-Dawley rats.  Naphthalene 1,2-dihydrodiol glucuronide was a
 major metabolite in  hepatocytes  incubated with  naphthalene, NADPH
 regenerating  system, and UDP-glucuronic acid.  In microsomes, the
 glucuronide conjugate was  formed only when UDP-N-acetylglucosamine,
 the positive allosteric effector of UDP-glucuronyltransferase was added. The
 authors  suggested that  the activation  of UDP-glucuronyltransferase by
 UDP-N-acetylglucosamine may be an important factor in the coupling of
 glucuronidation to functionally linked microsomal enzyme reaction.
    Strong evidence against such a coupled  mechanism has recently been
 presented  by Jerina and colleagues (van Bladeren et al.,  1984, 1985), who
 showed  that  a more likely  alternative is an  enantioselectivity by epoxide
 hydrolase  toward the enantiomers  of  naphthalene-1,2-oxide  formed in
 different ratios by specific  isozymes  of cytochrome P-450.  Through the
 application of trapping techniques for establishing the enantiomer ratios of
 metabolically formed arene  oxides, it was found that  cytochrome P-450b
 (the major isozyme induced in  rats  by  phenobarbital)  metabolized
 naphthalene predominantly to the (-)-(1S,2R) epoxide isomer  (74 percent of
 total), while cytochrome  P-450c (the isozyme induced  in rats treated with
 3-methylcholanthrene)  metabolized  naphthalene  primarily to the  ( + )-
 (1R.2S) epoxide  isomer (73->95 percent). Epoxide hydrolase preferentially
 metabolized the  (+ )-naphthalene oxide to the (-)-1 R,2R-dihydrodiol. In
 comparison,  the  (-)-(1S,2R)-naphthalene  oxide  was  metabolized by
 epoxide  hydrolase  to  both  the  (-)-(1R,2R)  and  the  ( + )-(1S,2S)-
 dihydrodiols. The apparent Km  for the epoxide hydrolase-mediated hydration
 of  ( + )-(1R,2S)-naphthalene  oxide  was  1  nM,  while  for (-)-(1S,2R)-
 naphthalene oxide the apparent Km was 12 pM.
    The  identification of 1-napthol as an  intermediate  in  the metabolism has
 led several groups of investigations to explore further the conversion  of 1-
 naphthol  to additional metabolites.
    Hesse  and Mezger  (1979), using  [1-i4C]-1-naphthol  in  a rat  liver
 microsomal preparation,  identified covalently  bound  products which  they
 suggested might be naphthoquinones and/or naphthosemiquinones. Because
 binding  was  not  decreased  by SKF-525A  or 7,8-benzoflavone,  they
concluded  1-naphthol metabolism was not mediated  by cytochrome  P450.
The studies of Doherty and Cohen (1984), using a similar protocol, found that
[1-i4C]-l-naphthol  was metabolized  to methanol-soluble  products
                                  19

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including  1,4-naphthoquinone  and  covalently bound  species.  It  was
suggested that 1,4-naphthoquinone most probably  was formed  via
autooxidation of 1,4-dihydroxy naphthalene. Hesse et al. (1982) reported that
inhibition of glucuronidation and sulfation in  isolated rat hepatocytes led to
several fold increase in covalent  binding  of i4C-naphthalene-derived
metabolites. Results suggested saturation of detoxification pathways may play
an important role at high levels of naphthalene.
    To more fully evaluate the role of cytochrome P450, Doherty et al. (1985)
conducted  additional experiments with  purified  P450  from  hepatic
microsomes of male Wistar albino rats, that had been pretreated with sodium
phenobarbitone in drinking water for 6 days.
    Incubation of  [1-14C]-1-napthol  in the fully reconstituted P450 system
and  NADPH led  to  the formation  of  methanol-soluble  products.  The
predominant metabolite,  identified by HPLC, was 1,4-naphthoquinone. 1,2-
naphthoquinone was not  found  in any significant amount. Production of 1,4-
naphthoquinone was rapid and dependent on the P450 concentration. The
apparent  Km for  1-naphthol was 17  urn and in agreement with the value
previously obtained (Doherty and Cohen, 1984; Hesse and  Mezger, 1979).
The  metabolism was inhibited by classic P450 inhibitors: metyrapone, SKF-
525A and CO:C>2 (9:1). The  apparent discrepancy with the results of Hesse
and  Mezger (1979) may have  been due to the higher concentration of 1-
naphthol used in the Hesse and Mezger study. When GSH, which reacts with
both  1,2- and 1,4-naphthoquinone was  added,  the  radioactivity  associated
with  the  HPLC  peak for  1,4-naphthoquinone disappeared  and  new
metabolites formed. When ethylenediamine,  which  reacts  specifically with
1,2-naphthoquinone was added, the  metabolite profile was not altered.
    Addition of ethylenediamine to the reaction mixture was found to signifi-
cantly inhibit covalent binding indicating  that 1,2-naphthoquinone may  have
been involved.  Inhibition  of binding  was  greater when  GSH was used. The
authors suggested that 1,2-naphthoquinone per se may not be involved but
rather another metabolic product possessing quinone groups. Such a product
could arise from further metabolism  of  1,4-naphthoquinone  or  1,4-
dihydroxynaphthalene.
    The in vitro metabolism of  naphthalene by human lung microsomes was
investigated by Buckpitt and Bahnson (1986).  Fresh lung tissue was  obtained
from  two elderly  individuals,  one of  which was  identified as a smoker. The
preparation from  patient  1 catalyzed the metabolism  of naphthalene to the
dihydrodiol and three  GSH  conjugates.  The rate of dihydrodiol formation
nearly equalled the total rate of formation  of the GSH conjugates.  This
observation is consistent with that of Oesch et al. (1980) who demonstrated
high activities of epoxide hydrolase  in lung microsomes. Cyclohexene oxide,
an inhibitor  of dihydrodiol formation, was added to the preparation  from
patient 2 and was  found to shunt metabolism, as expected, to formation of the
three GSH conjugates. Addition of lung microsomes (patient 1) to a mouse
liver  microsomal  preparation resulted in  a marked inhibition of naphthalene
metabolism. This was not  seen when   microsomes  from  patient 2  were
substituted. The  existence of  an inhibitor, possibly  released during tissue
homogenization was hypothesized  as  an  explanation for the inhibition
observed.
     Because studies (Cohen  et al.. 1983; Wilson et al.,  1985) had shown that
1-naphthol  has potential  selective toxicity  to human colonic tumor tissue,
Doherty et al. (1986) examined the peroxidase activation of 1-naphthol.
Horseradish peroxidase  was  incubated  with [1-14C]-1-naphthol  and  HaOg
in the presence and absence of bovine serum albumin (BSA). The amount of
                                   20

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  radiolabelled material  covalently bound to BSA also was  assessed  The
  mechanism of action was evaluated by  spectrophotometry and electron spin
  resonance (ESR). Results indicated that 62 percent of the radiolabel was
  covalently bound  to protein  following  a 60 min incubation. GSH inhibited
  binding in a dose-dependent manner. Evidence indicated that GSH acts as a
  radical scavenger (napthoxy or naphthoxy-derived).  In the absence of GSH
  ESR studies showed that napththoxy radicals decayed extremely readily and
  resulted  in polymeric products and covalently bound species.  At high GSH
  levels, naphthoxy radicals are repaired with concomitant formation  of  GS
  radicals.  GS radicals react to form GSSG, resulting in depletion of GSH with
  very little loss of 1-naphthol.
     In an in-vitro system with a human colonic adenocarcinoma cell line  the
  MA^r,uCtlon of  1-naPntho1 was  potentiated by  dicoumarol,  an inhibitor  of
  NADPH qumone reductase (Cohen et al., 1983). Wilson et al.  (1985) found
  that normal colon, in vitro formed significantly more 1-naphthyl sulfate than
  1-naphthyl-B-D-glucuronide.

  3.2 Mechanisms of Metabolite-Induced Toxicities

 3.2.7  Ocular Toxicity

     Ocular toxicity, particularly cataract formation, has long been associated
 with naphthalene administration  in  rodents and other laboratory  animals
 lovlmS>  1930; van Heyninaen and Pirie, 1966; Lindberg,  1922; Koch et al.,
 19/6}.
     Oral  administration of naphthalene is believed to result in its metabolism
 in the liver and metabolites then travel through the  bloodstream to the eye
 where further metabolism takes place (van Heyningen, 1979). Evidence in rats
 and rabbits suggest  that 1,2-dihydroxy  naphthalene is enzymatically
 converted to  1,2-napthoquinone  which then reacts with  eye  proteins
 resulting  in damage (Pirie  and van Heyningen, 1966; Rees and Pirie, 1967;
 t in©, 1968).
    Van Heyningen (1979), in her review of the literature,  hypothesized that
 susceptibility to  naphthalene-induced cataracts is more pronounced  in rat
 and rabbit strains with lightly pigmented or dark eyes, due to the presence of
 polypnenol oxidase.  This  nonspecific  enzyme,  found  only  in pigmented
 tissues, catalyzes the  formation of melanin from tyrosine. Nagata  (1984)
 detected   o-diphenol oxidase activity  in  strain ACI rats,  which  have
 pigmented eyes but not in albino Wistar rats.
    A  significant increase in o-diphenol oxidase activity in the lens  tissue of
 naphthalene-fed rabbits  also was reported by Srivastava and Nath (1969)
 -, o Van  Heynin9en and Pirie  (1967) suggested that the toxic metabolite is
 1,2-dihydroxy naphthalene.  In  gavage studies  in which naphthalene  was
 administered daily  to 39 rabbits at 1  gm/kg, they  detected 1,2-dihydroxy
 naphthalene and 1,2-naphthoquinone in the eyes and three metabolites  in
 blood: (1) naphthalene 1,2-dihydrodiol, (2) 1,2-dihydro-1,2-dihydroxy-
 1-naphthyl glucuronic acid  and  (3) 2-hydroxy-1-naphthyl sulfate  It was
shown  that each blood-borne metabolite  could be converted by a  different
enzyme in the  eye to   1,2-dihydroxynaphthalene. In  more than  half the
rabbits, lens opacities  and degeneration   of the retina  were observed
Occasional hemorrhages of the ear and intestine were also observed   In
addition,  1,2-naphthoquinone  can oxidize  ascorbic  acid  present in the
aqueous  and vitreous humors, resulting in  oxalic acid formation as the
ascorbic acid concentration decreases  (van  Heyningen, 1970a,b)  Although
ascorbic  acid  decreases in aqueous and  vitreous  humors, the  level is
                                  21

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maintained or  increases  in the  eye  lens  itself  (van  Heynigen,  1970b).
Presumably dehydroascorbic acid, formed by oxidation by naphthoquinones,
penetrates the  lens and is reduced to ascorbic acid.  Ascorbic acid diffuses
only slowly from the lens  (Wachtl and Kinsey, 1958).  Excessive depletion of
ascorbic acid may account for the appearance of calcium  oxalate crysta s
(Pirie and van Heyningen,  1966). GSH appears to be maintained at high levels
in the eye lens in spite  of extensive oxidative  reactions (van  Heyningen,

    Although ocular toxicity of naphthalene  is similar in both rat and  rabbit,
the severity  of effect may differ to  some extent because  of mterspecies

  ' evan Heyningen (1970a) found that the albino Wistar rat has only about 3
percent of the concentration  of catechol  reductase  (an  enzyme  which
catalyzes the interconversion of quinones and diols) found in the rabbit lens.
The rat also has  less ascorbic acid in aqueous humor than the rabbit  (van
Heyningen 1979). This would result in a higher level of 1,2-naphthoqumone.
Thus  polyphenol  oxidase may  be the most important factor in the rat eye
while  catechol reductase  may play  a crucial  role in ocular toxicity in the

     Rao and Pandya (1981) reported increased lipid peroxidation in the eyes
of male albino rats administered 1 gm naphthalene daily for 10 days. Alkaline
 phosphatase showed  a slight increase and aniline hydroxylase activity was
 not detected. Liver peroxide levels were elevated but serum lipid peroxides
 were not measured.                                           .
     Lipid  peroxides  have  been suggested as a causal factor  in  cataract
 formation. Yamauchi  et  al. (1986) investigated this aspect in  relation to
 naphthalene. Naphthalene (1  gm/kg) in acacia oil was administered to  male
 Wistar rats daily for up to 18 days. GSH content in lens and serum and liver
 lipid peroxide  levels were measured  during interim sacrifice. Serum peroxide
 levels increased significantly on the 4th day and reached a maximum on the
 7th day Liver peroxide levels had a similar pattern. GSH content in lenses
 decreased to  about 64 percent on the fourth day and remained depressed.
 The authors suggested that lipid peroxides are stable enough  to reach the
 lens  and cause  ocular  damage.  Microscopic  observation  indicated slight
 cataractous changes in some rats on the 14th day when serum lipid peroxide
 levels were elevated (Yamauchi et al.. 1986). It was suggested that peroxides
 may  play a role in  cataract formation,  in addition  to  role played  by 1,2-
 naphthaquinone.  A decrease in  nonprotein sulfhydryl  content in lens has
 previously  been  associated with  naphthalene-induced  cataracts in rabbits
  (Ikemoto and Iwata, 1978).

  3.2.2 Pulmonary Tox/cfty
      Various  investigators  have  observed that  i.p. administration  of
  naphthalene to rodents  results  in selective pulmonary  bronchiolar epithelial
  cell (Clara) necrosis, but  not hepatic or renal necrosis (Tong et al.,  1982;
  Warren et al., 1982; Tong et al., 1981; Mahvi et al.,  1977; Reid et al., 1973).
  Rats and hamsters  were reported to  be  much less  sensitive  than  mice
  (Buckpitt et al., 1984).
      In an effort to determine the mechanism of action, numerous studies have
  focused  on the biochemistry  of  naphthalene  and the  covalent  binding
  characteristics of its metabolites.
      Shank et al. (1980)  found that mice pretreated with diethyl maleate prior
  to i.p.  injection of naphthalene had  three times the level of covalently-bound
                                     22

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 naphthalene metabolites in lung, liver, kidney, and spleen. Studies with 14C-
 naphthalene injected into mice revealed a similar binding pattern: binding was
 highest in the lung but low in spleen. Increased binding corresponded to rapid
 and significant depletion of GSH in lung and liver, and to a lesser extent in
 kidney. Covalent binding was dose-dependent and exhibited a threshold at
 dosages between 200 and 400 mg/kg. Warren et al. (1982) suggested that
 lung  damage may be mediated by P450  dependent metabolism  and GSH
 depletion.
    Buckpitt and Warren (1983) extended these studies, utilizing a variety of
 metabolic  inhibitors.  The results  suggested that  some  of the  metabolites
 involved in  GSH  depletion  and covalent  binding  in extrahepatic tissues
 originated  in the liver. In vitro studies (Buckpitt et al., 1984) with mouse liver
 and lung  microsomes indicated the formation of  three  GSH conjugates.
 Evidence  indicated that two conjugates are  stereoisomers of 1-hydroxy-
 1,2-dihydro-2-S-glutathionyl  naphthalene  (Buckpitt,  1985).  The rates  of
 formation  differed; conjugate  2 was predominant in  lung  but  not liver
 preparations  and was considered  due to P450 selectivity or epoxide
 hydrolases. Buckpitt  (1985)  suggested that the differences in  the rates  of
 formation  between   target and  nontarget  tissues  may  reflect  the
 stereochemistry of epoxidation by the  tissue-specific P450 isozymes. This
 may, in turn, relate to  the selective  pulmonary necrosis observed in mice.
    Van Bladeren et  al. (1984) found that P450 catalyses the  formation  of
 naphthalene 1,2-oxide in a stereoselective manner (see  Section 3.1.1)  and
 that epoxide hydrolase determines the enantiomeric composition of the  1,2-
 dihydrodiols formed.
    Confirmation that  P450 was involved in pulmonary necrosis was obtained
 in the studies of Buckpitt et al. (1986). Liver microsomes from phenobarbitol-
 induced mice administered 300 mg naphthalene/kg  i.p. exhibited 73 percent
 less covalent binding  in the presence of piperonyl butoxide, a P450 inhibitor,
 than controls. A similar degree of inhibition also was observed with SKF 525A.
 It  was reported that  piperonyl  butoxide also blocked the pulmonary  injury
 exhibited  by  naphthalene in  controls. Covalent  binding was  higher  in
 nontarget tissues. Differences  in  covalent binding between  tissues were
 attributed to the  possibility that only some metabolites  are  toxicologically
 active and that reactive metabolites are stable enough to circulate in the blood
 (Buckpitt and Warren, 1983; Richieri and Buckpitt, 1985).
    Buckpitt et al. (1985)  provided  evidence that 1-naphthol is not  an
 obligate intermediate  in the covalent  binding or pulmonary necrosis caused
 by naphthalene. While 1-naphthol is formed at a higher rate by mouse lung
 rather than liver  microsomes,  the rate  of  covalent binding  after 1*C-1-
 naphthol administration was not higher than  that after  14C-naphthalene
 administration. In  addition, pulmonary necrosis was not observed after  either
 intraperitoneal or  intravenous administration of 1-naphthol.
    Naphthalene (i.p., 225/kg) was  shown to reduce the activity of a number
 of rat lung, but not liver, microsomal enzymes (Tong et al.,  1981,  1982).
 Enzymes  studied included  benzphetamine N-demethylase, arylhydrocarbon
 hydrolyase,  NADPH  cytochrome c reductase,  17-ethoxyresorufin  o-
 deethylase, and styrene epoxide hydrolase. Inhibition ranged from  30  to 70
 percent and lasted from 8 to 15  days. Changes  in enzyme  activity were
 reported to correlate with morphologic changes in the bronchiolar epithelium.
There were no morphologic changes noted in liver tissue.
    Buckpitt et al.,  (1986)  also  investigated the  role  of prostaglandin
synthetases in mediating the pulmonary toxicity of naphthalene. Prostaglandin
synthetases have  been  shown  to  catalyze the  metabolism  of aromatic
                                  23

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hydrocarbons and dihydrodiols and detectable activities have been measured
in  Clara cells,  a site of naphthalene-induced  toxicity. Naphthalene  was
administered to  phenobarbitol-induced mice at a  dose  of 300  mg/kg.
Indomethacin, an inhibitor of prostaglandin synthetases  but  not P450,  was
administered both 1  hr  before  and 6  hr  after  naphthalene.  In an  in  vitro
microsomal system  containing either an NADPH-generating system or
arachidonic acid (the  precursor to prostaglandin production), it was observed
that arachidonic  acid failed to  catalyze the formation of covalently bound
metabolites in any of the tissues studied. Indomethacin treatment of the mice
failed to protect against bronchiolar necrosis.
                                    24

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                          4.  Health Effects

 4.1.  Acute Toxicity

     The acute effects of naphthalene have been studied in rats, mice, rabbits,
 cats, and  dogs following administration of the compound by various routes
 The acute toxicity values  of  naphthalene for these laboratory animals are
 summarized  in Table 4-1. Additional information is presented in Section 3.2.

 Table 4-1.  Acute Toxicity Values of Naphthalene in Laboratory Animals

                                 Lethal Concentration
Route of
Administration
Oral








Species/Sex
Rat/M
Rat/F
Rat/M
Rat/F
Ratl-b
Ratl-
MouselM
Mouse/F
Mouse/F
Catl-
Dogl-
Rabbitl-
inyi
u>50
2,009
3,310
2,200
2,400
1,780
9,430
533
710
353
1,000
400
3
ny-
LCso Reference
Mallory et al. (1985a)
Mallory et al. (1985a)
Gaines (1969)
Gaines (1969)
TDB
U.S. EPA (1980)
Shopp et al. (1984)
Shopp et al. (1984)
Plasterer et al. (1985)
TDB
TDB
TDB
 Dermal         Rat/M           >2,500
                Rat/F           > 2,500
                Rabbit/M        > 2,000
                Rabbit/F         > 2,000
Gaines (1969)
Gaines (1969)
Mallory et al. (1985b)
Mallory et al. (1985b)
 Inhalation

 Intraperitoneal  Mouse/M         380

 Subcutaneous  Mouse/-         969
Warren et at. (1982)

Irie et al. (1973)
aUnless otherwise noted.
bData not available.
4.1.1.  Oral

   The acute LD50 values of naphthalene dissolved in peanut oil for male and
female  Sherman rats were 2,200 and 2,400 mg/kg, respectively  (Gaines,
1969). In two other studies, the LD50 values for rats were 1,780 (Toxicology
                                   25

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Data Bank) and 9,430 mg/kg (U.S. EPA,  1980), but the strain and sex of the
animals were not specified. For male and female CD-I  m.ce, the acute oral
Rvalues of naphthalene in corn oil were 533 and 710 rng/kg respect.vely
(Shopp et al., 1984). In a recent study (unpublished) conducted by Mai ory et
al. (1985a). the acute LD50 values of naphthalene in corn oil for mate and
female Sprague-Dawley rats were reported, to  be 2,009 and 3310 mg/kg
respectively.  In  a sub-acute study,  at  doses  ranging from 125 to 2,000
mg/kg given daily for 8 days, an LD50 of 353 mg/kg was determined for CD-
1 mice (Plasterer et al., 1985).
    Althouah cataract formation following oral  administration of naphthalene
has been known for many years (Fitzhugh and Buschke, 1949), recent studies
have shown that ocular changes can result from a single dose of naphthalene^
Van Heyningen  and Pirie (1967) found  that lens  changes developed in the
eyes of  rabbits  after a single dose of naphthalene (1 000 mg/kg) was
administered by gavage. In CD-1 mice,  oral doses of >400 mg/kg for males
and a 600 mg/kg for females  resulted in  ptosis with  clear, red secretions
around the eyes within 1 hr of dosing (Shopp et al., 1984).
     Ikemoto and Iwata (1978) reported that oral administration of naphthalene
(1 qm/kg) to male and female albino rabbits for 2 consecutive days resulted in
cataract formation. Occurrence  of cataracts was accompanied by a decrease
in sulfhydryl content in both soluble and insoluble lens protein.

4.1.2.   Dermal
    No deaths occurred when 2,500 mg/kg of naphthalene was applied to the
 skin of  male and female  Sherman  rats (Gaines,  1969) Theappl.cat.on  of
 2,000 mg naphthalene/kg  (dissolved in acetone to the skin of New Zealand
 white rabbits) did not cause mortality; the LD50 was  > 2,000 mg/kg (Mallory  et
 al   1985b)  This study suggests that  naphthalene may not be as readily
 absorbed through the skin  as it is through the intestinal mucosa.

 4.1.3.   Inhalation

    It  previously had  been reported that  the 8-hour  LC5o  value for
 naphthalene was 100 ppm (Union Carbide, 1968).  However, Buckpitt (1985)
 suggested that this value  may  be too low. He estimated that m 8 hours the
 bod? burden would be less than 30 mg/rat, or about 150 to 200 mg/kg. This
 concentration is far less than the oral  or intraperitoneal LD50 values for rats
 Fait and Nachreiner (1985) reported that exposure of male and female Wistar
 rats to  78 ppm for 4 hr resulted in no mortalities, nor any lung, liver, kidney,
 or nasal passage abnormalities. In an  unpublished inhalation study with male
 Swiss-Webster  mice, no  deaths were noted  following nose-only  exposures
 to 90 ppm for 4 hours. However, lung lesions were reported to be prominent
  (Buckpitt, 1985).

 4.1.4.   Intraperitoneal

     The 24-hour LD50 value of naphthalene in Swiss-Webster mice was 380
  (350 to 413)  mg/kg following  intraperitoneal injection  (Warren  et al., 198^;
  Shank et al., 1980). All deaths occurred within 24 hours, with survivors being
  observed for an additional 6  days. The  target  organ  was identified as  the
  lungs (see Section 4.1.6 below).                           .
     Tona et al  (1982) found remarkable histological changes in the lungs of
  C57BL/6J mice dosed intraperitoneally with naphthalene at 225 mg/kg. One
  day after dosing, the Clara cells in the terminal bronchioles were pyknotic,
                                     26

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 and hypereosinophilic nuclei were apparently detaching from the bronchiolar
 wall.  Three days  after dosing,  some surfaces  appeared to be completely
 denuded of Clara  cells, whereas other surfaces  appeared to have immature
 Clara cells scattered circumferentially. Five days after treatment, there was
 still  evidence of incomplete  recovery; by  8 days, most of the  terminal
 bronchioles were reepithelialized; and by 15 days, mature Clara  cells were
 common, but recovery was evidently  not  complete.  Similar findings  had
 previously  been reported by Reid et al. (1973) in C57BL/6J mice dosed i D
 with approximately 350 mg naphthalene/kg.
    Shank et al. (1980) found that GSH plays an important role in naphthalene
 toxicity. When male Swiss-Webster  mice  were  pretreated with  diethyl
 maleate prior to i.p. injection of  naphthalene  doses ranging from 0 to 500
 mg/kg, severely damaged lungs were seen in mice given 40 mg/kg. None of
 the animals given 300 mg/kg survived 24 hr. In  contrast, piperonyl butoxide
 decreased toxicity.
    See Section 3.2.2 for additional information related to pulmonary toxicitv
 and metabolite formation.

 4.1.5.  Subcutaneous

    Irie et al.  (1973)  studied the effects of naphthalene in  mice (strain not
 specified) following single subcutaneous injections at doses  of 650 to 1 348
 mg/kg. Vigorous tremors were noted  in the mice for 3 to 4 days following
 dosing. The LD50 value was calculated to be 969 (891 to 1053) mg/kg.

 4.1.6.   Eye  Irritation

    Acute ocular irritation was noted in two of six New Zealand white rabbits
 receiving no  postdose rinse after 24  and 48 hours of  exposure to 0 1  mq
 naphthalene (Mallory et  al.,  1985c).  This  response included slight iritis
 moderate redness and slight swelling and discharge. All  animals were normal
 by 72 hours postdosing.  No positive response was noted in  rabbits (three)
 receiving a postdose rinse.

 4.1.7.  Dermal Irritation and Sensitization

     Naphthalene (moistened with 2 mL of acetone) was found to be  slightly to
 moderately irritating to the skin of male and female New Zealand white rabbits
 30 to 60 minutes postdosing (Mallory et al., 1985d). Dermal irritation was  still
 evident up to  5 days after test material application. Fissuring of the skin was
 also noted.
    Naphthalene  (100 percent) did not cause delayed hypersensitivity in
 Hartley guinea pigs (Mallory et al., 1985e).

 4.2.   Subchronic Toxicity

    Naphthalene  toxicity  has been investigated  in  repeated dose  studies
following oral  administration.  Additional  studies  have  been  conducted to
determine the ocular effects of naphthalene following  administration  bv
various routes.

4.2.1. Oral

    Shopp et  al. (1984) conducted a 14-day  and  a 90-day study on groups
of  male and female CD-1 mice administered  naphthalene in corn oil by oral
                                  27

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gavage. In the 14-day study,  six groups of male and  female  mice (40 to
112/group) were  given  doses of 0  (naive),  0 (vehicle),  27,  53,  or 267
mg/kg/day; the highest  dose was one-half the LD50 for male mice. Male
mice demonstrated lower survival rates than females, apparently due to the
aggressive behavior of group-housed male mice; however, the mortality in
the high-dose groups of male  and female mice was 5 to 10 percent higher
than the control groups. There was a significant decrease (7 to 13 percent) in
body  weight in male and female mice receiving the high dose.  The high-
dose males exhibited a 30 percent decrease in thymus weight, while females
exhibited a decrease in spleen weight and an increase in lung weight. Gross
pathology but not  histopathology  was performed. No  biologically  relevant
changes were noted in treated animals for hematology, clinical  chemistry,
hexabarbital  sleeping time,  or immunotoxicity (humoral immune response,
lymphocyte  responsiveness, popliteal lymph  node response,  and bone
marrow function).
    For the  90-day study, five groups of  112 male and  112  female mice
were  given doses  of 0 (naive), 0 (vehicle),  5.3, 53,  or 133 mg/kg/day.  A
positive control for immunotoxicity  received 50  mg/kg cyclophosphamide
intraperitoneally on days 87, 88,  89, and 90. The mortality seen among all
groups of male  mice appeared  to  be  due  to the aggressive behavior  of
group-housed male mice.
    No significant effects on body weight were noted for males or females. A
significant decrease in the absolute weight of the brain, spleen,  and  liver was
noted for  females  receiving  133 mg/kg;  however,  organ-to-body weight
ratios were significantly different only for the spleen. Of the changes noted in
the clinical chemistry data, the increase in blood protein content in males and
females receiving 53 or 133 mg/kg, the decrease in blood urea nitrogen in  all
treated female groups, and the  decrease  in calcium ion concentrations  in
 males receiving 53 or 133 mg/kg were considered to be treatment related. No
 significant changes were noted in hematology, the  mixed-function oxidase
 activity, or immunotoxicity assays for either sex. Histopathology  data were not
 presented and it is not known if naphthalene caused bronchiolar  lesions.
     No evidence of cataract formation or hemolytic anemia was observed in
 CD-1  mice. Since the CD mouse is an albino strain, cataract formation was

     In a subchronic oral toxicity study performed for the NTP  (1980a),
 naphthalene in corn oil was administered by gavage to male and female F344
 rats (10/sex/dose)  at dose levels of 0, 25,  50, 100, 200 or 400 mg/kg/day, 5
 day/week for 13 weeks. At 400 mg/kg, two males died during  the first week
 and the treatment caused diarrhea, lethargy, hunched posture and roughened
 haircoats in rats of both sexes. A significant (i.e.,  >10%) decrease in body
 weight gain was observed among males and females at 200 and 400 mg/kg
 and in females at 100 mg/kg. Food consumption was not affected.
     All  the  rats  in the  study  were  necropsied and  comprehensive
 histopathological examinations were performed on  rats from the 0 and 400
 mg/kg groups.  Histopathological  examinations of the kidneys and  thymus
 were performed on rats from the  200  mg/kg group (according to the
 histopathology  tables;  the  100  mg/kg group  according  to the text). The
 authors stated that lesions of the kidney in males and thymus in females of
 the 400  mg/kg  group may have been  compound-induced,  and that no eye
 lesions were found. The incidences of lesions of kidney and  thymus were,
 however, very low. The renal lesions, which did not occur  in  females, were
 observed at incidences of 0/10 in controls, 2/10 in the 200 mg/kg group and
  1/10 in the 400 mg/kg group. These renal lesions consisted of focal cortical
                                    28

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            Hiff   f H", °r,fOCal tubular generation in  the two 200 mg/kg
       tinn n? h  tt     'ar de9eneration in »e one 400 mg/kg male.  Lymphoid
  deplet.on of the thymus occurred in 2/10 females of the 400 mg/kg group and

  '"  "6 M *he tTtr°' ?r 2°° mg/k9 females and in none <* *e male! of These
  fnd hi" Hfmat°lo9'ca' analvses revealed marginal  decreases in hemoglobin
  and hematocrit in males and females of the 400 mg/kg group and a moderate

  of^mnh1" *?e nUmb^ °f mature neutrophils andaL9creaPse ?n the ±£
  of lymphocytes m  males of the 400  mg/kg group, relative to controls No
  hematological changes were observed at the lower dosages
      In a similar ^study naphthalene was administered in corn oil by gavage at
  ?itJ   M   \?" o°° °r 20°  m9'kg/day,  5 day/week,  to B6C3F1 mice
  fem£ nf'S  pnn3 "%** (NTP' 198°b)' Seven mice  one female of the  25 ma/ka group and one
  control male)  died  durmg the  2nd, 3rd and  4th weeks of the  study from
  gavage  trauma  or  accident. Transient  signs  of toxicity (lethargy,  rough
  haircoats and decreased food consumption) occurred at weeks 3 to 5 in the
  w^Kh9 9H°HPS-  ?''trea*ed 9rouPs °f <"a'e mice gained somewhat more
  weight than did  control males.  Dose-related decreases in body weight oain
  were seen  in females but were not significant. All the mice were necropiied
  and comprehensive fustopathological examinations  were performed on the
  mice from the 0 and 200 mg/kg groups. No compound-related lesio^werl
                  0rganS'  includinQ  kidneys-  thvmus- ey^ and  lungs
                                                              '
     Fitzhugh and Buschke (1949) noted  the formation of cataracts within 3

           n^tT*! '" ^ fed dietS C°ntainin9 2 percent naphthalene or one
           naphthalene derivatives. The effects of pigmentation on cataract
 n- GrouPs of 15 mice were fed
ad libitum laboratory chow which had been soaked for at least 24 hr in corn
«n <:?ritaini;j9.15 or 10 mg/ml naphthalene. Feeding regimen was continued for
do^f nf •?£ !h9ff0,n I3S  "Ot  calculated  by the authors. Concomitant
doses of 3-methylcholanthrene or p-naphthoflavone  were given  twice
weekly. A 6.7% incidence in cataract formation was observed in C57BL/6J
                                  29

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mice at each dose. No cataracts were observed in  DBA/2N mice All mice
treated  with  3-methylcholanthrene died  within 6  weeks.  In  addition to
cataract formation, tissue degeneration in  the choroid, ciliary body, and iris
occurred.

4.3.  Chronic Toxicity
    A  chronic  inhalation study of naphthalene in  mice has recently been
conducted by the National Toxicology Program (NTP, 1985). The exposure
phase  of  the  2-year  inhalation study  has been completed,  but the
histopathology  data and the final report are not yet available. No other chronic
toxicity data were found.

4.4.   Carcinogenicity
    There is only limited information available on the carcinogenic potential of
naphthalene following oral,  dermal  or  subcutaneous administration  to
laboratory animals. The results of an  inhalation study in mice conducted by
the National Toxicology  Program (NTP) have not yet been Published.
Histopathology is currently being evaluated. Exposure  levels  in this study
were 10 and 30 ppm (NTP, 1985).
     Recently,  Adkins  et al. (1986) exposed groups  of 30 female A/J strain
 mice via inhalation to naphthalene at concentrations of  0, 10  or 30  ppm  fa
 hours a day, 5 days a week for 6 months. At the beginning of  the study, the
 mice were 6 to 8 weeks  of age and  weighed 15 to 25  g each. After the 6-
 month exposure  period,  a pulmonary tumor bioassay  was performed  on
 excised lungs. Naphthalene did  not result in changes in tumors per mouse
 but did cause a statistically significant increase (p  <0.05) in the number of
 adenomas per tumor-bearing mouse  lung (Table 4-2). The  tumors  were
 described as  alveolar adenomas consisting of large cuboidal or  columnar
 epithelial  cells supported by a  sparse fibroblastic stroma and arranged  in
 poorly defined acinar structures with  papillary formations. No apparent dose-
 response was observed.  Alveolar epithelial hyperplasia  was present in lungs
 of most treated  mice with adenomas. This lesion was  considered as a
 possible precursor to  adenomas. Bronchiolar epithelial hyperplasia was  not

 ° Sescnmahl (1955) reported  that naphthalene, administered in food or by i.p.
 injection  was not carcinogenic in rats  (in-house  strains  BDI and BDIM).
 Naphthalene was  dissolved in  oil and given six times weekly  in  food. The
 daily dose was  between  10  and 20 mg. After reaching a total dose of 10
 am/rat (food intake was not  reported), treatment was  stopped and animals
 observed until spontaneous death, between 700 and 800 days of age  In the
 i p experiments, 10 control rats were used and 10 were  injected i.p. The daily
 dose was 20 mg/rat. Injections were given weekly for 40 weeks. Animals were
 observed until spontaneous  death. Tissues were examined historically in
 each experiment. It was  reported that naphthalene caused no carcinogenic

  effeCBoyland  et al. (1964) implanted naphthalene  into  the bladder  of stock
  Chester  Beatty mice (23) and  followed the mice for 30 weeks. Tumor
  incidence was as low as when paraffin  wax was  used and lower than with
  cholesterol. Naphthalene was judged  to  be inert and to have no advantage
  over cholesterol as a base for implantation pellets.
      A study  was conducted on carcinogenicity testing of coal tar derived
  naphthalene that  contained about 10  percent unidentified impurities (Knake,
   1956)  White rats (40, sex unspecified) were given 7 subcutaneous injections
                                     30

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   Table 4-2. rumor Incidence in Female A/J strain Mice Exposed to
              Naphthalene via Inhalation for 6 Months *M>

                                          Surviving Animals

Exposure
Level
(ppm)
0
10
30

Survivors0
29/30
27130
29/30

Total No.
of Tumors
6
10
11

Animals
with
Tumors
(%)
21
29
30

Tumors/
Moused
0.21 ±0.39
0.35 ±0.55
0.37+0.55
Tumor/
Tumor-
Bearing
Mouse
Lungd
1.00 ±0.00
1.25 ±0.07'
1.25+0.07'
   aTaken from Adkins et al. (1986).
   bBased on animals that survived to study termination.
   ^Number of survivors at end of study/number of animals at start of studv
   "Mean ± SO.
   'Significantly different from control (p<0.05).

 of  500  mg/kg  naphthalene in  sesame  oil  at 2-week  intervals
 Lymphosarcomas were found  in 5 of 34  surviving  rats at  18 months (147
 percent), whereas vehicle controls had a 2 percent incidence of these tumors
 Mice (25, inbred black mice) were painted with 0.5 percent naphthalene in
 benzene  5 days a week  for life. Four treated mice developed leukemias in
 contrast to 0 of 21 vehicle controls;  the negative control incidence was 04
 percent.  The value of these studies for  assessing carcinogenicity is  very
 limited because the impurities may very well be carcinogenic. The vehicle in
 the mouse study has been shown to cause leukemias and the site of injection
 in  the rat study was painted, prior to injection, with carbofuchsin,  a  known
 carcinogen.
     Kennaway (1930) reported that naphthalene was not carcinogenic  in skin
 painting studies in mice. The concentration, purity, dosing regimen, and other
 details were not provided. The reaction product of naphthalene and aluminum
 trichloride was carcinogenic but the product was not identified.
 /D  Schmeltz et al- <1978) tested the  carcinogenic activity of benzo(a)pyrene
 (BaP) and naphthalene in female ICR/HA  (Sprague-Dawley) mice. A  100-ul
 test solution containing 0.25 percent naphthalene and 0.003 percent BaP was
 painted on the  shaved backs  of 30 mice 3 times a week for  78 weeks
 Naphthalene inhibited BaP-induced tumors; approximately 42 percent of the
 mice had skin tumors with BaP alone, and about 20 percent had skin tumors
 when naphthalene and BaP were administered together.
    Naphthalene was  not active in causing cellular transformation in a Fischer
 rat embryo cell line at a level of 100 ng/mL (Freeman  et al., 1973)  or in an
 AKR leukemia,  virus-infected Swiss  mouse embryo cell line at 5 ua/mL
 (Rhim et al., 1974).                                                 a
    Tsuda et al. (1980) administered  a  single gavage dose of 100  mg/kq
 naphthalene in corn oil to a group of  10 young adult F344 rats (sex not
 specified) at 12 hours after partial hepatectomy. A vehicle control group of 10
 rats was  included.  At 2  weeks  after surgery,  2-acetylaminofluorene was
added  to  the diet  at 200  ppm  to  inhibit proliferation of "nonresistant"
hepatocytes. After  1  week of  dietary 2-acetylaminofluorene,  a single  20
ml/kg dose of carbon tetrachloride was given  to  necrotize "nonresistant"
                                  31

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hepatocytes and permit proliferation of "resistant"  hepatocytes. Feeding of
2-acetylaminofluorene continued for 1  week, followed by a basal diet for 1
week  The  rats  were  then sacrificed and livers  were sectioned and
histochemically examined for the number  and size of gamma-glutamyl
transpeptidase (QGT)  positive foci.  These foci contain cells that  are
"resistant" to the necrotizing effects of carbon tetrachlonde and to  the
proliferation-inhibiting effects of  2-acetylaminofluorene  and are considered
to represent preneoplastic transformations. Neither the number nor the size of
GGT foci appeared  to  be  increased  in naphthalene-treated  rats compared
with  vehicle  controls.  The role  of  GGT  as  a  biochemical market_ Of
preneoplastic foci has recently been assessed by Hendnch and Pitot (1987).

4.5.   Mutagenicity
     Naphthalene  was reported to be nonmutagenic in Salmonella strains
TA98 A100, TA1535, and TA1537 when tested with or without S9 activation at
levels of up to 1,000 ug/plate (McCann et al., 1975). Similarly, Godek et al.
(1985) reported that naphthalene at concentrations up to  300 ng/plate  was
negative  in S. typhimurium strains  TA1535, TA1537,  TA1538  TA98,  and
TA100 with  or without metabolic activation. Connor et al. (1985) reported
naphthalene was  not mutagenic in  two DNA-repair deficient strains of^S_
typhimurium, TA100 and TA98 and two other strains UTH8414 and  UTH8413
which have full DNA repair capacity, both with and without S9 activation.
     Naphthalene at  250 mg/kg in corn oil did not induce micronuclei in bone
 marrow of CD-1 mice (Sorg et al., 1985). This dose level was determined to
 be  the  maximum  tolerated  dose in  a  range-finding  study and  is
 approximately 50 percent  of the oral  LD50 for  CD-1  mice  (Shopp et al.,
 1984) Barfknecht et al. (1985) reported that naphthalene at concentrations up
 to 16 ug/mL (0.32  ng) did not  induce unscheduled DNA synthesis in  rat
 hepatocytes. Concentrations greater than 16 yg/mL were  found to  be
 extremely cytotoxic.
 4.6.  Teratogenicity and Reproductive Effects

      In what appears to be the results of the  same study (Plasterer et  al.,
 1985- Booth et al., 1983), single oral  doses  (300 mg/kg) of naphthalene were
 administered daily for 8 consecutive  days to 50 pregnant mice beginning on
 day 7 of gestation. This  dose was estimated to be  at  or  just below the
 maximum tolerated dose for acute lethality. A significant increase in maternal
 lethality (p <0 05) and a decrease in mean  maternal body weights as well as
 the number of live pups per litter (p <0.05) on postpartum day 1 were noted
 when compared  to  the controls. There was not  a concomitant increase in
 dead pups  There were no effects on pup  survival and mean body weights.
 No gross congenital abnormalities were detected in the pups, although the
 method used to examine the pups was not reported.
      Hardin et al. (1981) administered naphthalene i.p. (395 mg/kg) in corn oil
 to  pregnant Sprague-Dawley rats on day 1  of  gestation.  Daily injections
 continued  through  day 15.  Treatment-related effects were  reported to  be
  limited to evidence of maternal or fetal toxicity.
      In a pilot range-finding  study, 20 artificially  inseminated New  Zealand
  white rabbits (at least 24  weeks of age and weighing  4 to 5 kg) were orally
  dosed with naphthalene (in 1% methylcellulose vehicle) at 50 to 1,000 mg/kg
  from gestational days (GD) 6 to 18. Maternal lethality and/or abortion were
  increased at doses of 630 mg/kg or greater, but  no data were collected.  No
                                    32

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  differences in reproductive parameters were noted, and no malformations or
  fetal death occurred at the lower dose levels (Naismith and Matthews  1985)
      In  the  mam study  by Naismith and  Matthews (1986), 18  a'rtificiallv
  n"fnehTfed %? Ze£la1nd11white rabbits per 9rouP were  oral|y dosed with
  naphthalene (1% methylcellulose vehicle) at 0, 40, 200, or 400 mg/kg from
  QD 6 to 18 (age was not specified; body weights were reported but data were
  incomplete). Maternal body weights and body weight gains were comparable
  among all test groups and controls. Food consumption of high-dose (400
  mg/kg) animals was significantly greater (p  <0.05) than controls during GD 7
  to 15 and significantly greater (p <0.05) than controls during GD 23 to 25 and
  *'}° 29-\ Pnarmacotoxic signs observed during the study included decreased
  activity,  dyspnea, weight loss,  cyanosis, salivation,  and  loose  stools  or
  diarrhea, and occurred  in  an  apparent dosb-related  manner   Gross
  examination  of dams and controls  indicated no differences in reproductive
  parameters: number of corpora lutea, total number of implantations, viable or
  nonviable fetuses, pre- or postimplantation loss, fetal body weights, and fetal
  sex distribution.  Several  malformations and  variations  were  observed
  However, they were equally  distributed among groups;  no dose-related
  trends were apparent. The study authors concluded that oral administration of
  naphthalene to pregnant rabbits did not evoke a teratogenic effect  However
  the teratogenic potential could not be adequately assessed because of lack of
  information on the  methods of  fetal  sacrifice  and of  visceral and skeletal
 /nn          (1982) rePorted that naphthalene administered by oral gavage
 (0.015, 0.15, and 1.5 mg/kg) on a chronic basis to pregnant female albino rats
 was  associated  with adverse effects  on reproductive  function and
 development of progeny (English translation of complete study). The reported
 threshold for effects was 0.075  mg/kg. Because of a lack of information  on
 ££ u   h   SP!?' l?sts jor significance,  experimental data,  these reported
 results should be viewed with caution until substantiated.
 4.7.   Neurotoxicity

     No  reports were  found  in  the  available literature  that described any
 neurotoxic effects due to naphthalene exposure except  for retinal effects in
 rats and rabbits, which are discussed in Section 4.4.2.

 4.8.   Effects on Humans

 4.8. 1 Hemotoxicity

    Acute hemolytic  anemia  is the most frequent manifestation  of
 naphthalene poisoning  in  humans. Case  reports have described the
.appearance of acute hemolytic  anemia  after: 1) naphthalene ingestion by
 children (Jacobzmer and Raybin, 1964; Athreya et al.,  1961; Gross  et al
 1958; Zinkham and Childs, 1958; Zinkham and Childs, 1957; Haggerty  1956:
 SSnH,,r«andiQlif'J95l5:lIBre9man'  1954;  MacGregor,  1954; Abelson and
 Henderson,  1951;  Mackell et al., 1951;  Zuelzer and  Apt, 1949;) and  adults
 ^ul®wicz  et al- 1959- Zinkham and Childs, 1958; Zinkham and Childs
 1957;  Gidron and  Leurer,  1956);  2) combined  dermal absorption  and
 inhalation of naphthalene vapor by neonates (Grigor et al., 1966; Naiman and
 ,ol?vy>  ?   :  alaes et al"  1963: Dawsor> et al., 1958; Cock, 1957; Schafer
 1951) and adults (Younis et al., 1957); 3) inhalation of naphthalene vap,.r by
 neonates (Hanssler, 1964; Irle, 1964);  4) inhalation of naphthalene vapor by a
 child and adults (Linick, 1983); and 5) transplacental exposure of the fetus to
                                  33

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naphthalene that had been ingested by the mother (Anziulewicz et al, 1959;
Zinkham and Childs, 1958; Zinkham and Childs, 1957).   -  -   •- •    .
    The reported mechanisms and range of exposure to na phthalene nn .these
case studies were: 1) chewing, sucking, or swal lowin g of mot hb  Is (one to
numerous) as a single incident or for periods up to 3 months, 2) 'ngestion of
toilet bowl deodorant cakes (pure naphthalene) by a child overa penod I  of a
year; 3) ingestion of naphthalene-containing deodorant in a diaper pail for an
unspecified  period; 4) combined dermal absorption and 'nhalabon for a few
days  of naphthalene  vapor from  apparel  and bed clothing hat had  been
stored in  mothballs; 5) inhalation  of vapor from  a naohthalene-conta mng
medication;  6) inhalation of  naphthalene vapor for several years  from
excessive numbers  of  mothballs kept  throughout the home, and I 7)
transplacental  exposure, for  about 3 months, of fetuses to naphthalene
      ooap         were not generally reported in these case studies
 because of the poorly defined nature  of  the  exposure.  Tests  to  detect
 naphthalene derivatives in the urine of the anemic individuals were negative in
 some cases (Zinkham and Childs, 1958; Cock,  1957) and positive » in others
 (Athreya et al.,  1961; Mackell  et al.,  1951; Zuelzer and Apt, 1949 . Some
 reports  noted the  odor of naphthalene  in  the  urine  at the time  of
 hospitalization (Cock, 1957; Mackell et al., 1951).                  HI*™™*
     Symptoms of naphthalene  toxicity that  frequently precede he diagnosis
 of acute hemolytic  anemia in  persons  of  all  ages include  mild I to severe
 jaundice, dark urine (red, orange, or port wine colored), pallor, and lethargy
 (Linick,  1983; Grigor et  al., 1966; Irle, 1964; Jacobziner and Raybm, 1964
 Naiman and  Kosoy, 1964;  Anziulewicz et al.,  1959;  Dawson et al., 1958
 ZinSam and ChiWs, 1958; Cock, 1957; Younis et al. 1957; Zinkham  and
 Childs  1957; Gidron and Leurer,  1956; Haggerty, 1956; Chusid and Fned
 i955; Bregman,  1954;  MacGregor, 1954; Abelson and  Henderson, 1951
 Mackell et al-  1951; Schafer, 1951; Zuelzer  and Apt, 1949; Nash,  1903).
 Severe  jaundice  is  often the  reason for hospitalization since the jaundice
 often develops before severe anemia  becomes mamfest (Valaes et al  1963).
 However, it is clear that anemia and jaundice can develop in Parallel as shown
 by a time-course study of hematologic changes  ma 16-year-old girt  who
 had ingested about 6 g of naphthalene  in a  suicide attempt  (G.dron and
 Leurer9 1956).  Vomiting and  tachycardia are occas lonally ^served as
 preclinical signs of naphthalene poisoning in persons of all ages (Linick, 198,3,
 Grigor et al., 1966;  Athreya, 1961; Zinkham and Childs, 1958; Dawson et aL,
 1958- Younis et al  1957; Zinkham and Childs, 1957; Haggerty, 1956,
 Breqman 1954;  MacGregor, 1954; Abelson and Henderson, 1951; Zuelzer
 and Apt, 1949). Preclinical signs of naphthalene toxicity observed primarily •in
  neonates or children include anorexia, cyanosis, shallow respiration or apnea
  convu lions, and  diarrhea (Grigor et al., 1966; Hanssler, 1964; Jacobzmer and
  RaybUi  1964; Naiman and Kosoy, 1964; Athreya et al  1961; Anziulewicz et
  al ,1959; Zinkham  and  Childs, 1958; Cock, 1957; Zmkham and Childs,  957,
  Haaqerty  1956;  Chusid and  Fried, 1955; Abelson and  Henderson,  951
  MackeJ et al., 1951; Schafer,  1951;  Zuelzer and Apt,  1949)^ P/eclimcal
  symptoms of naphthalene poisoning reported by children or adults  include
  S, confusion,  pain in abdominal or kidney region, pan at urination nausea^
  headkche, fainting, and vertigo (Linick, 1983; Athreya et  fl-, 1961, Zinkham
  and Childs,  1958;  Zinkham and Childs, 1957;  Youn.s  et al  1957; Haggerty
   1956; Gidron and  Leurer,  1956; Chusid and Fned 1955; MacGregor .954
   Bregman, 1954;  Mackell et al., 1951; Abelson and Henderson. 1951, Zuelzer
   and Apt, 1949; Nash, 1903).
                                    34

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      Frequent laboratory findings indicative of severe :hemolytic anemia after
  naphthalene  poisoning in persons of all ages include depressed hemoglobin
  hematocrit, and erythrocyte count; elevated leukocyte and reticuloeyte counts'
  erythrocyte  an.socytosis,  polychromatophilia, fragmentation,  spherocytosis'
  and microspherocytosis; and occasional hemoglobinuria (Grigor et al  1966:
  Hanssler  1964; Irle, 1964;  Naiman. and  Kosoy,  1964; Valais et  alt  S
  Athreya et al.,  1961; Anziulewicz et al.,  1959; Zinkham and Childs  195*
  Dawson et al., 1958; Younis  et al., 1957; Cock, 1957; Haggerty 1956  Chusid

                              1954:  Bre9man- 1954;        '
     Additional laboratory findings indicative of severe hemolytic anemia after
 exposure of primarily neonates or children to naphthalene include erythrocyte
 poikilocytosis and microcytosis;  elevated  serum bilirubin;  occasional
 £Sf£   H °f Hem2, b°dies.  nucleated erythrocytes, and  Howell-Jolly
 bodies, and occasional observation of methemoglobinuria (Grigor et al  1966-
 Hanssler, 1964;  Irle  1964; Naiman  and Kosoy, 1964; Valaes et al.',' 1963,:
 Athreya et  a., 1961;  Anziulewicz et al.,  1959; Zinkham and  Childs  1958:
 Dawson et  a   1958; Cock, 1957; Haggerty, 1956; Chusid and Fried  1955!
 1949^             Bregman,  1954;  Mackell et al.,  1951; Zuelzer and Apt,

     Many of the  studies of naphthalene toxicity in neonates included  tests to
 determine  whether Rh sensitization  was a complicating factor; these tests
 Kosovn°ieqR?nve, °f blotod,9roup incompatibility (Hanssler, 1964; Naiman and
 SV   '     la,6S et al" 1963; Athreya et al- 1961; Anziulewicz et al
  959; Dawson  et al., 1958;  Zinkham and Childs, 1958; Cock, 1957; Haggerty'
 Si Bregman' , 954: Schafer- 1951>- When  investigated in  some of these
 studies, sickle cell anemia also was not a complicating factor except in one of
 the four subjects studied by Zuelzer and Apt (1949).
 aft Jn most studies of Pfsons who have developed severe hemolytic  anemia
 ± h,XP*Sr to naPnthalene- treatment with  blood transfusions! treatment
 with blood transfusions plus alkali therapy, or observation without either of
 *™ r  t3   ?XS-has  led  to comPlete P^ent recovery  with  no observed
 SSSn  Si  (2r',90r ettalV 1?o«: HanSSler' 1964: lrle' 1964: Jacobinzer and
 Raybm  1964,  Valaes et al., 1963; Athreya et al., 1961; Anziulewicz et al
 1959; Dawson et al   1958; Zinkham and Childs, 1958; Cock, 1957; Younis e
 Rr^m/1  iQ^"  M  L^Urer' 1956= Ha99ertv- 1956: Chusid and Fried, 1955;
 HPnS     1Qt;i M|cGre9°r-  1954;  Mackell  et al.,  1951; Abelson and
 Henderson,  1951; Zuelzer  and Apt,  1949).  However,  deaths  have been
 observed  after naphthalene-induced hemolytic anemia (Schafer,  1951;
 Younis et al., 1 957; Valaes et al., 1 963; Naiman and Kosoy, 1 964)
tn n Wh^OUp^ °J '"^'duals have been shown to be especially susceptible
to naphthalene-induced  hemolytic anemia:                        v,CHuuic

 1. Persons whose  erythrocytes  are deficient in  glucose  6-phosphate
    dehydrogenase (G6PDH) or persons in  whom  erythrocyte GSH is  rapidly
    £ f  iQRy/?/rtain °Xidant chemicals  (Gri9°r et al.,  1966;  Naiman and
    SVV 964; Valaes et al" 1963; AtnreVa et al- 1961;  Dawson  et al
    1958;  Gross  et  al..  1958;  Zinkham and  Childs, 1958). The prec.se
    mechanism by which GSH is depleted or a deficiency of G6PDH leads to
    ^f r£Dnune"'nd^Ced hemo|ysis in these cases is  not clear. A deficiency
    of G6PDH  will decrease the rate  of conversion of nicotinamide adenine
    ^TnDu   oph°uSphate  fr°m its oxidized  
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   will decrease the conversion of oxidized glutathione to GSH, reduce the
   rate of conjugation and excretion of naphthalene metabolites and increase
   the  accumulation of naphthalene metabolites  in the  body  A  similar
   hvDothesis may explain increased naphthalene sensitivity in individuals in
   which erythrocyte  GSH can be rapidly  depleted  by certain ox.dant
   chemicals" (Naiman and Kosoy, 1964; Kellermeyeret a  1962; Dawson et
   al   1958; Gross et al., 1958; Zinkham and Childs,  1958). Gross et aL
   (1958) demonstrated  a  quantitative correlation between  G6PDH
   deficiency and  diminished levels of GSH in infants beyond  55 hours of
   age- however, diminished levels of erythrocyte GSH were  observed in
   infants of less than 55 hours of age despite high levels of G6PDH activity.
   A second hypothesis for  increased naphthalene sensitivity in G6PDH-
   deficient individuals is  that the  decreased availability of  NADPH will in
   the  presence  of  oxidant  metabolites  of  naphthalene, allow  the
   accumulation of methemoglobin and products of its further irreversible
   oxidation (Kellermeyer et al., 1962).

 2. Neonates (Grigor et al.,  1966;  Naiman and Kosoy,  1964; Valaes et al
   1963- Dawson et al.. 1958; Gross et al., 1958; Zinkham and Childs, 1958).
   The sensitivity of  neonates to  naphthalene is explained  in part by the
   same  factors that  confer  sensitivity  to  children and adults; namely,
   G6PDH deficiency and/or diminished levels of GSH  as described above.
   Additional naphthalene sensitivity in newborns may  be conferred by the
   immaturity of pathways necessary for the conjugation and excretion of
   naphthalene metabolites  (Valaes et al.,  1963).  Evidence for the  latter
   hypothesis  is  suggested by the finding  that glucuronide  excretion by
   human newborn infants increased gradually during  the first week of hfe
   and that the  initial  levels and the rate  of increase were  lower ini the
    premature infant than in the full-term infant (Brown and Burnett 1957).
    A single report described a case  of aplastic anemia in a 68  year-old
woman who had been exposed to naphthalene in the workplace (Harden and
Baetjer, 1978). The interpretation of this finding is difficult, since the woman
had been simultaneously exposed  to p-dichlorobenzene.

4.8.2.   Skin Sensitization

    Fanburg  (1940) described the case of  a man  who  had developed  an
allergic reaction  to naphthalene from  clothing  that  had  been stored  in
mothballs  The reaction was  an exfoliative dermatitis resembling  mycosis
funqoides  The elimination  of naphthalene  from the  patient's  environment
resulted in prompt recovery, which lasted uninterruptedly for a  7-year period
of observation.

4.8.3.  Ocular Toxicity

    Case studies that describe the presence of cataracts in persons exposed
to naphthalene  by  the  oral, dermal,  or  inhalation  routes have  been
 summarized in an ambient water  quality criteria document  for naphthalene
 (US  EPA  1980)  Ghetti and Mariani (1956) associated the occurrence of
 cataracts in 8  of 21 workers  with naphthalene exposure in  a  manufacturing
 plant.  Other cases of occupational instances of cataract formation have been
 described by Hollwich et al. (1975).
                                   36

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4.8.4.  Carcinogenicity
    Wolf (1976) reported 6 cases of carcinomas among 15 workers exposed
to vapors  of naphthalene  and coal  tar for 7-32  years at a  coal-tar
naphthalene production facility. Four of the workers developed carcinomas of
the larynx and all were smokers; the other two developed carcinomas of the
pylorus and cecum.  There was  no  control group. Experiments in  animals
however, suggest that coal tar fractions with boiling points higher than 270°C
contain  most of the carcinogenic activity  of the coal tar, and fractions  with
lower boiling points,  which  include naphthalene, are  generally  not
carcinogenic (Kennaway, 1930).
                                37

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