Histopathology guidelines for the Fathead Minnow
 (Pimephales promelas) 21-day reproduction assay
                  July 6, 2006

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ACKNOWLEDGMENTS

The following persons contributed time and effort toward the creation of this document:

       Gerald Ankley, USEPA, USA
       Christiana Grim, USEPA, USA
       Stephen Duffell, Syngenta, UK
       John Fournie, USEPA, USA
       Anne Gourmelon, OECD
       Rodney Johnson, USEPA, USA
       Christine Riihl-Fehlert, Bayer AG, Germany
       Christoph Schafers, Fraunhofer IME, Germany
       Masanori  Seki, CERI Environment, Inc., Japan
       Leo van der Ven, RIVM, The Netherlands
       Pieter Wester, RIVM, The Netherlands
       Jeffrey Wolf, Experimental Pathology Laboratories, Inc., USA
       Marilyn Wolfe, Experimental Pathology Laboratories, Inc., USA

INTRODUCTION

The purpose of this document is to provide guidelines for the preparation and
histopathological evaluation of gonads from fathead minnow (Pimephalespromelas).

The goals of these guidelines are to provide an updated source of direction for the
participating laboratories, to supply template text for laboratory protocols, and most
importantly, to facilitate non-biased comparisons of inter-laboratory results.

Throughout this document, the proposed procedures were derived from the consensus
opinions of various fish pathologists, recommendations from the Bilthoven 2002 and
Paris 2003 workshops, information distilled from previous guidelines, and the scientific
literature.

This guidance document is divided into three sections: I) Post-mortem  and Histotechnical
Procedures; II) Gonadal Histopathology Glossary and Diagnostic Criteria; and III)
Gonadal Staging Criteria.

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I. POST-MORTEM AND HISTOTECHNICAL PROCEDURES
The purpose of this section is to outline all of the post-mortem steps and procedures that
occur prior to the evaluation of histologic sections on glass slides, to include euthanasia,
necropsy, tissue fixation, decalcification, tissue trimming, processing, embedding,
microtomy, staining, coverslipping, and slide labeling.

       1.  Substrate obtained for vitellogenin analysis.
          Fathead Minnow (FHM): blood sample from the caudal vein/artery or heart
       2.  Tissue specimen for gonad histopathology. Techniques were selected that
          would most optimally: 1) preserve the cellular structure of the gonads; 2)
          maximize the amount of gonad tissue available for analysis; 3) sample the
          gonads in a representative and consistent fashion;  and 4) allow the pathologist
          to examine at least three step sections of both gonads on a single glass slide.
          In FUM, the gonads are  excised from the fish.

Davidson's fixative is the recommended fixative. Compared to other common fixatives,
such as 10% neutral buffered formalin or Bouin's fixative, the advantages of Davidson's
fixative are:  1) the morphologic appearance of gonad sections is generally considered to
be comparable to sections fixed in Bouin's fixative and superior to sections fixed in
formalin; 2)  compared to Bouin's fixative, which contains picric acid, Davidson's
fixative is generally considered to be less noxious, less hazardous, and more easily
disposed of;  3) there is anecdotal information which suggests that Bouin's fixative may
be difficult to obtain in the near future; 4) specimens fixed in Bouin's fixative require
multiple rinses prior to transfer to alcohol or formalin. Please see photographic
comparison of specimens fixed in Davidson's versus Bouin's fixatives (Appendix A, Fig.
I). Please be aware that different recipes and products that are designated as "Davidson's
fixative" may actually be modifications of the original formula (Appendix C); if a
modified Davidson's fixative is used, this should be noted by the laboratory.  If
necessary, a  recommended decalcification solution is listed (Appendix D). Factors that
may  affect the need for decalcification include  the size of the individual fish, the length
of time that the carcass was immersed in fixative, and the extent to which the abdominal
cavity came  into contact with the  fixative.

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I.    Fathead Minnow

     1.   Euthanasia, Necropsy, and Tissue Fixation

          Objectives:
              1.  Provide for the humane sacrifice of fish.
              2.  Obtain necessary body weights and measurements.
              3.  Obtain specimens for vitellogenin analysis.
              4.  Excise gonad specimens.
              5.  Evaluate secondary sex characteristics.
              6.  Provide for adequate fixation of the gonads and the carcass.

          Materials:
              1.  Fish transport container (-500 ml, contains water from the experimental
                 tank or system reservoir).
              2.  Small dip net.
              3.  Euthanasia chamber (-500 ml vessel).
              4.  Euthanasia solution (Appendix C or FA-100 [Japan]).
              5.  Electronic slide caliper (minimum display: < O.lmm)
              6.  Electronic analytical balance (minimum display: < O.lmg) and tared
                 vessels.
              7.  Stereoscopic microscope.
              8.  Pins and corkboard.
              9.  Small scissors (e.g., iris scissors).
              10. Small forceps.
              11. Microdissection forceps.
              12. Microdissection scissors.
              13. Gauze sponges.
              14. Davidson's fixative (Appendix C & Appendix D).
              15. Plastic syringe (3ml).
              16. Standard plastic tissue cassettes (one per fish).
              17. Fixation containers (100 ml, one per fish).

          Procedures:
              1.  Fish should be sacrificed within one to two minutes prior to necropsy.
                 Therefore, unless multiple prosectors are available, multiple fish should
                 not be sacrificed simultaneously.
              2.  Using the small dip net, a fish is removed from the experimental chamber
                 and transported to the necropsy area in the transport container. For each
                 test chamber, all male fish are sacrificed prior to the sacrifice of female
                 fish; the sex of each fish is determined by external body characteristics
                 (e.g., presence or absence of nuptial tubercles, dorsal pad, etc.).
              3.  The fish is placed into buffered MS-222 solution. The fish is removed
                 from the solution when there is cessation of respiration and the fish is
                 unresponsive to external stimuli.

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4.  The fish is wet weighed, measured according to protocol, and a blood
   sample is obtained from the caudal artery/vein or heart.
5.  The fish is placed on a corkboard on the stage of a dissecting microscope.
   Using iris scissors and small forceps, the abdomen is opened via a
   carefully made incision that extends along the ventral midline from the
   pectoral girdle to a point just cranial to the anus.
6.  The fish is placed in dorsal recumbency  and the opposing flaps of body
   wall are pinned laterally to expose the abdominal viscera (Appendix A,
   Fig. 2 & Fig. 3).
7.  Using the small forceps and small scissors, the abdominal viscera (liver,
   gastrointestinal tract, spleen, pancreatic tissue, and abdominal mesentery)
   are carefully removed en masse in the following manner:
   a.  The intestine is severed proximal to the anus.
   b.  A forceps is applied to the terminal portion of the intestine.  Using
       gentle traction and taking care not to disturb the gonads, the viscera
       are dissected out of the abdominal cavity in a caudal to cranial
       direction.
   c.  The distal esophagus is severed just proximal to the liver.
8.  Using a syringe, approximately 0.5 ml of Davidson's fixative is then
   gently applied to the gonads in situ. Approximately  90 seconds following
   the application of fixative, the liquid fixative within the abdomen is
   removed with a gauze sponge, and the gonads are excised in a manner
   similar to the abdominal viscera:
   a.  Using the microdissection scissors, the spermatic ducts or oviducts are
       severed proximal to the genital pore.
   b.  Microdissection forceps are then applied to the spermatic
       ducts/oviducts. Using gentle traction, the gonads are dissected out of
       the abdominal cavity in a  caudal to cranial direction, severing the
       mesorchial/mesovarial attachments as needed using the
       mi crodis section scissors.  The left and right gonads may be  excised
       individually or they may be excised simultaneously and subsequently
       divided at their caudal attachment.
9.  The gonads (right and left) are placed into a pre-labeled plastic  tissue
   cassette which is then placed into an individual container of Davidson's
   fixative accompanied by the abdominal viscera. The volume of fixative in
   the container should be at least  10 times the approximated volume of the
   tissues. The fixative container is gently agitated for five seconds to
   dislodge air bubbles from the cassette.
10. Using the carcass, the secondary sex characteristics are assessed (e.g.,
   dorsal nape pad, nuptial tubercles).  The carcass is then added to the
   fixative container.
11. All tissues remain in Davidson's fixative overnight followed by transfer
   to individual containers of 10% neutral buffered formalin the next day.
   Containers with cassettes are gently agitated for 5 seconds to ensure

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            adequate penetration of formalin into cassettes (it is not necessary to rinse
            with water or perform multiple changes in formalin).

2.   Tissue Trimming
     Tissue trimming is not required for FHM.

3.   Tissue Processing
     Objectives:
         1.  Dehydrate tissue to provide for adequate penetration of paraffin.
         2.  Impregnate the tissue with paraffin to maintain tissue integrity and create a
            firm surface for microtomy.

     Materials:
         1.  Tissue processor.
         2.  Paraffin heating pots.
         3.  Processing unit oven.
         4.  Activated charcoal.
         5.  Paraffin (Paraplast®, or equivalent, Appendix D).
         6.  10% neutral buffered formalin.
         7.  Ethyl alcohol (absolute and dilutions as required).
         8.  Proprietary clearing agent (Clear Rite-3™ or equivalent, Appendix D).
         9.  Xylene.

     Procedures:
         1.  Labeled tissue cassettes are removed from formalin storage and are
            washed in tap water.
         2.  The cassettes are placed in the processing basket(s) in a single layer. The
            processing basket is loaded into the tissue processor.
         3.  The processing schedule is selected (see Appendix B, Schedule 1).  The
            "Gonad Program"  or equivalent is selected for FHM.
         4.  After the tissue processor has completed the processing cycle, the
            basket(s) may be transferred to the embedding station.

4.   Embedding
     Objective:
         1.  Properly  orient the tissue in solidified paraffin for microtomy.

     Materials:
         1.  Embedding station (thermal, dispensing and cryo consoles).
         2.  Paraffin heating pots.
         3.  Paraffin transfer pots.
         4.  Laboratory oven.

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        5.  Thermometer.
        6.  Embedding molds.
        7.  Block drawers.
        8.  Forceps.
        9.  Scraper.
        10. Standard paraffin.

     Procedures:
        1.  The cryo console of the embedding station is turned on.  (Power to the
            dispensing console and thermal console should remain on at all times.)
        2.  The basket(s) of cassettes is/are removed from the processor and
            immersed in the paraffin-filled front chamber of the embedding station
            thermal console.
        3.  The first cassette to be embedded is removed from the front chamber of
            the thermal console. The cassette lid is removed and discarded, and the
            cassette label is checked against the animal records to resolve potential
            discrepancies prior to embedding.
        4.  An appropriately sized embedding mold is selected.
        5.  The mold is held under the spout of the dispensing console and filled with
            molten paraffin.
        6.  The gonads are removed  from the base of the cassette and are placed in the
            molten paraffin in the mold.  The two gonads (left and right) are oriented
            horizontal to their long axis in the mold to allow for longitudinal
            sectioning.
        7.  The base of the cassette is placed on top of the mold. Additional paraffin
            is added to cover the bottom of the base.
        8.  The mold with the cassette base is placed  on the cooling plate of the cryo
            console.
        9.  After the paraffin has solidified, the block (i.e., the hardened paraffin
            containing the tissues and the cassette base) is removed from the mold.
        10. Steps 3 through 10 are repeated for each cassette to be embedded.

5.    Microtomy
     Objective:
        1.  Create and mount histologic sections for staining.

     Materials:
        1.  Microtome.
        2.  Disposable microtome knives.
        3.  Lipshaw Pike® oil (or equivalent lightweight, machine oil).
        4.  Temperature-controlled water bath.
        5.  Ice.

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   6.  Microscope slides.
   7.  Staining racks.
   8.  Permanent slide marking pen.
   9.  Forceps.
   10. Fine-tipped paint brush.
   11. Temporary labels.
   12. Slide warmer/oven.

Procedures:
   1.  The temperature in the water bath is allowed to stabilize so that ribbons
       cut from the tissue blocks will spread out uniformly on the surface without
       melting. This temperature assessment is a qualitative judgment made by
       the microtomist before and during microtomy.
   2.  If necessary, a new blade is mounted onto the microtome and the
       microtome is lubricated with oil.
   3.  The initial phase of microtomy is termed "facing" the block and is
       conducted as follows:
       a.  The block is placed in the chuck of the microtome.
       b.  The chuck is advanced by rotating the microtome wheel and thick
          sections are cut from the paraffin surface of the block until the knife
          reaches the embedded tissues. This process is referred to as "rough
          trimming" of the block.
       c.  The section thickness on the microtome is set between 4-10 microns.
          The chuck is advanced and multiple sections are cut from the block to
          remove any artifacts created on the cut surface of the tissue during
          rough trimming.  This process is termed "fast trimming" of the block.
       d.  The block is removed from the chuck and placed facedown on ice to
          soak the tissue.
       e.  Steps a.  through d. are repeated until all blocks to be microtomed have
          been faced.
       f.  If it is determined during facing that any block is not of acceptable
          quality for microtomy, it is returned for re-embedding before
          proceeding with microtomy.
       g.  Any extraneous pieces of paraffin are removed from the microtome
          and workstation periodically during facing and before proceeding with
          the next phase of microtomy.
   4.  The next phase of microtomy is final sectioning and mounting of tissue
       sections on slides. These procedures are conducted as follows:
       a.  Macroscopic lesions (if any) that are reported in the records are noted.
          Care is taken to include any macroscopic lesions  in the sections
          collected during final sectioning.
       b.  The block is removed from the ice and placed in the chuck of the
          microtome.

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            c.  With the section thickness on the microtome set to 4-5 microns, the
               chuck is advanced by rotating the microtome wheel.  Sections are cut
               from the block until a "ribbon" containing at least one acceptable
               section has been produced. As necessary during sectioning, the block
               may be removed from the chuck, placed on ice to soak the tissue, and
               replaced in the chuck.
            d.  Each ribbon is floated flat on the surface of the water in the water bath.
               An attempt is made to obtain at least one section in the ribbon that
               contains no wrinkles and has no air bubbles  trapped beneath it.
            e.  A microscope slide is immersed beneath the best section in the floating
               ribbon.  The section is lifted out of the water using the slide.  This
               process is referred to as "mounting" the section on the slide.
            f.  A single slide is prepared for each fish. A total of three step sections
               (each section consisting of both the right and left gonad) are mounted
               on each slide.  The first section is obtained at the point where
               approximately half of the gonad has been removed and the size of the
               section is maximized. For both the testis and the ovary, the second
               and third sections are taken at 50 micron intervals following the first
               section.
            g.  With a slide-marking pen, the block number from which the slide was
               produced is recorded on the slide.
            h.  The slide is placed in a staining rack.
            i.  The block is removed from the chuck and placed facedown for storage.
            j.  Steps a. through h. are repeated for all blocks to be microtomed.

6.    Staining, Coverslipping, and Slide Labeling
     Objectives:
         1.  Differential staining of intra- and inter-cellular components of the gonads
            to facilitate diagnostic examination by brightfield microscopy.
         2.  Permanently seal mounted and stained tissues.
         3.  Permanently identify stained sections in a manner that allows complete
            traceability.

     Materials:
         1.  Automated  slide stainer (optional).
         2.  Robot coverslipping machine (optional).
         3.  Clarifier solution (Richard Allen or equivalent).
         4.  Bluing reagent (Richard  Allen or equivalent).
         5.  Eosin-Y (Richard Allen or equivalent, Appendix C & Appendix D).
         6.  Hematoxylin-2 (Richard Allen or equivalent, Appendix C & Appendix D)
         7.  Xylene.
         8.  Absolute ethyl alcohol (100% ETOH).
         9.  95% ETOH.

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    10. 80%ETOH.
    11. Coverslipping mountant (Permount or equivalent, Appendix D).
    12. Glass coverslips, No. 1, 24 x 50 (or 60) mm (Appendix D).
    13. Slide flats.

Procedures:
    1.  Staining
       a.  Slides are routinely air-dried overnight before staining.
       b.  An example H&E staining schedule for automated stainers is in
          Appendix B, Schedule 2. A similar schedule can be adapted for
          manual  staining.
    2.  Coverslipping
       a.  Coverslips can be applied manually or automatically.
       b.  A slide is dipped in xylene, and the excess xylene is gently knocked
          off the slide.
       c.  Approximately 0.1 ml of mounting medium is applied near the end of
          the slide opposite to the frosted end.
       d.  A coverslip is tilted at a shallow angle as it is applied to the slide.
    3.  Labeling
        a.  Each slide label should contain the following information:
              i. Laboratory name
              ii.  Species
             iii.  Specimen No. / Slide No.
             iv.  Chemical / Treatment group
              v. Date (optional)

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II. GONADAL HISTOPATHOLOGY GLOSSARY AND DIAGNOSTIC CRITERIA

The purposes of this section are:
       1) To provide general guidance for the light microscopic evaluation of tissue
       sections;
       2) To promote a common awareness of various pathological findings that may be
       observed; and
       3) To foster consistency in the use of diagnostic terminology.

General approach to reading studies

Studies are to be read by individuals experienced in reading toxicologic pathology
studies, and who are familiar with normal, small fish gonad histology, with gonadal
physiology, and with general responses of the gonads to toxicologic insult. Pathologists
may be board certified (e.g. American College of Veterinary Pathologists, The European
Centre of Toxicologic Pathology, or other certifying organizations), however certification
is not a requirement as long as the pathologist has obtained sufficient experience with,
and knowledge of, fish histology and toxicologic pathology.  Technicians should not be
used to conduct readings due to the subtle nature of some changes and the need for
subjective judgments based on  past experience.

It is recognized that there is a limited pool of pathologists with the necessary training and
experience  that are available to read the gonadal histopathology for the 21-day
reproduction assay. If an individual has toxicological pathology experience and is
familiar with gonadal histology in small fish species, he/she may be trained to read the
fish assay.  If pathologists with little experience are used to conduct the histopathological
analysis, informal peer review may be necessary.

Pathologists are to read the studies non-blinded (i.e. with knowledge of the treatment
group status of individual fish). However, it is expected that any potential compound-
related findings will be re-evaluated by the pathologist in a blinded manner prior to
reporting such findings, when appropriate.  Certain diagnostic criteria, such as relative
increases or decreases in cell populations, cannot be read in a blinded manner due to  the
diagnostic dependence on control gonads. As a rule,  treatment groups should be
evaluated in the following order: Control, High-dose, Intermediate-dose, and Low-dose.

It is suggested that the pathologists be provided with  all available information related to
the study prior to conducting their readings. Information regarding gross morphologic
abnormalities, mortality rates, and general test population performance and health are
useful for pathologists to provide comprehensive reports and to aid in the interpretation
of findings. For a more comprehensive discussion of standard reading approaches for
toxicologic pathology studies, please refer to the Society of Toxicologic Pathology Best
Practices for reading toxicologic histopathology studies (Crissman JW et al. 126-31).
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Diagnostic Criteria

Histopathology is a descriptive and interpretive science, and therefore somewhat
subjective. However, histopathologic evaluations of the same study by any qualified
pathologist should identify the same treatment-related findings (Crissman JW et al. 126-
31). Therefore, we aim to define the diagnostic criteria that will likely be encountered
during the histopathologic analysis of the 21-day reproduction assay in fathead minnow.

A consolidated set of diagnostic criteria follow. These criteria are based on pathologists'
experience with certain consistent histopathologic changes that occur in fathead minnow
gonads in response to chemical exposure, however novel findings that are exposure-
related shall also be reported.

The criteria below have been divided into two sections: 1.  Primary criteria, and 2.
Additional criteria. The criteria are graded for severity on a numerical scale.  Any novel
findings are either graded on a numerical scale, or are qualitatively described.

Primary Criteria - Males:

    1.  Increased proportion of spermatogonia: Increases in  the proportion of
       spermatogonia are consequent of changes of the relative ratios of spermatogenic
       cells. This could be due to an increase in the number  of spermatogonia, or a
       decrease in the number of other cell  types, such as spermatocytes, spermatids, and
       spermatozoa. Because the diagnosis of increased proportion of spermatogonia is
       dependant on a comparison to controls, it is necessary to establish the normal
       range of the ratios of spermatogenic cells in control male fish testes prior to
       making determinations on relative proportions in dose groups.
       Presence of testis-ova. The presence of one or more individualized or clustered
       oogenic cells within the testis. Oocytes within the testis may be determined to be
       perinucleolar, cortical alveolar, vitellogenic, or atretic. There is little or no
       evidence of ovarian architecture. Whenever applicable, the term testis-ova should
       be used in preference to less precise terms such as "intersex" or "hermaphrodite".
    3.  Increased testicular degeneration:  Testicular degeneration is characterized by 1)
       individual or clustered apoptotic germ cells; 2) vacuolated germ cells; and/or 3)
       multinucleated (syncytial) cells in the germinal epithelium or testicular lumen.
       Apoptotic germ cells are characterized by cell shrinkage, nuclear condensation,
       and fragmentation into spherical, membrane-bound bodies, which are often
       phagocytized by neighboring cells. There is no inflammation associated with
       these cells. If possible, testicular degeneration should be differentiated from
       necrosis, which is characterized morphologically by cytoplasmic coagulation or
       swelling, nuclear karyorrhexis or pyknosis, associated inflammation, a locally
       extensive pattern of tissue involvement, and/or the involvement of different local
                                                                                 11

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       tissue elements (e.g., both germinal and stromal tissues). Extensive testicular
       degeneration may lead to localized or generalized loss of the germinal epithelium.

    4.  Interstitial cell (Leydig cell) hyperplasia/hypertrophy: An increase in number
       and/or size of the interstitial cells responsible for producing androgens.
       Interstitial cells may have larger, more rounded nuclei, and interstitial cell
       aggregates may occupy and expand some interstitial spaces.
Primary Criteria - Females:

    1.  Increased oocyte atresia: An increase in degradation and resorption of oocytes at
       any point in development. Atresia is characterized by clumping and perforation
       of the chorion, fragmentation of the nucleus, disorganization of the ooplasm,
       and/or the uptake of yolk materials by perifollicular cells.

    2.  Perifollicular cell hyperplasia/hypertrophy: Increase in the size or number of
       granulosa, theca, and/or surface epithelium cells involved in a developing follicle.
       Abnormal perifollicular cell hypertrophy must be distinguished from the normally
       enlarged granulosa and theca cells of a post-ovulatory follicle.

    3.  Decreased yolk formation: A decrease in the amount of vitellogenic/yolk material
       that is deposited in the developing oocyte. Decreased vitellogenesis is
       characterized by the presence of oocytes in which yolk material is not present
       despite their relatively large size.  Note that oocytes may be affected to varying
       degrees.  Some affected oocytes have extremely fine vitellogenic granules, and
       this is interpreted as ineffective vitellogenesis.

    4.  Change in gonadal staging:   Gonadal staging results are virtually meaningless in
       terms of individual fish (versus treatment  groups). This is because considerable
       animal-to-animal variation in gonad cell proportions is to be expected, even
       among fish of the control groups,  as a consequence of spawning cycle
       asynchrony. Consequently, following the gonadal staging of individual fish, each
       treatment group is assessed as a whole and compared to the appropriate control
       group to determine if a compound-related effect has occurred. Hence, gonadal
       staging cannot be performed in a blinded manner.  Because the cell  distribution
       pattern is likely to vary throughout a given tissue section, the gonad should be
       staged according to the predominant pattern in that section. Similarly, both
       gonads should be staged as a single organ according to the  predominant pattern.
       Gonads that cannot be reasonably  staged for various reasons (e.g., insufficient
       tissue, or extensive necrosis, inflammation, or artifact) should be recorded as UTS
       (unable to stage).
                                                                                 12

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   Criteria for Staging Ovaries
   •   Juvenile: gonad consists of oogonia exclusively; it may be difficult or impossible
       to confirm the sex of these individuals.
   •   Stage 0 - Undeveloped: entirely immature phases (oogonia to perinucleolar
       oocytes); no cortical alveoli.
   •   Stage 1 - Early development: vast majority (e.g., >90%) are pre-vitellogenic
       follicles, predominantly perinucleolar through cortical alveolar.
   •   Stage 2 - Mid-development: at least half of observed follicles are early and mid-
       vitellogenic.
   •   Stage 3 - Late development: majority of developing follicles are late
       vitellogenic.
   •   Stage 4 - Late development/hydrated: majority of follicles are late vitellogenic
       and mature/spawning follicles; follicles are larger as compared to Stage 3.
   •   Stage 5 - Post-ovulatory: predominately spent follicles, remnants of theca
       externa and granulosa.
Secondary criteria - males:

    1.  Decreased proportion of spermatogonia: Decreased relative proportion of
       spermatogonia to other spermatogenic cell types. This can be due to a decrease in
       the number of spermatogonia, or an increase in the number of other cell types,
       such as spermatocytes, spermatids, and spermatozoa.  Because the diagnosis of
       decreased proportion of spermatogonia is dependant on a comparison to controls,
       it is necessary to establish the normal range of the ratios of spermatogenic cells in
       control male fish testes prior to making determinations on relative proportions in
       dose groups.

    2.  Increased vascular or interstitialproteinaceous fluid. Homogenous dark pink
       translucent material, presumably vitellogenin, within the testicular interstitium or
       blood vessels.  The presence of this fluid may cause a thickening of interstitial
       areas that might be misinterpreted as "stromal proliferation".

    3.  Asynchronous gonad development:  The presence of more than one developmental
       phase of spermatogenic cell within a single spermatocyst enclosed by a Sertoli
       cell.  For example, this term may be applied to a spermatocyst that contains a
       mixture of spermatocytes and spermatids, or a spermatocyst that contains more
       than one meiotic phase of primary spermatocyte (i.e., leptotene, pachytene, and/or
       zygotene). It also refers to the presence of distinctly different populations (i.e.
       developmental phases) of gametogenic cells in the right and left gonads.

    4.  Altered proportions of spermatocytes or spermatids: A change in the relative
       proportions of spermatocytes or spermatids to other spermatogenic cell types.
       Changes in relative ratios could be due to an increase in the number of
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    spermatocytes or spermatids, or to a decrease in the number of other cell types.
    Relative changes may also occur between spermatocytes and spermatids.

5.  Gonadal staging:  Gonadal staging results are virtually meaningless in terms of
    individual fish (versus treatment groups). This is because considerable animal-to-
    animal variation in gonad cell proportions is to be expected, even among fish of
    the control groups, as a consequence of spawning cycle asynchrony.
    Consequently, following the gonadal staging of individual fish, each treatment
    group is assessed as a whole and compared to the appropriate control group to
    determine if a compound-related effect has occurred. Hence, gonadal staging
    cannot be performed in a blinded manner. Because the cell distribution pattern is
    likely to vary throughout a given tissue section, the gonad should be  staged
    according to the predominant pattern in that section. Similarly, both gonads
    should be staged as a single organ according to the predominant pattern. Gonads
    that cannot be reasonably staged for various reasons (e.g., insufficient tissue, or
    extensive necrosis, inflammation, or artifact) should be recorded as UTS (unable
    to stage).

    Criteria for Staging Testes

•   Juvenile: gonad consists of spermatogonia exclusively; it may be difficult or
    impossible to confirm the sex of these  individuals.
•   Stage 0 - Undeveloped: entirely immature phases (spermatogonia to spermatids)
    with no spermatozoa.
•   Stage 1 - Early spermatogenic: immature phases predominate, but  spermatozoa
    may also be observed; the germinal epithelium is thinner than it is during Stage 2.
•   Stage 2 - Mid-spermatogenic: spermatocytes, spermatids, and spermatozoa are
    present in roughly equal proportions; the germinal  epithelium is thinner than
    Stage 1 but thicker than Stage 3.
•   Stage 3 - Late spermatogenic: all stages may be observed, however, mature
    sperm predominate; the germinal epithelium is thinner than it is during Stage 2.
•   Stage 4 - Spent: loose connective tissue with some remnant sperm.

.  Granulomatous inflammation: This process is characterized by the presence of
  epithelioid macrophages that typically form sheets or nodules (granulomas) due to
  desmosome-like cytoplasmic attachments (Noga et al., 1989). When compared to
  histiocytic-type macrophages, epithelioid macrophages have larger, more open-
  faced, centralized nuclei and less abundant cytoplasm. During resolution of
  inflammation, the epithelioid macrophages may become flattened into  fibrocyte-like
  cells.  Lymphocytes, granulocytes, and multinucleated giant cells may  also be
  components of granulomatous inflammation. Granulomatous inflammation  is
  intrinsically a pathologic process that is often associated with reactions to infectious
  agents, foreign materials or the aftermath of necrosis; therefore, it is important to
  distinguish this, if possible, from the presence of histiocytic cells in the lumen of
  the testis.
                                                                            14

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Secondary criteria -females:

1.  Interstitial fibrosis: The presence of increased fibrous connective tissue (collagenous
   fibers and fibrocytes or fibroblasts) within the ovarian interstitium (stroma).  Collagen
   may be difficult to appreciate in early phases of fibrosis.

2.  Egg debris in the oviduct: The presence of inspissated-appearing, homogenous,
   irregular, dense pink material, presumed to be yolk, within the oviduct.

3.  Granulomatous inflammation: This process is characterized by the presence of
   epithelioid macrophages that typically form sheets or nodules (granulomas) due to
   desmosome-like cytoplasmic attachments (Noga et al., 1989).  When compared to
   histiocytic-type macrophages, epithelioid macrophages have larger, more open-faced,
   centralized nuclei and less abundant cytoplasm. During resolution of inflammation,
   the epithelioid macrophages may become flattened into fibrocyte-like cells.
   Lymphocytes, granulocytes, and multinucleated giant cells may also be components
   of granulomatous inflammation.  Granulomatous inflammation is intrinsically a
   pathologic process that is often associated with reactions to infectious agents, foreign
   materials or the aftermath of necrosis; therefore, it is important to distinguish this, if
   possible, from the presence of macrophage aggregates in the ovary.

4.  Decreasedpost-ovulatory follicles:  A decrease in the number of collapsed
   perifollicular sheaths, or membranous structures lined by granulosa cells, theca cells
   and surface epithelium, following release of oocytes, in comparison to control fish.
   The granulosa cells are often hypertrophic, although this appears to be species
   dependent (Saidapur, 1982).
Severity Grading

In toxicologic pathology, it is recognized that compounds may exert subtle effects on
tissues that are not adequately represented by simple binary (positive or negative)
responses.  Severity grading involves a semi-quantitative estimation of the degree to
which a particular histomorphologic change is present in a tissue section (Shackelford et
al., 2002).  The purpose of severity grading is to provide an efficient, semi-objective
mechanism for comparing changes (including potential compound-related effects) among
animals, treatment groups, and studies.

Severity grading will employ the following system:

              Not remarkable
              Grade 1 (minimal)
              Grade 2 (mild)
                                                                                15

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              Grade 3 (moderate)
              Grade 4 (severe)

A grading system needs to be flexible enough to encompass a variety of different tissue
changes. In theory, there are three broad categories of changes based on the intuitive
manner in which people tend to quantify observations in tissue sections:
   Discrete: these are changes that can be readily counted.  Examples include atretic
   follicles, oocytes in the testis, and clusters of apoptotic cells.
   Spatial: these are changes that can be quantified by area measurements.  This
   includes lesions that are typically classified as focal, multifocal, coalescing, or
   diffuse.  Specific examples include granulomatous inflammation and tissue necrosis.
   Global: these are generalized changes that would usually require more sophisticated
   measurement techniques for quantification. Examples include increased hepatocyte
   basophilia, Sertoli cell/interstitial cell hypertrophy, or quantitative alterations in cell
   populations.

       General severity grading scale:

   •   Not Remarkable: This grade is used if there are no findings associated with a
       particular diagnostic  criterion.

   •   Grade 1:  Minimal.  Ranging from inconspicuous to barely noticeable but so
       minor, small, or infrequent as to warrant no more than the least assignable grade.
       For discrete changes, grade 1  is used when there are fewer than 2 occurances per
       microscopic field, or 1-2  occurances per section.  For multifocal or diffusely-
       distributed alterations, this grade is used for processes where less than 20% of the
       tissue in the section is involved.

       Grade 2: Mild. A noticeable feature of the tissue. For discrete changes, grade 2
       is used when there are 3-5 occurrences per microscopic field or per tissue section.
       For multifocal or diffusely-distributed alterations,  this grade is used for processes
       where 30-50% of the tissue in the section is involved.

   •   Grade 3: Moderate.  A dominant feature of the tissue.  For discrete changes,
       grade 3 is used when there are 6-8 occurrences per microscopic field or per tissue
       section.  For multifocal or diffusely-distributed alterations, this grade is used for
       processes where 60-80% of the tissue in the section is involved.

   •   Grade 4: Severe. An overwhelming feature of the tissue. For discrete changes,
       grade 4 is used when there are more than 9 occurrences per microscopic field or
       per tissue section.  For multifocal or diffusely-distributed alterations, this grade is
       used for processes where greater than 80% of the tissue in the section is involved.

At the discretion of the pathologist, the severity of a given change should be scored


                                                                                 16

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according to one of the following two methods: 1) score compound-exposed animals
relative to the severity of the same change in control animals, or 2) score all animals
relative to "normal" as determined by the pathologist's experience. For each important
(i.e., treatment-associated) finding, the method that was used should be stated in the
Materials and Methods section of the pathology narrative report (see Histopathology
Report Format). By convention, severity grading should not be influenced by the
estimated physiologic importance of the change. For example, the presence of two
oocytes in the testis should not be graded as "severe", even if the pathologist considers
this finding to be highly significant in terms of endocrine modulation.

Data recording

An Excel worksheet form has been created that includes worksheets for primary,
secondary, and additional diagnoses  to facilitate histopathology data collection.  In this
worksheet, each data entry cell represents an individual fish. Additional sheets are
available for comments and additional findings. For each fish, the pathologist records a
severity score associated with the diagnosis (see Severity Grading). Diagnostic criteria
with non-remarkable findings shall be denoted using (-).  If there is no reasonably
appropriate diagnostic term for a particular finding, the pathologist can create a term that
can be recorded in the "Additional diagnoses" worksheet. If insufficient tissue is
available for diagnosis, this should be recorded as IT (insufficient tissue). If a target
tissue is missing, this should be recorded as MT (missing tissue).

Adding a Modifier term to a diagnosis may help to further describe or categorize  a
finding in  terms  of chronicity, spatial distribution, color, etc. In many  instances,
modifiers are superfluous or redundant (e.g., fibrosis is always chronic); therefore, the
use of modifiers should be kept to a minimum. An occasionally important modifier for
evaluating paired gonads is unilateral (UNI); unless specified in this manner, all gonad
diagnoses  are assumed to be bilateral.  Other modifier codes can be created as needed by
the pathologist.
                                                                                17

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Histopathology Report Format

Each histopathology narrative report should contain the following five sections:
Introduction, Materials and Methods, Results, Discussion, Summary/Conclusions.
A References section can also be included if applicable.  The Introduction section
briefly outlines the experimental design. The Materials and Methods section describes
any items or procedures that are essentially different from Section 1: Post-mortem and
Histotechnical Procedures.  As applicable, specific severity grading criteria (see Severity
Grading) should also be listed in this section. The Results section  should report findings
that are: 1) compound-related; 2) potentially compound-related; 3) novel or unusual.
Detailed histomorphologic descriptions need only be included for findings that differ
substantially from diagnoses presented in Section IIB, Glossary and Diagnostic Criteria.
It is intended that the Results section should be as objective as possible (i.e., opinions and
theories should be reserved for the Discussion section).  The Discussion section, which
contains subjective information, should address relevant findings that were reported in
the Results section.  Opinions and theories can be included in this section, preferably
backed by references from peer-reviewed sources, but unsupported speculation should be
avoided. The Summary/Conclusions section should encapsulate the most important
information from the Results and Discussion sections.

Glossary / Diagnostic Criteria

The purposes of this section are: 1) to provide photomicrographs of normal gonadal
structure in fathead minnow, 2) to provide a common technical "language" and 3) to
create a reference atlas of both microanatomical structures and potential pathological
findings. The information in this section is derived from a number of sources including
scientific articles, conference proceedings, related guidelines, toxicologic pathology
textbooks, medical dictionaries, and the personal experience of various fish pathologists.
Regarding the last, opinions were solicited via a questionnaire that was circulated among
conference participants following the October 2003 meeting of the histopathology
subcommittee of the Fish Discussion Group in Paris. Consensus replies to this
questionnaire form the basis for naming many of these terms.  Other considerations
include traditional usage and scientific precedence,  and  attributes such as clarity and
brevity.

The section is arranged as follows:
       1.    Normal testicular architecture in fathead minnow
       2.    Normal ovarian architecture in fathead minnow
       3.    Primary diagnoses - males
       4.    Primary diagnoses - females
       5.    Additional diagnostic criteria and an illustrated glossary of microanatomical
            and diagnostic terms
                                                                                 18

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Normal Testicular Architecture in Fathead Minnow
Spermatogenic Cell Types:
Spermatogonia. Spermatogonia A in a male
FHM (GMA, H&E).
                                               Syermatosonia: The largest of the spermatogenic
                                               cells (~ 5-10 um), Spermatogonia generally have pale
                                               vesicular nuclei, prominent nucleoli, variably distinct
                                               nuclear membranes, perinuclear cytoplasmic granules,
                                               and moderate amounts of granular cytoplasm.
                                               Spermatogonia B are smaller than Spermatogonia A,
                                               and Spermatogonia B are usually present in larger
                                               clusters (e.g., > 4 cells). If at all possible, an attempt
                                               should be made to classify these cells as
                                               Spermatogonia rather than to label them with a non-
                                               specific term such as "pale cells" or "light cells".
Spermatocytes. FHM testis (GMA, H&E).
                                           Syermatocytes: Derived from Spermatogonia,
                                           spermatocytes are of intermediate cell size (~ 4-6 um), and
                                           have comparatively dense nuclei and minimal to moderate
                                           amounts of indistinct cytoplasm. Spermatocyte nuclei are
                                           usually evident in one of three meiosis phases: pachytene,
                                           leptotene, or zygotene. Primary spermatocytes are larger
                                           than secondary spermatocytes, and the latter are derived
                                           from primary spermatocytes following the first meiotic
                                           division.  Spermatocytes are usually one of the most
                                           abundant spermatogenic cells, and they tend to contribute
                                           to the largest spermatocysts.
Spermatids.  Spermatids in a male FHM. Intercellular
attachments are lost just prior to rupture of the spermatocyst
and release of these cells as spermatozoa (GMA, H&E).
                                                         Spermatids: Derived from spermatocytes
                                                         following the second meiotic division,
                                                         these cells have dense nuclei and narrow
                                                         rims of eosinophilic cytoplasm. They are
                                                         the smallest cells within the germinal
                                                         epithelium (~ 2-3 um), and the cells lose
                                                         their cytoplasmic attachments to one
                                                         another during spermiogenesis.
                                                                                             19

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Spermatozoa. Spermatozoa in a
male FHM (GMA, H&E).
                                            Spermatozoa: These cells have dark, round nuclei and
                                            minimal or no apparent cytoplasm. Tails are generally not
                                            apparent in histologic sections. Spermatozoa are the
                                            smallest spermatogenic cells (~ 2 um), and they exist as
                                            scattered individual cells within tubular lumen.
                                              Sertoli cells: These cells tend to have sharply-defined
                                              elongated or triangular nuclei, variably evident
                                              nucleoli, and cytoplasm that is often indistinct. The
                                              cytoplasmic arms of a Sertoli cell encircle a clonal
                                              group of spermatogenic cells, forming a spermatocyst.
                                              Compared to germinal cells, Sertoli cells are usually
                                              present in low numbers, usually as single cells located
                                              adjacent to lobular septa. In some instances,
                                              hypertrophic (enlarged, swollen) Sertoli cells may
                                              resemble spermatogonia.
Sertoli cells (FHM, GMA, H&E).
                                                                                               20

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                                                                    Interstitial (Leydis) cells: These
                                                                    cells have dense, dark round or
                                                                    oval nuclei with little detail and
                                                                    moderate amounts of variably-
                                                                    evident, faintly vacuolated
                                                                    cytoplasm. Compared to
                                                                    germinal cells, interstitial cells are
                                                                    usually present in low numbers,
                                                                    usually as single cells or small
                                                                    aggregates, within the interlobular
                                                                    interstitium. Although they may
                                                                    resemble spermatocytes,
                                                                    interstitial cells are only present
                                                                    in interlobular areas.
Interstitial cells (FHM, H&E). Interstitial cells (small arrows)
are only found in interlobular areas. Note the resemblance
between these cells and spermatocytes (large arrow).
                                         Spermatocyst:  The functional unit of the testis, this
                                         structure consists of a clonal group of spermatogenic
                                         cells (spermatogonia, spermatocytes, or spermatids)
                                         that are surrounded by the cytoplasmic arms of
                                         (usually) one Sertoli cell.  Cells within spermatocysts
                                         exist as syncytia, maintained by intercellular
                                         attachments (cytoplasmic bridges), until final
                                         maturation and release of spermatozoa occurs
                                         (spermiogenesis) (Grier, 1976).
Spermatocyst (FHM, adult male, plastic, H&E).
A group of dissociated spermatids are surrounded
by the cytoplasmic "arms" of a single Sertoli
cell (arrow).  This arrangement is usually not
as obvious as it is in this photograph.  The
nucleus of this particular Sertoli cell appears
enlarged (hypertrophic).
                                                                                                 21

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                                                  am
                                                  wSa    t».
Spermatocysts (FHM, adult male, GMA, H&E). Spermatocysts outlined in red and green contain
spermatocytes and spermatids, respectively. Spermatogonia (black arrows) and spermatozoa within tubular
lumina (blue arrows) are also indicated.
%'4sgp  ¥m^m^ ;*ss®m •
$P*                            *--id
k,                               ,4lS
                                                 Germinal epithelium (male): The
                                                 germinative intratubular (intralobular)
                                                 parenchyma of the testis, this
                                                 membrane-bound structure consists of
                                                 multiple Spermatocysts in various
                                                 phases of development.  For FHM,
                                                 boundaries of the germinal epithelium
                                                 at various locations throughout the
                                                 testis include the interlobular
                                                 interstitium, the lobular lumina,
                                                 collecting ducts, and the tunica
                                                 albuginea.
Germinal epithelium, male. Normal testis from an adult FHM.
Double arrow indicates width of germinal epithelium, which
extends from the interlobular interstitium to the lobular lumen
(GMA = glycol methacrylate, H&E, bar = 25 urn).
                                                                          22

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Normal Ovarian Architecture in Fathead Minnow
Oogenic Cell Types:
                                                        Oosonia: These cells represent the replicative
                                                        pool of the ovary. Unlike mammalian oogonia
                                                        (although this dogma may soon change based
                                                        on recent data from rodent research), piscine
                                                        oogonia continue to divide in juveniles and
                                                        adults. The smallest of the oocytic cells,
                                                        oogonia reside within the ovarian germinal
                                                        epithelium, usually in comparatively low
                                                        numbers.  Oogonia are characterized by a
                                                        relatively large nucleus with small or
                                                        inapparent nucleolus, and minimal amounts of
                                                        cytoplasm.
Oogonia (FHM, paraffin, H&E, bar = 10 um).  A small cluster
of oogonia reside within a portion of germinal epithelium; the
nucleus of only one oogonium is visible (small arrow). The
oogonia are dwarfed by a perinucleolar oocyte (large arrow).
                                                        Chromatin nucleolar oocytes: Slightly larger
                                                        than an oogonium, this oocyte is formed when
                                                        an oogonium becomes surrounded by
                                                        prefollicle cells (presumptive granulosa cells)
                                                        and the resulting complex buds from the
                                                        germinal nest as a primordial follicle. The
                                                        chromatin nucleolar oocyte has a relatively
                                                        large nucleus that contains a single, large
                                                        nucleolus.  Compared to an oogonium, there is
                                                        more cytoplasm which is slightly more dense
                                                        and finely granular.
Chromatin nucleolar oocyte (FHM, paraffin, H&E, bar = 10 um).
A single chromatin nucleolar oocyte protrudes from the germinal
epithelium (arrow).
                                                                                           23

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                                                   Perinucleolar oocytes: Concomitant with
                                                   oocyte growth, the nucleus (germinal vesicle)
                                                   increases in size and multiple nucleoli appear,
                                                   generally at the periphery of the nucleus. The
                                                   cytoplasm stains uniformly dark, although late
                                                   perinucleolar oocytes may have small clear or
                                                   amphophilic vacuoles in the cytoplasm. These
                                                   cells tend to be abundant in normal adult
                                                   ovaries.
Perinucleolar oocytes.  Several perinucleolar oocytes
in the ovary of a FHM. Arrows indicate nucleoli at the
periphery of the germinal vesicle (paraffin, H&E, bar
= 25 um).
                                                   Cortical alveolar oocytes:  Generally larger
                                                   than perinucleolar oocytes, this phase is
                                                   characterized by the appearance of cortical
                                                   alveoli (yolk vesicles) within the ooplasm.  The
                                                   cortical alveoli are technically not yolk, as they
                                                   do not provide nourishment for the embryo
                                                   (Selman and Wallace, 1989). The chorion
                                                   becomes distinctly evident in this phase, and
                                                   the perifollicular cells are more easily
                                                   visualized.
Cortical alveolar oocytes.  FHM ovary demonstrating
multiple cortical alveolar oocytes. The cytoplasm is
predominately filled by numerous cortical alveoli, which
are amphophilic with this preparation.  Evident are oocytes
in transition from the perinucleolar to cortical alveolar
phase (small arrow), and from the cortical alveolar to early
vitellogenic phase (large arrow) (paraffin, H&E, bar
= 100 um).
                                                                                               24

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Early vitellogenic oocytes. In this FHM ovary,
numerous fine pale pink granules (large arrow), and a
few larger dark red granules (small arrow), are evident
in the central region of an early vitellogenic oocyte.
Although nuclei are present they are not apparent in
every oocyte due to the comparatively vast amount of
cytoplasm (paraffin, H&E, bar = 100 um).
Late vitellogenic oocytes. Late vitellogenic oocyte
in a FHM ovary.  The yolk granules almost fill the
ooplasm. The nucleus has not yet begun to migrate
peripherally (paraffin, H&E, bar =100 um).
                                                     Early vitellosenic oocytes: Larger than
                                                     cortical alveolar oocytes, these cells are
                                                     characterized by the centralized appearance of
                                                     spherical, eosinophilic, vitellogenic yolk
                                                     granules / globules. In H&E sections,
                                                     accumulations of fine yolk granules in the
                                                     central region of the oocyte may somewhat
                                                     resemble (and thus be confused with) the
                                                     reddish nucleus.
                                                     Late vitellosenic oocytes: These cells are
                                                     characterized by an increased accumulation of
                                                     vitellogenic granules that displace the cortical
                                                     alveolar material to the periphery of the
                                                     cytoplasm. It is during this stage that the
                                                     nucleus begins to migrate toward the periphery
                                                     of the cell.
                                                                                                25

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Mature/spawning oocytes. Two mature/spawning
oocytes in a FHM ovary. The oocytes and the yolk
granules have attained their maximum size just prior
to spawning, and the nucleus is not evident (paraffin,
H&E, bar = 100 urn).
   Zona radiata
                                                    Mature/spawning oocytes: In this phase of
                                                    development, vitellogenesis has reached its peak,
                                                    the cell has become larger and more hydrated,
                                                    and the nucleus has migrated toward the
                                                    periphery of the cell and is in the process of
                                                    dissolution.  The loss of nucleus is not a very
                                                    helpful diagnostic feature, however, as the
                                                    nucleus is often not visible in larger oocytes due
                                                    to the plane sectioning. Because of the transient
                                                    nature of these cells in fractional spawning fish,
                                                    mature/spawning oocytes are uncommonly
                                                    observed.
    Ooplasm
                                              Grant losa
            Oocyie
                                   Follicle
Diagram of an ovarian follicle. From Tyler and
Sumpter, 1996.
Ovarian follicle: The functional unit of the ovary,
this term generally refers to an oocyte plus its
surrounding sheath of perifollicular cells (granulosa
cells, theca cells, and surface epithelium cells)
(Tyler and Sumpter,  1996). However, there are
subtypes of follicles in which the oocyte is not
present or may be difficult to appreciate; these
include post-ovulatory (spent), empty, and atretic
follicles. A post-ovulatory follicle (the follicle has
ruptured to release an oocyte during spawning) is
collapsed and often has enlarged (hypertrophic)
granulosa and theca cells. Conversely, an empty
follicle (in which the oocyte has been dislodged
from the histologic section as a post-mortem
artifact) generally retains the shape of the oocyte
and may or may not have enlarged granulosa and
theca cells. An atretic follicle must be distinguished
from both spent follicles and empty follicles; the
presence of at least some ooplasmic material (often
heterochromatic) within a follicle indicates that it
contains an atretic  oocyte.
                                                                                                 26

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Perifollicular cells. In this photomicrograph, the perifollicular cells
are compared to the cells of the ovarian wall epithelium, which
contains dark brown (melanin) pigment (arrow) and is comprised of
ciliated columnar cells in FHM. FHM, adult female, paraffin, H&E,
bar = 25 urn)
                                                                 Perifollicular cells:  These cells form a three-
                                                                 layered sheath around each oocyte, and combined
                                                                 with the oocyte itself comprise the ovarian
                                                                 follicle. These layers are more easily visualized
                                                                 as the oocyte matures.  The innermost layer
                                                                 consists of the granulosa cells, the middle layer
                                                                 consists of the theca cells, and the outermost layer
                                                                 consists of the surface epithelial cells. The
                                                                 granulosa cells especially may become enlarged
                                                                 and vacuolated following ovulation or during
                                                                 oocyte atresia. The perifollicular  sheath should
                                                                 not be confused with folds of the ovarian wall
                                                                 epithelium.
                                                                 Chorion: Usually pale to dark eosinophilic and
                                                                 refractile, the chorion is the thick external layer of
                                                                 an oocyte that surrounds the ooplasm. The terms
                                                                 zona radiata and vitelline envelope have been
                                                                 used synonymously. In mature, unspent follicles,
                                                                 the chorion is noticeably surrounded by
                                                                 perifollicular cells (granulosa cells, theca cells,
                                                                 and surface epithelial cells). As viewed by light
                                                                 microscope, the chorion is often minimally
                                                                 apparent or inapparent prior to the cortical
                                                                 alveolar phase of oocyte development.
Chorion. The chorions of two oocytes are indicated by large arrows.
A smaller arrow denotes a post-ovulatory follicle. (FHM, paraffin,
H&E, bar = 25  urn).
                                                                                                27

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                                                                 Post-ovulatory follicle:  A collapsed
                                                                 perifollicular sheath following release of the
                                                                 oocyte; this is a membranous structure lined by
                                                                 granulosa cells, theca cells, and surface
                                                                 epithelium. The granulosa cells are often
                                                                 hypertrophic, although this appears to be species
                                                                 dependent (Saidapur, 1982).  Mammalian terms
                                                                 such as "corpus lutea" and "Graafian follicles",
                                                                 are probably less desirable, due to structural and
                                                                 functional differences between these entities and
                                                                 piscine post-ovulatory follicles. Whenever
                                                                 possible, post-ovulatory follicles should be
                                                                 differentiated from atretic follicles, the latter of
                                                                 which contains oocyte debris.
Post-ovulatory follicle.  Situated between three oocyte-containing
follicles is a collapsed follicle that does not contain oocyte remnants
(arrows) (FHM, adult female, paraffin, H&E, bar = 25 um).
                                                                                                  28

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Primary Diagnoses - males:
Increased proportion of spermatogonia:
Increased cells, spermatogonia. A:. Testis from adult male
FHM negative control (GMA, H&E, bar = 25 urn).
BI Spermatogonia dominate the germinal epithelium in this
testis from adult male FHM exposed to 10 nM E2 for 10 days.
Other diagnoses for this section include "Decreased cells,
spermatocytes", "Decreased cells, spermatids" (GMA, H&E,
bar = 25 urn).
                                                        Increased proportion of spermatosonia: It is
                                                        recognized that endocrine active compounds may
                                                        alter the proportional distribution of gametogenic
                                                        cell types in the testis or ovary. Certain types of
                                                        alterations (for example, the proliferation or
                                                        absence of single cell population) may not be
                                                        adequately documented by gonadal staging. This
                                                        diagnostic term provides a mechanism for
                                                        documenting such changes. Quantitative
                                                        alterations are: 1) relative  to other cell types in
                                                        the gonad; 2) relative to cell numbers in control
                                                        animals;  and 3) estimates only, versus actual cell
                                                        counts.
                                                                                           29

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Grade 1
Grade 2

Grade 3
Grade 4
                                                   Testis from an adult male FHM. There is a minimal
                                                   (Grade 1) increase in the proportion of spermatogonia
                                                   (arrows). H&E.
                                                   Testis from an adult male FHM. There is a slight/mild
                                                   (Grade 2) increase in the proportion of spermatogonia
                                                   throughout the germinal epithelium. H&E.
                                                   Testis from an adult male FHM. There is a moderate
                                                   (Grade 3) increase in the proportion of spermatogonia.
                                                   H&E.
                                                   Testis from an adult male FHM. There is a severe (Grade
                                                   4) increase in the proportion of spermatogonia. H&E.
                                                                                          30

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Presence of testis-ova: An example of testicular oocytes is not available for FHM.
Increased testicular degeneration:
Testicular degeneration. Multiple clusters of apoptotic germ
cells (black arrows) and vacuolated germ cells (red arrow) within
the germinal epithelium. (FHM, adult male, GMA,H&E, bar =
25 urn).
Testicular degeneration: Examples of
degenerative findings in the testis include: 1)
individual or clustered apoptotic germ cells; 2)
vacuolated germ cells; 3) multinucleated
(syncytial) cells in the germinal epithelium or
testicular lumen. These diagnoses may be
"lumped" together under the term testicular
degeneration. Apoptotic germ cells are
characterized by cell shrinkage, nuclear
condensation, and fragmentation into spherical,
membrane-bound bodies, which are often
phagocytized by neighboring cells. There is no
inflammation associated with these cells. If
possible, testicular degeneration should be
differentiated from necrosis, which is
characterized morphologically by cytoplasmic
coagulation or swelling, nuclear karyorrhexis or
pyknosis, associated inflammation, a locally
extensive pattern of tissue involvement, and/or
the involvement of different local tissue elements
(e.g., both germinal and stromal tissues).
Extensive testicular degeneration may lead to
localized or generalized loss of the germinal
epithelium.
Interstitial cell (Leydig cell) hyperplasia/hypertrophy:
Non-Remarkable
                                                             Non - remarkable testis from males FHM. Interstitial
                                                             areas contain small aggregates of interstitial (Leydig) cells
                                                             (arrows).  Most interstitial cells have wispy, pale
                                                             cytoplasm. H&E.
                                                                                             31

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Grade 1

            _
                                       f*-;n£^
Grade 2
                                                                 Testis from an adult male FHM. Interstitial cell
                                                                 aggregates (arrows) in the testis of this fish are larger than
                                                                 in control fish, and the cytoplasm of these cells is slightly
                                                                 more dense. This was diagnosed as Increased Cells,
                                                                 Interstitial Cells, Grade 1 (minimal) severity.  H&E.
                                                                 Testis from an adult male FHM. Interstitial cell aggregates
                                                                 (arrows) in the testis of this fish are larger than in control
                                                                 fish, and the cells tend to fill and expand the interstitial
                                                                 spaces. This was diagnosed as Increased Cells, Interstitial
                                                                 Cells, Grade 2 (mild) severity. H&E.
                                                                                                  32

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Primary diagnoses - females:

Increased oocyte atresia:
                                    LV = late vitellogenic
                                    EA = early atretic
                                    LA = late atretic
                                    ve = vitelline envelope
                                                        LA
                                                 ve
Oocyte atresia, increased, immature /mature:
Degradation and resorption of an oocyte at any
point in development.  Histopathologically,
atresia is often characterized by clumping and
perforation of the chorion, fragmentation of the
nucleus, disorganization of the ooplasm, and/or
the uptake of yolk materials by perifollicular
cells (FHM, e.g.).  Separate diagnoses and
severity grades can be given to atretic  oocytes
that are  mature ("Oocyte atresia, increased,
mature") versus immature ("Oocyte atresia,
increased, immature"). In this context, oocytes
will be considered "mature" if they are appear
to have been interrupted in either the late
vitellogenic oocyte phase or mature / spawning
phase of development.
Oocyte atresia, mature oocytes. Note clumping and pore-formation
in the vitelline envelope (chorion) of the early atretic oocyte (large
arrow), and the vacuolar hypertrophy of its surrounding granulosa
cells (small arrows). Compare these with granulosa cells that
surround a non-atretic late vitellogenic oocyte (arrowheads). In FHM,
granulosa cells of atretic oocytes often appear to contain phagocytized
material, whereas the granulosa cells of non-atretic oocytes do not.
(FHM, adult female, paraffin, H&E).

Non Remarkable
                                                  Ovary from a control group female. H&E.
                                                                                              33

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Grade 3
                                              Ovary from an adult female FHM. Numerous atretic
                                              oocytes are evident (arrows). H&E.
Grade 4
                                   .
                                              Stage 4 ovary from an adult female FHM. This
                                              ovary is characterized by severe oocyte atresia.
                                              Asterisks indicate the relatively few non-atretic
                                              oocytes. H&E.
Perifollicular cell hyperplasia/hypertrophy: An example of perifollicular cell
hyperplasia/hypertrophy is not currently available for FHM.
Decreased yolk formation:

Not Remarkable
                                       -
                                             Ovary (Stage 3) from a control group female. A single
                                             atretic ovary is evident (arrow). H&E, bar = 250 microns.
                                                                                       34

-------
Grade 3
        „         f
           >:.-
                             O'
Ovary from an adult female FHM.  Decreased yolk
formation is characterized by the presence of oocytes in
which yolk material is not present despite their relatively
large size (large arrows). Note that oocytes are affected to
varying degrees. Some affected oocytes have extremely
fine vitellogenic granules (small arrow), and this is
interpreted as ineffective yolk formation and deposition.
H&E. bar = 250 microns.
Change in ovarian staging:  Photographic examples are not currently available that
demonstrate changes in ovarian staging.
                                                                                          35

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Additional diagnostic criteria and an illustrated glossary of microanatomical and
diagnostic terms
Asterisks denote "secondary" diagnoses for male and female FHM

** Asynchronous development, gonad (male or female): The presence of distinctly
different populations (i.e., range of developmental phases) of gametogenic cells in
different regions of a gonad.

Asynchronous development, spermatocyst (male):  The presence of more than one
developmental phase of spermatogenic cell within a single spermatocyst. For example,
this term may be applied to a spermatocyst that contains a mixture of spermatocytes and
spermatids, or a spermatocyst that contains more than one meiotic phase of primary
spermatocyte (i.e., leptotene, pachytene, and/or zygotene).

Asynchronous development, right and left gonads (male or female): The presence of
distinctly different populations (i.e., developmental phases) of gametogenic cells in the
right and left gonads.

**Egg debris, oviduct: The presence of inspissated-appearing, homogenous, irregular,
dense pink material, presumed to be yolk, within the oviduct.
                                                            D = debris
                                                            Ov = oviduct
Egg debris, oviduct. (FHM, adult female, paraffin, H&E).
Gender: Because the genetic sex of a fish cannot be determined within the context of a
screening assay, and because the external phenotypic sex may be an unreliable indicator
and/or is not easily determined in some species, by convention the gender of a fish will
be assigned according to the most abundant mature cell type that is present in the gonad.
                                                                              36

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Germinal epithelium (female): The germinative parenchyma of the ovary is a
membrane bound structure constitutively contains oogonia, prefollicular and prethecal
cells, epithelial cells, and occasionally small chromatin nucleolar (primary growth)
oocytes (Norberg et al., 2000; Parent and Grier, 2003).  The germinal epithelium
separates the ovarian lumen from the stroma, the latter of which often contains
perinucleolar, cortical alveolar, and vitellogenic follicles within a variably-apparent
extravascular space.

Germinal epithelium, atrophy / hypoplasia (male): Indicating loss or
underdevelopment of germinal epithelium, respectively, this condition may be associated
with interstitial fibrosis and increased prominence of interstitial cells in affected areas of
the testis. It may be difficult to distinguish atrophy from hypoplasia.  Care should be
taken to avoid mistaking areas of collecting ducts for atrophy. Severity of this finding can
vary from Grade 1 (minimum, focal) to Grade 4 (severe, diffuse). If thinning of the
epithelium appears to be caused by degenerative changes that are obvious in the section,
the diagnostic term testicular degeneration should be used instead.

                                              Germinal epithelium, atrophy.  A: Atrophy
                                              of germinal epithelium in an adult male
                                              FHM. Also note the prominence of
                                              interstitial (Leydig) cells (red circles) and
                                              interstitial fibrosis. (GMA, H&E, bar = 25
                                              Dm).  BI Normal FHM testis (GMA, H&E,
                                              bar = 25 Dm).  Ci Normal collecting duct
                                              region in an adult male FHM (GMA, H&E,
                                              bar = 25 Dm). The presence of pigment in
                                              the duct walls and the lack of interstitial cells
                                              are distinguishing features.
                                                                                   37

-------
**Granulomatous inflammation: In the early stages of inflammation, this process is
characterized by the presence of epithelioid macrophages that typically form sheets or
nodules (granulomas) due to desmosome-like cytoplasmic attachments (Noga et al.,
1989). When compared to histiocytic-type macrophages, epithelioid macrophages have
larger, more open-faced, centralized nuclei and less abundant cytoplasm.  During
resolution of inflammation, the epithelioid macrophages may become flattened into
fibrocyte-like cells. Lymphocytes, granulocytes, and multinucleated giant cells may also
be components of granulomatous inflammation.  Granulomatous inflammation is
intrinsically a pathologic process that is often associated with reactions to infectious
agents, foreign materials, or the aftermath of necrosis; therefore, it is important to
distinguish this, if possible, from the presence of macrophage aggregates in the ovary or
histiocytic cells in the lumen of the testis.
Granulomatous inflammation. A^ Sheets of macrophages and other inflammatory cells eclipse much of
the germinative tissue in this testis (FHM, adult male, paraffin, H&E). B: Relatively few viable-appearing
oocytes remain in this ovary. As in the testis photo, the inciting cause of the inflammation is not evident at
this magnification (FHM, adult female, paraffin, H&E).
Hepatocyte basophilia, increased / decreased: A generally diffuse increase in
hepatocyte cytoplasmic basophilia has been observed in male fish that have been exposed
to compounds that are able to interact with hepatic estrogen receptors, including E2 and
17a-methyldihydrotestosterone (Wester et al., 2003). This increase in basophilia, which
is correlated with increased vitellogenin production, presumably mimics the heightened
metabolic state (e.g., increased endoplasmic reticulum) that is required for the production
of vitellogenin in the reproductively-active female fish.
                                                                                 38

-------
Hepatocyte basophilia A:. The liver from an adult male FHM
control. In addition to the overall coloration, note the
hepatocyte cytoplasmic vacuolization as indicated by the arrows.
Ifc Liver from an adult male FHM that was exposed to a compound
with estrogenic activity. There is a diffuse increase in hepatocyte
basophilia, a loss of cytoplasmic vacuolization, and hepatic blood
vessels contain proteinaceous fluid  (arrows). (FHM, paraffin, H&E).
                                                                                               39

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Histiocytic cells (male): The presence of individual or clustered cells with small
eccentric nuclei and moderate to abundant, pale or vacuolated cytoplasm within the
testicular lumen, germinal epithelium, efferent ducts and/or ductus deferens. Such cells
may contain intracytoplasmic cellular debris (presumably phagocytized). The origin of
the histiocytic cells in each particular case may not be clear; for example, they may be
hematogenous macrophages or Sertoli cells. Histiocytic cells should be differentiated
from macrophage aggregates (these variably pigmented cells are primarily interstitial)
and granulomatous inflammation (which is predominately comprised of "epithelioid"
macrophages and/or flattened, fibrocytic cells).
 ym    •*&   m
    ]^p.c      ^t   •  .4m
    ^•tf*" "^^i''^'''-*.      »^1.

                            't:r-' ;.
                            ••»-/ '
Histiocytic cells. (FHM, adult male, GMA, H&E). A^ Cells with small
peripheral nuclei and abundant vacuolated cytoplasm are present within
the germinal epithelium and are scattered throughout the tubule lumen
(arrows). Some of these cells contain phagocytized cellular debris.
Ifc Similar cells are evident within the lumen of the collecting duct.
                                                                    40

-------
Interstitial fibrosis (male or female):  The presence of increased fibrous connective
tissue (collagenous fibers and fibrocytes or fibroblasts) within the testicular or ovarian
interstitium (stroma).  Collagen may be difficult to appreciate in early phases of fibrosis.
In most cases, this term should be used in preference to terms such as "stromal
hyperplasia."

Macrophage aggregates: These cell clusters are constitutively present in the interstitium
of the ovary primarily, although they may also be found in the fish testis (unusual for
tank-raised FHM). These phagocytes usually have small condensed eccentric or
peripheralized nuclei and various brown, yellow, red, or gold pigmented granules
(lipofuscin, ceroid, hemosiderin, and/or melanin) that often impart  a slightly crystalline
appearance to their comparatively abundant pale cytoplasm. In the normal ovary,
macrophage aggregates are thought to be involved in the processing of breakdown
products associated with atresia of unspawned oocytes.  It has been demonstrated that
macrophage aggregates may become larger and/or more numerous following exposure to
certain toxicants or infectious agents (Blazer et al., 1987). Whenever possible,
macrophage aggregates should be distinguished from granulomatous inflammation,
which is characterized by the presence of epithelioid macrophages. This is not always
easy, as macrophage aggregates often proliferate with,  and become incorporated into,
granulomatous inflammation.
                                  I*,- ^ **"
Macrophage aggregates. The arrows indicate multiple aggregates within
the ovarian interstitium. (FHM, adult female, paraffin, H&E).
                                                                                41

-------
Nephropathy: Degenerative renal disease has been observed in a variety of fishes that
have been exposed to compounds with estrogenic activity (Herman & Kincaid, 1988;
Zillioux et al., 2001; Palace et al., 2002).  Renal impairment presumably occurs due to
increased production of vitellogenin (especially in males) that stresses the kidney via
protein overload. Microscopic lesions may include swelling of tubular epithelial cells,
tubular necrosis, dilation of Bowman's capsule, interstitial fibrosis, casts, and hyaline
droplets in tubules or glomeruli.
                                     .
                                     **^»
                           •••  /%;*-.'
                           ..  -*.- .»••. - .'

                                                        •Sfe
Nephropathy. A:. Kidney from an untreated adult male FHM. Ifc Kidney from an adult male FHM
exposed to a compound with estrogenic activity. Changes include glomerular epithelial cell hypertrophy,
vacuolar swelling and necrosis of the tubular epithelium, and hyaline droplets within glomerular and
tubular epithelia (paraffin, H&E, bar = 25 um).

Ovarian spermatogenesis: The presence of non-neoplastic spermatogenic cells, usually
immature, within the ovary.  There is little or no evidence of lobular or tubular testicular
architecture.  Care should be taken to distinguish ovarian spermatogenesis from
mitotically dividing oogonia; a key feature of ovarian spermatogenesis is the presence of
multiple spermatogenic phases.
                                                                                  42

-------
Mitotically dividing oogonia.  Packets of cells that resemble spermatocytes (arrow)
are situated between perinucleolar and cortical alveolar oocytes. This should not be
mistaken for spermatogenesis. (FHM, adult female, paraffin, H&E).


**Proteinaceous fluid, interstitial (male or female): Homogenous dark pink
translucent material, presumably vitellogenin, within the testicular or ovarian interstitium.
In male fish especially, this finding has been associated with exposure to estrogenic
substances. The presence of this fluid may cause a thickening of interstitial areas that
might be misinterpreted as "stromal proliferation".
Proteinaceous fluid, interstitial.  There is homogenous
dark pink material in interstitial spaces (arrows). (FHM, adult
female, paraffin, H&E, bar = 50 um).
                                                                                      43

-------
**Proteinaceous fluid, intravascular (male or female): Homogenous dark pink
translucent material, presumably vitellogenin, within testicular or ovarian blood vessels.
In male fish especially, this finding has been associated with exposure to estrogenic
substances.
Proteinaceous fluid, intravascular.  There is
homogenous dark pink material within large and small
bloodvessels (arrows). Also note the increased
proportion of spermatogonia in the testis. (FHM,
adult male, GMA, H&E, bar = 25 urn).

Sertoli cell hypertrophy:  Exposure of male fish to estrogen-active compounds has been
reported to cause enlargement of Sertoli cells, with or without Sertoli cell proliferation
(Miles-Richardson et al., 1999a; Miles-Richardson et al., 1999b; Kinnberg et al., 2000;
van der Ven et al., 2003). In the scientific literature, the light microscopic appearance of
hypertrophic Sertoli  cells tends to be ambiguous, as Sertoli cells resemble spermatogonia
in some descriptions and images.

Vitellogenic oocyte: An oocyte that contains microscopically visible yolk material.
Generally, such material is strongly eosinophilic and slightly refractile in hematoxylin-
and eosin-stained sections. This material may be present in the  form of spherical,
globular, yolk granules.  In some scholarly sources (e.g., Iwamatsu, et al., 1998), the term
"vitellogenic" has been applied to cortical alveolar oocytes, which lack eosinophilic yolk
granules/globules (although their amphophilic or clear cortical alveoli are also known as
yolk vesicles).

GONDAL STAGING CRITERIA
The goal of gonadal  staging is to determine if the administration of a particular
endocrine-active substance affects the reproductive cycle status  of adult male and female
fathead minnows.  The purpose of this section is to describe a rapid, semi-quantitative
method for assessing the proportions of various gametogenic cell types (gonadal staging)
based on the light microscopic examination of hematoxylin and eosin-stained histologic
sections.
                                                                                 44

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Semi-quantitative gonadal staging has been proposed for, or employed in, studies
involving fathead minnows (Ankley et al., 2002; Jensen et al., 2001; Miles-Richardson et
al., 1999a; Nichols et al., 2001; US EPA, 2002), among other fishes.  Although such
studies generally included excellent descriptions of the different gametogenic maturation
stages (e.g., spermatogonium through spermatozoa for the testis), they did not incorporate
pre-defined categorical guidelines for evaluating and reporting the reproductive cycle
status of an individual fish.  To maintain scientific integrity across the board in a program
that involves multiple studies, multiple laboratories, and large numbers of animals, it is
essential that observations are recorded on a fish-by-fish basis.  The use of a
categorization system can improve the consistency and objectivity of reported
observations within and among experiments; consequently, comparisons of the results are
more meaningful. Categorization systems also have some drawbacks and limitations, the
most significant of which are: 1) the potential loss of discriminatory data when similar,
but not identical, types of observations are combined (binned) into a single class; 2) the
questionable biological relevance of the classification criteria in some cases; and 3) the
inability of any single classification system to address every type of observation (either
predicted or unforeseen).  To address this last limitation, gonadal staging is accompanied
by a complete histopathological evaluation of the gonads; in this manner, the loss or
overabundance of a specific gametogenic cell type, for example, can be documented.

The semi-quantitative gonadal staging scheme selected for analysis of FHM gonads is a
modification of a system adopted by the United States Department of the Interior, U.S.
Geological Survey, Biological Resources Division as part of the "U.S. Biomonitoring of
Environmental Status and Trends (BEST) Program" (McDonald et al., 2000).  The
authors  of the BEST system credit previous work by Treasurer and Holiday (1981),
Nagahama (1983), Rodriquez et al. (1995), and Goodbred et al. (1997). The foremost
benefits of this system are speed and ease of use, especially when compared to fully-
quantitative staging.  The basis of the BEST system is a visual assessment of the density
of gametogenic precursors as compared to mature gametocytes in one or more gonad
sections. Accordingly, the stage numbers (testis: Stages 0 to 4;  ovary: Stages 0 to 5)
increase in direct relationship to the relative proportion of mature cells. Although the
BEST system was initially developed to assess reproductive function in seasonal
spawners such as carp (Cyprinidae) and black basses (Centrarchidae),  the same stage
categories can be applied to fractional spawners such as fathead minnow. This was
demonstrated at the October 2003 meeting of the histopathology subcommittee of the
FDG in Paris, at which the participants were asked to briefly evaluate the applicability of
a modified BEST system using actual histologic specimens of these three species.  In
general, the participants agreed that they could readily recognize the various gonadal
stages as defined by modified BEST criteria.  The participants acknowledged that the
terminal stages of the system (testis: Stage 4, "Spent"; ovary: Stage 5, "Post-ovulatory")
would be minimally present (or possibly not present at all) among reproductively-active
adult FHM because they are not seasonal spawners.  Similarly, it was thought that Stage
4, "Late development/hydrated", would be rarely observed in the test fishes, due to the
very transient nature of this  stage in fractional spawners.

A few modifications have been made to the BEST system to adapt it for use. For
                                                                               45

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example, there is currently no provision in the system for gonads that are comprised
entirely of spermatogonia or oogonia. Although it is intended that reproductively mature
fish are used, it is possible that an occasional animal may not attain sexual maturity by
the time the experiment is terminated, or that certain test compounds might cause
reversion of the gonads to a juvenile phenotype. Therefore, as one modification of the
BEST system, a pre-staging category called "juvenile" has been added for both male and
female fish.  Another modification to the system involves an apparent discrepancy
between the BEST system and Goodbred et al. concerning the thickness of the testicular
germinal epithelium as a staging criterion. As indicated by Goodbred et al., the germinal
epithelium becomes thinner as the testis stage increases, whereas, the reverse occurs
according to the BEST system (as presented in McDonald et al.).  Although it is difficult
to find corroborating statements in the scientific literature, empirical evidence indicates
that Goodbred et al. is correct on this point. A third modification to the system is the
option to subdivide a stage into two subordinate stages (e.g., Stages 3A and  3B) if the
pathologist believes that this tactic would reveal a subtle, compound-related effect that
might otherwise be missed.  Other modifications to the system are relatively minor and
primarily involve rewording for clarification.

The cell distribution pattern is likely to vary throughout a given tissue section, the gonad
should be staged according to the predominant pattern in that section. Both gonads
should be staged as a single organ according to the predominant pattern. Gonads that
cannot be reasonably staged for various reasons (e.g., insufficient tissue, or extensive
necrosis, inflammation, or artifact) should be recorded as UTS (unable to stage).

Criteria for Staging Testes
   The following are morphologic criteria for staging male fish:
       •   Juvenile: gonad consists of spermatogonia exclusively; it may be difficult or
          impossible to confirm the sex of these individuals.
       •   Stage 0 - Undeveloped: entirely immature phases (spermatogonia to
          spermatids) with no spermatozoa.
       •   Stage 1 - Early spermatogenic: immature phases predominate,  but
          spermatozoa may also be observed; the germinal epithelium is thinner than it
          is  during Stage 2.
       •   Stage 2 - Mid-spermatogenic: spermatocytes, spermatids, and spermatozoa
          are present in roughly equal proportions; the germinal epithelium is  thinner
          than Stage 1 but thicker than Stage 3.
       •   Stage 3 - Late spermatogenic: all  stages may be  observed, however, mature
          sperm predominate; the germinal epithelium is thinner than it is during Stage
          2.
       •   Stage 4 - Spent: loose connective tissue with some remnant sperm.
                                                                               46

-------
                                        " S-?';1\ $-  f^|*V?5^£-  •:•>••'
      ':2ii^Pfill
Examples of staging system applied to the FHM testis.  Testes from four different adult male FHM.
There is progressive thinning of the germinal epithelium and expansion of the lobular lumen with each
increase in stage. Note that no spermatozoa are present at in the Stage 0 image (GMA, H&E).
                                                                                       47

-------
Criteria for Staging Ovaries
  The following are morphologic criteria for staging female fish:
  •  Juvenile: gonad consists of oogonia exclusively; it may be difficult or impossible
     to confirm the sex of these individuals.
  •  Stage 0 - Undeveloped: entirely immature phases (oogonia to perinucleolar
     oocytes); no cortical alveoli.
  •  Stage 1 - Early development: vast majority (e.g., >90%) are pre-vitellogenic
     follicles, predominantly perinucleolar through cortical alveolar.
  •  Stage 2 - Mid-development: at least half of observed follicles are early and mid-
     vitellogenic.
  •  Stage 3 - Late development: majority of developing follicles are late
     vitellogenic.
  •  Stage 4 - Late development/hydrated: majority are late vitellogenic and mature
     / spawning follicles; follicles are larger as compared to Stage 3.
  •  Stage 5 - Post-ovulatory: predominately spent follicles, remnants of theca
     externa and granulosa.

   QW^     u m  -. W  ^Q vVff^W^
 ho^O*tQ*«O<|Q$ ip<$5-  *'
 ^w^^Pte^'.;
      i A   fir>*rftMo°   .'IW1;,.  •   S^;      •
                            ,  O  '<»
                                     *','/    ^n  Stage 1
,r. •    StageO  D| . %
Examples of staging system applied to the FHM ovary. Ovaries from four adult female FHM. Due its
transient nature in FHM, Stage 4 is not often observed (paraffin, H&E).
                                                        48

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                      APPENDIX A: HISTOLOGY FIGURES
           Bouin's Fixative
Modified Davidson's Fixative
                                            m
                                            %£& "••••  .--V™
                                            mi$lffiz$i?i&$
                                            i£*«S SSPvMr.v;<


Fig. 1. Fathead Minnows, Testis (A&B) and Ovary (C&D): Gonads fixed in Bouin's fixative (A&C)
and modified Davidson's fixative (B&D). Color contrast was slightly superior in testes fixed with
Davidson's fixative and was clearly superior in ovaries fixed with Bouin's fixative. Either fixative is
satisfactory for diagnostic purposes; however, Davidson's fixative was selected for the Phase IB assay.
                                                                                    49

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Fig.  2. Fathead Minnow, Male: Excision of the testes during necropsy. A. The abdominal wall is
pinned laterally.  B. The terminal intestine is severed and retracted prior to removal. C. The testes are
grasped near the spermatic ducts. D. Removal of the testes is complete.
                                                                                           50

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Fig. 3. Fathead Minnow, Female: Excision of the ovaries during necropsy. A. The abdominal wall is
pinned laterally. B. The terminal intestine is severed and retracted prior to removal.  C. The ovaries are
grasped near the oviducts.  D. Removal of the ovaries is complete.
                                                                                          51

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                                      APPENDIX B: SCHEDULES
                                 Schedule 1.  Tissue Processing
Station
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Reagent
10% NBFa
70% ethyl alcohol
80% ethyl alcohol
95% ethyl alcohol
95% ethyl alcohol
100% ethyl alcohol
100% ethyl alcohol
100% ethyl alcohol
Clear Rite 3
Clear Rite 3
Paraffin
Paraffin
Paraffin
Paraffin
Pressure/
Vacuum
Cycle
On
On
On
On
On
On
On
On
On
On
On
On
On
On
Heat (°C)
Ambient
Ambient
Ambient
Ambient
Ambient
Ambient
Ambient
Ambient
Ambient
Ambient
60
60
60
60
GONAD
PROGRAM
(minutes)
40
40
40
40
40
40
40
40
60
60
45(60b)
45(60b)
45(60b)
45
WHOLE-FISH
PROGRAM
(minutes)
60
60
60
60
60
60
60
60
80
80
75(100b)
75(100b)
75(100b)
75
Drain and Clean Cycle0
a Neutral buffered formalin.
b Times are increased for processors that have three (versus four) final stations
c Automatic cleaning cycle to be run after removal of tissues from the processor. Time, temperature, and vacuum are preset by the
manufacturer.
                                                                                                     52

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Schedule 2. Hematoxylin and Eosin Staining

Reagent
Xylene
Absolute Alcohol
80% Alcohol
Water
Hematoxylin
Water
Clarifier
Water
Bluing
Water
95% Alcohol
Eosin
Absolute Alcohol
Xylene
Minutes in Reagent
4
2
1
1
3
2
1
1
1
2
1
1
4
3
Reagent Maintenance
After 1st Run
Remove
Remove
Renew
—
—
—
Renew
—
Renew
—
Renew
—
Remove
Remove
After 2nd Run
Remove
Remove
Renew
—
Remove
—
Renew
—
Renew
—
Renew
Renew
Remove
Remove
                                                     53

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                     APPENDIX C: FORMULARY
                           Euthanasia Solution

                       Tricaine methanesulfonate     100 mg
                       Sodium bicarbonate           200 mg
                       Tank or reservoir water        1 L
                     Davidson's Fixative (Fournie etal., 2000)

                       Formaldehyde (37-40%)       200 ml
                       Glycerol                     100ml
                       Glacial acetic acid             100 ml
                       Absolute alcohol              300 ml
                       Distilled water                300 ml
                          Modified Davidson's Fixative

                       Formaldehyde (37-40%)       220 ml
                       Glacial acetic acid             115 ml
                       95% Ethyl alcohol             330 ml
                       Distilled water                335 ml
It is recommended that hematoxylin and eosin be purchased as premixed solutions.
Examples are the Hematoxylin-2 (Gill hematoxylin) and Eosin Y solutions that are
manufactured by Richard-Allan Medical Industries (Appendix D).

                 Gill Hematoxylin Solution (Gill etal. 1974)

                   Distilled water                   730 ml
                   Ethylene glycol                  250 ml
                   Hematoxylin, anhydrous             2 g
                   Sodium iodate                    0.2 g
                   Aluminum sulfate                17.6 g
                   Glacial acetic acid                 20 ml
                              Eosin Solution

                Eosin Y (1% aqueous solution)          100 ml
                Ethyl alcohol, 95%                     600 ml
                Glacial acetic acid                       4 ml
                                   C-l

-------
APPENDIX D: EXAMPLE PRODUCT GUIDE
Example Product
Clear Rite-3™
Coverglass, 24x50 premier nonstick
Thinness: 0.13mm-0.17mm
Davidson's Fixative
Decalcifier: Formical-2000®
Eosin Y (for H&E Stain)
Eosin-Y
Reagent Alcohol
Deionized Water
Glacial Acetic Acid
Hematoxylin 2 (for H&E Stain)
Hematoxylin
Aluminum Sulfate
Sodium lodate
Ethylene Glycol
Deionized Water
Glacial Acetic Acid
MS-222 Fenquel™ ( Tricaine
Methanesulfonate)
Paraplast® (CSMP)
Kendall Paraplast Tissue Embedding
Medium 8889 50 1006
Permount® Mounting Media
Toluene 55%
BHT < 1%
Polymer Alpha pinene &
Betapinene 45%
Slide, Single Frosted, ground edge
Crystal Line Premier Brand
Catalogue #
6901
00145-ACS
S2250
1354
7111
7231
C-FINQ-UE
SHM8889-501006
SP15-500
8105
Supplier/Manufacturer
Richard Allen Medical Industries
8850 M89 Box 351
Richland, MI 49083
800-522-7270
http://www.rallansci.com.
Surgipath Medical Industries, Inc.
P. O. Box 528
Richmond, IL 60071
800-225-3035
Poly Scientific R&D Corp.
70 Cleveland Avenue
Bay Shore, NY 11706
631-586-0400
Decal Chemical Corp.
PO Box 9 16
Tallman, NY 10982-0916
800-428-5856
Richard Allen Medical Industries
8850 M89 Box 351
Richland, MI 49083
800-522-7270
http://www.rallansci.com.
Richard Allen Medical Industries
8850 M89 Box 351
Richland, MI 49083
800-522-7270
http://www.rallansci.com.
Argent Chemical Laboratories,
Redmond, WA 98052, USA.
Supplier: Laboratory Supply Co.
800-888-9004
Manufacturer:
Sherwood Services AG
Tyco Healthcare Group L
15 Hampshire Street
Mansfield, MA 02048
Fisher HealthCare
800-640-0640
C&A Scientific Co., Inc.
7241 Gabe Court
Manassas, VA 20109
703-330-1413
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