Contemporary Topics 36 (5)


Safety Testing - An Essential Use of Laboratory Animals. Contemporary Topics 36 (5): 40.
This article reviews the basic rationale for safety testing of consumer products and the importance of animal studies in this process. It places laboratory animal-based safety testing into historic and present day contexts of protecting public health and safety.
Safety testing permits manufacturers to label their products with appropriate instructions on the safe use of that product, precautions for preventing injury, and measures to take in case of accidental misuse.
Safety testing identifies products and substances that may be safely introduced into the global environment and those that require special handling and disposal.
Product safety requires biologic testing methods such as:
1. clinical, human volunteers
2. in vivo, using nonhuman living organisms
3. in vitro, tests that do not use whole animal systems
Safety testing keeps toxic products off the market and also determines safe levels of exposure and methods of use.
Toxicity studies obtain information about adverse effects and possible treatments for problems caused by acute exposure to a product as well as exposure over a period of time.
1938 Federal Food, Drug, and Cosmetic Act: mandates that before marketing, the safety of prescription drugs must be tested with adequate methods, including the use of experimental animals. Enforced by Food and Drug Administration.
1960 Federal Hazardous Substances Labeling Act: requires that a manufacturer determine if a product for household use should bear appropriate conspicuous labeling such as "Poison", "Danger", or "Caution" on the basis of testing in "normal living tissue" or "laboratory white rats". Animal testing is not required if determination of safety and labeling can be made on the basis of previous human experience, existing animals study data, or expert opinion.
The Environmental Protection Agency can ban or restrict the use of any substance that represents an "unreasonable risk of injury to health or the environment." To make these judgments, the EPA can require that specific animal safety testing be conducted by the manufacturer.
Questions:
1. Three biological testing methods that may used to test product safety are:
2. Who enforces the Federal Food, Drug, and Cosmetics Act?
Answers:
1. in vitro, in vivo (nonhumans), clinical (human volunteers).
2. FDA (Food and Drug Administration)

Institutional Animal Care and Use Committees: A Survey Covering 10 Years of Experience. Contemporary Topics 36 (5): 42.
A survey was performed of IACUCs at U.S. institutions that maintain an animal welfare assurance with OPRR. Questions were asked about the IACUC composition, function and procedures; training and education programs; controversial issues; protocol review and semi-annual program review and inspection; surgical or potentially painful procedure; characteristic of participating institutions.

>80% of institutions did not reimburse their non affiliasted members.
Questions:
1. Do the OPRR and the USDA allow institutions to reimburse the IACUC non-affiliated community members?
2. What three criteria must be fulfilled if IACUCs use electronic communication (fax, audio or videoconferencing, email) for the review
process?
Answers:
1. Yes but the amount of compensation, if any, should not be so substantial as to be considered an important source of income or to influence voting on the IACUC.
2. (i) must be fully described in the institution's PHS assurance statement
(ii) must allow a high degree of interaction and deliberation
(iii) a quorum of IACUC members must be in direct communication with each other and be given full opportunity to participate for the duration of the meeting

Barrier Film Protects Skin of Incontinent Rats. Contemporary Topics 36 (5): 46.
Urinary incontinence is often seen in spinal cord injury animal models. The sequelae of urinary incontinence can lead to removal of significant numbers of animals from a study. The paper reports the effectiveness of the use of a skin protectant barrier film product in preventing urine scalding. The barrier film product was a spray on product, containing polydimethylsiloxane in hexamethyldisiloxane carrier. It is non-alcohol based and non-irritating. It allows gas and mositure permeability, decreasing skin irritation.
Questions:
1) List three complications associated with urine scalding.
2) List examples of neurogenic urinary incontinence.
3) List examples of non-neurogenic urinary incontinence.
Answers:
1) Intractable skin ulceration; secondary bacterial dermatitis; self-trauma; urosepsis; urinary tract infections
2) Neoplasia or trauma to the sacral spinal cord; cauda equina syndrome; intervertebral disk protrusions; neoplasia or trauma to the upper regions of the spinal cord; meningitis; cerebral or cerebellar disease; over-distension of the bladder and associated depolarization of the detrusor muscle.
3) Hormonally induced; congenital genitourinary abnormalities; urethral strictures or calculi; senility

A Practical In-house Method for Bile Duct Cannulation of Rats. Contemporary Topics 36 (5): 49.
The author developed a technique to implant cannula in the bile duct. The goals were to improve failure rate of commercially available vendor-cannulated rats, shipping stress, weight loss and general health, and increase the longevity of patent canulas.
Catheters are constructed of PE-50 tubing and silicone tubing is used as beads. Both ends of catheters, bile duct and duodenum canulas, are linked by a customized U-Shaped piece off a 23-gauge needle and sutured dorsal to the scapulas.
All goals were attained without contamination of pancreatic secretions. Bile is used to evaluate drug absorption, bioavailability, pharmacokinetics, and metabilism of experimental compounds. With the improvement of general health as well as substantial improvement in reliability, the number of surgically instrumented rats required for each study protocol will be reduced.
No questions

Use of Computed Tomography to Aid in Diagnosing Transient Blindness in a Rhesus Macaque (Macaca mulatta). Contemporary Topics 36 (5): 51.
Computed Tomography (CT) uses coordinate movement between the x-ray source and detector keeping the orientation of the x-ray source and detector combination perpendicular to the long axis of the patient. The thickness of the each plane examined is governed by the x-ray beam width. Usually this width is 1 to 10 mm. These planes are further divided into volume subunits called pixels. By using complex mathematics and geometric processes, the relative density as compared to water of each pixel is determined. The calculated densities are assigned a shade of gray. The available shades of gray discernable by the human eye can be redistributed among these various relative densities to permit visual density discrimination far greater than that of general radiographic films. Sagittal, dorsal, and oblique orientations can be generated by computer manipulation of the raw data since algorithms originally generated it. Another name for CT is CAT (Computed Axial Tomography) scan. CT scans are used extensively to diagnose intracranial diseases in humans. In nonhuman primates (NHP), diagnosis of intracranial disease is difficult due to the inability to perform a neurologic exam on a conscious animal. Observations are limited usually to passive observations. CT has been used in NHP to diagnose cerebral aneurysms and cerebral infarcts. This paper examines and follows the progression of intracranial abnormalities potentially related to neurologic abnormalities seen in a female Macaca mulatta.
A 3-year female M. mulatta had a cephalic recording stainless-steel cylinder implanted surgically. The monkey showed no abnormalities as result of the surgery or after the stereotatic placement of electrodes in the cylinder was performed. The monkey initially developed lethargy, anorexia, weakness, and vomiting. The monkey then developed dysmetria and the inability to grasp foods that were offered. Clinical chemistries and CBC were normal. Observing the monkeys response to new people entering the room, to tracking visual objects, and to placement in a new cage suggested to the authors that the monkey was blind. Twenty-four days after the onset of clinical signs the monkey was anesthetized. A complete ophthalmic examination and CSF analysis were performed and found to be normal. At this time, a CT scan was performed without contrast enhancement. Enlarged lateral ventricles, cerebral aqueduct, third ventricle, and fourth ventricle were the only abnormalities found. A tentative diagnosis of hydrocephalus was made. Without treatment, the monkeys condition did not progress. Fifty-one days after the first examination the monkeys eye sight returned and the she became able to resume her experimental activity. Seven months after the initial CT scan a second CT scan was performed. There was a marked decrease in the size of all the ventricles especially in the fourth ventricle.
Hydrocephalus has been reported in Papio cynocephalus, Saimiri sp, macaques (M. mulatta, M. fascicularis, M. artoides), Aptus nancymai. In this monkey magnetic resonance imaging was not chosen since the indwelling metal implants precluded its use. The implants did limit analysis to the level of the implants. Apparently, the algorithms used in CT scan can be set to accommidate metal objects to avoid streaking and other artifacts as a result.
Questions:
1. Only one orientation can be generated with CT scans. T or F
2. What does CT and CAT stand for?
3. Magnetic resonance imaging can easily replace CT scan analysis in all instances. T or F
Answers:
1. F
2. Computed tomography and computed axial tomography
3. F

Urinary Excretion of Cortisol from Rhesus Monkeys (Macaca mulatta) Habituated to Restraint. Contemporary Topics 36 (5): 55.
The introduction of this study specifically addressed the issues surrounding long term (12- to 14- day) restraint of monkeys for research conducted during space flights... ie, muscle atrophy, neuroendocrine stress. The authors premise was that prior habituation to restraint would attenuate cortisol excretion in urine (an index of stress) and decrease muscle atrophy. Urinary excretion of cortisol, creatinine, electrolytes, and food and water intake were compared between nonrestrained monkeys (ie, samples taken before and after a restraint phase) and restrained monkeys. Restraint devices used were Primate Products restraint (PPR) system and a flight chair restraint (FCR)system. (Please refer to the article for a description of this restraint system.) Because the flight chair system was in development during the study, monkeys were initially trained to the PPR system, then switched to the FCR system for more advanced training. Training was conducted over a 4-year period typically for 4-8 hours/day initially and progressing up to 20 days. Thereafter, they were maintained on 10-day cycles of alternating restraint and nonrestraint. When not restrained, monkeys were maintained in metabolism cages. Five weeks prior to study, monkeys were instrumented for EMG and had muscle, lymph node, and bone biopsies performed as part of another study being conducted.
Study design: 4 male 9 to 10 year-old monkeys were used;
Prestudy - nonrestraint; phase I - monkeys in metabolism cages for 7 days; urine collected via metab cage ;
Day 8 - placed in FCR system for restraint phase II for 18 days; urine collect via sheath attached to penis.
Day 26 - returned to metabolism cage for 5 days of phase III-postrestraint phase.
Urine samples were analyzed for cortisol, sodium, potassium, creatinine. Excretion rates of each were calculated. Statistical comparisons were made between the 3 phases. Values for the nonrestraint phases (I and III) were used as baseline control values to which restraint values were compared.
Results: One monkey was removed from restraint prematurely ( d 16 of restraint) because of an ulcer on its callosity. Body weights did not change between start of phases I and III. Mean excretion rate of creatinine, sodium, and potassium were also not altered.
Conclusions: Prior habituation to restraint attenuated neuroendocrine responses and the chair restraint system used (FCR) allowed adequate activity to prevent muscle wasting.
No questions

A Rapid and Simple Technique for Serial or Continous Collection of Blood Samples and Intravenous Administration of Drugs to Consious Swine. Contemporary Topics 36 (5): 58.
This paper describes a procedure to construct a catheter using a butterfly catheter, non-thrombogenic polyethylene tubing and a syringe with a 23 ga. needle. The catheter was placed in the auricular vein along the caudal ear margin of a conscious pig immobilized in a sling.
The pig was acclimated to handling. They were placed in an up-right sling and the ear was clipped and cleaned. Lidocaine ointment was applied to the ear margin. A rubber band was placed around the base of the ear. The catheter was placed and then taped to the ear. Heparin was infused in order to maintain catheter patency. These catheters were used for infusion, and periodic blood sample collection. 74 catheters were placed. Average time required for a successful catheterization was 30 minutes. The maximum volume of blood that could be collected was approx. 1 ml/min. Some irritation around the catheter site was noted 4-6 hours after cannulation. Patency was maintained up to 28 hrs. No major complications were noted.
Questions:
1) What is the mechanism of heparin as an anticoagulant?
a) It combines with antithrombin III to inactivate factor Xa,
preventing the conversion of prothrombin to thrombin.
b) it inactivates thrombin
c) it blocks the conversion of fibrinogen to fibrin
d) it combines with anatithrombin III and inactivates factors IX,
X, XI, XII
e) all of the above
2) What is the origin of heparin?
a) pig intestine
b) horse hooves
c) cow lungs
d) recombinant E. coli
e) a and c
f) all of the above
Answers
1) e
2) e. Heparin is a sulfated glycosaminoglycan found naturally in mast cells. It has a MW of 12,000.

The Influence of Position and Orientation of Racks on Airflow Dynamics in a Small Animal Room. Contemporary Topics 36 (5): 62.
A series of 7 studies were conducted to assess the effects of rack placement on animal room ventilation. Heating, ventilation, and air conditioning (HVAC) room configurations were studied. Computational fluid dynamics (CFD) was used to evaluate the data. 3 animal rooms were used to conduct the studies. One was equipped with the newly developed air capture and containment (ACC) system. The other 2 rooms were conventionally configured. The ACC room had 2 radial diffusers and 6 extract vents as a single overhead unit. One conventional room had 2 radial diffusers placed in the center of the long axis of the room with 4 low-level extract vents. The other room had a linear-slot diffuser with 4 low level extract vents. An additonal set of studies were conducted to compare the effects of rack orientation with a heavy animal load (6 racks @200 watts/rack; 3 racks on each wall). Parallel and perpendicular rack placements were compared. The low to moderate load was 2-3 racks of rats; 100 rats/rack x 200g/rat= 200watts/rack.

Study 1 - 2 racks (1 on each side of wall) were placed on opposite sides of the room adjacent to a low-level extract vent in a corner.
Study 2 - 2 racks on opposite walls located away from the extract vent in a position such that they were centered on a radial diffuser.
Study 3 - 2 racks adjacent to each other on same side of wall and located under an extract vent.
Study 4 - 2 racks on same side of the wall centered under the radial-type inlet diffusers.
Study 5 - 2 racks on same wall under an extract vent and one rack on the opposite wall also under an extract vent.
Study 6 - racks positioned similar to 5 but centered under the radial-type inlet diffusers.
Study 7 - 3 racks on same wall and each positioned under an ACC system extract vent.
Each study was done with the racks placed perpendicular to or parallel with the side walls for each placement/number combination and HVAC configuration. 42 separate studies were actually conducted.
CONCLUSIONS
Position and geometric orientation had substantial effects on airflow and balance. Conventional room-radial type diffusers and 4 corner exhaust vents with racks in close proximity and centering them under the diffusers resulted in best air circulation with lowest amount of re-entrainment and dead space. Placing the racks parallel or perpendicular had no impact. The ACC system had the best ventilation for animals and staff regardless of geometric positioning.
STUDY QUESTIONS
1. When did orientation have little or no effect on ventialtion?
2. What can cause a deterioration in airflow around a rack?
3. What is the rat breeze effect?
4. How can you minimize this effect?
ANSWERS
1. when there were 2 opposing racks in a room
2. moving it further away from a corner extract vent or a perpendicular arrangement along the same wall
3. areas of low velocity flow and dead space developed immediately in front of the racks. Cool, fresh air flowed down from the inlet to the floor while the air warmed by the animals rose above the rack and proceeded to the ceiling, where in a conventional setting, is mixed with fresh air, re-entrained, and re-circulated thoughout the room.
4. balancing opposite sides of the room

Spontaneous Hypertrophic Osteopathy in a Wistar Rat. Contemporary Topics 36 (5): 68.
Report is first case of hypertrophic osteopathy reported in a rodent. A colony of SPF WI/HicksCar rats were being monitored during a study of aging. No experimental procedures had been performed on the rats. A 34month old male rat was presented for lethargy, pale mucous membrans, bilateral swelling of rear metatarsal regions, bilateral rear limb and tail paresis.
Necropsy revealed bilateral swollen, firm, fused hock joints, enlarged distal tail, nodule in right caudal lung, distended urinary bladder, enlarged pituitary gland, hepatomegaly, red mesenteric mass. Radiology = periosteal new bone growth in hocks and tail. Serology and bacteriology were negative.
Histology = periosteal new bone formation, pulmonary adenoma, multifocal granulomatous pneumonia, cardiac fibrosis and heart failure, bilateral interstitial cell tumors, pituitary adenoma, mesenteric hemangioma, bilateral nephrosis, chronic periodontitis, squamous metaplasia of nasal respiratory epithelium, axonal degeneration and polyradiculoneuropathy of cauda equina.
Hypertrophic osteopathy (HO),[ aka Marie's disease, acropachia, and hypertrophic pulmonary osteoarthropathy], is characterized by increased blood flow to limbs, thickened parosteal connective tissue, and periosteal new bone formation. Condition is usually associated with intrathoracic neoplasia, but also reported with bladder, liver, and ovarian tumors in man and other animals.
HO had been induced in rats by chronic administration of an isoquinoline, but had not been seen as a spontaneous condition. In dogs and man, HO has been associated with heart disease, pneumonia, intrathoracic and extrathoracic neoplasms. This rat had congestive heart failure, multifocal granulomatous pneumonia, and multiple neoplasms; contribution of these lesions to development of HO is suspected but unproven; developing an animal model to study HO may be possible.
Questions:
1) What is hypertrophic osteopathy?
2) What infectious agent(s) might be considered in a rat with arthropathy?
Answers:
1) HO is a disease of unknown etiology, reported in many different animals and man, consisting of increased blood flow to limbs, thickened parosteal connective tissue, and periosteal new bone formation associated with degenerative and neoplastic conditions.
2) Mycoplasma arthritidis
Streptobacillus moniliformis
Corynebacterium kutscheri

Hemangiopericytoma in a Rat. Contemporary Topics 36 (5): 71.
This is the first report of a spontaneous hemangiopericytoma in a rat. A 13month old male SpragueDawley rat developed a mass on the right pinna. The rat had not been used experimentally. The mass was excised; histo = fusiform cells arranged in a whirling fingerprint pattern which converged on a central vascular structure; this pattern is characteristic of hemangiopericytomas.
Hemangiopericytomas are uncommon in all species. They are thought to arise from the pericyte of Zimmerman cells found adjacent to capillaries. They have been experimentally induced in the medaka (Oryzias latipes) and mice, and been reported spontaneously in man and dogs. They are slowgrowing tumors, but have incidence of metastasis of 50%. Not all hemangiopericytomas display the characteristic fingerprint pattern; immunohistochemistry and ultrastructure can be used to achieve a diagnosis. Pericytes are pluripotential, and may express a variety of antigens depending on the location of the cells in a given species, so diagnosis can be challenging.
Questions:
1. T or F All hemangiopericytomas display a characteristic fingerprint pattern, so diagnosis is easy.
2. T or F All hemangiopericytomas express the same antigens.
Answers:
1. F; the pattern is characteristic, but some hemangiopericytomas do NOT display this patterns; conversely, some other neoplasms may display this pattern, so diagnosis cannot be based on this alone.
2. F; pericytes are pluripotential, and show different patterns of differentiation and express different antigens depending on location and species.

Spontaneous Carotid-Cavernous Sinus Fistula in an Aged Rhesus Monkey (Macaca mulatta). Contemporary Topics 36 (5): 73.
A Carotid Cavernous Sinus Fistula (CCSF) results from an abnormal shunting of blood between an intracranial branch of the carotid artery and the venous cavernous sinus located just caudal to the eye.
Direct fistulas--arterial blood passes through a defect in the wall of the intracavernous segment of the internal carotid artery. Usually due to trauma involving fractures or to the rupture of an aneurysm or as a result of atherosclerosis in the internal carotid (humans). The classical clinical picture is exophthalmos, severe orbital vascular congestion, limited ocular motility and bruit (abnormal sound or murmur heard on auscultation).
Spontaneous CCSF--usually dural shunts between branches of the carotid and dural veins in the region of the cavernous sinus. Clinical symptoms are: lesser degree of congestion, conjunctival arterialization, ocular hypertension, abduction deficit; less likely to detect bruit.
This case involved a 35 year old rhesus monkey with clinical signs of a direct fistula, but diagnosis of a spontaneous CCSF. The clinical history is similar to an older female human suggesting that macaques may be a good model for this disease.
History: Swollen right eye (no previous history of surgery or therapy other than routine testing and amputation of a digit). Initially, mild periorbital edema and erythema with slight scleral and conjunctival injection. Rapidly progressed to chemosis (conjunctival edema), and hyphema (blood in the anterior chamber), exophthalmos, engorgement of vessels, decreased ocular motility and increased intraocular pressure. Culture, radiography, conjunctival scrapings and blood values led to no significant findings. A bruit was discovered on auscultation of the eyebrow. A CCSF was diagnosed by orbital ultrasound ( dilated superior ophthalmic vein, low reflective widening of Tenon's capsule, thickening of extraocular muscles, enlargement of the retrobulbar optic nerve positions) and indirect fundic exam (massively dilated retinal veins, disc edema, retinal hemorrhage, venous stasis retinopathy, and choroidal effusions).
Treatment: Analgesics, ophthalmic beta blocker to relieve glaucoma. Clincal signs worsened the first week, then regressed with disappearance of the bruit during the second week. US findings revealed normal orbital structures, but follow-up exam revealed blindness, optic atrophy, afferent pupillary defect, and anisocoria.
Histological exam: Anterior synechiae, loss of some retinal layers, marked cupping of the optic nerve head, and atrophy of the optic nerve.
Discussion: Once a fistula has formed between the cavernous sinus and the carotid arterial supply, the AV shunting of blood results in increased venous pressure and decreased arterial perfusion. The orbital veins (outflow from the sinuses) becomes engorged and there is secondary congestion of the orbital soft tissues. Decreases arterial perfusion causes hypoxic changes that contribute to soft tissue swelling, muscle paralysis, and ischemia of the anterior chamber (can result in protein flare, cells in aqueous humor, corneal edema, glaucoma, iris rubeosis, cataracts).
In humans, spontaneous CCSF have developed most commonly in postmenopausal women. Predisposing factors include aneurysm or AV malformation, atherosclerotic changes, collagen vascular disease, hypertension, and childbirth. The carotid vasculature of the macaque in this case was not analyzed, but there was atherosclerosis of the abdominal aorta and the uterine vessels. The ovarian and uterine changes were consistent with postmenopausal changes in rhesus monkeys and human beings.
Up to 60% of spontaneous CCSF in human beings will resolve naturally, are generally not considered life threatening, and the clinical course is usually benign. Treatments are aimed at relieving pain and ocular signs, preventing glaucoma and ischemic retinopathy. Currently intravascular closure using detachable balloon catheterization is performed if there is a threat of visual loss.
Questions:
1. Spontaneous carotid cavernous sinus fistula occur most frequently in:
a. Aged sprague dawley rats
b. Post-menopausal primates
c. Guinea pigs with vitamin C deficiency
d. Rabbits with cholesterolemia
2. A common clinical sign detected in an animal with a direct carotid-cavernous sinus fistula is:
a. seizures
b. cerebral edema
c. bruit
d. epistaxis
QUESTIONS:
1) Define bruit:_________________________________________
2) Genus, species of a Rhesus Monkey: ________ __________
3) Which of the following diagnostic procedures can be used to diagnose a CCSF
a. ultrasound
b. angiography
c. fine-needle aspiration
d. auscultation
e. a & b
f. a,c, & d
g. a,b, & d
Answers:
1. b (post-menopausal primates)
2. c (bruit)
ANSWERS:
1) A sound or murmur heard during auscultation, especially an abnormal one; aneurysmal bruit: a blowing sound heard over an aneurysm.
2) Macaca mulatta
3) G

In-House Development of an Integrated Management Information System For a Laboratory Animal Facility. Contemporary Topics 36 (5): 77.
Establishing a computerized system to manage a laboratory animal facility can be accomplished through the use of commercial software packages, or software developed in-house.
To identify a suitable software package from the commercially available products, compare the programs based on the following questions:
1.Does the software provide the basic functionality required to manage the animal facility (example: does it manage research protocols, animal procurement, census, billing, and cost accounting )?
2. Will the software adapt to the animal facility requirements, or will facility procedures have to be changed in order for the software to work ?
3.How expandable and flexible will the software be to future facility changes ?
4.How much would the system cost for installation and customization, and would upgrades, support and future maintenance incur additional charges?
If the expense or extra work required to install and customize commercially available software is too great, the development of software in - house may be more time and cost effective. The following is an outline for the development of in-house software:
1. Identify the major objectives the new system has to address
2. Select an application development tool for software development
3. Identify major operational and functional areas; an operational area performs a specific duty, a functional area provides support for one or more operational areas
4. Develop a software program to include the operational and functional areas
QUESTIONS
1. Which of the following is not an operational area?
a. Animal Procurement Office
b. Census
c. Animal Facility
d. Business Office
2. When identifying the system objectives, which staff members should be consulted (list 3 major groups)?
1.______________________
2.______________________
3.______________________
3. True or False: Future flexibility and adaptability of a software package is not a major concern during system design, or selection.
ANSWERS: 1. B | 2. husbandry, clinical, and administrative | 3. False