ASTM E2045-1999(2014) Standard Practice for Detailed Clinical Observations of Test Animals《对试验用动物进行详细临床观察的标准实践规程》.pdf

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1、Designation: E2045 99 (Reapproved 2014)Standard Practice forDetailed Clinical Observations of Test Animals1This standard is issued under the fixed designation E2045; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last

2、revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice describes the terms used in observing andrecording cutaneous, gastrointestinal, respiratory, reproductive,neu

3、romuscular, ocular, and general clinical signs of animalsundergoing toxicological testing. This practice also assists inproperly observing and assessing laboratory animals for signsof disease or adverse effects of compound administration.1.2 This practice includes codes and descriptions for a wideva

4、riety of clinical signs, anatomical locations, and otherdescriptive qualifiers, and a technique for scoring the extent orseverity of clinical signs.1.3 This practice assumes that the reader is knowledgeablein animal toxicology and related pertinent areas and is trainedin making clinical observations

5、.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced

6、Documents2.1 Federal Standards:Title 40, Code of Federal Regulations (CFR), EnvironmentalProtection Agency, Subchapter E, Pesticide Programs,Part 160, Good Laboratory Practice Standards2Title 40, Code of Federal Regulations (CFR), Toxic Sub-stances Control Act, Part 792, Good Laboratory PracticeStan

7、dards2Title 40, Code of Federal Regulations (CFR), EnvironmentalProtection Agency, Part 798, Health Effects TestingGuidelines23. Significance and Use3.1 This practice pertains to all forms of toxicologicaltesting (acute, subchronic, or chronic) performed by any routeof administration (inhalation, or

8、al, dermal, ocular, or other).3.2 The U.S. Environmental Protection Agency, GoodLaboratory Practices for Nonclinical Laboratory Studies, aslisted in 40 CFR, requires that a testing facility maintainspecific standard operating procedures (SOPs) including anSOP covering clinical observations in test a

9、nimals.3.3 This practice serves as a basis for consistency in clinicalobservations. Actual procedures and forms to be used inrecording observations must be described in individual studyprotocols.4. Procedure4.1 Observe the health of an animal at a distance and of itshousing environment to gain a gen

10、eral impression of its health.Also note environmental factors such as temperature, humidity,ventilation, air quality and hygienic conditions.4.2 Observe each animal and note any subtle changes inanimal behavior, physical appearance, posture, gait,vocalization, food and water consumption, and waste p

11、roduc-tion. See Section 5 for details.4.3 Observe control animals first, followed by test groups inorder of increasing level of treatment. Observe positive controlgroup, if any, last.4.4 Note any dead animals and collect necessary tissues anddata before decomposition occurs.4.5 Report animals that s

12、how signs of sickness so thatappropriate diagnosis, treatment, or euthanasia, if appropriate,can be performed.5. General Clinical Signs5.1 Note the overall activity, behavior, and condition of theanimal. Determine the hydration status by examining skinturgor, position of the eyes such as normal or s

13、unken, mucousmembrane color, and capillary refill time. Look for asymmetryor the presence of abnormal swellings, hemorrhage or signs ofpain.1This practice is under the jurisdiction of ASTM Committee E50 on Environ-mental Assessment, Risk Management and Corrective Action and is the directresponsibili

14、ty of E50.47 on Biological Effects and Environmental Fate.Current edition approved Oct. 1, 2014. Published December 2014. Originallyapproved in 1999. Last previous edition approved in 2009 as E2045 99(2009).DOI: 10.1520/E2045-99R14.2Available from U.S. Government Printing Office, Superintendent ofDo

15、cuments, Washington, DC 20402.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States15.2 The following are some general conditions along withsuggested codes for record keeping that do not fall into anyspecific organ system. Refer to Annex A1

16、 Annex A3 for adetailed listing of the codes and their descriptions. Othergeneral reference material will also be helpful.3,4,55.2.1 Activity may be described as: decreased (ACD);increased (ACI); hyperexcitable (HX); hyperactive (HYP);lethargic (LE); irritable (IRR); moribund (MB), that is neardeath

17、; prostate (PRO), that is, exhibiting inability or unwill-ingness to maintain upright posture.5.2.2 Body condition may be described as: obese (OBS);thin (THN); decreased rectal temperature (BTD); increasedrectal temperature (BTI); hypothermia that is cold to touch(HPO); hyperthermia that is warm to

18、touch (HPR).5.2.3 Death may be described as: accidental death (AD);euthanized (ETH); found dead (FD).5.2.4 Examine skin for dehydration (DHY). The skin shouldfall back into place immediately after it is pulled out ofposition; if the skin is pulled out of position and tends to sticktogether or slowly

19、 fall back into place, the animal may bedehydrated. Other signs of dehydration include sunken eyeball(SUN), pale or dry mucous membranes (MM), and a capillaryrefill time of 3 s (CR4). Distinguish between dehydration andvarious types of shock.5.2.5 Generalized edema (EDE) may appear as swelling ofthe

20、 limbs, lower abdomen, head or under the mandible. Whenthe apparently fluid-filled tissue is pressed, an indentation maypersist for a short time.5.2.6 Evidence of hemorrhage (HE) may appear on thehaircoat (HEH) or underlying skin or nails (HES), in urine(HEU) or feces (HEF), from the mouth (HEM), no

21、se orepistaxis (EPI), eyes (HEO), ears (HEE), genitalia (HEG), oranus (HEA).5.2.7 Jaundice (JAU) is an overall slight yellow to paleorange tinge to the skin and mucous membranes.5.2.8 Mucous membrane condition (MM) is noted by thecolor and condition of the mucous membranes of the eye, nose,mouth, or

22、 external genitalia.5.2.9 Swelling (SW) is noted by the size, location andprobable cause, such as edema (SWE) from: a solid tissue ortumor (SWT); blood (SWH); air (SWA); or pus (SWB).6. Specific Clinical Signs6.1 Inspect the entire haircoat and underlying skin forintegumentary signs. Some common cli

23、nical signs and theirsuggested codes are as follows:6.1.1 Alopecia, that is, hair loss (ALO), includes hairthinning, patchy/focal hair loss or balding.6.1.2 Haircoat condition (HC) may be described as: oily(HCO); rough (HCR); wet (HCW); soiled (HCS); dry (D);bloody (HEH); or piloerection (HCP), that

24、 is, distinctly raisedfur, excluding the vibrissae, giving a bristled or porcupine-likeappearance.6.1.3 Swelling (SW) is an increase in tissue size or in-creased abnormal shape of the skin or other organs fromabnormal presence of: air, that is, emphysema (SWA); fluid orwater, that is, edema (SWE); s

25、olid tissue or tumor (SWT);blood, that is, hematoma (SWH); pus, that is, abscess (SWB).6.1.4 Skin condition (SK) may be described as: thickened(SKT); thinned (SKH); scaly (SKS); dry (SKD); or red (SKY)(see 6.1.5).6.1.5 Erythema (ERY) is an increased pink or red color onsmooth skin.6.1.6 Rash (RAS) i

26、s small red, pink or white dots orpustules on the skin; petechiae (PET) are red dots formed fromblood.6.1.7 Blisters (BLS) are fluid-filled vesicles. The fluid isusually clear, but can be pink (blood-tinged) or red/brown(filled with blood). White-filled vesicles are either pustules(RAS) ( 5 mm).6.1.

27、8 Color change (CC) may be other than pink or red, forexample, bluish-black as in brushing, green as in bruising orsevere infection, brown as in increased pigmentation, or whiteas in blanching.6.1.9 Abrasions (ABR) are denuded skin or mucous mem-brane.6.1.10 Lacerations (LCN) are cuts in the skin fr

28、om mechani-cal injury, that is, bite, scratch, foreign object, and so forth.6.1.11 Ulceration (ULC) is an open sore accompanied bythe disintegration of tissue, usually with necrosis, that is, deathof tissue.6.1.12 Scab (SCB) is an eschar formed from sloughed skin.6.1.13 Pruritis (PRU) is itching evi

29、denced by scratching,with or without a rash or abrasion.6.1.14 Urticaria (URT) is a transient appearance of smooth,slightly elevated bumps which are redder or paler than thesurrounding skin and often accompanied by severe itching.Uricaria often appears as localized, discrete or confluent areasof ede

30、ma.6.1.15 Purpura (PUR) is confluent petechiae, that is, pin-point hemorrhages, which form ecchymoses, that is, blotchyhemorrhages over any part of the body.6.1.16 Common manifestations of dermal sensitivity reac-tions are:6.1.16.1 Contact dermatitis (COD) is pruritis, erythema andvesiculation that

31、may be followed by pustulation and necrosisand that has a pattern consistent with the touch of a foreignobject or substance.6.1.16.2 Exanthema (EXA) is macular or papular redness indiscrete areas.6.1.16.3 Exfoliation (EXF) is loss of superficial skin layerswith redness, swelling, and presence of fre

32、e blood.6.1.16.4 Bullous eruption (BUL) is the presence of discreteserous or seropustular areas.6.1.16.5 Erythema multiform (EMF) is the presence ofmultiple types of macules, papules and nodules.6.2 Gastrointestinal signs are observed during externalevaluations of the gastrointestinal system conduct

33、ed from theoral cavity to the anal area. Visually inspect the teeth andmucous membranes of the oral cavity, palpate the abdomen and3Taylor, E.J., ed., Dorlands Illustrated Medical Dictionary, W.B. Saunders,Philadelphia, PA, 27th edition, 1988.4Stedmans Medical Dictionary, Williams and Wilkins, Balti

34、more, MD, 25thedition, 1990 .5Thomas, C.L., ed., Tabors Cyclopedic Medical Dictionary, F. A. Davis Co.,Philadelphia, PA, 17th edition, 1993.E2045 99 (2014)2inspect the perianal area. An inspection of the animals cagewill allow evaluation of the volume, color, and consistency ofthe stool.6.2.1 Oral c

35、avity signs and codes are:6.2.1.1 Salivation may be described as: increased salivation(SAL); or lack of salvia, that is, xerostomia (XER).6.2.1.2 Dentition (TE) includes: missing teeth (TEM); looseteeth (TEL); discolored teeth (TEC); damaged teeth (TED); ormalocculation (TEO).6.2.1.3 For mucous memb

36、ranes, note capillary refill time(CR), color, and condition, such as erosions or vesicles.6.2.1.4 Gums may be described as: healthy, intact (GUH);or gingivitis (GUI), that is, inflamed or bleeding gums.6.2.2 For the abdomen, look at the overall symmetry andsize. The abdomen may be described as: smal

37、ler or more“tucked-in” (STA) if the animal is dehydrated; larger asdistended or pendulous abdomen (OPA); or asymmetrical as ifan enlargement or swelling in a focal area (SW).6.2.3 In the perianal area, look for: abnormal anal sphincter(OEA); fecal (FEF) or urine staining (PEU); matter hair (PEH);muc

38、ous (PEM); or rectal prolapse (RPR), that is, a red to darkred tubular protrusion from the anus.6.2.4 For feces, note: consistency, such as normal (FEN),hard or dry (FEH), soft or watery (FED), oily (FEO); amount,such as none (FEA), small (FES), normal (FEN) or large(FEL); content, such as normal (F

39、EN), blood (FEB), mucous(FEM) or foreign material (FEF); or evidence of straining todefecate, that is, tenesmus (TEN). Hard feces may indicateconstipation. Soft or watery feces may indicate diarrhea.6.2.5 Function may be anorexia or loss of appetite (ANO),emesis or vomiting (EM).6.3 Respiratory sign

40、s are found by evaluating the following:6.3.1 Rate of breathing (RR) may be slow (RRS), normal(RRN), or fast (RRF).6.3.2 Depth of breathing (RD) may be shallow (RDS),normal (RDN), or deep (RDD).6.3.3 Difficulty in breathing is dyspnea (DYS).6.3.4 Periodic cessation of breathing is apnea (APN).6.3.5

41、Nasal discharge (ND) is either none (NDN), clear(NDC), yellow (NDY), green (NDG), or white (NDW).6.3.6 Respiratory sounds include rales (RAL), coughing(COU), gasping for air (G), and sneezing (SNE).6.3.7 Epistaxis (EPI) is the free flow of blood or hemorrhagefrom the nose. This is sometimes indicate

42、d by the presence ofdry blood or dark material around the nose.6.4 For reproductive or urogenital signs, carefully examinethe external genitalia and look for evidence of normal orabnormal reproductive discharge. Examine the amount andcolor of urine and whether or not the animal is expressing signsof

43、 incontinence or difficulty in urination (difficult to distinguishfrom tenesmus). When applicable, note breeding behavior,pregnancy, abortion, and quality of mothering.6.4.1 Male examination is as follows:6.4.1.1 For external genitalia, look for the presence (TSB),absence (TSA or TSC), and condition

44、 of the testicles (TSE,TED, or TSN); paraphimosis (PM), that is, inability to retractpenis into foreskin, or abnormal discharge from the penis.6.4.1.2 Penile discharge is either none (PDA), normal(PDN), increased (PDI), bloody (PDB), serous (PDS), ormucous (PDM).6.4.2 Female examinations include:6.4

45、.2.1 In external genitalia look for mucous membraneabnormalities (MM) or swellings (SW) of the vagina (VA) orvulva (VA).6.4.2.2 In vaginal discharge types or consistency of dis-charge are: none (VDN), normal (VDN), increased (VDI),decreased (VDD), bloody (VDB), serus (VDS), or mucous(VDM).6.4.3 For

46、urine or urination note the following conditions:6.4.3.1 Hematuria (HEU) is bloody urine. Use caution withrabbits as their urine may range from amber to light red withoutthe presence of blood.6.4.3.2 Anuria (ANU) is the absence of urine for a pro-longed period.6.4.3.3 Dysuria (DYU) is difficulty uri

47、nating; be sure todifferentiate with tenesmus.6.4.3.4 Polyuria (PLY) is excessive volume of urine.6.4.4 Fertility signs include the following:6.4.4.1 Breeding efficiency may be failure to breed (FTB),conceive (FTC), or low litter size or weight (LLS).6.4.4.2 Abortion (ABO) is premature delivery of d

48、eadoffspring.6.4.4.3 For pregnancy status, animal appears pregnant(APR).6.4.4.4 Mothering may be described as: poor care of young(PCY); evidence of cannibalism (CAN); or poor milk produc-tion (PMP).6.5 Neuromuscular signs include disease, trauma, and com-pounds which adversely affect the central or

49、peripheral nervoussystem resulting in structural or functional changes being seenin the neuromuscular system, or degree of alertness or activityin animals. Evaluation of locomotion and coordinated move-ments may reflect the status of the animals neuromuscularsystem.6.5.1 Musculoskeletal signs may be lameness or weightbearing (LMW) or non-weight bearing (LMN), limb paralysis(LP), or enlarged appendage (ENA).6.5.2 Posture or head carriage may be normal (HDN), tilted(HDT), raised (HDR), lowered (HDL), or hunched posture(HP); gait may be normal (GAN), exaggerated (GAE), or slow(GAS