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The various end points that may be examined include maternal toxicity, embryo-fetal toxicity, external malformations, and soft tissue and skeletal malformations Careful evaluation of maternal toxicity is necessary in assessing the validity of the high-dose level, and the possibility that maternal toxicity is involved in subsequent events The parameters evaluated include body weight, food consumption, clinical signs, and necropsy data such as organ weights Because exposure starts after implantation, conception and implantation rates should be the same in controls and all treatment levels If not, the test is suspect, with a possible error in the timing of the dose or use of animals from a source unsuitable for this type of testing Embryo-fetal toxicity is determined from the number of dead fetuses and resorption sites relative to the number of implantation sites.

59 Andrei, G; De Clercq, E Inhibitory effect of selected antiviral compounds on arenavirus replication in vitro Antiviral Res 1990, 14, 287 300 60 Weissenbacher, M C; Calello, M A; Merani, M S; McCormick, J B; Rodriguez, M Therapeutic effect of the antiviral agent ribavirin in Junin virus-infection of primates J Med Virol 1986, 20, 261 267 61 McKee, K T; Huggins, J W; Trahan, C J; Mahlandt, B G Ribavirin prophylaxis and therapy for experimental Argentine hemorrhagic fever Antimicrob Agents Chemother 1988, 32, 1304 1309 62 Enria, D A; Maiztegui, J I Antiviral treatment of Argentine hemorrhagic fever Antiviral Res 1994, 23, 23 31 63 Weissenbacher, M C; Avila, M M; Calello, M A; Merani, M S; McCormick, J B; Rodriguez, M Effect of ribavirin and immune serum on Junin virus infected primates Med Microbiol.

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In addition to the possibility of lethal malformations, such toxicity can be due to maternal toxicity, stress, or direct toxicity.

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to the embryo or fetus that is not related to developmental malformations. Fetal weight and fetal size may also be a measure of toxicity but should not be confused with the variations seen as a result of differences in the number of pups per litter. Smaller litters tend to have larger pups while larger litters have smaller pups. Anomalies may be regarded either as variations that may not adversely affect the fetus and not have a fetal outcome or as malformations that have adverse effects on the fetus. For some ndings there is disagreement as to which class it belongs, such as the number of ribs in the rabbit that inherently has a large amount of variability. Common external anomalities are listed in Table 21.7 and are determined by examination of

Immunol 1986, 175, 183 186 64 Kirsi, J J; North, J A; Mckernan, P A; Murray, B K; Canonico, P G; Huggins, J W; Srivastava, P C; Robins, R K Broad-spectrum antiviral activity of 2-beta-Dribofuranosylselenazole-4-carboxamide, a new antiviral agent Antimicrob Agents Chemother 1983, 24, 353 361 65 Lucia, H L; Coppenhaver, D H; Baron, S Arenavirus infection in the guinea pig model: antiviral therapy with recombinant interferon-alpha, the immunomodulator CL246,738 and ribavirin Antiviral Res 1989, 12, 279 292 66 Smee, D F; Gilbert, J; Leonhardt, J A; Barnett, B B; Huggins, J H; Sidwell, R W Treatment of lethal Pichinde virus infections in weanling LVG/Lak hamsters with ribavirin, ribamidine, selenazofurin, and ampligen Antiviral Res 1993, 20, 57 70 67 Huggins, J W; Robins, R K; Canonico, P G.

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Table 21.7 External Malformations Commonly Seen in Teratogenicity Tests Brain, cranium, spinal cord Encephalocele protrusion of brain through an opening of the skull. Cerebrum is well formed and covered by transparent connective tissue. Exencephaly lack of skull with disorganized outward growth of the brain. Microcephaly small head on normal sized body. Hydrocephaly marked enlargement of the ventricles of the cerebrum. Craniorachischisis exposed brain and spinal cord. Spina bi da Nonfusion of spinal processes. Usually ectoderm covering is missing and spinal cord is evident. Nose Enlarged naris enlarged nasal cavities Single naris a single naris, usually median Eye Microphthalmia small eye Anophthalmia lack of eye Open eye no apparent eyelid, eye is open Ear Anotia absence of the external ear Microtia small ear Jaw Micrognathia small lower jaw Agnathia absence of lower jaw Aglossia absence of tongue Astomia lack of mouth opening Bi d tongue forked tongue Cleft lip either unilateral or bilateral cleft of upper lip Palate Cleft palate a cleft or separation of the median portion of the palate Limbs Clubfoot foot that has grown in a twisted manner, resulting in an abnormal shape or position. It is possible to have a malposition of the whole limb Micromelia abnormal shortness of the limb Hemimelia absence of any of the long bones, resulting in a shortened limb Phomelia absence of all of the long bones of a limb, the limb is attached directly to the body

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