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Table 21.8 Some Common Visceral Anomalies Seen in Teratogenicity Tests Intestines Umbilical hernia protrusion of the intestines into the umbilical cord Ectopic intestines extrusion of the intestines outside the body wall Heart Dextrocardia rotation of the heart axis to the right Enlarged heart either the atrium or the ventricle may be enlarged Lung Enlarged lung all lobes are usually enlarged Small lung all lobes are usually small; lung may appear immature Uterus/testes Undescended testes testes are located anterior to the bladder instead of lateral; may be bilateral or unilateral Agenesis of testes one or both testes may be missing Agenesis of uterus one or both horns of the uterus may be missing Kidney Hydronephrosis uid- lled kidney, often grossly enlarged; may be accompanied by a hydroureter (enlarged, uid- lled ureter) Fused kidneys fused, appearing as one misshapen kidney with two ureters Agenesis one or both kidneys missing Misshapen small, enlarged (usually internally), or odd-shaped kidneys
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fetuses at C-section. Visceral anomalities are determined by examination of fetuses after xation using either the dissection method of Staples or by the hand-sectioning method of Wilson. Common visceral ndings are listed in Table 21.8. Fetal skeletons are examined after rst xing the fetus and then staining the bone with Alizarin red. Numerous skeletal variations occur in controls and may not have an adverse effect on the fetus (Table 21.9). Their frequency of occurrence may, however, be dose related and should be evaluated. Almost all chemically induced malformations have been observed in control animals, and most malformations are known to be produced by more than one cause. Thus it is obvious that great care is necessary in the interpretation of teratology studies. For an agent to be classi ed as a development toxicant or teratogen, it must produce adverse effects on the conceptus at exposure levels that do not induce toxicity in the mother. Signs of maternal toxicity include reduction in weight gain, changes in eating patterns, hypo or hyperactivity, neurotoxic signs, and organ weight changes. Adverse effects on development under these conditions may be secondary to stress on the maternal system. Findings in the fetus, at dose levels that produce maternal toxicity, can not be easily separated from the maternal toxicity. Compounds can be deliberately administered at maternally toxic dose levels to determine the threshold for adverse effects on the offspring. In such cases conclusions can be quali ed to indicate that adverse effects on the offspring were found at maternally toxic dose levels and may not be indicative of selective or unique developmental toxicity.
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Effect of Chemicals in Late Pregnancy and Lactation (Perinatal and Postnatal effects). These tests are usually carried out on rats, and 20 pregnant females per
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Table 21.9 Skeletal Abnormalities Commonly Seen in Teratogenicity Tests Digits Polydactyly presence of extra digits, in mouse six or more, instead of ve Syndactyly fusion of two or more digits Oligodactyly absence of one or more digits Brachydactyly smallness of one or more digits Ribs Wavy ribs may be any aberrant shape Extra may have extra ribs on either side Fused may be fused anywhere along the length of the rib Branched single base and branched Tail Short short tail, usually lack of vertebrae Missing absence of tail Corkscrew corkscrew-shaped tail
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dosage group are treated during the nal third of gestation and through lactation to weaning (day 15 of pregnancy through day 21 postpartum) (Figure 21.4). The duration of gestation, parturition problems, and the number and size of pups in the naturally delivered litter are observed, as is the growth performance or the offspring. Variations of this test are the inclusion of groups treated only to parturition and only postpartum in order to separate prenatal and postnatal effects. Cross-fostering of pups to untreated dams may also be used to the same end. Behavioral testing of the pups has been suggested, and this and other physiological testing is to be recommended.
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