ABSTRACT

Section 5. Hematology Parameters Table 18.4 Routine Hematology Testing Recommendations in Nonclinical

Safety Assessment Studies Section 6. Urinalysis Parameters

Table 18.5 Routine Urinalysis Testing Recommendations in Nonclinical Safety Assessment Studies

Section 7. Reference Values Table 18.6 Factors that can Affect Clinical Chemistry and Hematology

Test Measurements Table 18.7 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in CD® Rats Table 18.8 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in F-344 Rats Table 18.9 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in B6C3F1 Mice Table 18.10 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in CD-1 and BALB/c Mice Table 18.11 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in Beagle Dogs Table 18.12 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in Nonhuman Primates Table 18.13 Mean Control Ranges of Typical Serum Clinical Chemistry

Measurements in New Zealand White Rabbits Table 18.14 Mean Control Ranges of Typical Hematology Measurements

in CD® Rats Table 18.15 Mean Control Ranges of Typical Hematology Measurements

in F-344 Rats Table 18.16 Mean Control Ranges of Typical Hematology Measurements

in B6C3F1 Mice

Table 18.18 Mean Control Ranges of Typical Hematology Measurements in Beagle Dogs

Table 18.19 Mean Control Ranges of Typical Hematology Measurements in Nonhuman Primates

Table 18.20 Mean Control Ranges of Typical Hematology Measurements in New Zealand White Rabbits

Section 8. Glossary References Additional Related Information

Table 18.21 Normal Human Laboratory Values Table 18.22 Erythrocyte Life Span in Various Animals

The volume of blood in healthy mammals is relatively constant and typically represents about 5 to 9% of body weight, depending on species.1 Blood volumes of Ý1% of body weight can be collected during the course of a study, (i.e., Ý2.5 ml for a 250 g rat); however, this may cause minimal to moderate stress and/or result in a mild compensatory response by the bone marrow. For frequent periodic sampling, e.g., once weekly, blood volumes of Ý0.5-0.75 ml can be collected from a 250-300 g rat without any untoward effects. Somewhat larger volumes, e.g., Ý1.5-2.0 ml, can be obtained routinely from this size animal on a monthly basis. At necropsy, about 50% of an animal’s total blood volume can be obtained using suitable techniques as subsequently discussed. Approximate blood volumes for typical species used in toxicology research are shown in Table 18.1.

Numerous sampling techniques are available to collect blood samples in toxicology research. Table 18.2 contains those procedures which are used most typically. Terminal sample procedures listed are usually utilized only when a nonterminal sample procedure would not provide sufficient quantities of blood.