Lip salivary-gland hamartoma in a cynomolgus macaque (Macaca fascicularis).

An incidental, asymptomatic, well-circumscribed, solitary, submucosal nodular mass was detected on the mucosal surface of the inner lower lip in a female cynomolgus macaque (age, approximately 2.4 y) during a juvenile chronic toxicology study. Grossly, the nodule was soft with brown to tan discoloration and measured approximately 4 mm in diameter. Microscopically, the nodule was covered by normal stratified squamous epithelium and composed of well-circumscribed irregular lobules containing hyperplastic and normal-appearing mucinous salivary gland acini and ducts, which were separated by thick connective tissue septae. In light of the gross pathology and results of microscopic examination, salivary gland hamartoma was diagnosed. This lesion resembles adenomatoid hyperplasia of mucous salivary glands in humans, which is a rare nonneoplastic swelling. To our knowledge, this case description is the first report of a cynomolgus macaque with the rare entity of lip salivary gland hamartoma, which likely represents adenomatous hyperplasia in humans.

Recommended tissue list for histopathologic examination in repeat-dose toxicity and carcinogenicity studies: a proposal of the Society of Toxicologic Pathology (STP).

The Executive Committee of the Society of Toxicologic Pathology (STP) appointed an ad hoc task force to devise and recommend a standard list of tissues to be evaluated histopathologically in repeat-dose toxicity and carcinogenicity studies that are used to support the registration of new pharmaceutical products. The recommended tissue list is intended to be a minimum core list that can be used for all types of repeat-dose toxicity and carcinogenicity studies, regardless of route of administration, species or strain of mammalian laboratory animal, duration, or class of drug to be tested. The resulting recommendations of the task force, presented here, were subsequently reviewed by the STP membership and endorsed by the STP Executive Committee.

Semiautomated analysis of alkaline phosphatase isoenzymes in serum of normal cynomolgus monkeys (Macaca fascicularis).

Alkaline phosphatase (ALP) isoenzyme analysis, using a combination of wheat germ lectin (WGL) precipitation, levamisole inhibition and an automated p-nitrophenylphosphate assay was validated for use with serum from monkeys (Macaca fascicularis) and used to determine the activities of liver ALP (LALP), bone ALP (BALP) and intestinal ALP (IALP). Based on serial dilution studies and within-run and between-run coefficients of variation, each assay had excellent linearity and acceptable precision. In addition, liver and intestinal mucosa extracts for tissue specific alkaline phosphatases were used to confirm assay validations. Gender-specific differences for total ALP, LALP, and BALP activities were present in sera from normal monkeys between 2 and 4 years of age. Males had 1.3-fold higher total ALP and LALP activities, and 1.5-fold higher BALP activity compared with females. The majority of ALP activity in normal monkey serum was LALP isoenzyme activity, which ranged from 56.7% to 94.7% of total activity. Serum BALP activity ranged from 5.3% to 42.8%. There was negligible IALP activity in all serum samples.