Reproductive and Developmental Toxicity

Study Types and Duration

SNBL DSR maintains a large stock of cynomolgus and rhesus monkeys showing regular menstrual cycles (rhesus monkeys have their breeding season between November and January). Segment III non-human primate study reports (40 to 48 animals per study) can be submitted in a similar timeframe as those for rabbit studies. The times required from approval of the protocol to the submission of the draft report are as follows:

Effects on fertility and early embryonic development to implantation

Rats and mice: 6 months
Cynomolgus monkeys: 9 months (males), 10 months (females)

Effects on embryo-fetal development

Rats and mice: 6 months
Rabbits: 7 months
Cynomolgus monkeys: 8 months

Effects on pre and postnatal development including maternal function

Rats and mice: 10 months
Cynomolgus monkeys: 15 months

SNBL has extensive experience with the following studies:
Newborn and juvenile toxicity studies: cynomolgus monkey, beagle dog, rat, and mouse
Testicular toxicity studies: cynomolgus and rat
Fostering studies: rat

Administration routes:
Oral, intravenous (including infusion), intramuscular, and subcutaneous

Cynomolgus monkey
Day 40 of gestation

Advantages of Using NHP for Reproductive and Developmental Toxicity Studies

For studies of biotechnology-derived pharmaceuticals, primates are a useful alternative to rodents and rabbits, in which bioactivity is not clearly seen. Cytokines are reported to induce spontaneous abortion and/or embryo death in rodents or rabbits at dosages below the toxic level, and it is considered essential to investigate abortifacient effects in primates.
Blood and semen can be sampled at several points. Changes in toxicokinetics, hematology, blood chemistry, hormone levels (testosterone, estradiol, progesterone, prolactin, inhibin), immunophenotyping of lymphocytes in peripheral blood, and sperm characteristics (IVOS or manual) can be evaluated chronologically.
Suitable for studies of antibiotics, where rabbits cannot be administered sufficiently high doses
Reproductive and embryonic development is similar to that in humans.
With a high non-positive reactivity to human non-teratogens, primates can be selected as the second or third species to elucidate inter-species differences.
SNBL can detect pregnancy as early as 14 days after mating. Pregnancy is monitored by ultrasonic diagnostics. If embryonic death occurs, the embryo and placenta are removed, and if necessary, observed histopathologically.

Immunological parameters (T-cell dependent antibody response, immunophenotyping of lymphocytes in peripheral blood, immunohistochemistry, delayed type hypersensitivity, etc) can be investigated in cynomolgus dams and F1 infants. SNBL can produce a protocol to meet your requirements: Please contact us.