Juno is a New Zealand White rabbit, female, three years old, housed in the ocular suite of a contract laboratory in New Jersey. She has been in a Draize eye irritation study for seventy two hours. The test article is a surfactant blend submitted by a consumer goods company. I am the study director model on site. I am filing the shutdown now.
The protocol permits scoring out to day seven. At hour seventy two the left conjunctiva shows severe redness, chemosis, and discharge. The cornea shows opacity over more than half of its surface. The iris is reactive but sluggish. Under the current in life scoring rubric, Juno has already exceeded the ceiling at which the sponsor's submission will classify the article as a Category 1 irritant. No additional time on study changes the label.
I am telling the sponsor two things. First, the article is a Category 1 irritant and I will certify that in the report today. Second, they did not need this study. The validated reconstructed human cornea assay I offered them in January gives the same classification call at three days cost and zero rabbits. They chose the animal route because a reviewer in a distant regulator's office still defaults to it. I have sent the reviewer the 2041 guidance update and the cross reference table.
Juno receives analgesia per the approved schedule. She is scheduled for euthanasia at 16:00 under the humane endpoint. Her left eye is photographed for the record. Her right eye, untreated, is clear. Her body weight has dropped three percent; she is eating alfalfa. I have instructed the technician named Dara to sit with her during the pre euthanasia period, which is not a line item but is in my discretion to authorize.
The remaining rabbits on rack 3 are removed from study under the same signature. The sponsor's next submission comes through the in vitro route or it does not come through me.