Appendix XIV E. Test for Abnormal Toxicity

(Abnormal Toxicity Ph. Eur. method 2.6.9)

GENERAL TEST

Inject intravenously into each of 5 healthy mice, weighing 17 g to 24 g, the quantity of the substance to be examined prescribed in the monograph, dissolved in 0.5 mL of water for injections R or of a 9 g/L sterile solution of sodium chloride R. Inject the solution over a period of 15 s to 30 s, unless otherwise prescribed.

The substance passes the test if none of the mice die within 24 h or within such time as is specified in the individual monograph. If more than one animal dies the preparation fails the test. If one of the animals dies, repeat the test. The substance passes the test if none of the animals in the 2nd group die within the time interval specified.

IMMUNOSERA AND VACCINES FOR HUMAN USE

Unless otherwise prescribed, inject intraperitoneally 1 human dose but not more than 1.0 mL into each of 5 healthy mice, weighing 17 g to 24 g. The human dose is that stated on the label of the preparation to be examined or on the accompanying leaflet. Observe the animals for 7 days.

The preparation passes the test if none of the animals shows signs of ill health. If more than one animal dies, the preparation fails the test. If one of the animals dies or shows signs of ill health, repeat the test. The preparation passes the test if none of the animals in the 2nd group die or shows signs of ill health in the time interval specified.

The test must also be carried out on 2 healthy guinea-pigs weighing 250 g to 400 g. Inject intraperitoneally into each animal 1 human dose but not more than 5.0 mL. The human dose is that stated on the label of the preparation to be examined or on the accompanying leaflet. Observe the animals for 7 days.

The preparation passes the test if none of the animals shows signs of ill health. If more than one animal dies the preparation fails the test. If one of the animals dies or shows signs of ill health, repeat the test. The preparation passes the test if none of the animals in the 2nd group die or shows signs of ill health in the time interval specified.