Clostridium Perfringens Type C Toxoid and Bacterin-Toxoid.

CFR · 2024-01-01 · US · Title 9

Clostridium Perfringens Type C Toxoid and Clostridium Perfringens Type C Bacterin-Toxoid shall be produced from a culture of (a) (b) (c) (1) When used in this test, the following words and terms shall mean: (i) (ii) (iii) (iv) (v) (vi) (2) Each of at least eight rabbits of a strain acceptable to APHIS, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the largest recommended dose for any species indicated on the product label. A second equivalent dose shall be given not less than 20 days nor more than 23 days after the first does. (3) Fourteen to seventeen days after the second dose, all surviving rabbits shall be bled and the serum tested for antitoxin content. (i) At least seven rabbits are required to make an acceptable serum pool. (ii) Equal quantities of serum from each rabbit shall be combined and tested as a single pooled serum. (iii) If less than seven rabbits are available, the test is a No Test and shall be repeated: (4) The antitoxin content of the rabbit serums shall be determined as follows: (i) Make a dilution of Standard Antitoxin to contain 10 International Units of antitoxin per ml. (ii) Make one dilution of Standard Toxin to contain 10 L (iii) Combine 10 International Units of Standard Antitoxin with 10 L (iv) Combine 1 ml of undiluted serum with 10 L (v) Neutralize all toxin-antitoxin mixtures at room temperature for 1 hour and hold in ice water until injections of mice can be made. (vi) Five Swiss white mice, each weighi

official document · source cfr-2024 · id 9:§ 113.111