Clostridium Novyi Bacterin-Toxoid.

CFR · 2024-01-01 · US · Title 9

Clostridium Novyi 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 the Animal and Plant Health Inspection Service, each weighing 4-8 pounds, shall be injected subcutaneously with not more than half of the recommended cattle dose. (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 invalid and shall be repeated: (4) The antitoxin content of the rabbit serums shall be determined by the serum neutralization test as follows: (i) Make a dilution of Standard Antitoxin to contain 0.1 International Unit of antitoxin per ml. (ii) Make a dilution of Standard Toxin in which 0.1 Lo dose is contained in a volume of 1 ml or less. Make a second dilution of Standard Toxin in which 0.1 L + dose is contained in a volume of 1 ml or less. (iii) Combine 0.1 International Unit of Standard Antitoxin with 0.1 Lo dose of diluted Standard Toxin and combine 0.1 International Unit of Standard Antitoxin with 0.1 L + dose of diluted Standard Toxin. Each mixture is adjusted to a final volume of 2.0 ml with diluent. (iv)

official document · source cfr-2024 · id 9:§ 113.108