ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Biological Reactivity Tests, In Vivo

This classification is based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. Six Plastic Classes are defined:

1. Class I – Uses a specified dosage of an extract of sample in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.

2. Class II – Same as Class I but in addition uses an extract of sample in 1 in 20 Solution of Alcohol in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.

3. Class III – Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil, both applied either intraperitoneally or intracutaneously into a mouse.

4. Class IV – Same as Class II but in addition uses an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit. Also uses implant strips of sample into a rabbit.

5. Class V – Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit.

6. Class VI – Same as Class V but in addition uses implant strips of sample into a rabbit.



These tests are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described:

1. Systemic Injection Test – Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.

2. Intracutaneous Test – Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.

3. Implantation Test – Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue.

With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of the three standard temperatures: 50°, 70°, and 121°. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction e.g., IV - 121°, which represents a class IV plastic extracted at 121°).

See also: Plastics, USP Classification

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