GB/T 21798-2008Chemicals -- Test method of mouse heritable translocation (English PDF)

3.1 Test sample

The test substance is dissolved in isotonic saline solution. Water-insoluble test substance can be dissolved or suspended in appropriate excipients, the test substance should be used before Freshly prepared. If excipients are used to solubilize, the excipients should not interfere with the properties of the test substance nor do they produce toxic effects.

3.2 Test animals

For the convenience of feeding and for cytological verification, the mice were selected for the experiment. There are no special requirements for mouse strains. But requires the average of the strains used Nursery pups should be greater than 8, and relatively stable. Should be used healthy, sexually mature animals.

3.3 The number of animals the number of animals depends on the frequency of spontaneous translocations and the minimum induction rate required for positive results. This test is completed by analyzing the male F1 generation, at least 500 F1 male rats per dose level are required. If female F1 generation is included, 300 males and 300 females are required.

3.4 Control

Control data must be sufficient, you can use the parallel control and historical control. A recent available positive result from the same laboratory can replace the test Parallel test of positive control.

3.5 Dose level

The highest dose, which produces minimal toxicity but does not affect reproductive behavior and does not cause death, is usually used as the test dose. In order to build the agent Volume - response relationship, but also need to set up two other low-dose group. For non-toxic subjects, use the highest dose that can be achieved by exposure.

3.6 Exposure route

Commonly used routes of exposure for oral gavage and intraperitoneal injection, but also other suitable ways. The same way as human exposure Toxicity, the test results obtained on the risk assessment of the most effective.

3.7 Operating procedures

3.7.1 Handling and mating

There are two methods of exposure, the most commonly used for a method of exposure; can also be used weekly 7d, continuous 35d exposure method. According to the method of exposure indeed Set the number of mating after mating to ensure that each phase of infected sperm cells have the same chance of conception. At the end of mating, the females should be kept in a single cage.

The time of delivery of female mice, the numbers of littermates and the sex of the mice were recorded. In addition to the test requirements, females should be discarded; all male offspring should be kept to weaning.

3.7.2 Translocation heterozygosis test

There are two ways to do this.