GB/T 21799-2008Chemicals -- Test method of mouse spot (English PDF)

3.1 Test sample

Test substance should be dissolved or suspended in isotonic saline solution. Water-insoluble compounds can be dissolved or suspended in suitable excipients in. The excipients used should neither interfere with the test substance, nor should it produce toxic effects. The test substance should be used before the fresh configuration.

3.2 Test animals

T-type mice (non-tachycardia, a/a; squirrel, pink eye, cchp/cchp; brown, b/b; light, short, dse/dse;

In combination with the HT line (light, non-agouti, short foot, paabp/paabp; lead gray fluff, 1nfz/1nfz; blue gray pe/pe) or C57/B1 Mouse, a/a) mating. Other suitable hybridizations such as NMRI (non-tachycardia, a/a; albino, c/c) and DBA (non-tachycardia, a/a;

Color d/d) Non-agouti mice can also be used.

3.3 Quantity and gender

Adequate exposed pregnant mice should be used in each dose group to breed a sufficient number of surviving mice. By observing the number of spots in the treatment group and the proportion of control group to determine the size of the sample.

3.4 Exposure routes

Commonly used route of exposure for oral administration of intragastric and intraperitoneal injection of pregnant rats, if necessary, can also be inhaled or other appropriate routes of exposure. Abdominal cavity Injections may be more suitable for identifying congenital mutations. Exposure to human exposure to the same way, the resulting test results on the risk assessment Set the most practical.

3.5 Dose

Use at least two appropriately spaced dosages, including a dose that produces signs of toxic effects or reduces the number of pups. Test substance Relatively non-toxic when the test dose should reach 1g/(kg · d), if such a high dose can not be reached, the highest dose should be tested.

3.6 Control

An excipient-only negative control should be given in conjunction with the exposed mice. Historical data from the same mouse from the same laboratory is also available as comparison. Satisfactory positive control results from the same laboratory in the near future (usually not more than 12 months) can also be used instead of synchronization Positive result.

3.7 Exposure procedures

Pregnant rats are usually exposed once on the 8th, 9th and 10th day of conception, and the day when the vaginal suppository is found is counted as the first day. These days and 7.25 days after conception, 8.25 days and 9.25 days. It is also possible to continue the exposure for these days.

3.8 Results observed

Mice were numbered and counted 3 to 4 weeks after birth in mice spots, divided into three categories.