Table 1.
Control limits (95 %) for the interpretation of data (no. or revertant colonies per plate) from tester strains and untreated controls in the Bacterial Reverse Mutation Test (Ames Test). Control limits were inclusive and based on historical control data.
| 95 % Control limits (99 % Upper Limit)2 for no. of spontaneous revertant colonies/plate, applied to bacterial tester strains | |||||
|---|---|---|---|---|---|
| Presence/absence of metabolic activation1 | TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA |
| -S9 (without metabolic activation) | 5−25 (30) | 66−114 (126) | 4−20 (24) | 2−14 (17) | 10−38 (45) |
| +S9 (with metabolic activation) | 10−34 (40) | 66−122 (136) | 4−20 (24) | 3−15 (18) | 13−41 (48) |
1
Aroclor 1254-induced rat liver S9 was used as the metabolic activation system.
2
Calculated from laboratory historical control data, where: 95 % upper control limit = mean + (2 x standard deviation); 95 % lower control limit = mean – (2 x standard deviation); 99 % upper control limit = mean + (3 x standard deviation). With Study Director justification, values including the 99 % upper control limit and above were considered acceptable.