D-10-camphorsulfonic acid: Safety evaluation.

The safety of D-10-camphorsulfonic acid (CSA) was evaluated by genotoxicity testing and in a subchronic 90-day study in rats. Ames test and in vitro micronucleus test results, either in the absence or the presence of metabolic activation, were negative. Administration of CSA to Wistar rats in the drinking water (0.05, 0.20, or 1.00 mg/mL), for 90 days caused neither test-item-related mortality nor adverse clinical signs. The only macroscopic change seen at necropsy was enlarged testes in the high-dose animals. The 0.20 mg/mL (25 mg/kg bw/day) dose level was considered to be the no observed adverse effect level (NOAEL). A total intake calculation for consumers was performed, based on the intended maximal amount of 0.5 ppm CSA in feed, published transfer factors, and conservative tissue consumption data, resulting in 0.29 μg/kg bw/day. Therefore, the NOAEL is approximately 80,000 × the maximum estimated human exposure, a margin that is more than adequate to ensure consumer safety.