Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Physical chemical data and data from the toxicological data package may be used to predict the potential ADME characteristics of PMDA. The low toxicity of PMDA in repeat dose studies also lend support to mteabolites of low to no appreciable toxicity.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
The physical chemical characteristics of PMDA and the data from the repeat dose toxicity study clearly suggest and demonstrate that PMDA is likely to be readily absorbed, distributed and excreted with limited bioaccumulation. The data suggest that the liver is a target organ and that enhanced metabolism is likely to occur, although the toxicity of metabolites is likely to be limited as in the genotoxicity studies metabolic activation was without demonstrable effect. Considering these attributes, the most likely route of excretion would be primarily via the urine and secondarily the faeces.