GENERAL TOXICOLOGY OF MNDPDP

Purpose: To investigate the general toxicology of mangafodipir trisodi um (MnDPDP, Teslascan). Material and Methods: Studies were performed i n accordance with standard methods and in compliance with regulations current at the time of conduct. Results: Single-dose studies in rodent s and dogs showed that MnDPDP was tolerated at doses of approximately 2000 mu mol/kg, approximately 400 times a single imaging dose of 5 mu mol/kg. The single dose tolerance of MnDPDP was approximately 10 times greater than MnCl2. A good safety profile of MnDPDP was also shown in repeat-dose studies (3 weeks), in which the no-observed-adverse-effec t level for the rat, monkey and dog was 116, 29 and 10 mu mol/kg, resp ectively. The local tolerance studies indicated that no adverse local tissue reactions are likely to occur after i.v. injection. Other studi es indicate that accidental spillage of MnDPDP onto the skin is not ex pected to lead to significant systemic exposure, or to local irritatio n or hypersensitivity. MnDPDP was not genotoxic in a battery of severa l different tests. Conclusion: MnDPDP was shown to have a good safety profile suitable as an hepatobiliary MR contrast agent for i.v. admini stration.