Toxicology testing, preliminary

Van Loveren, H., Vohr, H.-W, Hartung, T. and Gribaldo, L. (2007) In vitro tests to evaluate immunotoxicily a preliminary study. Toxicology, 229, 11—22. 

Under the sponsorship of the National Cancer Institute and the National Toxicology Program, two chronic tests of CN and CS administered by inhalation are under way. > Preliminary data obtained in the subchronic studies preparatory to the definitive inhalation carcinogenicity tests are presented in the sections of this chapter dealing with CS and CN. One probable adverse effect, to judge from... 

Carfi M, Gennari A, Malerba I, Corsini E, Pallardy M, Pieters R et al (2007) In vitro tests to evaluate immunotoxicity a preliminary study. Toxicology 229 11-22... 

As noted above, there is a need for a portable rapid blood test to screen for the presence of toxicologically significant concentrations of CN in blood, in order to aid in the immediate definitive diagnosis of CN intoxication on-site. Preliminary studies using Cyantesmo strips, used by water treatment facilities, showed that the strips accurately and semi-quantitatively detected CN in solutions at concentrations > 1 qg ml 1 in 5 min (Rella et al, 2003,2004). 

A 13-week inhalation study in rats sponsored by the National Toxicology Program (NTP) has been completed, but the results were not published as of March 1996. The NTP has also reported that an inhalation carcinogenicity study in rats has been planned, but no details on this study are available. Preliminary reports on NTP-funded genotoxicity studies indicate positive results in a sister chromatid exchange assay (in vitro) and negative results in both a chromosome aberration assay (in vitro) and in two Salmonella tests. No further data on these studies were available. 

Information to support the stability of the drug substance during the toxicologic studies and the proposed clinical study or studies should include a brief description of the stability study and the test methods used to monitor the stability of the drug substance, and preliminary tabular data based on representative material. Neither detailed stability data nor the stability protocol need to be submitted. 

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