Investigational
novartisnovartisnovartis
novartisnovartisnovartis
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LOEL in genotoxicity assays by structural alert class<br />
Salmonella Reverse<br />
Mutation Assay<br />
Anthraquinones (12)<br />
N-Oxides (Aromatic) (5)<br />
Azirine/Aziridine (5)<br />
Aromatic Nitro (45)<br />
Aromatic Amines (48)<br />
Chromium (10)<br />
Vic Dihalides (6)<br />
Quinolines (18)<br />
PAHs (K-, Bay-Region) (7)<br />
Alkylating Agents (15)<br />
Nitrosamines/N-Nitroso (32)<br />
Isocyanate (4)<br />
Aliphatic Epoxides (21)<br />
Hydroxamates (13)<br />
Heterocyclic Nitro (3)<br />
Halogenated Methane (3)<br />
Hydrazo/Hydrazine (9)<br />
Rodent Micronucleus Assay<br />
0.0<br />
0.001<br />
0.01<br />
0.1<br />
Azirine/<br />
Aziridine (6)<br />
N-Nitroso (4)<br />
Alkylating<br />
Agent (15)<br />
Triazene (6)<br />
Aromatic<br />
Amine (9)<br />
Hydrazine (4)<br />
NOVARTIS<br />
mg/kg<br />
1<br />
100.0<br />
10.0<br />
0.0<br />
0.1<br />
1<br />
10.0<br />
100.0<br />
1000<br />
µg/ml<br />
0.0<br />
0.0001<br />
0.001<br />
0.01<br />
0.1<br />
1.0<br />
10.0<br />
Theoretical detection limit<br />
1 ppm<br />
% of drug substance if drug substance is 1mg/ml<br />
L. Müller, Swissmedic, 21-Oct-2003
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