[Mutagenicity study of gadobenate dimeglumine formulation (E7155) (2)--Chromosome aberration test with human lymphocytes in culture].
The mutagenic potential of gadobenate dimeglumine formulation (E7155) was studied by the chromosome aberration test in cultured human lymphocytes. Human lymphocytes were exposed to E7155 at 0.078-10 mM both in the presence and absence of S9 mix derived from rat livers. Three dose levels (2.5-10 mM) were selected for the metaphase analysis. E7155 induced no increase in the incidence of aberrant cells or polyploid cells in any treatments both in the presence and absence of metabolic activation. Thus, it is concluded that E7155 has shown no evidence of clastogenic or polyploidy-inducing activity under these experimental conditions.
Toritsuka
N
N
Department of Developmental Safety Assessment Research, Eisai Co., Ltd., Gifu, Japan.
Daimon
H
H
Sawada
S
S
Sagami
F
F
Tirone
P
P
Morisetti
A
A
Bussi
S
S
Adams
K
K
D000818:Animals; D002478:Cells, Cultured; D002869:Chromosome Aberrations; D003287:Contrast Media / Q000633:toxicity*; D005682:Gadolinium / Q000633:toxicity*; D006801:Humans; D008214:Lymphocytes / Q000187:drug effects*; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000031:analogs & derivatives* / Q000633:toxicity; D009152:Mutagenicity Tests; D009153:Mutagens; D009942:Organometallic Compounds / Q000633:toxicity*; D051381:Rats
D003287:Contrast Media; D009153:Mutagens; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium