R. W. Johnson Pharmaceutical Research Institute
Positive Signal: Dysmorphogenesis
1) Co-Existence of Maternal Toxicity Score = +1
While fetal effects were seen only in the presence of maternal toxicity, the types of dysmorphogenic effects observed were not considered to be attributable to the maternal toxicity
2) Presence of a Dose-Response Relationship Score = +1
a) Increased severity of effects with an increase in dose score=+1
b) Increase in the incidence of animals affected with an increase in dose score=+1
c) A high incidence of effects across all dose groups
Effects observed only at the higher dose levels for both rats and rabbits score= 0
3) Observation of Rare Events Score = +1
Rare events are detected in one or more species