Division 1.4.4 Limit test

If an oral study at one dose level of at least 1000 mg/kg body weight/day or, for dietary or drinking water administration, an equivalent percentage in the diet or drinking water using the procedures described for this study, produces no observable toxic effects in either parental animals or their offspring and if toxicity would not be expected based upon data from structurally and /or metabolically related compounds, then a full study using several dose levels may not be considered necessary. The limit test applies except when human exposure indicates the need for a higher oral dose level to be used. For other types of administration, such as inhalation or dermal application, the physical-chemical properties of the test substance, such as solubility, often may indicate and limit the maximum attainable level of exposure.