In a [#]-generation reproduction study (MRID [number if available]) [Chemical name (% a.i.)] was administered to [(# of animals) strain, species]/sex/dose in [diet, water, by capsule, by gavage] at dose levels of 0, x, x, x ppm (0, x, x, or x  mg/kg bw/day).  (Mention number of litters per generation and other critical or unusual procedures)

 

[Describe toxicity briefly.  If no toxicity state that there were no compound related effects in the main categories of systemic or reproductive toxicity evaluated.]  The LOAEL is     ppm (    mg/kg bw/day in males,     mg/kg bw/day in females), based on [endpoint].  The NOAEL is     ppm (    mg/kg bw/day in males,     mg/kg bw/day in females).  Describe treatment-related effects at doses >LOAEL if applicable. 

 

[Note: If unequivocal evidence of reproductive toxicity was observed, then determine separate LOAELs and NOAELs for systemic toxicity and for reproductive toxicity, providing a description of the toxic effect(s) that defines each LOAEL, including a description of treatment-related effects at doses > LOAEL if applicable.]

 

This study is [acceptable, unacceptable(why); note if it is a range-finding study] and satisfies (does not satisfy) the guideline requirement for a [#]-generation reproductive study (OPPTS 870.3800); OECD 416 in [species].  [If it does not satisfy the requirement, concisely list only major deficiencies or refer to deficiency section.]