Division Circumstances in which required

The reproductive toxicity of the active substance to mammals shall be investigated, unless a justification is provided by the applicant showing that exposure of adults, during the breeding season is unlikely to occur. Such a justification shall be supported by information showing that no exposure or delayed effects will occur during the breeding season.

The most sensitive ecotoxicologically relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg substance/kg bw/day shall be reported. The EC₁₀ and EC₂₀ shall be reported together with the NOEC expressed in mg substance/kg bw/day. Where EC₁₀ and EC₂₀ cannot be estimated an explanation shall be provided.