User Guide to Thresholds and Classification - Environmental ...

236User Guide for Thresholds and Classifications(q) reliable information for the substance indicates to an expert that exposure to thesubstance causes an adverse reproductive effect; or(r) reliable information for the substance indicates to an expert that exposure to thesubstance causes an adverse developmental effect.16.2.2. Reproductive or developmental effects classification criteria for substancesSchedule 4 to the Hazardous Substances Classification Regulations 2001 identifies two classificationcategories for substances that are reproductive or development toxicants and one classification category forsubstances that product effects on or via lactation (subclass 6.8).Category 6.8A – substances that are known or presumed human reproductive or developmentaltoxicantsa. A substance for which data indicate evidence of a causal relationship in humans between exposureto the substance and adverse effects on reproductive ability, reproductive capacity, or development.b. A substance for which data indicate evidence of adverse reproductive or adverse developmentaleffect in animals as a result of exposure to the substance, where that adverse effect occurs:i. in the absence of other adverse effects from exposure to the substance; orii. in the presence of other adverse effects that occur as a result of exposure to the substance,where the adverse reproductive or adverse developmental effect is considered by an expert notto be a secondary non-specific consequence of those other adverse effects.Category 6.8B – substances that are suspected human reproductive or developmental toxicantsA substance for which data indicates evidence from human epidemiological or animal studies of anadverse reproductive or developmental effect as a result of exposure to the substance, where:a. that effect is considered by an expert not to be a secondary non-specific consequence of any otheradverse effect; andb. the strength and weight of the evidence indicate to an expert that the evidence is not sufficient toclassify the substance in hazard classification 6.8A.Category 6.8C – substances that produce toxic human reproductive or developmental effects on or vialactationA substance for which data from studies of absorption, metabolism, distribution, and excretion of thesubstance indicate evidence that the substance would be present in potentially toxic levels in humanbreast milk.A substance for which data indicate evidence in humans of toxicity to babies during the lactationperiod as a result of exposure.A substance for which data from one- or two-generation studies indicate evidence of any adverseeffect in the offspring of animals due to the transfer of the substance in the milk as a result ofexposureJanuary 2012 EPA0109