Tier 1 EDSP: Other Scientifically Relevant Information. Barbara Neal Exponent December 13, 2010. Endocrine Disruptor Screening Program. Tier 1 Test Orders for 67 chemicals, mostly pesticides
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December 13, 2010
“Other scientifically relevant information” is information that informs the determination as to whether the substance may have an effect that is similar to an effect produced by a substance that interacts with the estrogen, androgen, and/or thyroid hormonal systems (e.g., information that identifies substances as having the potential to interact with the estrogen, androgen, and/or thyroid system(s); information demonstrating whether substances have an effect on the functioning of the endocrine system). OSRI may either be functionally equivalent to information obtained from the Tier 1 assays—that is, data from assays that perform the same function as EDSP Tier 1 assays—or may include data that provide information on a potential consequence or effect that could be due to effects on the estrogen, androgen or thyroid systems.”
In most EPA OSRI responses a generic letter from Kavlock is cited providing no detail for the rejection of ToxCast data, however in one recent decision more detail is provided:
“The cited ToxCast data may be appropriate for use in priority setting for in vitro assays, however protocol information on individual assays is limited and there is no indication of the sensitivity or specificity of ToxCast, e.g., demonstrated by how weak positive, negative controls and proficiency chemicals would perform in this assay.” Dimethoate OSRI EPA review Nov. 10, 2010.