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3.13.2.1 Alkane Example

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Three of the chemicals chosen for the pilot were n‐decane, undecane, and dodecane. These chemicals were sponsored in the pilot by a consortia organized by the ACC. The ACC n‐alkanes VCCEP Consortium Tier 1 submission was reviewed by an independent peer consultation panel in September 2004. That review and EPA's analysis resulted in a short list of additional data/analysis. One item was occupational exposure monitoring data at n‐alkane production facilities. Consortia members had previously checked for this type of data and found that none existed. Traditional IH assessment strategies would not necessarily have developed quantitative data for these alkanes since none of these chemicals have established occupational exposure limits, they exhibit low inherent hazard and none have been identified as causing unique workplace exposure concerns.

EPA's stated reasons for wanting the exposure data was to ensure they could adequately address risks to prospective parents. The data would demonstrate to EPA that the exposures (and corresponding risks) are low, thereby eliminating the need to consider the need for a two generation reproductive study. These studies are costly (frequently $1 million or more) and raise animal welfare issues. There is no guarantee that if these data are collected, EPA will not require such a study, but all the options would be reviewed more rationally.

Patty's Industrial Hygiene, Program Management and Specialty Areas of Practice

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