Derivation of a No-Significant-Risk-Level (NSRL) for diethanolamine (DEA).

Abstract Diethanolamine (DEA) has been listed on the State of California’s Proposition 65 List. This listing is based in part on tumors reported in a National Toxicology Program (NTP) 2-year dermal carcinogenicity study in mice which found clear evidence of carcinogenic activity in B6C3F 1 mice based on increased incidences of liver neoplasms in both sexes, and increased incidences of renal tubule neoplasms in males. Although considerable controversy exists on the relevance of the NTP study to humans, industries are obligated to comply with the Proposition 65 labeling requirement and drinking water discharge prohibition, unless they are able to demonstrate that DEA levels in their products are below a specific No Significant Risk Level (NSRL). The State of California has not published an NSRL for DEA. In this article, a NSRL of 5.6 μg/day and a life-stage-adjusted NSRL adj of 1.4 μg/day are derived from the NTP carcinogenicity study using a benchmark dose modeling method based on the incidence of hepatocellular carcinomas in female mice, in accordance with the guidelines of California EPA.