June19, 2001

Alkylphenols Bulletin:
NTP Panel Conclusions Support Safe Use Of OP, NP

The Alkylphenols Bulletin periodically notifies manufacturers and users of alkylphenols and their derivatives of national and international developments of interest. For further information, please contact the APE Research Council at the address below.

The conclusions of a National Toxicology Program (NTP) peer-review of reported "low-dose effects" of hormonally active agents, released for public comment May 14, supports the safety and continued use of nonylphenol and octylphenol.

The peer-review report, requested by the US Environmental Protection Agency (EPA), was conducted over three days in October 2000. Studies on nonylphenol and octylphenol were reviewed by the "Other Environmental Estrogens and Estradiol" Subpanel. Specifically, the subpanel concluded:

"There was no evidence of a low dose effect [of octylphenol] in a five dose multigeneration study." A definitive study on octylphenol reviewed by the subpanel clearly demonstrated a lack of any low-dose effect in an animal model. This study was conducted under rigorous Good Laboratory Practices and reflected the most recent guidance of US EPA for examining reproductive and developmental endpoints — particularly those that may be influenced by hormonal activity.

"There is no evidence that octylphenol induces hormonal activity at low doses." The subpanel was satisfied that there is a complete lack of any low-dose effect from exposure to octylphenol (OP). In fact, there were no effects of any kind from 0.2 to 200 parts per million (ppm) of OP in the diet, and no estrogenic effects at any dose including the high dose of 2000 ppm.

Unpublished findings on nonstandard endpoints were reviewed by the panel which concluded: "The SDN-POA changes are difficult to interpret at the moment, as are the anti-CD3 findings." The subpanel acknowledged that the unusual findings, which were reported for several test compounds including nonylphenol, have no known health effects. In the case of nonylphenol, these findings were observed at levels at least 500 times greater than human exposure levels.

"The 'low dose' of nonylphenol is questionable." The findings discussed above led to the conclusion that the observed changes did not occur at actual "low-dose" levels, as effects reported in studies of nonylphenol were at levels too high to be considered low. It said more data would be needed at the level of human exposure in order to evaluate actual low-dose exposures of nonylphenol.

The Alkylphenols & Ethoxylates Research Council's comments on the subpanel's conclusions will be published as an addendum, along with other comments received, in the final report. These comments will reflect the industry's support of the conclusions reached by the subpanel and indicate areas of future planned research that may further clarify the available data on nonylphenol.

For more information on nonylphenol and octylphenol, please visit the APERC web site at www.aperc.org.

 

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