FDA should consider new safety data supporting Category I (safe and effective) status for triclosan in the OTC Tentative Final Monograph for Health Care Antiseptic Drug Products, CIBA Specialty Chemicals and an alliance of six triclosan manufacturers/marketers state in a Sept. 13 citizen petition.

As part of its request that the agency "reopen the administrative record to allow for the submission and evaluation of additional safety data," the petition includes the results of three repeat-dose dermal studies of triclosan in mice and rats completed in April 1997.

When FDA issued the TFM in June 1994, the agency classified triclosan's safety as a patient preoperative skin prep for short-term use as Category I, but designated its efficacy as Category III (more data needed). For antiseptic handwashes, health care personnel handwashes and surgical hand scrubs, triclosan was deemed Category III for both safety and efficacy.

The agency maintained additional chronic exposure data were necessary to assess triclosan's long-term safety, prompting CIBA to begin drafting a protocol for a dermal carcinogenicity study in rats.

However, CIBA and the five other members of the Triclosan Industry Alliance note separate studies have been conducted since and the "existing database on the carcinogenic potential of triclosan is adequate." Consequently, "a dermal carcinogenic study in rats is not necessary," they aver.

Among the studies and papers cited are a "16-volume submission...which included various metabolism, mutagenicity and genotoxicity studies," and a "chronic exposure study...of triclosan following prolonged dietary administration to hamsters."

Regarding efficacy, CIBA and TIA note another citizen petition "supporting the Category I efficacy status of triclosan will be submitted...shortly."

An alliance position paper submitted to FDA in August reviews much of the research conducted on triclosan. The paper concludes "a database consisting of short-term and lifetime studies in three rodent species, an extensive battery of genetic toxicity data and 30 years of human experience support the safe use of triclosan in dermal applications. A dermal cancer bioassay of triclosan in rats is unnecessary and unlikely to add useful information for assessing the safety of this chemical."

Triclosan Antiseptic Category I Status Requested By CIBA

More from Archive

More from Pink Sheet