Nomination Summary for p-Chloro-m-xylenol (PCMX) (N95004)
Nominated Substances: p-Chloro-m-xylenol (PCMX)
Nomination Date: 11/16/1994
Nominator: Private Individual
Rationale: Though PCMX has been used as an active antimicrobial agent in OTC topical health care antiseptic products for over 50 years, FDA has recommended that NIPA Laboratories conduct 90-day dose range-finding studies and lifetime carcinogenicity studies to confirm the safety of this product and to establish essential toxicological parameters. Because the concentration of PCMX in antiseptic products is low, only a small amount of PCMX is manufactured thus it will be difficult for NIPA to pay for these expensive long-term toxicological tests from funds generated from the sale of this "low volume" chemical. NIPA is requesting that NTP perform the tests requested by the FDA.
NTP Principles: not specified
Status: In Review/Pending