In March 1993, the NHMRC placed crystal (gentian) violet in schedule 4 of the Standard for the Uniform Scheduling of Medicines and Poisons. Schedule 4 applies to ‘Prescription Only Medicine’. The NHMRC recommended that the APVMA (then the NRA) withdraw all clearances for the use of crystal (gentian) violet as a marker dye and as an active constituent.
According to the NHMRC, ‘Crystal violet demonstrated carcinogenic/tumorigenic effects in mice in life-span studies. Hepatocellular carcinoma, adenoma of the Harderian gland and Type A reticular cell sarcomas in multiple sites were found in 18–24-month-old mice, and in vitro studies revealed that crystal (gentian) violet) is a mutagen and clastogen’.
In January 1994 the APVMA began a special review of crystal (gentian) violet to formally consolidate the previous regulatory action by the Pesticides and Agricultural Chemicals Standing Committee, the Australian Agricultural and Veterinary Chemicals Council and the NHMRC.