Crystal (gentian) violet chemical review

In January 1991 the Pesticides and Agricultural Chemicals Standing Committee of the National Health and Medical Research Council (NHMRC) asked the Australian Agricultural and Veterinary Chemicals Council to withdraw all clearances and maximum residue limits (MRLs) for crystal (gentian) violet. Concerns had been held for some time about the toxicity of crystal (gentian) violet, based on data that demonstrated that it was a potential carcinogen.

The APVMA (then the NRA) reviewed the use of crystal violet because of concerns about its carcinogenicity potential and possible risks to public health.

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.

The APVMA completed the special review of crystal (gentian) violet in September 1994 but did not publish a final report. The APVMA found that the data demonstrated that crystal (gentian) violet posed a potential risk to public health.

The APVMA:

• cancelled the clearance certificates for crystal (gentian) violet, with effect from 1 November 1994
• cancelled the MRLs for crystal (gentian) violet, with effect from 1 November 1994
• cancelled all registrations and relevant approvals of veterinary products containing crystal (gentian) violet, with effect from 1 November 1994.

No veterinary products containing crystal (gentian) violet are currently registered for use in Australia.

Contact the APVMA for copies of the APVMA Gazette notice: Cancellation of registration for agricultural products.