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Crystal (gentian) violet review history and regulatory outcomes
Nomination for review
In January 1991 the Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) requested the Australian Agricultural and Veterinary Chemicals Council (AAVCC) to withdraw all clearances and Maximum Residue Limits (MRLs) for crystal (gentian) violet. Concerns had been held for some time regarding the toxicity of crystal (gentian) violet, based on data that demonstrated that it was a potential carcinogen.
In March 1993 the National Health and Medical Research Council (NHMRC) placed gentian violet in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP); 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 PACSC, AAVCC and NHMRC.
Crystal (gentian) violet review
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 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.
For more information please contact the Chemical Review Program on (02) 6210 4749 or by email to chemrev@apvma.gov.au