Final report on the safety assessment of Basic Violet 1, Basic Violet 3, and Basic Violet 4.
Basic Violet 3, Basic Violet 1, and Basic Violet 4 are triphenylmethane dyes that function as direct (nonoxidative) hair colorants. No current uses or use concentrations in cosmetics are reported. The term Gentian Violet is used synonymously with Basic Violet 1 and Basic Violet 3, although the chemical structures of these 2 dyes are not the same. The Cosmetic Ingredient Review Expert Panel noted that Basic Violet 1, 3, and 4 contain quaternary ammonium ions, and therefore the rate of penetration across the epidermis is expected to be slow. The panel concluded that because of the carcinogenic potential of these dyes, insufficient data exist to support the safety of Basic Violet 1, 3, and 4 in cosmetic formulation. Dermal absorption data and a risk assessment are needed to complete this safety assessment.
Diamante
Catherine
C
Cosmetic Ingredient Review, 1101 17th Street, NW, Suite 412, Washington, DC 20036, USA.
Bergfeld
Wilma F
WF
Belsito
Donald V
DV
Klaassen
Curtis D
CD
Marks
James G
JG
Shank
Ronald C
RC
Slaga
Thomas J
TJ
Snyder
Paul W
PW
Alan Andersen
F
F
D000818:Animals; D002470:Cell Survival / Q000187:drug effects; D003358:Cosmetics; D005128:Eye Diseases / Q000139:chemically induced / Q000473:pathology; D005260:Female; D005840:Gentian Violet / Q000009:adverse effects* / Q000032:analysis / Q000737:chemistry / Q000633:toxicity; D006202:Hair Dyes / Q000009:adverse effects* / Q000032:analysis / Q000737:chemistry / Q000633:toxicity; D006801:Humans; D007509:Irritants / Q000633:toxicity; D011247:Pregnancy; D012098:Reproduction / Q000187:drug effects; D012394:Rosaniline Dyes / Q000009:adverse effects* / Q000032:analysis / Q000737:chemistry / Q000633:toxicity; D012449:Safety; D012871:Skin Diseases / Q000139:chemically induced; D013723:Teratogens / Q000633:toxicity; D001745:Urinary Bladder Diseases / Q000139:chemically induced
D003358:Cosmetics; D006202:Hair Dyes; D007509:Irritants; D012394:Rosaniline Dyes; D013723:Teratogens; C034887:ethyl violet; C548657:Basic Violet 1; D005840:Gentian Violet