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EC number: 220-562-2
CAS number: 2814-77-9
Ten male and ten female rats per group were exposed to C.I. Pigment Red
4 in the diet for 90 days at two concentrations of 5% and 1%.
No rats died during the study. The general behavior of rats at 5% and 1%
was not affected. The body weight gain was lower in the 5% group
compared to controls for male rats. Body weight gain of female rats at
5% concentration of test substance in the diet were not affected.
The histological examination of the organs did show some signs of
changes related to the experiment in the kidney and spleen when exposed
to 1% of C.I. Pigment Red 4 and more prominently at 5%.
A series of 14 cosmetic colors were submitted to dermal toxicity testing
in accordance with a protocol designed by the Food and Drug
Administration and agreed upon with the Cosmetic, Toiletry and Fragrance
Association (formerly the Toilet Goods Association). Dosage levels were
based on lipstick use determinations made in a group of human female
volunteers. The groups of lipstick colors were divided into three
treatment series and painted on twice weekly to an area approximately 6
cm2. A total of 1400 mice were used comprising groups of 100
mice (50 per sex) plus additional positive control group of the same
size and a vehicle control group of 300 mice (150 per sex). All colors
were prepared at 1.0% suspensions in water. The positive control
received 3.4–benzpyrene dissolved in acetone. Survival was approximately
equivalent in all experimental groups except the positive controls who
died earlier consistent with survival recorded by others for
3.4–benzpyrene treated mice. Extramedullary hematopoesis was found in
all treated groups, equivalent to the findings in the controls. The
repeated application of 0.1 ml containing 1.0% dye did not increase the
incidence of neoplasia when compared to controls in any of the groups
receiving application of the 14 dyes.
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