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EC number: 213-022-2
CAS number: 915-67-3
Table 1: Skin Painting studies in mice
Mean body weighta
FD&C Red 2
a- Treatment groups-50 persex.
b- Control group size- 100 malesand100 females
Table 2: Skin Painting Studies in mice (%
survival and survival rate)
a - %S denotes percent survival.
b - SI,survival index: %ratio of mousedayssurvived compared to
anticipated number ofdaysif all the surviving animals lived to the end
of the experiment.
Table 3: Histopathological Observations in Mice in Skin Painting
Studies with FD&C Dyes
No of mice examined/sex
Malignant lymphoma – all grades
Increased number of megakaryocytes
Leukemic and round cell infiltration
Leukocytic aggregations and perivascular infiltration
Inflammation, pneumonia, bronchitis
Skin painting studies in Swiss
Webster mice were carried out using FD&C Red 2 to determine the dermal
toxicity and carcinogenicity of the test chemical.
Amaranth dye was dissolved in
water for application to the depilated skin of mice once a week for
approximately 19.5 months. 50 male and 50 female Swiss Webster mice were
used as test animals.100 female and 100 male mice were used in each
control group. Swiss-Webster mice with an initial weight ranging from 17
to 25 g were used in this study. All groups were equally divided as to
sex. Mice of the same sex were housed five per cage and were allowed
free access to pellets of Purina Laboratory Chow and fresh water.
Initially, the hair on the dorsal area of each animalwasclipped with an
animal clipper free of lubricating oil. Subsequent periodic clipping was
performed according to the rate of hair growth.Anarea of
approximately 6 cm2 was treated twice weekly.
Materials were prepared fresh
each week by homogenizing in a Waring Blender and kept under magnetic
stirrer during treatment. The dosage was applied with an automatic
syringe and uniformly distributed on the exposed skin with a rubber
applicator. Once each week for the duration of the study 0.1 ml of the
solvent or of the color solution containing 1.0% of the Amaranth dye on
an actual pigment basis was applied to the depilated area of the mice.
Each mouse was observed daily for behavior, survival and visible or
palpable growth. Records included observations on the incidence, size,
and description of any such growths.
All surviving animals were
terminated after approximately 19.5 months, when a marked increase of
geriatric mortality became apparent. All mice were necropsied after they
died or were sacrificed. Organs were fixed in 10% formalin solution
after recording any gross pathological findings. The initial microscopic
examinations of the tissues listed below involved approximately 50% of
the treated animals in this group, but was enlarged in a supplemental
series to include histological examinations carried out on all tumors
and all grossly abnormal organs or tissues.
The following tissues were
preserved in 10% formalin:
Brain, Pituitary. Thyroid,
Spleen,Thymus, Liver, Kidney, Adrenal, Stomach, Small intestines, Large
intestines, Urinary bladder, Axillary lymph node, Kidney, ovary, Skin
from area of treatment, Any tissue masses, Grossly abnormal organs or
There were no significant
differences in survival rate in groups that had the color applied.No
adverse reactions or pathological changes were observed after 19.5
months dermal application of test chemical.Unusually high or low body
weights observed late in the study for some of the groups, were due to
only a few surviving animals which reduced the biological significance
of the averages. During the study, there were no abnormalities observed
in behavior of mice in the experimental or control groups nor were there
any significant differences in rate of growth.
dermal application of 0.1 ml of dye solution applied to the dorsal area
of Swiss Webster mice weekly for 19.5 months failed to increase the
incidence of neoplasia resulting from the Amaranth dye when compared to
the findings in the concurrent control water groups.
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