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EC number: 278-770-4
CAS number: 77804-81-0
The test item Pigment Yellow 180 showed no mutagenic activity in a bacterial mutagenicity assay (Ames) in both experiments (plate incorporation assay, preincubation assay) each with and without metabolic activation in five strains.
The analogue substance Pigment Orange 36 did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test substance is considered to be non-mutagenic in this HPRT assay.
The analogue substance Pigment Yellow 175 did not increase the mutant frequency at the TK+/- locus in L5178Y cells and is therefore considered to be non-mutagenic under the conditions of the Mouse Lymphoma test.
was not continued since a minimum of only four analysable concentrations
was not continued to avoid analysis of too many precipitating
test item was assessed for its potential to induce gene mutations at the
HPRT locus using V79 cells of the Chinese hamster.
The study was performed in
two independent experiments, using identical experimental procedures. In
the first experiment the treatment period was 4 hours with and without
metabolic activation. The second experiment was performed with a
treatment time of 4 hours with and 24 hours without metabolic
The highest applied
concentration of 1200 µg/mL was limited by the solubility properties of
the test item in DMSO and aqueous medium.
relevant cytotoxic effects defined as a reduction of the relative
cloning efficiency I and/or relative cell density to values below 50% in
both parallel cultures were noted up to the maximum concentration with
and without metabolic activation.
No relevant and reproducible
increase in mutant colony numbers/106cells was observed in
the main experiments up to the maximum concentration. The mutation
frequency remained within the historical range of solvent controls.
A linear regression
analysis (least squares) was performed to assess a possible dose
dependent increase of mutant frequencies. No significant dose dependent
trend of the mutation frequency indicated by a probabilityvalue of <0.05
was determined in any of the experimental groups.
In both experiments of this
study (with and without S9 mix) the range of the solvent controls was
from 13.3 up to 18.9 mutants per 106cells; the range of the
groups treated with the test item was from 6.1 up to 40.2 mutant
colonies per 106cells.
EMS (150 µg/mL) and DMBA
(1.1 µg/mL) were used as positive controls and showed a distinct
increase in induced mutant colonies.
effects, evident as a reduction in the number of revertants, were observed
at the following concentrations (µg/plate).
without S9 mix
with S9 mix
1000 - 5000
/ = no
toxic effects observed
The test item
precipitated in the overlay agar at the following concentrations
particles had no influence on the data recording.
Mutagenic activity of the test item was investigated in Salmonella
typhimurium strains TA 1535, TA 1537, TA98 and TA100 as well as
Escherichia coli strain WP2 uvrA with (induced rat liver S9 mix) and
without metabolic activation at concentrations of 3, 10, 33, 100, 333,
1000, 2500 and 5000 µg/plate using the plate incorporation assay. Due to
the test items characteristic as an azo-dye the test was also conducted
using the Prival modification, i.e. testing the above mentioned
bacterial strains in the preincubation assay without and with uninduced
hamster liver S9 mix for metabolic activation. This test was performed
using the concentrations 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate.
The test item did not reveal any mutagenic activity under the conditions
tested. The appropriate reference mutagenes showed distinct positive
Mouse Lymphoma cells (L5178Y TK+/-) were treated with the test substance
at five or six concentrations in the range of 11.7 to 375 microgram/mL.
Precipitation of the test substance was detectable at dose level 187.5
and 375 microgram/mL. The solvent control gave mutant frequencies within
the normal range. The positive controls gave marked increases in the
mutant frequency, both in the presence or absence of metabolic
activation, indicating the satisfactory performance of the test system.
The test substance demonstrated no statistically significant or dose
related increases in mutant frequency at any dose level, either with or
without metabolic activation, thus indicating that the test item is not
mutagenic under the conditions tested.
The analogue substance Pigment Orange 36 did not induce micronuclei in
erythrocytes in mice in vivo. Therefore, the test item is considered to
The test item was
tested in a micronucleus test conducted similar to OECD guideline 474.
The test compound was administered
orally by gavage to male and female mice. The following doses were tested:
0, 50, 500 and 5000 mg per kg bodyweight.
animals were treated twice within 24 h with the test compound and
according to the test procedure
the animals were killed 6 hours after the second administration of the test
incidence of micronucleated polychromatic erythrocytes of the animals
with the test item was within the normal range of the negative control.
of normochromatic erythrocytes containing micronuclei was not increased
compared to the control animals.The
ratio of polychromatic/normochromatic erythrocytes in both male and
remained unaffected by the treatment.
positive control (Cyclophosphamide = EndoxanR)
yielded positive results and therefore indicating
the sensitivity of the system.
No classification: No adverse effects observed
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