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EC number: 229-355-1
CAS number: 6486-23-3
The test item did not exert mutagenic activity in the reverse bacterial
mutation assay (plate incorporation assay and preincubation assay
according to Prival) with and without metabolic activation.
In conclusion it can be stated that under the experimental conditions
reported the close structural analogue (PY001) did not induce gene
mutations at the HPRT locus in V79 cells. Therefore, the test item is
considered to be non-mutagenic in this HPRT assay.
In conclusion, it can be stated that under the experimental conditions
reported, the close structural analogue d
Therefore, the test item is considered to be non-clastogenic in this
chromosome aberration test in the absence and presence of metabolic
activation, when tested up to precipitating and cytotoxic concentrations.
The test item showed no mutagenic activity in both experiments (plate
incorporation assay, preincubation assay) each with and without
Mutagenic activity of the test item was investigated in Salmonella
typhimurium strains TA 1535, TA 1537, TA98, TA100 and E. coli WP2 uvrA
with (induced rat liver S9 mix) and without metabolic activation at
concentrations of 0, 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 with uninduced hamster liver S9 mix for
metabolic activation. This test was performed using the concentrations
0, 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
Summary of results of the chromosome aberration study
Exposure period 4 hrs without S9 mix
Exposure period 18 hrs without S9 mix
Exposure period 4 hrs with S9 mix
cells carrying exchanges
of 50 metaphases per culture
occurred at the end of treatment
frequency statistically significant higher than corresponding control
1 DMSO 0.5%
2 EMS 1000.0
3 EMS 600.0
4 CPA 1.4
The test item , suspended in DMSO, was
assessed for its potential to induce structural
chromosome aberrations in V79 cells of the Chinese hamster in
vitro in three independent experiments. The following study design
Without S9 mix
With S9 mix
In each experimental group two parallel
cultures were set up. 100 metaphases per culture were evaluated for
structural chromosome aberrations, except for the positive control in
Experiment II without metabolic activation, where 50 metaphases were
The highest applied concentration (385.0 µg/mL) was chosen with
regard to the solubility properties of the test item and with respect
to the current OECD Guideline 473.
Dose selection for the cytogenetic experiments was performed
considering the toxicity data and
the occurrence of precipitation.
In Experiment I in the absence of S9 mix no cytotoxicity was
observed up to the highest applied concentration. In Experiment I in
the presence of S9 mix concentrations showing clear cytotoxicity were
not scorable for cytogenetic damage due to the absence of metaphases
and severe test item precipitation on the slides. In Experiment IIA in
the absence of S9 mix no cytotoxicity was observed up to the highest
evaluable concentration. However, higher concentrations were not
evaluable due to severe test item precipitation on the slides. In
Experiment IIB in the presence of S9 mix cytotoxicity indicated as
reduced cell numberswas observed at
the highest evaluated concentration.
In both independent experiments, neither a
statistically significant nor a biologically relevant increase in the
number of cells carrying structural chromosomal aberrations was
observed after treatment with the test item.
No evidence of an increase in polyploid
metaphases was noticed after treatment with the test item as compared
to the control cultures.
Appropriate mutagens were used as positive controls. They
induced statistically significant increases (p < 0.05) in cells with
structural chromosome aberrations.
not continued to avoid evaluation of too many precipitating
The test item was assessed
for its potential to induce gene mutations at the HPRT locus using V79
cells of the Chinese hamster.
The assay was performed in
two independent experiments, using two parallel cultures each. The first
main experiment was performed with and without liver microsomal
activation and a treatment period of 4 hours. The second experiment was
performed with a treatment time of 4 hours with and 24 hours without
maximum concentration of the main experiments was limited by the
solubility of the test item. Precipitation at the end of treatment,
visible to the unaided eye occurred in the first and the second
experiment at 21.3 µg/mL and above with and without metabolic activation.
relevant cytotoxic effects, indicated by a relative cloning efficiency I
(survival) of less than 50% compared to the corresponding solvent
control occurred up to the maximum concentration with and without
metabolic activation following 4 and 24 hours treatment.
No relevant and reproducible
increase in mutant colony numbers/106cells was observed in
the main experiments up to the maximum concentration. The mutant
frequency remained well within the historical range of solvent controls.
An increase of the induction factor exceeding the threshold of three
times the mutation frequency of the corresponding solvent control was
observed in the second culture of the second experiment with metabolic
activation at the lowest concentrations of 2.7 and 5.3 µg/mL. However,
this increase was based on a rather low mutation frequency of the
solvent control of just 3.4 colonies per 106cells.
Furthermore, the effect was not reproduced in the parallel culture under
identical experimental conditions. Therefore, the increase of the
induction factor was judged as biologically irrelevant fluctuation.
A linear regression
analysis (least squares) was performed to assess a possible dose
dependent increase of the mutation frequency. No significant dose
dependent trend of the mutation frequency indicated by a probability
value 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 3.4 up to 18.5 mutants per 106cells; the range of the
groups treated with the test item was from 4.3 up to 23.4 mutants 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.
The study used as source investigated C.I. Pigment Yellow 1. The study results of the source compound were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
The test item and a close structural analogue did not cause geneotoxic
effects in mammalian or bacterials cells
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