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EC number: 220-562-2
CAS number: 2814-77-9
This report describes the results of an in vitro study for the detection
of structural chromosomal aberrations in cultured mammalian cells. It
supplements microbial systems insofar as it identifies potential
mutagens that produce chromosomal aberrations rather than gene mutations
(Scott et al, 1990). The method used was designed to be compatible with
that described in the OECD Guidelines for Testing of Chemicals (1997)
No. 473 "Genetic Toxicology: Chromosome Aberration Test", Method B10 of
Commission Regulation (EC) No. 44012008 of 30 May 2008 and the USA EPA
OPPTS guideline 40 CFR 799.9537. The study design also meets the
requirements of the UK Department of Health Guidelines for Testing of
Chemicals for Mutagenicity.
Duplicate cultures of human lymphocytes, treated with the test item,
were evaluated for chromosome aberrations at up to four dose levels,
together with vehicle and positive controls. Four treatment conditions
were used for the study; i.e. In Experiment 1, 4 hours in the presence
of an induced rat liver homogenate metabolising system (S9), at a 2%
final concentration with cell harvest after a 20-hour expression period
and a 4 hours exposure in the absence of metabolic activation (S9) with
a 20-hour expression period. In Experiment 2, the 4 hours exposure with
addition of S9 was repeated (using a 1% final S9 concentration), whilst
in the absence of metabolic activation the exposure time was increased
to 24 hours.
The dose levels used in the main experiments were selected using data
from the preliminary toxicity test and were as follows:
Test item (ug/ml) 25, 50, 100, 200, 400, 800
All vehicle (solvent) controls had frequencies of cells with aberrations
within the range expected for normal human lymphocytes. All the positive
control items induced statistically significant increases in the
frequency of cells with aberrations indicating the satisfactory
performance of the test and of the activity of the metabolising system.
The test item did not induce any statistically significant increases in
the frequency of cells with aberrations, in either the absence or
presence of a liver enzyme metabolising system in either of two separate
experiments. The maximum dose tested was limited by formulation
difficulties and was also limited by precipitate of the test item
occurring on the slides at the maximum dose and restricting the ability
to accurately Score metaphases.
The test item was considered to be non-clastogenic to human
lymphocytes in vitro.
Pigment Red 4 does not have
to be classified for mutagenicity according to the criteria laid down in
the EU Dangerous Substances Directive (67/548/EEC) and in the EU
Classification Labelling and Packaging Regulation (1272/2008/EC) because
no adverse effects due to the
test item have been seen in vitro in OECD 473 and OECD 476 studies –
also for C.I. Pigment Red 3 and C.I. Pigment Orange 5. While
ambiguous, possitive and negative test results have been seen intests
with and without metabolic activation (OECD 471). In vivo there were no
marked increases in the incidence of unscheduled DNA synthesis in
animals dosed with the test item (OECD 486) for C.I. Pigment Red 3 and
C.I. Pigment Orange 5.
Clear and negative
studies for mutaginicity have been seen in vitro in OECD 473 and OECD
476. In vivo there were no marked increases in the incidence of
unscheduled DNA synthesis in animals dosed with the C.I. Pigment Red 3
and C.I. Pigment Orange 5 (OECD 486).
the test item is not considered to be mutagenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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