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EC number: 240-521-2
CAS number: 16470-24-9
Mutagenicity in bacterial reverse mutation
assays (Ames test) was investigated in four tests.
The key study conducted in the Salmonella
typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA1538 was
performed according to the OECD guideline 471, except for fact that the
OECD recommended combination of strains was not respected, because none
of the E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium
TA102 was tested (CCR- Cytotest Cell Research GmbH & Co. KG, 1987).
Nevertheless, a second key study was here reported, in which the
substance was tested for detecting its potential gene mutagenic activity
using the Escherichia Coli strain WP2 uvrA (Guenard J., 1982). The test
item did not cause relevant increase of the revertant colony numbers in
The same results were recorded also in
further two AMES supporting studies (Bayer AG, 1979 and Bayer AG, 1979),
in which no genotoxic and no cytotoxicity were observed during the
Thus, negative results were obtained in
all tests with and without metabolic activation.
Mammalian mutagenicity test according to
OECD 476 (HPRT) was performed on 3a-DSA, the analogous dihydroxyethyl
hexasulphonated sodium salt; the substance has the same functional
groups and it is a representative of the group 3 (further details are
given in the Category Justification Report, Section 13 of the technical
dossier). The in Vitro Mammalian Cell Gene Mutation Test was
performed with V79 hamster fibroblast. The test substance was tested at
the concentrations of 0.15; 0.5; 1.5 and 5 mg/ml. Each concentration was
tested in two replicates. Experiments were performed without as well as
with metabolic activation using the supernatant of rat liver and a
mixture of cofactors. No evidence of the mutagenicity of test substance
was recorded, thus the test substance resulted non-mutagenic for V79
cells without as well as with metabolic activation (Täublová E., 2014).
The chromosome aberration potential was
investigated on the substance under registration both in vivo and
in vitro: no indication of a mutagenic effect were recorded in the in
vitro test (CCR- Cytotest Cell Research GmbH & Co. KG, 1991) and in
the in vivo dominant lethal assay (Bayer AG, 1995); furthermore
the substance did not induce micronuclei as determined by the
micronucleus test with bone marrow cells of the mouse (CCR - Cytotest
Cell Research GmbH & Co KG, 1991).
According to CLP regulation (EC1272/2008),
for the purpose of the classification for germ cell mutagenicity,
substances are allocated in one of two categories in consideration of
the fact that they are: - substances known to induce heritable mutations
or to be regarded as if they induce heritable mutations in the germ
cells of humans or substances known to induce heritable mutations in the
germ cells of humans or - substances which cause concern for humans
owing to the possibility that they may induce heritable mutations in the
germ cells of humans.
All different tests related to genetic
toxicity are negative
In conclusion, the available experimental
data are adequate for classification and labelling and the substance is
not classified for genetic toxicity according to the CLP Regulation (EC
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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