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EC number: 411-370-1
CAS number: 82857-68-9
GM 102 E
vitro tests (bacterial reverse mutation test, mammalian cell gene
mutation test and mammalian chromosome abberation test) and one in
vivo genotoxicity test (mammalian bone marrow micronucleus test) are
available. The studies were performed according to standard OECD
guidelines and in compliance with GLP. None of the tests showed evidence
reverse gene mutation assay in bacteria, performed according to the OECD
No.471 guideline and in compliance with GLP, GM102E diluted in DMSO was
tested in S. typhimuriumT A 1535, TA 1537, TA 1538, TA 98 and TA
100 in the presence and the absence of mammalian metabolic activation
(S9). Four known mutagens (Sodium azide; 2-Aminoanthracene;
2-nitrofluorene and 9-aminoacridine), dissolved in dimethylsulfoxide
(except for sodium azide which was dissolved in sterile distilled
water), were used to check the sensitivity of the test system.
of the two main tests showed that toxicity was observed in the presence
of S9-mix in strains TA 1535 and TA 1538 at the top dose tested of 3.3
mg/plate. In the absence of S9-mix, toxicity was noted from 333 µg/plate
in strain TA 1535, from 1 mg/plate in strain TA 1538 and at 3.3 mg/plate
in strains 1537, TA 98 and TA100. The number of revertants for the
vehicle and positive controls met the acceptance criteria. The study was
therefore considered to be valid. The test item did not induce any
noteworthy or biologically relevant increase in the number of
revertants, in any of the other tested strains.
test conditions, GM102E did not show any mutagenic activity in the
bacterial reverse mutation test using Salmonella typhimurium.
cell gene mutation:
In an in
vitro mammalian cell mutation assay, performed according to the OECD
No.476 and in compliance with the GLP, GM102E dissolved in water for
injections was tested in the L5178Y Tk +/- mouse lymphoma cell line in
the presence and the absence of mammalian metabolic activation (S9 mix).
controls had acceptable mutant frequency values that were within the
normal range for the L5178Y cell line at the TK +/- locus. The positive
control items induced marked increases in the mutant frequency
indicating the satisfactory performance of the test and of the activity
of the metabolising system.
experimental conditions of this study, the GM102E did not show any
mutagenic activity in the mouse lymphoma assay, up to 2 mM in the
presence of a rat metabolizing system (3-hour treatment) or up to 75
μg/mL (3-hour treatment) or 50 μg/mL (24-hour treatment) in the absence
of a rat metabolizing system. In conclusion, the test item was
considered not to be mutagenic to L5178Y cells under the conditions of
potential of the test item, GM102E, to induce chromosome aberrations in
cultured human lymphocytes was investigated in an in vitro mammalian
chromosome aberration test, performed according to the OECD No.473 and
in compliance with the GLP.
frequencies of cells with structural chromosome aberrations for the
vehicle and positive controls were as specified in acceptance criteria.
The study was therefore considered to be valid.
experimental conditions of this study, the GM102Edid not induce
chromosome aberrations in cultured human lymphocytes, either in the
presence or absence of a rat liver metabolizing system. In conclusion,
the test item was considered not to be mutagenic to human lymphocytes
under the conditions of the test.
marrow micronucleus assay was conducted in Sprague-Dawley rats according
to the micronucleus test in order to assess the in vivo genotoxicity
of GM102E. The study was conducted to a standard OECD guideline and in
compliance with good laboratory practices. Animals (15 males and females
per test substance dose and negative control) were treated by gavage
with the test substance at 50 mg/kg bw in deionized water in a single
administration. The positive control, Mitomycin C, was administered
intraperitoneally to 5 males and 5 female.
cells were harvested at 18-hour, 42 -hour and 66 -hour post-treatment.
There is no significant difference between the micronucleus frequency in
the treated group in comparison with the control group at any sampling
time. The group of animals treated with the positive control, Mitomycin
C, showed a statistically increased frequency of micronucleated cells in
comparison with the control group. Under the conditions of the in vivo
test, the registered substance showed no evidence of causing chromosome
damage or bone marrow cell toxicity.
None of the
available tests showed evidence of genotoxicity. GM102E is therefore
considered to be non-genotoxic and does not require classification for
genetic toxicity according to the classification criteria of EU
Regulation 1272/2008 (CLP).
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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