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EC number: 446-990-1
CAS number: -
Two in vitro tests performed according to OECD 471 and 473 guidelines
are available and did not show any genotoxic effect.
Analysis : Reverse mutation assay.
Test substance : LCA01006 LEMI code : DIB190601-2
Test procedure : Reverse mutation assay on “Salmonella typhimurium his-“
and “Escherichia coli” WP2 (pKM 101) strains according to the OECD
guideline n° 471 (LEMI operating procedure MB08/45).
Test result : The product did not induce reverse mutation, Salmonella
typhimurium and Escherichia coli WP2 (pKM 101) strains according to the
OECD guideline n° 471 and according to the test method B13/B14 of the
E.C. Directive n° 2000/32.
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 followed that described in the OECD
Guidelines for Testing of Chemicals (1997) No. 473 "Genetic Toxicology:
Chromosome Aberration Test" and Method B10 of Commission Directive
2000/32/EC. The study design also meets the requirements of the UK
Department of Health Committee on Mutagenicity Guidelines for the
Mutagenicity Testing of Chemicals.
Duplicate cultures of human lymphocytes, treated with the test material,
were evaluated for chromosome aberrations at up to three dose levels,
together with vehicle and positive controls. Four treatment conditions
were used for the study, ie. 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.
All vehicle (solvent) controls had frequencies of cells with aberrations
within the range expected for normal human lymphocytes. All the positive
control materials 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 material was non-toxic and did not induce any statistically
significant increases in the frequency of cells with aberrations, in
either of two separate experiments, using a dose range that included a
dose level that was the maximum recommended dose level.
The test material was considered to be non-clastogenic to human
lymphocytes in vitro.
The objective of this study was to evaluate the potential of the test
item LCAO5 005 to induce structural or numerical damage in bone marrow
cells of mice. The study was performed according to the international
guidelines (OECD 474 and Commission Directive No. B12) and in compliance
with the Principles of Good Laboratory Practice Regulations.
A preliminary toxicity test was performed to define the dose-levels to
be used for the cytogenetic study. In the main study, three groups of
five male and five female Swiss Ico: OF1 (IOPS Caw) mice were given oral
administrations of LCAO5005 at dose-levels of 500, 1000 or 2000
mg/kg/day, over a 2-day period. One group of five males and five females
received the vehicle (water for injections) under the same experimental
conditions, and acted as control group. One group of five males and five
females received the positive control test item (cyclophosphamide) once
by oral route at the dose-level of 50 mg/kg. The animals of the treated
and vehicle control groups were killed 24 hours after the last treatment
and the animals of the positive control group were killed 24 hours after
the single treatment. Bone marrow smears were then prepared. For each
animal, the number of the micronucleated polychromatic erythrocytes
(MPE) was counted in 2000 polychromatic erythrocytes. The polychromatic
(PE) and normochromatic (NE) erythrocyte ratio was established by
scoring a total of 1000 erythrocytes (PE + NE).
The highest dose-level for the cytogenetic test was selected according
to the criteria specified in the international guidelines; since no
toxic effects were observed, the highest dose-level was 2000 mg/kg/day.
The two other selected dose-levels were 1000 and 500 mg/kg/day. For both
males and females, the mean values of MPE as well as the PEINE ratio in
the groups treated with the test item, were equivalent to those of the
vehicle control group. The mean values of MPE as well as the PEINE ratio
for the vehicle and positive controls were consistent with our
historical data. Cyclophosphamide induced a significant increase in the
frequency of MPE, indicating the sensitivity of the test system under
our experimental conditions. The study was therefore considered valid.
Under our experimental conditions, the test item LCAO5 005 did flot
induce any damage to the chromosomes or the mitotic apparatus of mice
bone marrow cells after two oral administrations, at a 24-hour interval,
at the dose-levels of 500, 1000 or 2000 mg/kg/day.
The substance is not classified as genotoxic according to the criteria
of the CLP regulation n°1272/2008/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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