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EC number: 202-739-6
CAS number: 99-20-7
different Guideline studies on genetic toxicity available.
No indication of genetic toxicity found.
Osmolality and pH Values
The osmolality and the pH values of the solvent controls, the positive
controls as well as
the test item concentrations (in DMEM medium with 5 % horse serum (HS))
used in the pre-test were determined to exclude a negative influence on
the assay by
those parameters. The osmolality was determined using an osmometer and
the pH value
was determined using a pH meter. The results are summarized in the
Table 6-a Osmolality and pH values
Sample Osmolality in mosm/kg H2O pH-Value
DMEM (5 % HS) + DMEM 333 7.830
DMEM (5 % HS) + DMSO 408 7.909
DMEM (5 % HS) + EMS (60 mg/mL) 334 7.845
DMEM (5 % HS) + DMBA (0.3 mg/mL) 407 7.832
DMEM (5 % HS) + Test Item 20 mg/mL 337 7.878
DMEM (5 % HS) + Test Item 10 mg/mL 340 7.961
DMEM (5 % HS) + Test Item 5 mg/mL 334 7.924
DMEM (5 % HS) + Test Item 2.5 mg/mL 332 7.879
DMEM (5 % HS) + Test Item 1.3 mg/mL 331 7.923
DMEM (5 % HS) + Test Item 0.6 mg/mL 331 7.920
DMEM (5 % HS) + Test Item 0.3 mg/mL 331 7.865
None of the tested positive controls or test item concentrations
provoked a critical change
of the osmolality and the pH value in comparison to the solvent
controls. Therefore, a negative influence of these parameters on the
assay can be excluded.
This study was performed to investigate the potential of TREHALOSE,
induce mutations at the hypoxanthine-guanine phosphoribosyl transferase
(HPRT) locus in
Chinese Hamster cells (V79).
The assay comprised a pre-test and two independent valid experiments
(experiment I and
II). Due to a technical error, the first experiment I was terminated and
repeated. The collected
data of this invalid experiment is not included in this final report but
will be archived
with the raw data. The pre-test was done to detect a potential cytotoxic
effect of the test
item. Based on the results of this test the concentrations for the main
The first valid main experiment (experiment I) was performed with and
activation (liver S9 mix from male rats, treated with Aroclor 1254) and
a treatment period of
4 hours. The second experiment (experiment II) was performed with a
treatment period of
24 hours without metabolic activation.
The highest nominal concentration (2 mg/mL) applied was chosen with
regard to the solubility
of the test item in organic solvents and aqueous media and the
Appropriate reference mutagens, used as positive controls, induced a
distinct increase in
mutant colonies and thus, showed enough sensitivity of the testing
procedure and the activity
of the metabolic activation system.
No substantial and reproducible dose dependent increase in mutant colony
observed in both experiments up to the maximal concentration of the test
In this in vitro assessment of the mutagenic potential of trehalose
(crystal), histidine dependent
auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537,
TA 98 and TA 100）and
a tryptophan dependent mutant of Escherichia coli (WP2 uvrA) were
exposed to the test substance,
diluted in water which was also used as a negative control.
Two independent mutation tests were performed, in the presence and
absence of liver preparations
from Aroclor 1254-induced rats.
In the preliminary dose range finding study with dose levels of up to
5000 μ.g/plate no toxicity was
observed. A top dose level of 5000 μ.g/plate was chosen for the
subsequent mutation study. Other
dose levels used in the mutation assays were: 2500, 1250, 625, 312.5
No evidence of mutagenic activity was seen at any dose level of
trehalose (crystal) in either mutation
The concurrent positive control compounds demonstrated the sensitivity
of the assay and the
metabolising activity of the liver preparations.
It is concluded that,when tested in water, trehalose (crystal) was not
mutagenic in this bacterial
This study was performed to evaluate the ability of Trehalose to induce
aberrations (CA) in Chinese hamster ovary (CHO) cells in the presence
and absence ofrat S9
metabolic activation (MA).
In the cytotoxicity assay, CHO cells were exposed for 3 hr to Trehalose
of 312, 1250, and 5000 μg/mL in both the absence and presence of MA.
Metaphase cells were
harvested at 21 hr after initiation of exposure. No significant decrease
in mitotic index or
confluency was observed at any dose level.
Based on the cytotoxicity results, the initial chromosomal aberration
performed by exposing CHO cells for 3 hr to Trehalose concentrations of
1250, 2500, and 5000
μglmL in both the absence and presence of MA. Metaphase cells were then
harvested at 21 hr
after initiation of exposure. In the absence and presence of MA, no
increase in the frequency of cells with structural chromosomal
aberrations was observed at any
dose. As expected, the positive controls (methyl methane sulfonate and
produced significant increases in the number of cells with structural
For the replicate experiment cultures were exposed to Trehalose for 21
hr in the absence
of MA or 3 hr in the presence of MA. Cultures were then harvested at 21
hr and, in the case of
the vehicle control and high dose, at 45 hr. At the 21- and 45-hr
harvest times no statistically
significant increases in the frequency of cells with structural
chromosomal aberrations were
observed at any dose in the presence or absence of MA. The positive
significant increases in the number of cells with structural chromosomal
aberrations The 45-hr
harvest was also evaluated for frequency of polyploidy at the
5000μg/rnL. No increase in
polyploidy above control values were observed.
Based on the criteria established in the protocol, it is concluded that
Trehalose elicits a
negative response in the CHO chromosomal aberration assay in the absence
and presence of
one Guideline study present, no effects observed
The genotoxic potential of Trehalose administered by intraperitoneal
(ip) injection to
induce micronucleus formation in bone marrow erythrocytes was determined
In the micronucleus experiment, 10 mice per sex per dose group were
treated with a
single i.p. dose of Trehalose at 1250, 2500, or 5000 mg/kg. Five mice
per sex per dose group
were sacrificed approximately 24, or 48 hours after treatment and bone
marrow was evaluated for
cytotoxicity and micronucleus formation. A vehicle control group and a
positive control group were treated similarly and evaluated concurrently
with the Trehalosetreated
test groups. There were no early deaths or significant clinical signs.
significant increases in micronucleated PCE frequency was seen in any of
In conclusion, Trehalose meets the criteria established in the study
protocol for a negative
response in the mouse bone marrow erythrocyte micronucleus assay.
No mode of action identified.
The presented information is conclusive but not sufficient for
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