Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-004-2
CAS number: 102-08-9
The objective of this study was to
evaluate the potential of the test item to induce damage to the
chromosomes or the mitotic apparatus in rat bone marrow cells.
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.
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 Sprague-Dawley rats received two oral
treatments of 1,3-Diphenyl-2-thiourea at dose-levels of 500, 1000 and
2000 mg/kg/day, at a 24-hour interval. For the high-dose group only, two
supplementary males and three supplementary females were also treated
with the test item in case of mortality.
One group of five males and five
females received the vehicle (corn oil) 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 15 mg/kg/day.
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).
According to the criteria specified in
the international guidelines, since no toxic effects were observed at
2000 mg/kg/day in the preliminary test, this dose-level was selected as
the top dose-level for the main test. The two other selected dose-levels
were 500 and 1000 mg/kg/day.
No mortalities and no clinical signs
were observed at any of the tested dose-levels during the study.
The mean values of MPE as well as the
PE/NE ratio for the vehicle and positive controls were consistent with
our historical data.
Cyclophosphamide induced a significant
increase (p < 0.001 males and p < 0.05 females) in the frequency of MPE,
indicating the sensitivity of the test system under our experimental
conditions. The study was therefore considered to be valid.
The test item did not induce any
noteworthy decrease in the PE/NE ratios when compared to the vehicle
The mean values of MPE in the test
item-treated groups were found equivalent to those of the vehicle group.
These results met the criteria of a negative response.
The test item did not induce damage to
the chromosomes or the mitotic apparatus of rat bone marrow cells after
two oral administrations, 24-hour apart, at the dose-levels of 500, 1000
and 2000 mg/kg/day.
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.
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again