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EC number: 215-149-9
CAS number: 1306-25-8
A group of 10 animals was treated
with the test item during the induction phase of the study. Injections
were given intra-dermally with and without FCA (sensitisation
phase I) and one week later
the test item was applied dermally on the same site (sensitisation
phase II). The animals were
challenged by dermal exposure two weeks laterwith the test
item at a concentration of 100 % (w/v)
in 1 % methylcellulose.
Five control guinea pigs were simultaneously exposed to
1 % methylcellulose during the sensitisation phase I (intra-dermal
treatment; with and without FCA). During the sensitisation phase II
(dermal treatment) thecontrol animals were treated
with1 % methylcellulose and theywere treated with the test item at
a concentration of 100 % (w/v) in1 % methylcellulose
only on the challenge day.
Skin Effects after the Challenge Exposure
After the challenge with the test item at a concentration of
100 % (w/v) in 1 % methylcellulose, no positive response was observed in
the treated animals. The mean of the scores was 0.00 according to the 24
and 48-hours results. The right shaved flank area of all animals was
treated with a test item concentration of 50 (w/v) % in
1 % methylcelluloseas a safeguardand no reaction was noted.
After the challenge with the test itemat a concentration of
100 % (w/v) in 1 % methylcellulose no visible changes were found at the
24 and 48 hours examinations. The right shaved flank area of control
animals was treated with a test item concentration of 50 (w/v) % in
1 % methylcelluloseas a safeguard and no reaction was noted.
There were no overt signs of an adverse clinical response to
treatment with the test item during the course of the study.
There were no moribund or dead animals during the study.
The individual body weights of the guinea pigs were measured at
the beginning and at the end of experiment. There were no notable
differences between the test animal group and the control group.
A skin sensitisation study was performed in the guinea pig
according to the Magnusson-Kligman method, using a maximisation method
with Freund's complete adjuvant to evaluate the sensitisation potential
of test itemCadmium telluride (CdTe).
Ten test animals were subjected to sensitisation procedures in a
two-stage process, i.e. an intra-dermal treatment and a topical
application. The test item was used at a concentration of 0.1 % (w/v) in
1 % methylcellulose for intra-dermal injections and at a concentration
of 100 % (w/v) test item suspension in 1 % aqueous methylcellulose for
dermal sensitisation treatment.Two
weeks after the last induction exposure, a challenge dose (at a
concentration of100 % (w/v) test item suspension in
1 % methylcellulose)
was administeredon the left flank of animal.The
right flank area of animals was treated with 50 %
dilution with 1 % methylcellulose of the maximum dermal challenge dose
as a safeguard dose.Challenge
was performed by dermal application of the test item. Five
control guinea pigs were simultaneously exposed to 1 % methylcellulose
during the sensitisation phase I (intra-dermal treatment). During the
sensitisation phase II (dermal treatment) the control animals were
treated with1 % methylcellulose and they were treated with the test item at
a concentration of 100 % (w/v) and
50 % (w/v) in1 % methylcellulose
only during the challenge (phase III).
No signs of contact sensitisation were detected in guinea pigs
previously exposed to the test item during the experiments.
Intensity of Sensitisation Response:
In the control and treated animals the mean of the scores was
0.00 according to the 24 and 48-hour results.
In conclusion, under the conditions of the present assay
the test itemCadmium telluride (CdTe)(Batch No.: 138683)was shown to
have no sensitisation potential and classified as a non-sensitizer,
according to current EU-regulations.
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