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EC number: 221-312-5
CAS number: 3064-73-1
In a dermal sensitization study (3248.34) with TiBTD, young adult
Hartley-derived albino guinea pigs (5/sex/dose) were tested using the
Buehler test method. For induction, 100% TiBTD (epicutaneous occlusive)
and was used. For challenge, 100% TiBTD (epicutaneous occlusive) was
used. The evaluation of skin reactions after challenge was carried out
at 24 and 48 hrs. The positive control was 1-Chloro 2,4 nitrobenzene
DNCB caused a positive skin reaction (moderate, confluent erythema to
severe erythema with or without edema) in 10 of 10 animals. TiBTD caused
a positive skin reaction (slight patchy erythema) in 1 of 10 animals.
There were no reactions in the control group. The exposed animals showed
no other negative clinical symptoms throughout the experiment. The body
weight of animals increased during the study and it was not affected by
the treatment. In this study, TiBTD is not a dermal sensitizer.
This dermal sensitization study is acceptable and satisfies the
guideline requirement for an OECD 406 study. The guideline recommends 20
animals in the test group and 10 in the control group. As there was only
one reaction (slight patchy erythema) in 1 animal of 10 animals in the
test group, it is not expected that the number of the test animals will
affect the conclusion that the substance is not a skin sensitiser. The
results of the DNCB positive control study demonstrated that a valid
test was performed and indicated that the test design would detect
potential contact sensitisers.
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