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EC number: 603-094-7
CAS number: 125904-11-2
The Irritation Severity Index was also
calculated for each group at each time point. At 24 hours the irritation
severity index was 0.1, 0.0 and 1.8 in the treated, negative and
positive control groups, respectively. At 48 hours the irritation
severity index was 0.2, 0.1 and 1.8 in the treated, negative and
positive control groups, respectively.
In a Buheler test, a group consisting of 6
male and 6 female Hartley albino guinea pigs was induced by topical
application of the test substance at 25% in acetone for 9 times, 2 -3
days apart one from the other. The test material induced generally very
slight to slight (grade +/- to grade 1) reactions during the induction
phase, the incidence and severity of which increased as induction
treatment progressed. Other findings of fissuring, desquamation and
scabbing were noted during the induction phase. Treated and negative
control animals were therefore challenged with the test substance at 5%
in acetone applied to a previously unexposed area of skin. Only very
slight reactions (grade +/-) were observed in 2 treated and 0 negative
control animals at the 1st reading 24 hours after challenge. Very slight
reactions (grade +/-) were observed in 5 treated and 1 negative control
animals at the 2nd reading 48 hours after challenge. All the positive
control animals showed evidence of skin sensitisation at both the 24 and
48 hours readings (grades 1 to 3), demonstrating test system sensitivity
and appropriateness of the test method.
On these bases the test substance was
considered to not be a skin sensitizer.
The key study, Naas D.J. (1987),
was considered reliable and accurate as a standalone study to fulfil the
data requirement. The study was conducted to OECD 406 and in compliance
with GLP, accordingly the study was assigned a reliability score of 1.
Migrated from Short description of key
The test substance failed to reveal skin
sensitization potential at challenge, following 9 exposure inductions,
in a Buhler test.
Justification for selection of skin
A single good quality study was available to
address the endpoint.
According to the criteria in directive
67/548/EEC and regulation (EC) No 1272/2008, the substance does not meet
the criteria for classification. The substance was found not to induce
sensitisation when tested in animals, and there are no known concerns in
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