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EC number: 442-390-9
CAS number: 40573-09-9
The dermal sensitization potential of the test article was determined in
guinea pigs. The study was conducted in accordance with OECD GLP (1999).
The test method was based on EU Method B.6 (1996), OECD Guideline 406
(1992), and U.S. EPA: OPPTS:870.2600 (1998). On Study Day 1, female
guinea pigs (10, test group) were induced with 0.1 mL of 5% test article
in Tylose by intradermal injection in the dorsal region (2x4 cm). A
control group (5 female) were exposed in the same manner without the
addition of the test article. Two intradermal injections per animal of
50% Freund's Adjuvant, 5% test substance in Tylose, and test article
mixture in 50% Freund's Adjuvant were administered. The injection sites
were left uncovered. On Study Day 8, the second induction exposure of
0.5 mL of 25% test article in Tylose was administered to a 2 x 4 cm
cellulose patch. The patch was placed over the area where the
intradermal injections were administered. The exposure area was kept
under an occlusive bandage for 48 hours. No treatment was conducted from
Study Days 11-21. On Study Day 22, the challenge exposure of 0.5 mL of
25% test article in Tylose was administered on a 2 x 4 cm cellulose
patch. The administration area was kept under an occlusive bandage for
24 hours. Approximately 24 and 48 hours after the removal of the patches
the exposure area was examined for erythema and edema according the the
Magnusson/Kligmann scale. Body weights (Day -1 and Day 25) and clinical
signs (Daily) were recorded. The body weight gains of the animals were
not impaired. The treated animals showed no clinical signs of toxicity
throughout the study. No skin reactions were observed in the control and
treatment group 24 and 48 hours after removal of the challenge patch.
Based on the results of the study, the test article showed no evidence
for dermal sensitization potential.
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