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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) was 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.
for classifying as a dermal sensitizer are not met.
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