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EC number: 248-607-1
CAS number: 27689-12-9
primary skin irritation potential of the test article (liquid, batch
P2274001) was evaluated in New Zealand White rabbits. This study was
conducted in accordance with Swiss GLP (1986), OECD GLP (1992), US FDA
GLP 21CFR58, Japan MHLW (1988). The study design was based on Directive
92/69/EEC, B.4 (1992) and OECD 404 (1993). The test article was
administered as received. Hair was clipped from the dorsal skin of three
rabbits (1 male, 2 females). The test article (0.5 mL) was applied to a
6 cm2 area on the skin. Gauze was used to cover the site and create a
semi-occlusive dressing. The dressing was secured around the abdomen
with tape for a 4-hour exposure. Observations for skin irritation
(erythema and edema) were recorded at 1, 24, 48 and 72 hours after
unwrapping. The Primary Irritation Index (PII) was calculated. There
were no abnormal clinical signs or changes in body weight. All erythema
and edema scores were 0 throughout the study and the PII was 0. Based on
the results of this study (all scores were 0; PII = 0), the test article
is not a dermal irritant.
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