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EC number: 257-406-8
CAS number: 51772-35-1
In a GLP-compliant acute dermal toxicity study (Limit Test) following
OECD guideline 402, young adult Wistar rats (5 males and 5 females) were
dermally exposed to a single dose of 2000 mg/kg bw of the test article
(as suspension in olive oil Ph.Eur) to the clipped skin (dorsal and
dorso-lateral parts of the trunk) and covered by semi-occlusive dressing
for 24 hours. The application area comprised at least 10% of the total
body surface area. The animals were observed for 14 days. No mortality
occurred. No signs of systemic toxicity or skin effects and no
macroscopic pathologic abnormalities were noted in the animals examined
at the end of the study. The mean body weight of the female animals did
not adequately increase during the first post-exposure observation week,
probably due to the bandage procedure, but increased during the second
week within the normal range. The mean body weight of the male animals
increased within the normal range throughout the study period, with the
exception of one male which showed stagnation of body weight during the
second week. Accordingly, the acute dermal median lethal dose (LD50) in
rats was determined to be greater than 2000 mg/kg bw.
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