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EC number: 500-464-9 | CAS number: 160901-27-9 1 - 2.5 moles ethoxylated
Gonadal tissues were examined for both gross pathology and histopathology and no treatment-related effects were detected.
The objective of the study was to obtain scientific data to determine the histopathological effects of the skin at treatment sites after repeated dermal exposure to the test substance over 91 days with a 28 day interim sacrifice.
Fifty ICR-Swiss CD-1 mice (25M, 25F) per group were assigned to each of the following treatment groups. The dose volume for each group was 0.1mL with the control group being sterile water, a 2.38 mg/day test group, and a 6.91 mg/day test group.
An area of 2 x 3 cm of the dorsal area of all animals was clipped and treated with the appropriate dose five times per week.
All animals were observed daily for signs of general health, mortality and gross skin irritation effects. Gross signs of toxicity and body weights were recorded on a weekly basis throughout the study.
After 28 days (21 dermal applications) 10 males and 10 females from each group were sacrificed and necropsied. The remaining animals continued on the treatment regimen until the termination of the study. At study termination (90-92 days from initiation of the study), 5 females from each group were sent to the sponsor for in-vitro skin penetration studies. The remainder of the animals, were sacrificed and necropsied.
At the 28 and 91 day necropsies, the following tissues were examined and preserved in formalin: brain, pituitary, thyroid, thymus, small and large intestine, heart, trachea, axillary and mesenteric lymph nodes, stomach, esophagus, uterus, skin from treated and dorsal non-treated areas, lungs, liver, spleen, kidneys, adrenals, urinary bladder, ovary, testis, eyes, aorta, pancreas, and carcass. The skin tissues from treated animals and dermal non-treated areas were examined histopathologically.
No mortalities were attributed to treatment and there were no significant differences in body weights in any animals throughout the study. Gross necropsies at interim or terminal sacrifice did not reveal any compounds related lesions with the exception of skin effects at the site of treatment.
At the 28 day interim evaluation, repeated dermal applications of 2.38 mg/day and 6.91 mg/day of the test substance did not result in any gross skin effects with exception of two animals per group, which exhibited scaling and erythema or scales in the dorsal area which were not deemed to be of significance. Histopathologic examinations of skin from animals treated with 2.38 mg/day and 6.91 mg/day of the test substance exhibited comparable skin effects as controls.
Furthermore, animals treated with 2.38 mg/day of the test substance did not exhibit any gross or microscopic compound related irritative effects after 91 days of treatment. However, mice treated with 6.91 mg of the test substance showed minimal or slight acanthosis in 12 of the 25 mice.
The test substance did not produce dermal irritation after 91 days of treatment at a dose of 2.38 mg/day. Increasing the dose to 6.91 mg/day over 91 days did induce some irritation effects. No systemic effects were identified at either dose level.
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