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EC number: 629-661-9 | CAS number: 83834-59-7
Three groups of rats, each containing 5 male and 5 female animals with intact skin and 5 male and 5 female animals with abraded skin were treated by topical application with test article Ethylhexyl Methoxycinnamate at levels of 500, 1500 and 5000 mg/kg bw/day for 28 consecutive days. In addition a control group of 5 male and 5 female animals with intact skin and 5 male and 5 female animals with abraded skin was given a similar topical application of distilled water at a dose level of 5000 mg/kg bw/day for 28 days.
No animals died during the observation period in any group. No overt signs of toxicity were apparent in any treated group or control group during the observation period. No effect on body weight gain was apparent in any treated group compared with the control groups. The skin reactions observed suggest the test article is a low grade irritant under the experimental conditions used. No ocular defects related to treatment could be detected during an ophthalmoscopic examination at week 4. No treatment-induced effects were apparent in the haematology and blood chemistry parameters measured. No treatment related changes in individual organ weights or organ/body weight ratios were apparent. No evidence of systemic toxicity was noted at necropsy in any of the tissues and organs evaluated. Histological evaluation of the skin sites revealed a low grade epidermal proliferation in all groups.The degree of epidermal change tended to be dose-related, and males tended to show more epidermal change than females. There was no appreciable difference between intact and abraded skin sites, and no significant dermal inflammatory or fibrotic responses were seen in any rat.
Overall, a minimal to moderate epidermal proliferation in the absence of significant dermal changes suggested that the test article was a relatively low grade irritant under the prevailing experimental conditions. There was no evidence of systemic toxicity histologically in any of the other organs or tissues examined. A NOAEL of 5000 mg/kg bw/day was established and the substance does not need to be classified as toxic after repeated exposure according to the criteria outlined in Annex I of 1272/2008/EC.
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