Registration Dossier
Registration Dossier
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EC number: 434-850-2 | CAS number: 1680-31-5
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
The phototoxicity of the test item was assessed via the vitality of mice fibroblasts in the presence and in the absence of UVA irradiation. Comparing the cytotoxicity effects with and without UVAirradiation, the photoirritative potential of the test item can be deduced.
In a further study phototoxicity of topically applied test item was investigated. Skin reactions were not observed at any reading. Thus, the test item did not show any irritant or phototoxic effects in this investigation.
Additional information
The phototoxicity of the test item was assessed via the vitality of mice fibroblasts in the presence and in the absence of UVA irradiation. Results on the cytotoxicity effects with and without UVA irradiation revealed that the test item does not induce photoirritative effects. Phototoxicity is expected when the cytotoxicity effects increase at least by factor 5.
In a further study phototoxicity of topically applied test item was investigated in 30 volunteers (8 males and 22 females). The test item was applied once for 24 hours in duplicate occlusive patches to the skin of the upper arm. Patch area of one duplicate was irradiated with UV-A immediately after patch removal, the other duplicate area remained non-irradiated. Skin reactions were read immediately, 24, and 48 hours after patch removal and irradiation. Skin reactions were not observed at any reading and the overall irritation score of the two test articles is 0 for the non-irradiated and 0 for the irradiated patch areas.
Thus, the test item did not show any irritant or phototoxic effects in this investigation and has to be considered as non-irritant and non-phototoxic.
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