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EC number: 928-868-4 | CAS number: 1073126-60-9
Table 7.10.4/2: Preliminary Phase I Study results: Intensity of responses observed on irradiated sites:
Duration of Exposure
Irritating reactions were observed for the 30 panelists. The least duration of UV-B exposure which produced erythema of Grade 1 (considered as the qualifying erythematous reaction) or greater was selected as the MED value for each panelist.
In four individuals, an exposure of 20 seconds of UV-B sufficed to produce the qualifying erythematous reactions. Exposure of 30 seconds in twenty individuals and 40 seconds in six individuals were required to achieve the same intensity of response.
This data is being read across from the source study that tested Hydrocarbons, C14-C19, isoalkanes, cyclics, <2% aromatics based on analogue read across.
This study included three phases which evaluated different propensities of the MRD-88-295 test substance as the first phase was only a preliminary test condition study.
The phase III of the study was performed to determine the potential of MRD-88-295 to cause dermal irritation and sentization in humans with or without UV irradiation.
A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin is irradiated by UV-B light. The least duration of UV-B exposure which produced erythema of Grade 1 or greater was selected as the MED value for each panelist. One volunteer was dropped out at the end of the phase II of the study.
Twenty-nine humans were exposed to MRD-88-295 for 24 hours followed by UV-B and UV-A irradiation (during three weeks). Then, exposure to MRD-88-295 was repeated for 24 hours. Dermal examinations occured at 24, 48 and 72 h test substance post-exposure. Dermal irritation and damage was scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" for slight erythema. MRD-88-295 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-88-295 showed no evidence being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen.
Under these test conditions, MRD-88-295 was not classified as a irritant to skin and a skin sensitiser.
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