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EC number: 224-506-8
CAS number: 4390-04-9
7.10.4/2: Intensity of responses observed on irradiated and control
sites (upper Right Arm)
Sites treated with MRD-88-295
Sites NOT Treated with MRD-88-295
Baseline - Examination before application of test material.
Results of examination after 24 hours of contact with either the test
material or control.
Results of examination 24 hours post-irradiation.
Results of examination 48 hours post-irradiation.
Results of examination 72 hours post-irradiation.
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 II study was performed in
order to determine the Phototoxicity and the Primary irritancy
propensities of MRD-88-295 in human skin.
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.
The Phase II study was performed with
a panel of 30 volunteers. The test substance was diluted at 50% w/w in
petrolatum and 0.3 g of solution were applied to skin of volunteers
under semi-occlusive patches for a period of 24 hours. The control site
was also covered with a similar semi-occlusive bandage without test
substance. After exposure, skin examinations were conducted. After
first exposure, participants received 0.3 g of undiluted MRD-88-295 (or
water for negative control site) on the same sites, which was removed
after 10 minutes. Then, for the phototoxicity determination, the right
arm was exposed to 15 min UV-A followed by 1 MED of UV-B. The left arm
was not exposed to UV to determine the primary irritancy. Both arms were
examined for dermal irritation at 24, 48 and 72 hours after exposure.Skin
reaction was not observed in any subjects.
Under the test conditions, MRD-88-295
did not elicit any effects which could be construed as characteristic of
a phototoxic propensity or a primary irritant.
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