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EC number: 232-476-2
CAS number: 8050-15-5
data is being read across from the source study that tested Resin acids
and Rosin acids, esters with pentaerythritol based on category read
across that is explained in the category justification document attached
in Section 13 of the dossier.
In a primary dermal irritation study, using
the method described in the International Standard ISO 10993-10:1995,
Biological Evaluation of Medical Devices-Part 10: Tests for Irritation
and Sensitization, Section 5.2 Skin Irritation Test, three male New
Zealand white rabbits were dermally exposed to two applications of 0.5
gram of UNITAC RLM (Resin acids and Rosin acids, esters with
pentaerythritol) for 4 hours under semi-occluded contact to intact skin.
Animals were then observed for 72 hours. No edema was observed during
the study. No signs of irritation were noted during
the study for one animal. Very slight erythema was noted at the
application site of two animals one hour after termination of exposure.
For one of these two animals, the very slight erythema persisted to the
24-hour observation. The irritation response was completely reversible
by 48 hours. The test substance produced individual Primary Irritation
Scores of 0.0, 0.0, and 0.3 for the three animals tested and a Primary
Irritation Index of 0.1 (negligible irritation). UNITAC RLM (Resin acids
and Rosin acids, esters with pentaerythritol) is not considered a dermal
irritant in this study.
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