Human Sensitization and Irritation Tests

The fact that sodium hypochlorite is not a sensitizer is a significant advantage that sodium hypochlorite solutions have over some other topical antiseptics. To clarify sensitization potential, Hazelton Laboratories examined 1.1% sodium hypochlorite solution using a standard test for predicting sensitization or allergic reactions, the Guinea Pig Maximization Test [46]. This test consisted of dermal and intradermal application of various concentrations of test solutions of sodium hypochlorite as an induction dose, followed 2 weeks later by a challenge dose of sodium hypochlorite solution. No reaction to the challenge dose was observed with sodium hypochlorite. The author concluded that sodium hypochlorite was not a skin sensitizer in guinea pigs. This test has often been used as a screening test for human use and has been predictive of potential sensitization in humans. The most used predictive test procedure for topical products is a human patch test read for irritation and a patch test using induction and challenge doses to produce sensitization reactions.

Alcavis has conducted both tests with their product containing 0.1% (1,100 ppm) sodium hypochlorite.

(1) A cumulative Irritation Patch Study was conducted on the Amuchina 0.11% sodium hypochlorite, then called Amu-Skin [47]. The formulation and the vehicle were both tested for its potential to cause irritation and/or sensitization to the skin of normal volunteer subjects using a blinded, randomized, semi-occlusive 21-day cumulative irritation patch study with challenge. There was no significant irritation in the irritation phase of the study. There was no evidence of sensitization to any of the products evaluated in the challenge phase of the study.

(2) A Repeated Insult Patch Study was also performed by Amuchina (TKL Laboratories [48] performed the test). In this test, 0.1% sodium hypochlo-rite (Amu-Skin) was evaluated neat to determine its ability to sensitize the skin of normal volunteer subjects using a blinded, randomized, occlusive, repeated insult patch study. Under the conditions employed in this study, using 194 subjects, there was no evidence of sensitization to Amu-Skin or to the vehicle.

Sodium hypochlorite has been showed to be essentially non-irritating, and not an inhibitor of the wound healing process. Further, it has not shown any potential as a skin sensitizer. Therefore, sodium hypochlorite should be safe for the proposed indications at the proposed concentrations.

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  • juhana sainio
    Is sodium hypochlorite a sensitizer?
    3 years ago

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