RESUMEN CORTO - SHORT SUMMARY:

A new ear cleaner has been developed for cats and dogs. It contains Ophytrium, a purified natural ingredient selected for its high tolerance and simultaneous threefold action on skin barriers. In absence of guidelines for non-drug veterinary products, original protocols were designed to test target species tolerance.

First, the ototoxicity of key ingredients was checked with an in vitro zebrafish assay.

Then, sixteen cats and sixteen dogs were separately enrolled in two tolerance studies. In each study, two groups of eight animals were designed: group 1 received the lotion three times a week for three weeks, and group 2 received the lotion every day for two weeks. In each animal, the left ear received the test lotion, and the right ear received a 0.9% NaCl solution as a negative control. Investigations consisted of neurological examinations, auditory brain response (cats only), video-otoscopy, Interleukin-8 (IL-8) dosage, ear canal cytology and blood analyses.

All examinations were normal for both groups and both species. The only significant finding was an increase in the cerumen production in the left ears after one week of applications, with no cytological evidence of microbial development. This effect reversed spontaneously. Concentrations of IL-8 (inflammation marker of the ear canal) remained stable, excluding inflammatory origin. A “bouncing effect” (compensation of the delipidation due to intense cleaning of healthy ears) could explain this cerumen increase. Such effect is considered as non-adverse.

In conclusion, the new Ophytrium-containing ear cleaner was well tolerated in cats and dogs under acute conditions.

BIBLIOGRAFÍA:

1. Ollivier E, Zemirline C, Amalric N, Rahoul V, Reymond N, Cadiergues M-C. “Efficacy of the ingredient A97614A1 in a model of reconstructed human epidermis stressed by cytokines,” in BSAVA 62nd BSAVA Congress Proceedings; 2019 Apr 4-7th. British Small Animal Veterinary Association (2019). p. 442–3.

2. Ollivier E, Zemirline C, Marchand L, Closs B. Effect of the ingredient A97614A1 on the adhesion and biofilm formation of Staphylococcus pseudintermedius in a model of reconstructed canine epidermis. 62nd BSAVA Congress Proceedings; 2019 Apr 4-7th, Birmingham, UK. British Small Animal Veterinary Association (2019). p. 442–3.

3. Regulation (EC) No 1223/2009 of the European Parliament and of The Council of 30 November 2009 on Cosmetic Products (recast). Available online at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20190617

4. Ribet V, Gurdak M, Ferret PJ, Brinio E, Giordano Labadie F, Rossi AB. Stepwise approach of development of dermo-cosmetic products in healthy and atopic dermatitis (AD) paediatric population: safety evaluation, clinical development and post-market surveillance. J Eur Acad Dermatol Venereol 2019; 33(12):2319-2326.

5. Chiu et al. (2008) Using the zebrafish lateral line to screen for ototoxicity. J Assoc Res Otolaryngol. 9(2):178-90.

TOLERANCE ASSESSMENT OF A NEW OPHYTRIUM-CONTAINING EAR CLEANER IN CATS AND DOGS.