Topical Benzyl Alcohol Reduces Cataract Surgery Need: Two Long-Term Double Blind Studies

Testa, M.; Iuliano, Giuseppe; Morton, Pamela B.; Longoni, A.

doi:10.1089/jop.1987.3.211

Cited by 8 publications

(9 citation statements)

References 9 publications

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“…In each of two double-blind studies, 25 patients suffering from early progressive idiopathic cataracts, subcapsular or cortical in site, received one drop of saline containing 0.07% Benzyl Alcohol every 8 hours (Testa et al 1987). The eyelid was held open for at least 2 minutes.…”

Section: Benzyl Alcoholmentioning

confidence: 99%

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Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate

Nair¹

2001

Int J Toxicol

215

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Benzyl Alcohol is an aromatic alcohol used in a wide variety of cosmetic formulations as a fragrance component, preservative, solvent, and viscosity-decreasing agent. Benzoic Acid is an aromatic acid used in a wide variety of cosmetics as a pH adjuster and preservative. Sodium Benzoate is the sodium salt of Benzoic Acid used as a preservative, also in a wide range of cosmetic product types. Benzyl Alcohol is metabolized to Benzoic Acid, which reacts with glycine and excreted as hippuric acid in the human body. Acceptable daily intakes were established by the World Health Organization at 5 mg/kg for Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate. Benzoic Acid and Sodium Benzoate are generally recognized as safe in foods according to the U.S. Food and Drug Administration. No adverse effects of Benzyl Alcohol were seen in chronic exposure animal studies using rats and mice. Effects of Benzoic Acid and Sodium Benzoate in chronic exposure animal studies were limited to reduced feed intake and reduced growth. Some differences between control and Benzyl Alcohol-treated populations were noted in one reproductive toxicity study using mice, but these were limited to lower maternal body weights and decreased mean litter weights. Another study also noted that fetal weight was decreased compared to controls, but a third study showed no differences between control and Benzyl Alcohol-treated groups. Benzoic Acid was associated with an increased number of resorptions and malformations in hamsters, but there were no reproductive or developmental toxicty findings in studies using mice and rats exposed to Sodium Benzoate, and, likewise, Benzoic Acid was negative in two rat studies. Genotoxicity tests for these ingredients were mostly negative, but there were some assays that were positive. Carcinogenicity studies, however, were negative. Clinical data indicated that these ingredients can produce nonimmunologic contact urticaria and nonimmunologic immediate contact reactions, characterized by the appearance of wheals, erythema, and pruritis. In one study, 5% Benzyl Alcohol elicited a reaction, and in another study, 2% Benzoic Acid did likewise. Benzyl Alcohol, however, was not a sensitizer at 10%, nor was Benzoic Acid a sensitizer at 2%. Recognizing that the nonimmunologic reactions are strictly cutaneous, likely involving a cholinergic mechanism, it was concluded that these ingredients could be used safely at concentrations up to 5%, but that manufacturers should consider the nonimmunologic phenomena when using these ingredients in cosmetic formulations designed for infants and children. Additionally, Benzyl Alcohol was considered safe up to 10% for use in hair dyes. The limited body exposure, the duration of use, and the frequency of use were considered in concluding that the nonimmunologic reactions would not be a concern. Because of the wide variety of product types in which these ingredients may be used, it is likely that inhalation may be a route of exposure. The available safety tests are not considered sufficient to support the safety of these ingredients in formulations where inhalation is a route of exposure. Inhalation toxicity data are needed to complete the safety assessment of these ingredients where inhalation can occur.

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Section: Benzyl Alcoholmentioning

confidence: 99%

“…Benzyl Alcohol was well tolerated except in two patients (4%) where tolerance was fair in one and poor in the other. The investigators encouraged a large scale prospective trial noting that Benzyl Alcohol is already contained (though not at anticataract concentrations) in ophthalmic solutions (Testa et al 1987).…”

Section: Benzyl Alcoholmentioning

confidence: 99%

Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate

Nair¹

2001

Int J Toxicol

215

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“…This activity is attributed to mainly its antioxidant activity in addition to its stabilizing effect on lens membrane integrity and a stimulating effect on Na-K ATPase and membrane sodium pump (54). On the other hand, BB is reported to be irritating to the eyes on direct contact, but no damage has been reported from it (55).…”

Section: Discussionmentioning

confidence: 99%

In Vitro-Controlled Release Delivery System for Hydrogen Sulfide Donor

2014

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Abstract. Hydrogen sulfide (H 2 S) is having many potential pharmacological and physiological actions which reported that therapeutically useful concentration is low (100-160 μM) and a higher concentration could be toxic. Most of its donors produce it on coming into contact with water. All of these problems could be solved by a controlled-release delivery system which does not utilize water in any of its development steps. Therefore, 12 sustained release formulations were prepared by dissolving sodium hydrogen sulfide (NaHS)-a model H 2 S donor-in polymer solutions, prepared by dissolving polymers (consisted of either polylactide (PLA) or polylactide co-glycolide (PLGA), containing free carboxylic acid or capped allyl ester end group) in a mixture of benzyl benzoate (BB) and benzyl alcohol (BA). The formulation was injected in simulated tear fluid (STF) from which samples were withdrawn at specified times and assayed for NaHS content. We found decrease in burst and overall release with increase in polymer concentration from 10 to 20% w/v. The formulations containing free end group showed significant (p<0.05) reduction of burst release (11% vs 21%). However, the overall release or the average amount released per hour was found to be significantly (p<0.05) increased for formulations containing polymers with free end group than those with capped end group. A sustained level of H 2 S was found to be maintained for 72 h which should be further increased to a month to make it a viable H 2 S donor delivery system in addition to investigating toxicity profile specifically for the purpose of subconjunctival ocular delivery.KEY WORDS: controlled release; hydrogen sulfide; hydrogen sulfide donor; in situ gel forming; phase sensitive; smart polymer.

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“…The effects of DSF and CMZ on the development of selenite-induced cataracts in rats were compared with PRX because it is the most widely available preparation in Japan for the treatment of senile cataracts (25)(26)(27). However, some investigators have reported that PRX was not effective for the treatment of human cataracts (41,42). In this study we used PRXliposomes and a PRX solution at 5 and 6 times the concentration used clinically.…”

Section: Discussionmentioning

confidence: 99%

Preventive Effect of Eye Drops of Liposomes Containing Disulfiram and Cefmetazole on Selenite-Induced Cataract in Rat Pups

et al. 2006

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Disulfiram (DSF) and cefmetazole (CMZ), which possess with anti-oxidative activities were tested for anti-cataract effect in rats and were compared with pirenoxine (PRX), which is a marketed product used for the treatment of cataract. These compounds were encapsulated in liposomes and the results were compared with the anti-cataract effect of suspension and solution formulations containing same contents of each other agents. Instillations of DSF-and CMZ-liposomes prevented the development of cataract in seleniteinjected rat pups. On the other hand, no anti-cataract effects were observed in selenite-induced cataract rats instilled with DSF suspensions and CMZ solutions. The reduced form of glutathione (GSH) content of the lenses was decreased by approximately 60% of normal level 96 h after the sodium selenite-injection and the calcium (Ca 2+ ) content was increased. The decreased GSH and increased Ca 2+ levels were prevented by instillation of DSF-and CMZliposomes. Instillation of PRX-liposomes and 0.03% PRX solution had no effect on the development of cataract. The results of this study confirmed that anti-oxidative agents such as DSF and CMZ were useful to prevent cataract development related to oxidative stress.

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Topical Benzyl Alcohol Reduces Cataract Surgery Need: Two Long-Term Double Blind Studies

Cited by 8 publications

References 9 publications

Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate

Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate

In Vitro-Controlled Release Delivery System for Hydrogen Sulfide Donor

Preventive Effect of Eye Drops of Liposomes Containing Disulfiram and Cefmetazole on Selenite-Induced Cataract in Rat Pups

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