Alternative Methods for Eye and Skin Irritation Tests: An Overview

Vinardell, M. Pilar; Mitjans, Montserrat

doi:10.1002/jps.21088

Cited by 163 publications

(108 citation statements)

References 90 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Alternative methods have been discussed for ocular toxicity assessment (30) . Many tests have been published using ex vivo tissue and cell culture of animal and human tissue (27,30,31) . Despite good reproducibility and sensitivity of several in vitro alternative model assays for ocular irritation, their predictive power was not as reliable as the rabbit Draize eye test (30) .…”

Section: Discussionmentioning

confidence: 99%

Assessment of ocular surface toxicity after topical instillation of nitric oxide donors

Cariello¹,

Souza²,

Lowen³

et al. 2013

Arq. Bras. Oftalmol.

View full text Add to dashboard Cite

Ethic committee from UNIFESP: number 1573/08. ABSTRACTPurpose: To evaluate the ocular surface toxicity of two nitric oxide donors in ex vivo and in vivo animal models: S-nitrosoglutathione (GSNO) and S-nitroso-Nace tylcysteine (SNAC) in a hydroxypropyl methylcellulose (HPMC) matrix at final concentrations 1.0 and 10.0 mM. Methods: Ex vivo GSNO and SNAC toxicities were clinically and histologically ana lyzed using freshly excised pig eyeballs. In vivo experiments were performed with 20 albino rabbits which were randomized into 4 groups (5 animals each): Groups 1 and 2 received instillations of 150 µL of aqueous HPMC solution containing GSNO 1.0 and 10.0 mM, respectively, in one of the eyes; Groups 3 and 4 received instillations of 150 µL of aqueous HPMC solution-containing SNAC 1.0 and 10.0 mM, respectively, in one of the eyes. The contralateral eyes in each group received aqueous HPMC as a control. All animals underwent clinical evaluation on a slit lamp and the eyes were scored according to a modified Draize eye test and were histologically analyzed. Results: Pig eyeballs showed no signs of perforation, erosion, corneal opacity or other gross damage. These findings were confirmed by histological analysis. The re was no difference between control and treated rabbit eyes according to the Draize eye test score in all groups (p>0.05). All formulations showed a mean score under 1 and were classified as "non-irritating". There was no evidence of tissue toxicity in the histological analysis in all animals. Conclusion: Aqueous HPMC solutions containing GSNO and SNAC at concentrations up to 10.0 mM do not induce ocular irritation.

show abstract

Section: Discussionmentioning

confidence: 99%

Assessment of ocular surface toxicity after topical instillation of nitric oxide donors

Cariello¹,

Souza²,

Lowen³

et al. 2013

Arq. Bras. Oftalmol.

View full text Add to dashboard Cite

show abstract

“…This key factor assists in the formulation of candidate selection for in vivo clinical studies. 11,12 Porcine ocular tissues offer a good model system because they are the closest to human beings after primate; this is due to the absence of the tapetum layer in porcine eyes, which is present in many other animals such as cows, sheep, and rabbits. Research into other mammalian corneas, mainly those of farmed animals, could also aid the research of veterinary ophthalmic formulation development.…”

Section: Introductionmentioning

confidence: 99%

The influence of freeze drying and &upsih;-irradiation in pre-clinical studies of flurbiprofen polymeric nanoparticles for ocular delivery using D-(+)-trehalose and polyethylene glycol

Yacasi¹,

López²,

Espina³

et al. 2016

IJN

View full text Add to dashboard Cite

This study investigated the suspension of poly(ε-caprolactone) nanoparticles as an ocular delivery system for flurbiprofen (FB-PεCL-NPs) in order to overcome the associated problems, such as stability, sterility, tolerance, and efficacy, with two different FB-PεCL-NP formulations. The formulations were stabilized with poloxamer 188 (1.66% and 3.5%) and submitted individually for freeze-drying and γ-irradiation with polyethylene glycol 3350 (PEG3350) and d -(+)-trehalose (TRE). Both formulations satisfied criteria according to all physicochemical parameters required for ocular pharmaceuticals. The FB-PεCL-NP formulations showed non-Newtonian behavior and sustained drug release. Ex vivo permeation analysis using isolated ocular pig tissues suggested that the presence of PEG3350 results in a reduction of FB transcorneal permeation. Moreover, TRE improved the penetration of FB across the cornea, especially after γ-irradiation. In addition, both formulations did not show a significant affinity in increasing FB transscleral permeation. Both formulations were classified as nonirritating, safe products for ophthalmic administration according to hen’s egg test-chorioallantoic membrane and Draize eye test. Furthermore, an in vivo anti-inflammatory efficacy test showed that irradiated FB-PεCL-NPs prepared with PEG3350 (IR-NPsPEG) have longer anti-inflammatory effects than those presented with irradiated FB-PεCL-NPs prepared with TRE (IR-NPsTRE). IR-NPsPEG showed a suitable physical stability after an aqueous reconstitution over >30 days. This study concludes that both formulations meet the Goldman’s criteria and demonstrate how irradiated nanoparticles, with innovative permeation characteristics, could be used as a feasible alternative to a flurbiprofen solution for ocular application in clinical trials.

show abstract

“…The study of eye irritation is one of the more classical studies performed on animals, usually rabbits and was developed many years ago to evaluate cosmetics and cosmetic ingredients [5]. This method is highly controversial and much efforts have been made to develop alternative methods [6].…”

Section: Eye Irritationmentioning

confidence: 99%

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

Vinardell

Mitjans

2017

Cosmetics

View full text Add to dashboard Cite

Abstract:The safety of cosmetics sold in Europe is based on the safety evaluation of each individual ingredient conducted by those responsible for putting the product on the market. However, those substances for which some concern exists with respect to human health (e.g., colorants, preservatives, UV-filters, nanomaterials) are evaluated at the European Commission level by a scientific committee, currently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulation (European Commission, 2009), it is prohibited in the European Union (EU) to market cosmetic products and ingredients that have been tested on animals. However, the results of studies performed before the ban continue to be accepted. In the current study, we evaluated the use of in vitro methods in the dossiers submitted to the SCCS in the period between 2013 and 2016 based on the published reports issued by the scientific committee, which provides a scientific opinion on these dossiers. The results of this evaluation were compared with those of an evaluation conducted four years previously. We found that, despite a slight increase in the number of studies performed in vitro, the majority of studies submitted to the SCCS is still done principally in vivo and correspond to studies performed before the ban.

show abstract

Alternative Methods for Eye and Skin Irritation Tests: An Overview

Cited by 163 publications

References 90 publications

Assessment of ocular surface toxicity after topical instillation of nitric oxide donors

Assessment of ocular surface toxicity after topical instillation of nitric oxide donors

The influence of freeze drying and &upsih;-irradiation in pre-clinical studies of flurbiprofen polymeric nanoparticles for ocular delivery using D-(+)-trehalose and polyethylene glycol

Alternative Methods to Animal Testing for the Safety Evaluation of Cosmetic Ingredients: An Overview

Contact Info

Product

Resources

About