• Toxicological Research
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• v.19 no.1
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• pp.39-44
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• 2003

Two local irritation and skin sensitization studies of nonspecific immunostimulator, $BARODON^{\circledR}$ were carried out with New Zealand White rabbits and Hartley guinea pigs. In skin irritation test of male New Zealand White rabbits, body weights were not significantly changed and there were no responses after treatment for 24 or 72 hours and the Primary irritation index (P.1.1.) was '0'. And, in the eye irritation test, there were chemosis in some of rabbits. One of 3 rabbits in washing group was detected chemosis after 24 and 72 h following treatment and 2 of 6 rabbits in non-washing group were detected chemosis after 24h and 7 days following treatment. Therefore, total score is '4' after 24 h and '2' after 72 h following treatment by conforming article "some blood vessel are clearly hyperemic" . However evaluation value is non-irritant because M.O.I. (Mean ocular irritation index) score is below during the all experimental period and no significance through individuals and exposure time. In skin sensitization, the score of skin reaction was graded 1 with 0% sensitization rate. Taken together, these results indicate that $BARODON^{\circledR}$ may be non-irritant material. material.

• Biomolecules & Therapeutics
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• v.23 no.4
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• pp.379-385
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• 2015

The eye irritation potential of drug candidates or pharmaceutical ingredients should be evaluated if there is a possibility of ocular exposure. Traditionally, the ocular irritation has been evaluated by the rabbit Draize test. However, rabbit eyes are more sensitive to irritants than human eyes, therefore substantial level of false positives are unavoidable. To resolve this species difference, several three-dimensional human corneal epithelial (HCE) models have been developed as alternative eye irritation test methods. Recently, we introduced a new HCE model, MCTT HCE$^{TM}$ which is reconstructed with non-transformed human corneal cells from limbal tissues. Here, we examined if MCTT HCE$^{TM}$ can be employed to evaluate eye irritation potential of solid substances. Through optimization of washing method and exposure time, treatment time was established as 10 min and washing procedure was set up as 4 times of washing with 10 mL of PBS and shaking in 30 mL of PBS in a beaker. With the established eye irritation test protocol, 11 solid substances (5 non-irritants, 6 irritants) were evaluated which demonstrated an excellent predictive capacity (100% accuracy, 100% specificity and 100% sensitivity). We also compared the performance of our test method with rabbit Draize test results and in vitro cytotoxicity test with 2D human corneal epithelial cell lines.

• Journal of Applied Biological Chemistry
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• v.59 no.3
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• pp.233-237
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• 2016

Deep sea water (DSW) contains many inorganic materials and minerals, which are extracted for use in diverse fields. However, before application, safety tests should be performed. In the present study, two DSW-extracted minerals were analyzed: calcium (Ca) and magnesium (Mg). Eye and skin irritation tests of DSW-extracted Ca and Mg were performed according to the guidelines of the Ministry of Food and Drug Safety of Korea. These two types of mineral extracts caused no symptoms of eye and skin irritation when compared to the control. These results suggest that DSW-extracted minerals caused no irritation in the eyes and on the skin, and could be safely applied to these areas.

• Toxicological Research
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• v.33 no.3
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• pp.191-203
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• 2017

Human eyes and skin are frequently exposed to chemicals accidentally or on purpose due to their external location. Therefore, chemicals are required to undergo the evaluation of the ocular and dermal irritancy for their safe handling and use before release into the market. Draize rabbit eye and skin irritation test developed in 1944, has been a gold standard test which was enlisted as OECD TG 404 and OECD TG 405 but it has been criticized with respect to animal welfare due to invasive and cruel procedure. To replace it, diverse alternatives have been developed: (i) For Draize eye irritation test, organotypic assay, in vitro cytotoxicity-based method, in chemico tests, in silico prediction model, and 3D reconstructed human cornealike epithelium (RhCE); (ii) For Draize skin irritation test, in vitro cytotoxicity-based cell model, and 3D reconstructed human epidermis models (RhE). Of these, RhCE and RhE models are getting spotlight as a promising alternative with a wide applicability domain covering cosmetics and personal care products. In this review, we overviewed the current alternatives to Draize test with a focus on 3D human epithelium models to provide an insight into advancing and widening their utility.

• YAKHAK HOEJI
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• v.38 no.5
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• pp.562-567
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• 1994

Now para-phenylenediamine(PPDA) is generally used as component of most hairdyes because it can be used more conveniently and effectively than the others. But PPDA become known to cause side effects such as skin sensitization, contact dermatitis and eye irritation. So this study was done to restudy the safety of hairdyes containing PPDA. The results of experiment were as follows. 1. As a result of primary skin irritation test and eye irritation test in white rabbits, the solution containing 5% PPDA(in saline) were classified as weak irritant but four kinds of commercial hairdyes containing PPDA were proved not to have any irritation. 2. As a result of skin sensitization test in guinea pig, four kinds of commercial hairdyes were classified as Calss I(week irritant) but three kinds of commercial hairdyes induced skin sensitization for guinea pig to 5% in test groups. These results indicate that the actual toxicity of commercial hairdyes(four kinds) is negligible. But based on the results of experiment, it is thought that there is possibility of some commercial hairdyes to induce skin sensititization.

• Molecular & Cellular Toxicology
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• v.3 no.1
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• pp.68-75
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• 2007

[ $\alpha$ ]-Terpinene has been known as a repellent against the mosquito Culex pipiens pallens Coquillett based on a human forearm bioassay. $\alpha$-Terpinene showed significantly greater repellency than a commercial formulation, N, N-diethyl-m-methylbenzamide (deet). In this study, skin and eye sensitivity of $\alpha$-terpinene (2%) was examined with bioassays using white New Zealand rabbits. There were somewhat gross and histological changes observed in these treatments. Eye irritancy assays examined gross changes to cornea, iris and conjuctiva, and histological changes to smear of ocular discharge and eye tissue. Treated rabbits were divided into two cohorts, a saline washed cohort (W) or a non-washed cohort (NW). Opacity of cornea and redness, chemosis and discharge of conjuctiva were observed in both cohorts, but disappeared within 4 and 10 days in W and NW, respectively. Main components of ocular discharges were fibrin, epithelial or epitheloid cells, lymphoid cells, erythrocytes and granulocytes. These abnormal cellular components disappeared within 4 days and 10 days in W and NW, respectively. No permanent histological differences were observed between the two cohorts. However, severe irritation was determined as 57.2 of I.I.O.I value on the first day after treatment. These findings indicate a spray-type solution containing 2% $\alpha$-terpinene may serve as an alternative mosquito repellent and further studies need to reduce the eye irritation with formulation changes.

• Herbal Formula Science
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• v.24 no.4
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• pp.289-300
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• 2016

Objectives : Taglisodog-eum(TSE), a poly herbal formula, has been widely used to improve carbuncles by removing inflammation of the lymphatic channels in Traditional Korean Medicine. We previousely reported the action mechanism of TSE on experimental atopic dermatitis and the establishment of formulation for TSE ointment. In this study, we examined the toxicity test on skin and eye irritation by TSE ointment to prove the safety of Taglisodog-eum ointment in clinical use. Methods : Acute skin toxicity of the TSE ointment was evaluated in Sprague-Dawley(SD) rats. After dermal administration of TSE ointment(2,000mg/kg), body weight, mortality, and clinical signs of the rats were observed for 14days. Primary skin irritation and ocular irritation tests for TSE ointment were performed in male New Zealand White Rabbits. In dermal and ocular irritation test, body weight, mortality, clinical signs, Primary Irritation Index(P.I.I.), and The Index of Acute Ocular Irritaion(I.A.O.I.) of rabbit were observed after applying at abraded skin and eye balls with Taglisodog-eum ointment. Results : In the results of acute skin toxicity, no significant differences were found in body weight, the clinical sign and the mortality between control and TSE ointment treated group. In primary dermal irritation test, body weight, the clinical sign and the mortality were not significantly changed and Primary Irritation Index(P.I.I.) was 0.8, indicating TSE ointment as weak irritant material. In ocular irritation test, The Index of Acute Ocular Irritaion was 0.0, indicating TSE ointment as non-irritating to the eye of the rabbits. To evaluate toxicity of the TSE ointment in animal test, body weight, the clinical signs, the skin and eye irritation check were conducted; TSE ointment was considered to be weak dermal irritant in test animals. The no response of eye irritation test was observed in this experimental condition. Conclusions : According to the above toxicity test, We consider that this results is helpful for saying about the safety of TSE ointment in clinical use.

• Korean Journal of Pharmacognosy
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• v.42 no.1
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• pp.76-81
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• 2011

The study of irritation and toxicity of honeybee(Apis mellifera. L) venom collected by a bee venom collector applied topically to the skin and mucous membrane were carried out to prove the safety of honeybee venom in clinical use. Animal for the research was the rabbit and the solution for the test was made from honeybee venom. Six animals were used for the skin test and nine animals were used for the eye mucous membrane test. In results, both tests proved that honeybee venom makes no irritable reaction on skin and eye mucous membrane of rabbit. We consider that this result is helpful for saying about the safety of honeybee venom in clinical use.

• Environmental Mutagens and Carcinogens
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• v.22 no.4
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• pp.296-302
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• 2002

In recent years, the safety of sunscreens have been challenged based on the reports of its adverse effects on users; dermatitis, allergic contact dermatitis, photoallergic contact dermatitis. In the toxicological aspect, the need to investigate the safety of sunscreens is steadily increasing. However, there were few studies on the correlation between sun protection factor (SPF) and the safety of sunscreens. The objective of this study was to assess whether there was a correlation between SPF and the skin irritation index of sunscreens. Octyl methoxycinnamate (OMC) was selected, which was the most frequently used (about 92% in korea and about 90% in the world) in sunscreens. In vitro SPF test was performed using the standard samples recommended by KFDA guideline. We examined primary and cumulative skin irritation and eye irritation of OMC standard sample as well as homosalate. As in vitro SPF was increased, skin irritation index was increased in primary skin irritation test ($r^2$=0.986) and cumulative skin irritation test ($r^2$=0.939). In addition, OMC was non-irritating and non-sensitizing. In this results, there was a good correlation between SPF index and skin irritation index.

• Analytical Science and Technology
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• v.34 no.6
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• pp.275-283
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• 2021

This study presents the development of cell-based microfluidic chips for the performance of acute eye irritation tests due to chemicals and examined some of their applications. Microfluidic chips were fabricated by photolithography and soft lithography, and they had three compartments with different areas for cell culture. Rabbit corneal epithelial cells were used for the eye irritation test. The death of cells cultured inside the chip was monitored at regular time intervals after treatment with an aqueous solution of chemicals, and the cell death rate constants were calculated based on the viability curve. The performance of the microfluidic chip was verified by examining the effects of cell-cell junctions, cell-substrate adhesion, and initial cell numbers compared to cell death rates. Eye irritation tests were performed at various concentrations of an aqueous solution of sodium dodecyl sulfate (SDS), a standard substance for the eye irritant test. The cells were exposed to the SDS aqueous solution for 300 s, and the resulting eye irritation was assessed by cell viability. Finally, the equation for calculating the toxicity score (TS) was derived based on the weighting factor for each compartment in the chip. The cell-based microfluidic chip developed in this study may be used for eye irritation tests from chemicals used in cosmetics and pharmaceuticals.