• Journal of Pharmacopuncture
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• v.25 no.1
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• pp.46-51
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• 2022

Objectives: This study was performed to evaluate the skin irritation toxicity of processed sulfur. Methods: All experiments were conducted at Medvill (Korea), an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate skin irritation toxicity of processed sulfur, we divided the back of six rabbits into two control sites and two test sites. One of each of the two control and test sites was then designated abraded sites and intact sites. In test sites, 0.5 g of processed sulfur was applied to the back of the rabbit for 24 hours, and in control sites, 0.5 g of sterile distilled water was applied in the same way. We observed and evaluated mortality, weight, general symptoms, and skin irritation toxicity. This study was conducted with the approval of the Animal Ethics Committee (Approval number: IAC2020-1549). Results: In all experiments, no dead animals were observed. In all cases, skin coloration was observed at 24 hours after processed sulfur administration. This coloration lasted up to 48 hours and is believed to be the effect of the administration of test substances. Weight measurement indicated that weight was lost 72 hours after administration in three cases, but this is considered an accidental weight change. Normal weight gain was observed in the remaining subjects. In all animals, no skin irritation toxicity was observed, and the primary irritation index (P.I.I) was calculated as 0.0 according to Draize's evaluation method. Conclusion: The above findings suggest that it is relatively safe to apply a processed sulfur to the skin. Further research on this topic is needed to provide more specific evidence.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.17 no.1
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• pp.64-80
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• 1991

The SKINTEX Method is based on a two-compartment physico-chemical model which includes a Biomembrane Barrier in compartment one and an organized macromolecular matrix in compartment two. Test samples absorb onto or permeate through the keratin/collagen Biomembrane Barrier and then can interact with the organized macromolecular matrix. Changes in the integrity of the barrier release a dye indicator: Changes in the matrix can alter its transparency. The sum of these two responses is read spectrophotometrically at 470nm. An early investigation of 950 chemicals and formulations in the SKINTEX System produced results which were 89% concordance to in vivo Draize dermal irritation results obtained with 24-hour occluded application of test samples with-out abrasion and standard scoring. Alkaline materials were analyzed in a specialized SKINTEX AMA Protocol. In this early study, the model did not distinguish nonirritant test materials and formulation with PDII(Primary Dermal Irritation Index)in the range from 0 to 1.2, A High Sensitivity Assay Protocol(HSA)was developed to amplify the changes in both compartments of this model and provide more accurate calibration of these changes. A study of 60 low irritation test samples including cosmetics, household products, chemicals and petro-chemicals distinguished nonirritants with PDII $\leq$ 0.7 for 26 of 30 nonirritants. A second protocol was developed to evaluate the SKINTEX model predictability with respect to human irritation. The Human Response Assay (HRA )has been optimized based on differences in penetration and irritation responses in humans and rabbits. An additional 32 test materials with different mechanisms and degrees of dermal toxicity were evaluated by the HRA. These in vitro results were 86% concordant to human patch test results. In order to further evaluate this model, a Standard Chemical Labelling (SCL) Protocol was developed to optimize this system to predict Draize dermal irritation results after a 4-hour application of the test material. In a study of 52 chemicals including acids, bases, solvents, salts, surfactants and preservatives, the SCL results demonstrated 85% concordance to Draize results for a 4-hour application of test samples on non-abraded rabbit skin. The SKINTEX System, including three specialized protocols, provided results which demonstrated good correlation to the endpoint of dermal irritation in man and rabbits at different application times.

• Journal of the Korean Society of Food Science and Nutrition
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• v.39 no.8
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• pp.1213-1219
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• 2010

We evaluated the anti-aging potential and safety of black garlic extract for cosmeceutical ingredient. Black garlic was made by spontaneous fermentation for 40 days at $60{\sim}70^{\circ}C$, 85~95% RH without any additives. The 10% black garlic extract had sweet odor, antioxidant activities and inhibitory activities of skin againg enzymes such as tyrosinase and elastase. The skin safety was performed to evaluate of potential toxicity using the primary irritation test and skin sensitization test. The black garlic extract did not show any adverse reactions such as erythema and edema on intact skin sites at primary irritation test, but on abraded sites, some experimental animals showed very slight erythema. So, the black garlic extract was classified as a practically non-irritating material based on the score 0.23 of primary irritation index. The skin sensitization study was tested by the guinea pig maximization test (GPMT) and Freund's complete adjuvant (FCA) with intradermal injection of 10% black garlic extract. The skin sensitization test showed no skin sensitization. The allergic sensitization depends on tumor necrosis factor-$\alpha$ (TNF-$\alpha$) and interleukin-6 (IL-6). The concentration of IL-6 on challenged tissue of treated with black garlic extract was not significantly different with negative control group (saline treated group). Based on this study, the potential for black garlic as a cosmeceutical ingredient was proven.

• Journal of Food Hygiene and Safety
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• v.22 no.2
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• pp.110-115
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• 2007

This test was performed to evaluate the skin irritation and sensitization of Creocomplex, disinfectant, Containing 10% 4-chloro-m-cresol, 10% didecyl dimethyl ammonium chloride, and 10% glutaraldehyde. In primary skin irritation test, rabbits were dermally treated with Creocomplex for 24 hrs. The disinfectant did not induce any adverse reactions such as erythema and edema on intact skin sites, but on abraded skin sites, some rabbits showed very slight erythema and edema 24hr after topical application. So, the disinfectant was classified as a practically non-irrifating material based on the score 0.13 of primary irritation index. In the skin sensitization test, guinea pigs were sensitized with intradermal injection of 0.1ml Creocomplex for 24 hr. After 1 week, Creocomplex was treated on the site of injection, and challenged 2 weeks later. Creocomplex did not induce any allergic reactions. Therefore, 10% Creocomplex was graded as a weak material from 0 in both sensitization score· and rate. From results of the present study, it is suggested that 10% Creocomplex does not cause contact irritation and sensitization.

• Journal of Food Hygiene and Safety
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• v.36 no.1
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• pp.17-23
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• 2021

This evaluation tested the skin irritation and sensitization of an acaricide (Wagoojabi II®, WGJB) for the control of poultry red mite, containing 20% Chamaecyparis obtusa oil and 56% Cinnamomum camphora oil. In a primary skin irritation test, rabbits were dermally treated with WGJB for 24 h. The acaricide did not induce any adverse reactions such as erythema and edema on intact skin sites, but on abraded skin sites, some rabbits showed very slight erythema and edema 24 h after topical application. So, the acaricide was classified as a practically mild-irritating material based on a 0.625 primary irritation index score. In the skin sensitization test, guinea pigs were sensitized with intradermal injection of 0.1mL WGJB for 24 h. After 1 week, The WGJB was treated on the site of injection, and challenged 2 weeks later. The WGJB did not induce any allergic reactions. Therefore, the WGJB was graded as a weak material at '0' in both sensitization score and rate. From the results of this study, it is suggested that WGJB does not cause contact irritation and sensitization.

• Journal of Food Hygiene and Safety
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• v.26 no.4
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• pp.377-382
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• 2011

This test was performed to evaluate the acute oral toxicity and skin irritation of Lamia-Kill$^{(R)}$, disinfectant, containing 20% benzalkonium chloride and 10% citric acid. In acute oral toxicity, Lamia-Kill$^{(R)}$ was orally administered at dose levels of 2,000, 1,000, 500, 250 and 0 mg/kg body weight. After single oral administration to both sexes of SD rats, the rats were observed for 14 days. In primary skin irritation test, New Zealand white rabbits were dermally treated with Lamia-Kill$^{(R)}$ for 24 hr and observed for 3 days. All rats treated with Lamia-Kill$^{(R)}$ were induced no toxic signs in mortalities, clinical findings, body weights and gross findings. Also, the disinfectant did not induce any adverse reactions such as erythema and edema on intact skin sites for the most part rabbits, but on abraded skin sites, some rabbits showed very slight erythema on 24 hr after topical application. With the results of this study, Lamia-Kill$^{(R)}$ have no effect on acute toxicity and side effect in SD rats and was classified as a practically non-irritating material based on the score 0.50 of primary irritation index.

• Parasites, Hosts and Diseases
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• v.55 no.4
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• pp.409-416
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• 2017

The high prevalence of pediculosis capitis, commonly known as head lice (Pediculus humanus capitis) infestation, has led to the preparation of a community-based pediculicidal ointment, which is made of common household items and the extract of Tinospora crispa stem. The present study aimed to evaluate the safety, efficacy, and physicochemical characteristics of the T. crispa pediculicidal ointment. The physicochemical properties of the ointment were characterized, and safety was determined using acute dermal irritation test (OECD 404), while the efficacy was assessed using an in vitro pediculicidal assay. Furthermore, the chemical compounds present in T. crispa were identified using liquid-liquid extraction followed by ultra-performance liquid chromatography quadruple time-of-flight mass spectrometric (UPLC-qTOF/MS) analysis. The community-based ointment formulation was light yellow in color, homogeneous, smooth, with distinct aromatic odor and pH of $6.92{\pm}0.09$. It has spreadability value of $15.04{\pm}0.98g{\cdot}cm/sec$ and has thixotropic behavior. It was also found to be non-irritant, with a primary irritation index value of 0.15. Moreover, it was comparable to the pediculicidal activity of the positive control $Kwell^{(R)}$, a commercially available 1% permethrin shampoo (P>0.05), and was significantly different to the activity of the negative control ointment, a mixture of palm oil and candle wax (P<0.05). These findings suggested that the community-based T. crispa pediculicidal ointment is safe and effective, having acceptable physicochemical characteristics. Its activity can be attributed to the presence of compounds moupinamide and physalin I.

• Journal of Pharmaceutical Investigation
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• v.28 no.3
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• pp.177-183
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• 1998

Low toxicity, reverse thermal gelation and high drug loading capabilities suggest that poloxamer 407 gels have great potential as a topical drug delivery system. Kojic acid (KA) is an antimelanogenic agent which has been widely used in cosmetics to whiten the skin color. However, it has the drawbacks of skin irritancy due to its acidic pH. Poloxamer gels of different polymer contents were formulated to overcome the problem and compared to the cream type formulations of either w/o/w multiple emulsion cream or o/w type emulsion cream. Using Franz diffusion cells mounted with a synthetic cellulose membrane (MWCO 12,000), drug release characteristics of the formulations were evaluated by the HPLC assay of KA concentration in the receptor compartment of pH 7.4 phosphate buffered saline solutions. Drug release from w/o/w multiple emulsion cream was controlled by oil membrane, showing the apparent zero order release kinetics. The KA release from the poloxamer gels was also controlled by the gel matrix, showing that drug release increased linearly as KA contents increase, but decreased exponentially as the polymer contents increase. In the skin irritancy test, the primary irritancy index(PII) of poloxamer gel base was lower than those of multiple emulsion cream base and o/w cream. Depending on KA contents or polymer contents in the gel. PH values in poloxamer gels were ranged from 1.3 to 2.0, which are interpreted as low or negligible irritation on skin. There was a good correlation between the log value of flux in drug release and PII value in skin irritation. It was possible to conclude that the poloxamer gels containing KA might be a good candidate for an antimelanogenic topical delivery system by virtue of the controlled release of the drug and the reduced skin irritancy.

• The Korean Journal of Pesticide Science
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• v.16 no.3
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• pp.261-266
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• 2012

It is common to use many experiment animals to evaluate the toxicity of chemicals including pesticides. For protecting animal, the concepts of 3R (Reduction, Replacement, Refinement) were introduced and in vitro alternatives methods actively have been developed all over the world. Many experimental animals for toxicological tests have been used, so that it is important to establish the alternative methods. In this study, the alternative method using reconstituted human skin model (Keraskin$^{TM}$) was conducted for classification of skin irritation on pesticides. Sixteen formulations selected on the basis of the degree of irritation were treated by Keraskin$^{TM}$ test. The percent of cell viability was measured into the culture medium collected after treatment of the pesticides for 24-72 hrs. The skin irritations of formulations were evaluated by the cell viability. In this study, The 4 formulations with mild irritation in rabbits were evaluated as nonirritant, the 6 formulations with moderate and severe irritation were evaluated as irritant in human skin model test. We suggest that the alternative test using Keraskin$^{TM}$ model could be used as toxicity evaluation for primary irritation index (P.I.I.) score of greater than or equal to 2.1 of pesticides. The further studies should be required to apply for hazardous assessment of pesticides on alternative skin irritation methods because of the interindividual variability of the sensitivity of skin irritation on pesticides.

• Journal of the Korean Society of Food Science and Nutrition
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• v.33 no.4
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• pp.641-645
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• 2004

Crude chondroitin sulfates extracted from midduck tunics (Styela clava) and munggae tunics (Halocynthia roretzi) were examined in vivo in order to be utilized as a cosmetic material which was followed by an in vitro assay. Examinations, such as acute oral toxicity, skin sensitization, acute eye irritation, and primary skin irritation, were peformed with a variety of laboratory animals. Phototoxic and photosensitization tests were not conducted since all chondroitin sulfates failed to absorb U.V. light at the range of 280 to 420 nm. In acute dermal and eye irritation, both specific clinical signs and dead cases were not demonstrated during the test period, but crude chondroitin sulfates from midduck and munggae tunics, and standard chondroitin sulfate from bovine trachea were showed 2.5, 1 and 1.25 of acute ocular irritation index (A.O.I.), respectively. In the case of skin sensitization, crude chondroitin sulfate from midduck tunics exhibited neither specific clinical signs nor dead cases in the entire course of the examination. While in acute oral toxicity, crude chondroitin sulfates from both midduck and munggae tunics found neither specific clinical signs nor dead cases during the test, and LD50 was suspected to be over 2 g/kg. Based on this study, it was proven that crude chondroitin sulfates from either midduck or munggae tunics can be used safely as a cosmetic material.