• 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.

• Biomolecules & Therapeutics
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• v.10 no.4
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• pp.246-252
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• 2002

In recent years, the safety of sunscreens has been challenged based on the reports of their adverse effect on users; dermatitis, allergic contact dermatitis and photo allergic contact dermatitis. The unscientific idea that higher SPF sunsreen is good for health mealeads many users to tend to prefer higher SPF sunscreen. 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 safety of sunscreens. We measured in vitro SPF index using homosalate as a standard and examined the toxicity tests such as primary skin irritation tests, ocular irritation test and skin sensitization test. Homosalate (HS), octyl methoxycinnamate (OMC), octyl salicylate (OS), octocrylene (OC) as UVB organic filter and benzophenone-3 (BP3), butyl methoxy dibenzoil methane (BMDM) as UVA organic filter, and titanium dioxide (TD), zinc oxide (ZO) as inorganic filters were used. The skin irritation indexes in rabbits treated with HS, OMC, OS, BP3, and BMDM were significantly increased as SPF indices were increased. Neither ocular irritation in rabbits nor skin sensitization in guinea pigs were increased. It suggests that there might be a good correlation between SPF and the skin irritation indices of organic UV filters and skin irritation might be one of most sensitive index to assess the safety of sunscreens.

• Journal of Physiology & Pathology in Korean Medicine
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• v.25 no.2
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• pp.212-216
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• 2011

In traditional medicines, Dansam-samul-tang and Samwhang-sasim-tang extracts were known to effects of antioxidant and antimicrobial activity. To investigate the safety evaluation of skin, these extracts were measured to skin safety testing such as primary skin irritation test, eye irritation test and skin sensitization test. The results of the primary skin irritation test and eye irritation test in vitro showed that these extracts included in the nonirritating area. Skin sensitization test results by Guinea Pig Maximization (GPMA) indicated that there was no allergy reaction. Therefore, Dansam-samul-tang and Samwhang-sasim-tang extracts were very safe in every safety test of skin. These results suggests that Dansam-samul-tang and Samwhang- sasim-tang extracts in 1 % concentration can be useful cosmetic ingredients.

• Biomolecules & Therapeutics
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• v.2 no.1
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• pp.71-76
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• 1994

Anti-inflammatory and analgesic activities and skin irritation of piroxicam patch were investigated. Piroxicam patch increased the pain threshold in rat hind paw inflamed by carrageenan and inhibited writhing induced by acetic acid in mice. Piroxicam patch also inhibited the carrageenan-induced edema in rat hind paw as well as the increased vascular permeability induced by histamine in rats. In adjuvant arthritis of rats, piroxicam patch showed anti-inflammatory effects. Skin irritation of piroxicam patch was tested in Newzealand White rabbits and evaluated by Primary Irritation Index of Draize. The results from skin irritation test showed that piroxicam patch seemed practically non-irritating. The result from the present study indicates that piroxicam may be useful without serious side effects as anti-inflammatory analgesics in this patch form.

• Journal of Food Hygiene and Safety
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• v.6 no.3
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• pp.171-177
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• 1991

According to the Established Regulations of National Institute of Safety Research, the skin-irritation test of BST-SR (Lucky Ltd.) was perfonned for seven days in New Zealand White Rabbits. During treatment periods no significant clinical symptom was observed. Significant changes such as erythema, scar tissue and edema were not shown on the applicating sites. According to Primary Irritation Index of Draize, skin irritation rate was assessed as "Zero". The eye irritation of BST-SR (Lucky Ltd.) was examined in nine New Zealand White rabbits, based on the Established Regulation of National Institute of Safety Research. 0.1 ml of test material was dropped on right eye, and after 20~30 seconds, three rabbits' eyes were cleaned with wann saline for 1 minute. Other six rabbits' eyes were left uncleaned. The untreated left eyes were negative control. The lesions of cornea, iris and conjuntiva were assessed by the Grade table (from the Regulation of National Institute of Safety Research), and it is concluded that BST-SR has no eye-irritation.

• Toxicological Research
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• v.21 no.1
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• pp.39-43
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• 2005

The present study was carried out to investigate the antibacterial activity against Staphylococcus aureus with antibiotic-resistance in vitro and the skin irritation in rabbits with surfactin produced by Bacillus subtilus Complex BC1212. The antibacterial activities of selected antimicrobial agents (surfactin, amoxacillin, colistin, norfloxacin and streptomycin) were evaluated by using the broth microdilution method. As the results, the minimum inhibitory concentration (MIC) of the surfactin was less than 15.6 ㎍/ml. In the skin irritation test, two out of 4 rabbits showed very slight edema at 24 h after the administration of surfactin, and then recovered at 72 h. The change of body weight was normal during the skin irritation test. The primary irritation index in accordance with the Draize evaluation of topical reaction was calculated to be '0.125', which meant not irritating. Based on these results, it could be concluded that the test agent, surfactin, was a non-irritant. We could also think that the surfactin may be useful for the treatment of S. aureus infections such as bovine mastitis.

• Toxicological Research
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• v.18 no.1
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• pp.87-98
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• 2002

This study was conducted to evaluate the safety of a recombinant human Factor VIII(GC-$\gamma$ AHF) manufactured by Korea Green Cross Company with different technology according to the Regulation of Korean Food and Drug Administration (l 998. 12. 3). In acute toxicity test, both genders of Sprague-Dawley rats and Beagle dogs were administered intravenously with GC-$\gamma$ AHF of three doses (3,125, 625 and 125 IU/kg), and single dose of 3,125 IU/kg, respectively. No dead animal and abnormal autopsy findings were found in Control and GC-$\gamma$ AHF treated group. Therefore, the 50% lethal dose ($LD_{50}$) of GC-$\gamma$ AHF was conidered to be higher than 3,125 IU/kg in rats and dogs. In the four weeks repeated intravenous toxicity study, GC-$\gamma$ AHF was administrated intravenosly to both genders of rats and dogs with 3 doses (500, 150, 50 IU/kg). There were neither dead animals nor significant changes of body weights during the experimental Period. In addition, no significant GC-$\gamma$ AHF related changes were found in clinical sign, urinalysis and other finding. Statistically changes were observed in hematological, biochemical and organ weight parameters of treated groups: however these changes were not dose dependent. No histopathological lesion were observed in both control and treated animals. Above data suggest that no observed adverse effect level of test materials in rats and dogs might be over 500 IU/kg/day in this study. In ocular irritation test, any injury on iris, conjunctiva and cornea in rabbits were not observed. The acute ocular irritation index (A.O.I.), mean ocular irritation index (M.O.I.) and Day-7 individual ocular irritation Index (I.O.I.) of GC-$\gamma$ AHF were 0. In the primary skin Irritation test, the primary irritation index (P.I.I.) oj GC-$\gamma$ AHF were 0. Therefore, the GC-$\gamma$ AHF is considered not to have the primary skin and eye toxicity in rabbits. In active systemic anaphylaxis (ASA) test, GC-$\gamma$ AHF and GC-$\gamma$ AHF emulsified with Freund's complete adjuvant (FCA) did not induce any symptom of anaphylactic shock in guinea pigs. In passive cutaneous anaphylxis (PCA) test, after sensitization with antisera of GC-$\gamma$ AHF sensitized mice, blue spots were observed on the hypodermis of back of rats, but diameter of each spot was smaller than 5 mm in each test groups except the positive control group. Based on the results of this study, GC-$\gamma$ AHF is not conidered to have any antigenic potential. In conclusion, at levels of up to 500 IU/kg, GC-$\gamma$ AHF did not produce treatment-related toxicity under the conditions of these acute-, four week repeated-toxicity, primary skin and eye toxicity, and antigenicity test.

• Proceedings of the Korean Society of Toxicology Conference
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• 2002.05a
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• pp.138-138
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• 2002

In recent years, the safety of sunscreens has been challenged based on the reports of its adverse effect on users; dermatitis, allergic contact dermatitis, photoallergic contact dermatitis. To investigate a correlation between sun protection factor (SPF) and the safety of sunscreens, we measured in vitro SPF index using homosalate as a standard and examined the toxicity tests on cosmetics; primary and cumulative skin irritation tests, ocular irritation test, and skin sensitization test.(omitted)

• 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.27 no.2
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• pp.188-193
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• 2012

This study was designed to evaluate to acute oral toxicity and skin irritation of Chrysanthemum dye in Sprague-Dawley (SD) rats. SD rats were orally treated with Chrysanthemum dye at a dose of 0, 1 and 2 ml/kg body weight. After oral administration, the rats were observed for 14days. In primary skin irritation test, SD rats were dermally treated with Chrysanthemum dye and observed for 3 days. To ensure the safety of Chrysanthemum dye such as the following were observed and tested. We examined the body weight, the feed intake, the clinical signs, the ophthalmological test, the histopathological test, the mortality and skin irritation. As a result, no significant differences were found in body weight, feed intake and histopathological test between control and Chrysanthemum dye treated group. In the result of skin irritation test, Chrysanthemum dye did not induce erythema and edema after topical application. Primary irritation index was "0" in the test. Therefore, it is suggested that Chrysanthemum dye has no effect on acute toxicity and side effect in SD rats and is non-irritant material based on the score "0" of primary irritation index.