• 약학회지
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• 제38권5호
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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.

• Toxicological Research
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• 제13권1_2호
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• pp.161-165
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• 1997

This study was conducted to investigate the skin irritation by transdermal administration of the three dyes. These dyes were originated from onion by using extraction method. By the order of extraction from onion, A-dye was obtained from onion by using water at 90-100$\circ$C. B-dye was extracted from A-dye with ethylacetate. After ethylacetate extraction from A-dye, the lower layer named as C-dye. Twenty-four New Zealand white rabbits were divided into three groups. The each groups was consisted of two subgroups according to high dose (extracted dyes) and low dose (the 100-fold dilutions of A-, Band C-dye). In primary skin irritation test of male New Zealand White rabbits, body temperature and weights were not significantly changed and blood cells were positioned in normal blood cell ranges of health rabbits. Primary irritation index was "0" in the test and control sites of all animals used in this study. By the results obtained in the present test, all dyes were evaluated as a non-irritant on the basis of the criteria of Draize.of Draize.

• Toxicological Research
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• 제26권1호
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• pp.61-66
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• 2010

Retinoids have many beneficial effects on dermatological applications. But, retinoids cause skin irritation. In this study, the safety of retinoids was clarified via both primary skin irritation test in rabbits and sensitization study using an integrated model for the differentiation of chemical-induced allergic and irritant skin reaction (IMDS), an alternative method to sensitization test. The effects of retinoids on the change of ultraviolet A (UVA)-induced matrix metalloproteinase-1 (MMP-1) in human skin fibroblasts and the modulation of type-1 pN collagen synthesis in hairless mice were examined to clarify the anti-wrinkle effects. Alltrans retinol (t-ROL) and its derivative, all-trans retinoic acid (t-RA), showed mild skin irritation but did not induce the sensitization. t-ROL and t-RA exerted anti-wrinkle effects by inhibiting the UVA-induced MMP-1 in human skin fibroblasts and increasing the type-1 pN collagen synthesis in hairless mice. These findings suggest that retinoids do not induce the allergy, and show anti-wrinkle effects by decreasing MMP-1 activation and increasing collagen synthesis.

• 동의생리병리학회지
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• 제25권2호
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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.

• 대한한의학방제학회지
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• 제24권4호
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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.

• Toxicological Research
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• 제19권1호
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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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• 제4권4호
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• pp.415-418
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• 1996

This study was conducted to investigate the skin irritation toxicity of Syndella gel, a combination topical drug containing a deproteinised dialysate of calf's blood and micronomicin sulfate in the ratio of 20 to 1, in New Zealand White rabbits. In the primary skn irritation test with male New Zealand White rabbits, there was no treatment-related effect on clinical sign, nd body weight was not significantly changed. The Primary Irritation index (PII) was 0.33, indicating that Syndella gel was a mildly irritating formulation.

• Biomolecules & Therapeutics
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• 제2권1호
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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.

• Biomolecules & Therapeutics
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• 제10권4호
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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.

• 약학회지
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• 제45권3호
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• pp.310-319
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• 2001

To compare skin irritation and cytotoxicity of anti-wrinkle agents, we examined skin irritation of six anti-wrinkle agents (ascorbic acid, glycolic acid, all trans-retinoic acid, ginseng extract, retinol, EB) in New Zealand white rabbit. Cytotoxicity of these agents was determined by MTT [tetrazolium salt 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide] at multi-time points in cultured HaCaT cell, a human immortalized keratinocyte cell. We then analyzed correlation between skin irritation and cytotoxicity by spearman's rank correlation analysis. All trans-retinoic acid showed the highest primary irritation index (0.92) in skin irritation test. Being all the six agents not irritant, retinal showed the most cytotoxic agents. The correlation between skin irritation and cytotoxicity ($IC_{50}$/ at different time point was 0.814, 0.757, 0.814 and 0.7 at 3, 24, 48 and 72 h, respectively. We also fecund that IC$_{20}$ and IC$_{80}$ of these agents showed similar correlation with skin irritation. These results therefore demonstrated that there is close correlation between skin irritation and cytotoxicity $IC_{50}$/ value by MTT in HaCaT cell at early time points by anti-wrinkle agents or IC$_{20}$ value. $IC_{50}$/ at earily time point or IC$_{20}$ values may be reliable alternative determinant of skin irritation.n.