• 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)

• Biomolecules & Therapeutics
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• v.4 no.2
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• pp.202-204
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• 1996

Clonidine, an antihypertensive drug, stimulates postsynaptic $\alpha_2$adrenergic receptors in the CNS and lowers arterial pressure by erects on both cardiac output and peripheral resistance. However, many patients experience that sedation and xerostomia occured upon oral administration of clonidine. These side effects are due to high plasma peak concentration and can be avoided when clonidine is given transdermally. In this study, we performed the skin irritation test for transdermal administration of clonidine patch on New Zealand white rabbits. Twelve New Zealand white rabbits were divided into two groups according to the dose levels, respectively. After transdermal administration of clonidine patch with two doses, clinical manifestations, body weight loss and postmortem findings were observed. We could not find any significant evidence of skin irritation by transdermal administration of clonidine patch.

• Journal of Pharmacopuncture
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• v.12 no.3
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• pp.61-72
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• 2009

Objectives : This experimental study was performed to investigate the safety and efficacy of Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. To identify the use of it as eye drop, the eye irritation test of rabbits and the antibacterial test of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans were performed. Methods : 1. The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Bovis Calculus pharmacopuncture solution was administered in the left eye of the rabbits, eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 2. After administering Bovis Calculus pharmacopuncture solution on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis, MIC(Minimum Inhibition Concentration) and the size of inhibition zone were measured. Anti-bacterial potency was also measured using the size of inhibition zone. Results : 1. After Bovis Calculus pharmacopuncture solution was administered in the left eye of the rabbits, it was found that none of nine rabbits have abnormal signs and weight changes. 2. After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, no eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 3. There was no response to MIC on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) after Bovis Calculus pharmacopuncture solution was medicated. Conclusions : The present study suggests that Bovis Calculus pharmacopuncture solution is a nontoxic and non-irritant medicine, which does not cause eye irritation in rabbits, but dosen't have antibacterial effects on bacterial species(Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis. These study result recommends that more research on other herbal medicines of eye drop for Keratitis are required.

• Journal of Pharmacopuncture
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• v.12 no.1
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• pp.21-33
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• 2009

Objective : This experimental study was performed to investigate the safety of Soyeom Pharmacopunture solution manufactured by extraction of alcohol and water. To identify the use of it as eyedrops, the eye irritation test of rabbits and antibacterial test of Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, and Candida albicans was performed. Methods : 1. The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Soyeom pharmacopuncture solution was administered in the left eye of the rabbits, eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 2. After administering Soyeom Pharmacopuncture solution on bacterial species (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) which cause Keratitis, MIC(Minimum Inhibition Concentration) and the size of inhibition zone were measured. Anti-bacterial potency was also measured using the size of inhibition zone. Results : 1. After Soyeom pharmacopuncture solution was administered in the left eye of the rabbits, it was found that none of nine rabbits have abnormal signs and weight changes. 2. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, no eye irritation of the cornea, iris and conjunctiva was observed at 1, 2, 3, 4 & 7day. 3. There was no response to MIC on bacterial species (Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Aspergillus niger, Fusarium oxysporum, Candida albicans) after Soyeom pharmacopuncture solution was medicated. Conclusions : The present study suggests that Soyeom pharmacopuncture solution is a non-toxic and non-irritant medicine, which does not cause eye irritation in rabbits, but dosen't have anti-bacterial effects on bacterial species which cause Keratitis. These study result recommends that more research on other herbal medicines of eye drop for Keratitis are required.

• Biomolecules & Therapeutics
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• v.2 no.3
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• pp.247-255
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• 1994

As a series of safety studies of DA-3030, a new rhO-CSF, its local irritancy was examined in the rabbits after the following treatment; application into the conjunctival sac of the eye(single), subcutaneous injection(single), intramuscular injection(single), and intravenous injection(8-day repeated). In addition, paravenous irritation of DA-3030 was investigated in mice. The results obtained were as follows. 1. In the result of ocular irritation test, 0.03% solution of DA-3030 could be considered as a non-irritating material. 2. The local irritation of DA-3030 by an injection of 0.5mι of its solution subcutaneously or intramuscularly was negligible and not so much different from that of saline. 3. In the vascular irritancy test, macro- and microscopic observations revealed that the irritating activity of DA-3030 in blood vessels was not different from that of saline when they were injected once a day into vein retroauricularis of rabbits for 8 days.4. The paravenous administration of DA-3030 did not induce any abnormal changes at injection sites except mild swelling in 1 mouse at 3 hours after injection which was thought to be due to slow absorption. The above-mentioned results suggest that DA-3030 has no irritating activity when injected through intravenous or subcutaneous route for clinical practice as 0.03% solution.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.30 no.1
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• pp.23-28
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• 2004

The aim of this study is to assess the anti-irritation activities of mung bean (Phaseolus aureus) extract against various irritants used in cosmetics. For its antidotal activity, mung bean has been used as a medicinal or cosmetic material since ancient times. However, there have been few reports describing the biological activities of these beans and no comprehensive surveys of the constituents. We obtained an ethanolic extract of mung bean and isolated the major constituents, such as vitexin and isovitexin. And we previously reported that the mung bean extract containing vitexin and isovitexin had excellent antioxidant and anti-inflammatory activities. To investigate the mechanisms of anti-inflammatory activity of mung bean extract, we examined the inhibitory effects on histamine release from rat peritoneal mast cells and lipoxygenase activity. Mung bean extract inhibited histamine release in a concentration dependent manner but showed no inhibitory activity in the 5-lipoxygenase assay. And, clinical studies were conducted to evaluate the anti-irritation effects of mung bean extract against various irritants used in cosmetics such as lactic acid, retinol, and preservatives. When 2.0％ of mung bean extract was applied to cosmetic formulae containing each of irritants, it revealed considerable anti-irritation efficacy. Our results of the human patch test with 20 volunteers showed that this extract reduced skin irritations caused by 5.0％ lactic acid, 4000 IU retinol, and 1.0％ preservative mixture by about 60％, 30％, and 50％ respectively. The stinging potential test for assessing subjective irritation also showed that the extract reduced the unpleasant sensations by about 50∼30％. Finally, we performed a double-blind usage test with 30 subjects to compare formulae containing mung bean extract with placebo. From the results of questionnaires for 4 weeks of use, we confirmed the excellent anti-irritation effect of mung bean extract. Conclusively, we could discover new material that had anti-irritation effects and apply this mung bean extract to the final cosmetic products successfully.

• Toxicological Research
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• v.21 no.3
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• pp.249-253
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• 2005

The present study was carried out to investigate the skin irritation potential of lemon grass essential oil in rabbits. A volume of 0.5 ml of test article was applied to intact and abraded skins, respectively, for 24 h in 6 healthy male New Zealand White rabbits. Parameters measured during 72 h observation period were mortality, clinical signs, body weight changes, and local irritation. All rabbits showed severe edema at both 24 h and 72 h after the application of test article. These animals also showed very slight to severe erythema and/or slight eschar formation at both 24 h and 72 h. The edema and erythema induced by lemon grass essential oil were recovered on day 7 of additional 11-day recovery period, but the eschar formation was not recovered at the end of recovery period. On the other hands, there were no treatment-related adverse effects on clinical sign, body weight and gross finding in rabbits. Based on these results, it was concluded that a single dermal application of the undiluted lemon grass essential oil caused very slight to severe edema, erythema and eschar formation in rabbits and showed a primary irritation index score of 5.63 indicating severe irritation. The results of this study strongly suggest that lemon grass essential oil should be used with care and in highly diluted forms especially when directly applied to the skin.

• Biomolecules & Therapeutics
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• v.3 no.3
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• pp.242-244
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• 1995

In vitro cell culture system has been proposed as a promising alternative model to in vivo skin irritation test. These studies were performed to screen the cytotoxicity effects of surfactants using normal human skin fibroblasts. Cell membrane integrity assessed by the leakage of lactate dehydrogenase (LDH) and mitochondrial integrity by MTT [3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyl tetrazolium bromides reduction test were affected in a dose dependent manner. The irritation potential of surfactants to human skin patch test, and the changes of capillary permeability by rabbit intradermal safety test were assessed as in vivo methods. Our results suggest that LDH leakage assay and MTT reduction test using cultured human fibroblasts could be predictive for the irritancy of various surfactants in human, and LDH assay is superior correlated with in vivo test (r=0.886) to MTT test with in vivotest (r=0.757).

• Journal of Apiculture
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• v.33 no.4
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• pp.277-282
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• 2018

Ethanol extracted propolis (EEP) was mixed with honey (honeypolis) to dissolve well in water and in vitro skin irritation test was conducted. In vitro method is designed to predict and classify the skin irritation potential of a chemical by assessment of its effect on $EpiDerm^{TM}$, a reconstituted three-dimensional human epidermis model. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure period. In this study under the given conditions honeypolis showed no irritant effects. Honeypolis meets acceptance criteria if: mean absolute OD 570 nm of the three negative control tissues is ${\geq}0.8$ and ${\leq}2.8$, mean relative tissue viability of the three positive control tissues is ${\leq}20%$, standard deviation of relative tissue viability obtained from each three concurrently tested tissues is ${\leq}18%$. Honeypolis is therefore classified as "non-irritant" in accordance with UN GHS "No Category".

• Biomolecules & Therapeutics
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• v.4 no.4
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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.