• Korean Journal of Organic Agriculture
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• v.30 no.3
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• pp.423-439
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• 2022

The acute dermal and eye irritation tests of Photorhabdus temperata, a symbiotic bacterium of Heterorhabditis megidis Gwangju strain, were carried out in New Zealand white rabbit (Oryctolagus cuniculus), following the guidelines of OECD and Rural Development Administration (RDA) of Korea. In both tests, neither dermal nor eye responses were found from all the P. temperata treated rabbits and the results were classified as non-irritating. That is, erythema, eschar, edema, and any other dermal critical signs were not observed from all the experimental rabbits in the dermal irritation test. In the acute eye irritation test, no clinical signs of cornea, iritis, conjunctiva (redness, edema, lacrima, and chemosis) were observed from all the experimental rabbits. Individual ocular irritation, mean ocular irritation, and acute ocular irritation were calculated as 0.0. The results of dermal and eye irritation studies on P. temperata indicated that this bacterium could be a safe and effective alternative bionematicide against the most serious plant-parasitic root-knot nematodes in the genus Meloidogyne.

• 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.

• Toxicological Research
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• v.17 no.2
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• pp.91-96
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• 2001

Phthalates are widely used as plasticizers to impart softness and flexibility to normally rigid polyvinylchloride products. However, there are not much studies jar dermal and ocular irritation toxicity of phthalates. So we investigated the skin or eye irritation effect of some phthalates which was not reported. The primary skin irritation of diethyl phthalate (DEP), diisodecyl phthalate (DIDP), diisononyl phthalate (DINP), dipropyl phthalate (DPP) and dipropyl phthalate (DPrP) was studied. The ocular irritation of dibutyl phthalate(DBP), DIDP, DINP, DPP and DPrP was also studied. DEP, DIDP, DINP, DPP, and DPrP were found to be non-irritating to the skin of the test animals. DBP, DIDP, DINP and DPP were found to be non-irritating to the eye of the rabbits. DPrP caused the slight irritations to the eye in 1 or 2 days after treatment but irritation of the animals was soon recovered.

• 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.

• Toxicological Research
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• v.25 no.4
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• pp.237-242
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• 2009

This study was carried out to investigate the irritation of the prodigiosin isolated from Zooshikella rubidus on the skin and eyes in New Zealand white rabbits. The tests were performed on the basis of Korea Food and Drug Administration (KFDA) guidelines. Prodigiosin induced severe eye irritation at high concentration (0.5 g/site/ml) but there was no eye irritation at low concentration (0.3 mg/sitel ml). The primary irritation index was calculated from higher concentration (0.5 g/site/ml) to lower concentration (0.3 mg/site/ml). There were found non-irritation or induced mild irritation at lower concentration of prodigiosin application. On the basis of this study, it could be concluded that the prodigiosin may be non-irritant to mild irritant of usual application at lower concentration (0.3 mg/site) resulting it is safe and useful in dyeing technology of fabrics.

• 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.

• Toxicological Research
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• v.21 no.2
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• pp.115-119
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• 2005

In the present study, we evaluated the free radical scavenging and xanthine oxidase inhibitory activities exhibited by extracts obtained from the dried stems (and leaves) of Lespedeza bicolor We also assessed its potential irritation activities with regard to cosmetic use. When the DPPH radical scavenging activities of L. bicolor were assessed at six different concentrations (0, 50, 100, 250, 500 and 1000 ${\mu}g/ml$), the concentration of L. bicolor required to inhibit DPPH radical formation by $50\%$ was found to be $164.90{\mu}g/ml$. The effects of L. bicolor on the inhibition of xanthine oxidase were determined at seven different concentrations. The $50\%$ effective concentration was found to be $282.75{\mu}g/ml$. In the skin irritation test, all animals survived for the duration of the study, and all exhibited normal gains in body weight. The control sites exhibited no response to the control procedures. No edema, erythema, or eschar formation was observed in any of the tested rabbits. In the ocular irritation study, all of the rabbit eyes remained normal. In summary, L. bicolor extracts were considered to be non-irritating to the skin and eye.

• Toxicological Research
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• v.26 no.1
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• pp.9-14
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• 2010

The evaluation of eye and skin irritation potential is essential to ensuring the safety of human in contact with a wide variety of substances. Despite this importance of irritation test, little is known with respect to the irritation potency of lomefloxacin, a fluoroquinolone antibiotic, which has been known to cause phototoxicity with an abnormal reaction of the skin. Thus, to investigate the tendency of lomefloxacin to cause eye and skin irritation, we carried out in vitro eye irritation test using Balb/c 3T3, and in vitro skin irritation test using $KeraSkin^{TM}$ human skin model system. 3T3 neutral red uptake assay has been proposed as a potential replacement alternative for the Draize Eye irritation test. In this study, the $IC_{50}$ value obtained for lomefloxacin was 375 ${\mu}g$. According to the classification model used for determining in vitro categories, lomefloxacin was classified as moderately irritant. For evaluation of skin irritation, engineered epidermal equivalents ($KeraSkin^{TM}$) were subjected to 10 and 25 mg of lomefloxacin for 15 minutes. Tissue damage was assessed by tissue viability evaluation, and by the release of a pro-inflammatory mediator, interleukin- 1${\alpha}$. Lomefloxacin increased the interleukin-1${\alpha}$ release after 15 minutes of exposure and 42 hours of post incubation, although no decrease in viability was observed. Therefore, lomefloxacin is considered to be moderately irritant to skin and eye.

• Toxicological Research
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• v.18 no.1
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• pp.79-85
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• 2002

YHB216 is one of new recombinant human erythropoietins (rHu-EPO) developed by Yuhan Research Institute. The rHu-EPO products are widely being used for the treatment of various types of anemia. As a series of safety studies on YHB216, we performed the local irritation test (dermal & ocular application) in male New Zealand White rabbits and micronucleus test in male ICR mice. In the skin irritation test, 0.5 ml of YHB216 10,000 IU/ml solution was applied to the back skin of rabbits for 24 hours and sub-sequent observation was performed. There was no induced response after the treatment and the primary irritation index (P.I.I.) was‘0’. In the eye irritation test, 0.1 ml of YHB216 10,000 IU/mL solution was instilled into the conjunctiva of the eye. No treatment-related reaction was observed at the cornea, iris, and conjunctiva. In the micronucleus test, YHB216 was administered intravenously to male mice (6 mice per group) at dose levels of 0, 6,250, 12,500, and 25,000 IU/kg. Bone marrow cells were collected at 24 hours after the treatment. YHB216 treated groups showed no significant difference in the P/N (polychromatic erythrocyte/ normochromatic erythrocyte) ratio and in the number of micronucleated polychromatic erythrocyte com-pared with the control. In conclusion, YHB216 was found to be a non-irritating material up to 10,000 IU/ml in the local irritation test and to be a non-mutagen up to 25,000 IU/kg in the micronucleus test.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.26 no.1
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• pp.17-40
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• 2000

Cytotoxicity assays using artificial skins have been proposed as in vitro alternatives to minimize animal ocular and dermal irritation testing. Accordingly, the responses of artificial skins to the well-characterized chemical irritants toluene, glutaraldehyde, and sodium lauryl sulfate (SLS), and the nonirritant polyethylene glycol were studied. The evaluation of the irritating and non-irritating test chemicals was also compared with the responses observed in human dermal fibroblasts and human epidermal keratinocytes grown in a monolayer culture. The responses monitored included an MTT mitochondrial functionality assay. In order to better understand the local mechanisms involved in skin damage and repair, the production of several mitogenic proinflammatory mediators, interleukin-l$\alpha$, 12-HETE, and 15-HETE, was also investigated. Dose-dependent increases in the levels of かIn and the HETEs were observed in the underlying medium of the skin systems exposed to the two skin irritants, glutaraldehyde and SLS. The results of the present study show that both human artificial skins can be used as efficient in vitro testing models for the evaluation of skin toxicity and for screening contact skin irritancy.