• 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.

• YAKHAK HOEJI
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• v.40 no.2
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• pp.155-162
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• 1996

Hyperkeratinization is a dermatologic disorder, which is due to the increase of corneocyte cohesion force. Glycolic acid, an alpha hydroxy acid(AHA), has been used to breakdown the hyperkeratinization processes. However, it has a problem of skin irritation when applied topically, due to the strong acidity especially in high concentration. A molecular optimization of glycolic acid has been tried to reduce the skin irritation by the way of prodrug formation. Ethyl glycolate was synthesized by the esterification of glycolic acid with ethanol in acidic conditions in the presence of sulfuric acid, and examined under the spectroscopic trials, such as UV, IR, $^1H$-NMR, and GC-MS. The physicochemical and biopharmaceutical properties of the prodrug were also evaluated. Through the toxicological tests of both skin irritation and eye mucous irritation, it has been proved that ethyl glycolate was less irritant than glycolic acid, since the pH value of synthetic prodrug was higher than that of glycolic acid. In the penetration test through nude mouse skin by diffusion cell, ethyl glycolate was continuously hydrolyzed to glycolic acid, which was assayed form the receptor compartment. It was obtained that the penetrated amount of ethyl glycolate was five times higher than that of glycolic acid. These results suggest that ethyl glycolate might be a successful prodrug of glycolic acid to reduce the skin irritation and to increase the skin penetration as well.

• 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.

• 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.

• 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.

• Biomolecules & Therapeutics
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• v.1 no.1
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• pp.20-25
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• 1993

DA-125, a new anthracycline derivative, shows significant anticancer activities. We conducted a study to examine the local irritating effect of DA-125 using mice and rabbits. In the skin test in mice, intradermal injection of 0.4 mg of DA-125, compared to a dosage of 0.2 mg of adriamycin, had weak irritating potentials to induce skin ulceration and erythematous induration. A dosage of 0.6 mg of DA-125 produced similar degree of lesions in perivascular irritation model to that of 0.2 mg of adriamycin, but the healing time was shorter in the case of mice treated with DA-125. In ocular irritation study in rabbit, the highest M.O.I.(mean ocular irritation index) of 0.5% DA-125 solution was 0.67, therefore DA-125 could be considered as a practically non-irritating anticancer agent. These results suggest that substitution of DA-125 for Adriamycin would reduces the possibility of outbreaks of local irritation and the severity of the lesions.

• Proceedings of the Korean Society of Toxicology Conference
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• 2002.11b
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• pp.195-195
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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 skin irritation tests, ocular irritation test, and skin sensitization test.(omitted)

• Biomolecules & Therapeutics
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• v.10 no.3
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• pp.170-174
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• 2002

The local irritation study (skin and occular irritation tests) of HM10411, a rhG-CSF (recombinant human granulocyte-colony stimulating factor) was carried out in New Zealand White rabbits. HM10411 was applied to the bare skin at a dose of 2.5 mg/rabbit (5.0 mg/ml, 0.5 ml) and to the conjunctival sac of eye at a dose of 0.5 mg/rabbit (5.0 mg/ml, 0.1 ml) , respectively. In this study, there were no clinical signs which were related to HM10411 compared with those of control group. From above results, HM10411 has not any irritating activity to skin and eye in rabbits.

• Korean Journal of Pharmacognosy
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• v.49 no.3
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• pp.246-254
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• 2018

Pectin lyase-modified red ginseng extract (GS-E3D) is a newly developed ginsenoside Rd-enriched ginseng extract. This study was designed to investigate the skin safety of GS-E3D. Single oral toxicity, single dermal toxicity, bovine corneal opacity and permeability (BCOP) assay, skin irritation test with $SkinEthic^{TM}$ human epidermis model, skin sensitization local lymph node assay, and human patch test, were examined. The oral and dermal $LD_{50}$ value of GS-E3D was over 2,000 mg/kg in rats. GS-E3D was identified as a non-irritant to skin in BCOP assay, human epidermis models, and patch test from the 32 human subjects. The skin sensitization potential of GS-E3D was less than 25% in local lymph node assay. These results indicate that GS-E3D can be used as a safe ingredient without adverse effects in various skin care products.