• Biomolecules & Therapeutics
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• v.4 no.4
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• pp.364-372
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• 1996

The primary skin and eye irritation test of 0.3% DA-5018 cream, a capsaicin analogue, were carried out in rabbits. As control materials, Zostrix-HP cream (0.075% capsaicin cream) and the base of 0.3% DA-5018 cream were used in the same manners. In the primary skin irritation test, the Primary Irritation Index (P.I.I.) was 1.6, 1.9 and 0.5 in groups treated with 0.3% DA-5018 cream, Zostrix-HP cream and the base of 0.3% DA-5018 cream, respectively. The irritation ratings of 0.3% DA-5018 cream and Zostrix-HP cream were mildly irritating. The base of 0.3% DA-5018 cream was evaluated as a non-irritating material. In the eye irritation test, 0.3% DA-5018 cream and Zostrix-HP cream could be considered as mildly irritating materials. But, the base of 0.3% DA-5018 cream was a non-irritating material. These results suggest that 0.3% DA-5018 cream has mildly irritating activity and its irritancy is similar to that of Zostrix-HP cream.

• 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.

• 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.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1996.04a
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• pp.250-250
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• 1996

Eye irritation, primary skin irritation and skin sensitization tests for Aloewhite were tested in New Zealand White rabbits and Hartley guinea pig. In primary skin irritation test of male New Zealand White rabbits, body weights were not significantly changed and primary Irritation Index(PII) was 0.47, indicating Aloewhite as mildly irritating material, In ocular irritation test, any injury on iris, conjunctival membrane, and cornea in New Zealand White rabbits was not observed. No injuries of the ocular mucous membrane were also recorded. Skin sensitization was tested in guinea Peg after intradermal and epicutaneous induction and graded I with zero % sensitization rate. These results indicate that Aloewhite was not considered to be irritant in test organs of animals.

• 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.

• Korean Journal of Veterinary Research
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• v.45 no.1
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• pp.39-43
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• 2005

The present study was carried out to investigate the skin irritation potential of oregano 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. Treatment-related toxic symptoms, as evidenced by anorexia and decreased locomotor activity, were observed in all rabbits tested. Two rabbits out of the 6 total died on day 2 after the application of test article due to treatment-related toxicity. The mean body weight of test animals decreased progressively during the 72 h observation period. All animals showed very slight edema at 24 h and then recovered at 72 h. These animals also showed very slight to severe erythema and/or slight eschar formation at both 24 h and 72 h. The eschar formation induced by oregano oil was not recovered at the end of additional 11-day recovery period. Based on these results, it was concluded that a single dermal application of the undiluted oregano oil caused an increased incidence of clinical signs and death and a decrease in the body weight and showed a primary irritation index score of 2.79 indicating moderate irritation.

• 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.

• Toxicological Research
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• v.13 no.1_2
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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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• v.19 no.1
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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.

• 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.