• Biomolecules & Therapeutics
• /
• 제10권3호
• /
• pp.170-174
• /
• 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.

• Biomolecules & Therapeutics
• /
• 제5권2호
• /
• pp.150-157
• /
• 1997

Capsaicin cream has been used to attenuate the pain associated with diabetic neuropathy, rheum-atoid arthritis, osteoarthritis and postherpetic neuralgia. But its common side effect, local irritation, limits the use of it and there is still a need for a new analgesic devoid of this side effect. This study was conducted to compare the local irritant effect of DA-5018, a new capsaicin derivative, with that of capsaicin in various animal models and human beings. Capsaicin, applied topically to the mouse ear, produced dose-dependent increase of ear volume and the frequency of ear scratching behavior in mice. Neither ear volume nor scratching behavior was affected by DA-5018. In eye wiping test of rat, DA-5018 was 10 times less irritant than capsaicin. Capsaicin administered intradermally into the rat paw elicited paw lick/lift response with a potency which was three times that of DA-5018. Zostrix-HP (0.075% capsaicin cream), but not DA-50180.3% cream, increased ear volume of rat and induced thermal hyperalgesia in normal and carrageenan inflamed paws. Six day-treatment of Zostrix-HP failed to develop tolerance against this thermal hyperalgesia. In human beings, Zostrix-HP produced burning sensation and itching in more than 90% of volunteers involved and its maximum irritant effect was significantly higher than that of DA-5018 cream. These results suggest that local irritation and burning sensation produced by DA-5018 is much less than capsaicin.

• Toxicological Research
• /
• 제19권1호
• /
• pp.39-44
• /
• 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.

• 약학회지
• /
• 제40권2호
• /
• pp.155-162
• /
• 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.

• Toxicological Research
• /
• 제16권1호
• /
• pp.17-25
• /
• 2000

Chitosan cross-linked collagen-glycosaminoglyan (CCGM) is an artificial skin substitute made to form a sponge like dimensional matrix. It can be used to facilitate reconstruction of dermal tissue when applied on large wounds such as severe burns. In order to study the toxicological effects of CCGM the cytotoxicity, local irritation and skin sensitization test were carried out according to the standards of ISO 10993. In the cytotoxicity test utilizing LDH and MTT test, both the CCGM and its extract had no toxicity of Balb/c 3T3 cells. The local irritatioin test on rabbit skin demonstrated that CCGM did not promote any harmful when directly applied on skin. In addition, it did not elicit any allergic reaction in the guinea pig maximization test. Based on these results, it is suggested that CCGM is a material without cytotoxicity, local irritation and allergenicity.

• 생약학회지
• /
• 제48권3호
• /
• pp.202-207
• /
• 2017

The purpose of this study was to investigate the skin irritation of bee venom (melittin) in human. Skin irritation test was performed at 0.05% bee venom by 48 h single patch test in 30 healthy volunteers with no skin disease and skin sensitization test was performed by local lymph node assay in animal. In single patch test, 28 human subjects showed no reaction and 2 subjects showed 1+ or 3+ grade skin reaction. In a skin sensitization test of bee venom conducted using mice. no erythema was observed on the dorsal side of mice up to 8 days after application of bee venom on the skin. The results of the average stimulation index by ATP values showed that there was no irritation to the mice skin at 0.005% and 0.01% of bee venom. Therefore, bee venom is not likely to induce a significant skin irritation under 0.05% concentration.

• Journal of Korean Dental Science
• /
• 제13권1호
• /
• pp.35-41
• /
• 2020

Irritation fibroma is a reactive hyperplastic lesion caused by chronic stimuli with low intensity in the oral cavity. Irritation fibroma is common in middle-aged females but it may also occur at any age and sex. Clinical characteristics of irritation fibroma are similar to other reactive lesions or benign tumors, therefore, histological examination is essential to make an accurate diagnosis. This case report presents two cases of irritation fibroma occurred on the gingiva in young males. Two male patients in their 20s and 30s of age visited the clinic for the evaluation and treatment of painless gingival overgrowth in the anterior region. Clinically, the lesions were well-defined and firm, with similar color and texture to the adjacent normal gingiva. Excisional biopsy under local anesthesia was conducted with a scalpel, and the lesions were completely removed. Histopathologically, connective tissue consisting of dense collagen bundles, proliferation of fibroblasts and minor infiltrated inflammatory cells were observed. Based on the clinical and histopathological findings, the diagnosis of irritation fibroma was confirmed in both cases.

• 대한수의학회지
• /
• 제45권1호
• /
• pp.39-43
• /
• 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
• /
• 제21권3호
• /
• pp.249-253
• /
• 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.

• Journal of Oral Medicine and Pain
• /
• 제17권2호
• /
• pp.75-86
• /
• 1992

Of the many first-occuring major manifestations of Behcet's disease, the oral ulcer is most frequently observed, shows the highest mean recurrence rate, and the longest mean duration period. A study of the relationship between mechanical irritation buy local factors and the recurrence of oral ulcers was carried out to see if there is a correlation. The subjects chosen for the study were 81 patients who were referred to the Department of Oral Diagnosis at Yonsei University Dental Hospital from the Behcet clinic of Severace Hospital after being diagnosed as Behcet's disease patients. 1. By Shimuzu's classification, possible type was the most numerous with 55.55% ; while suspected type was 19.76% ; incomplete type, 17,28% ; and complete type, 7.41% were observed in that order. The male to female ration was 1 to 1.61, and the average age of onset was 17.63 years. 2. Oral ulcers developed most frequently on the tongue (48.28%), and lip(23.15%), buccal mucosa (20.69%), palate\pharynx(4.43%), and gingiva(3.45%) also showed ulceration. 3. 38.27% of the patients were HSV positive : 27.16% were CRP positive ; 12.34% were ASO positive ; 9.87% were RF positive ; and 3.7% were ANA positive. 4. According to the answers to the survey, fatigue(85.18%) was most frequently associated with Behcet's diseage. Trauma by tooth brushing (22.22%), un specified reasons (20.98%), hard food chewing (12.35%), and irritation by dentition and/or prosthesis (13.58%) were observed in association with Behcet's disease. 23.46% had a history of tonsilitis. 5. Oral ulcers on the anterior part of tongue and buccal mucosa were associated with local irritatants. 6. Oral ulcers on the lip and posterior portion of tongue were not associated with local irritants. Local irritation by dentition and oral ulcer on the anterior part of tongue and buccal mucosa was observed to coexit with one another : in other words, lo9cal factors can act to cause of recurrence of an oral ulcer and to delay the healing process in Behcet's disease. Therefore, elimination of local factors along with systemic therapy must be recommended when treating oral ulcers.