• 생약학회지
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• 제49권3호
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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.

• Toxicological Research
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• 제18권1호
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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.

• Parasites, Hosts and Diseases
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• 제55권4호
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• pp.409-416
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• 2017

The high prevalence of pediculosis capitis, commonly known as head lice (Pediculus humanus capitis) infestation, has led to the preparation of a community-based pediculicidal ointment, which is made of common household items and the extract of Tinospora crispa stem. The present study aimed to evaluate the safety, efficacy, and physicochemical characteristics of the T. crispa pediculicidal ointment. The physicochemical properties of the ointment were characterized, and safety was determined using acute dermal irritation test (OECD 404), while the efficacy was assessed using an in vitro pediculicidal assay. Furthermore, the chemical compounds present in T. crispa were identified using liquid-liquid extraction followed by ultra-performance liquid chromatography quadruple time-of-flight mass spectrometric (UPLC-qTOF/MS) analysis. The community-based ointment formulation was light yellow in color, homogeneous, smooth, with distinct aromatic odor and pH of $6.92{\pm}0.09$. It has spreadability value of $15.04{\pm}0.98g{\cdot}cm/sec$ and has thixotropic behavior. It was also found to be non-irritant, with a primary irritation index value of 0.15. Moreover, it was comparable to the pediculicidal activity of the positive control $Kwell^{(R)}$, a commercially available 1% permethrin shampoo (P>0.05), and was significantly different to the activity of the negative control ointment, a mixture of palm oil and candle wax (P<0.05). These findings suggested that the community-based T. crispa pediculicidal ointment is safe and effective, having acceptable physicochemical characteristics. Its activity can be attributed to the presence of compounds moupinamide and physalin I.

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

• 한국산업보건학회지
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• 제28권2호
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• pp.175-189
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• 2018

Objectives: In this study, we analyze statistics on industrial accidents caused by chemical skin contact and provide skin toxicity hazard information on the related domestic system and circulation volumes. Methods and Results: We analyzed occupational fatalities and skin diseases caused by chemical leaks and contact from 2007 to 2016(10 years) and surveyed data on occupational skin diseases using the 2014 work environment survey data. The NIOSH Skin Notation Profiles for 57 chemical substances, which are provided to prevent occupational skin diseases, were searched and hazard information on skin contact with chemical substances was classified. In order to identify skin toxicity information among domestically distributed and legally regulated substances and to investigate skin-toxic substances, MSDS basic data on 19,740 chemical substances provided on the homepage of Korea Occupational Safety & Health Agency were searched. Acute toxicity(dermal) category 1-4 substances totaled 1,020, and the number of chemical substances classified as category 1 and 2 substances were 135 and 137, respectively. In the chemical substances prescribed by the Ministry of Employment and Labor, 173 substances were classified into acute toxicity(dermal) categories 1-4, 58 of which correspond to category 1 or 2. Conclusions: Within the present range of industrial accidents, the proportion of skin diseases due to contact with chemicals is not high. However, there is always a risk of occupational skin diseases due to increasing chemicals and due to the use of new chemicals. It is hoped that this information will be used by workplace safety and health officials and health and safety experts to prevent acute toxity(dermal) due to chemical skin contact.

• 대한화장품학회지
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• 제26권1호
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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.

• 보존과학회지
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• 제33권4호
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• pp.255-266
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• 2017

국내 문화재 생물피해 방제는 농약에서 유래한 화학적 약제를 사용하여 왔다. 그러나 인체와 환경에 대한 유해성 문제로 인하여 사용이 점차 제한되고 있으며, 새로운 방제약제의 탐색과 안전성 연구에 대한 관심이 지속적으로 증가되고 있다. 개발된 천연 생물방제제의 안전성은 동물실험을 통한 독성평가로 확인하고 있으며, 치사량과 자극성 평가를 위하여 경구독성, 경피독성, 안점막자극 및 피부자극 시험법을 이용하여 안전성을 평가한다. 독성평가를 위해 실험용 쥐와 토끼를 이용하며, 쥐에 대해 단회 경구독성과 경피독성 시험을 실시하고, 토끼에 대해 안점막자극시험 및 피부자극 시험을 시행한다. 본 시험에 이용한 천연 생물방제물질은 목재부후균과 흰개미에 대한 항진균활성 및 살충활성이 조사된 족두리풀 추출물을 적용하였다. 쥐에 대한 단회 경구투여한 결과 $LD_{50}$ 값이 수컷 4,000 mg/kg 이상, 암컷 2,000 mg/kg 이상으로 판정되었으며, 단회 경피 투여한 결과 $LD_{50}$ 값이 암수 모두 10,000 mg/kg 이상으로 판정되었다. 토끼의 눈에 대한 자극시험에서는 무자극성으로 판정되었으며, 피부에 대해서는 약한 자극성이 있는 물질로 판단되었다. 본 연구를 통해 천연 생물방제물질인 족두리풀 추출물의 안전성을 동물실험으로 확인함으로써 화학 물질의 안전성 검증을 위한 기본적인 유해성 평가 방법으로 제시하고자 한다.

• 한국식품영양과학회지
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• 제33권4호
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• pp.641-645
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• 2004

단회경구독성시험에서 미더덕 및 멍게 유래 crude콘드로이틴황산의 LD$_{50}$는 2g/kg 이상으로서 판명되어, 단회경구독성 측면에서 는 안전한 원료로 판단되었다. 비록 기니픽을 이용한 감작성시험은 미더덕 유래 crude 콘드로이틴황산만을 사용하여 실시하였고, 시험 농도는 GAGs의 임상 사용 예정량이 0.03∼0.15%임을 고려하여 inductiuon 농도는 임상사용 예정량의 10배인 3.0%, challenge 적용 농도를 0.3% 이하로 잠정 설정하여 3.0%, 0.3%, 0.03%농도에서 실시하였다. 그 결과 0.03% 및 0.15% 농도에서는 반응을 나타낸 개체가 없었으나, 양성대조군과 비교할 때 0.3% 농도에서는 24시간 후에는 10% 그리고 48시간 후에는 5%의 반응율을 나타냈지만 사용가능범위에 해당되어 미더덕의 GAGs은 감작성 측면에서 안전성이 높은 원료로 0.3%이하 농도에서는 사용 가능하다고 판단되었다. 토끼를 이용한 안점막 자극시험에서는 미더덕과 멍게 유래 crude 콘드로이틴황산 및 bovine trachea 콘드로이틴황산의 3.0% 적용 시 모두 A.O.I.가 기준치 이하로 나타나 실제 사용 시 눈에 자극성이 없음이 판명되었다. 토끼를 이용한 피부일차자극 시험에서는 미더덕 및 멍게 유래 crude 콘드로이틴황산을 3.0% 및 1.5%는 무자극을 보였지만, 멍게 유래 crude 콘드로이틴황산에서는 미약하게 보이던 피부반응이 미더덕 유래 crude 콘드로이틴황산에서는 3.0% 적용에서 다소 강한 반응을 보였다. 광독성 및 광감작성을 위한 UV 흡광 실험결과 미더덕 및 멍게 유래 crude 콘드로이틴황산과 대조군으로서 사용한 표품 콘드로이틴황산 모두 자외선영역(280∼420 nm)에서 흡광을 보이지 않아서 광독성 및 광감작성 시험을 시행하지 않았다. 실험동물을 사용하여 조사한 결과 화장품 원료로서의 미더덕 및 멍게 유래 crude 콘드로이틴황산은 3.0% 이내에서는 사용이 안전함이 증명되었고, 멍게가 미더덕 유래의 콘드로이틴황산에 비교하여 생체반응에 나은 것으로 나타났다.다.

• 대한화장품학회지
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• 제41권1호
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• pp.1-7
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• 2015

말채나무는 한국의 민간요법으로 사용되던 약재이다. 자외선은 피부의 광손상을 일으키는 것으로 알려져 있다. 본 연구에서는 자외선에 의한 손상된 세포를 회복시키기 위해서 효소처리 된 말채나무잎추출물(CWE)을 사용하였다. 섬유아세포에 UVB를 조사한 후, CWE를 처리하여 세포의 회복을 조사하였다. UVB를 조사한 섬유아세포에는 caspase-3 활성, phospho-p53, ${\gamma}H2AX$, cyclobutane pyrimidine dimers (CPDs) formation, 그리고 DNA fragmentation이 증가하게 된다. 그러나 CWE를 UVB가 조사된 섬유아세포에 12 h 처리하였을 때 caspase-3 활성, phospho-p53, ${\gamma}H2AX$, CPDs formation, 그리고 DNA fragmentation이 감소하였다. 또한 CWE은 인체첩포시험을 통해 인체피부에 자극을 유발하지 않음을 확인하였다. 이러한 결과를 종합할 때 CWE는 자외선에 대한 광보호 효과가 있는 원료로서 가능성을 가지고 있다고 판단된다.

• 대한임상독성학회지
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• 제2권2호
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• pp.101-105
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• 2004

Purpose: Paraquat is the most commonly used herbicide in Korea. Exposure to paraquat through the skin has resulted in local irritation or inflammation of varying degree, sometimes severe. The purpose of this study was to review the patients with paraquat poisoning by skin absorption. Methods: We analysed retrospectively the clinical and laboratory findings of 45 patients with paraquat poisoning after dermal exposure, who were admitted to Soonchunhyang University Cheonan Hospital from January 1999 to December 2003. Results: Among 870 cases of paraquat poisoning, 45 cases were exposed to paraquat through the skin. The peak incidence was the fifth decade($40\%$). The clinical symptoms were pain, pruritus, nausea, and vomiting. The major skin lesions were generalized vesicobullae and necrotic erosion in face, scrotum, trunk, upper and lower extremities and etc. All patients were survived after skin contact or inhalation of paraquat. Conclusion: This study illustrates the extreme toxicity of paraquat and demonstrates that lethal quantities of paraquat may be absorbed if repeated exposure to it. Stricter precautions, including the mandatory use of protective clothing, should be recommended whenever this material is used.