• 약학회지
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• 제39권2호
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• pp.137-140
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• 1995

Saponin isolated from Sapindus mukorossi Gaertn has been shown to contain a strong anti-inflammatory activity. In this study, several pharmacological properties such as acute toxicity, local irritation and hemolytic activity of Sapindus saponin and its genin component, hederagenirl, were examined. The acute toxicity of Sapindus saponin was very low. Estimated from the LD$_{50}$ values, it showed much weaker toxicity in oral administration than in intraperitoneal injection. Hederagenin gave a very high LD$_{50}$ value even in intraperitoneal injection. Sapindus saponin showed a potent local irritation after topical application, whereas hederagenin did a very weak local irritation. Sapindus saponin also gave a high hemolytic activity.

• 대한약침학회지
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• 제25권1호
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• pp.46-51
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• 2022

Objectives: This study was performed to evaluate the skin irritation toxicity of processed sulfur. Methods: All experiments were conducted at Medvill (Korea), an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate skin irritation toxicity of processed sulfur, we divided the back of six rabbits into two control sites and two test sites. One of each of the two control and test sites was then designated abraded sites and intact sites. In test sites, 0.5 g of processed sulfur was applied to the back of the rabbit for 24 hours, and in control sites, 0.5 g of sterile distilled water was applied in the same way. We observed and evaluated mortality, weight, general symptoms, and skin irritation toxicity. This study was conducted with the approval of the Animal Ethics Committee (Approval number: IAC2020-1549). Results: In all experiments, no dead animals were observed. In all cases, skin coloration was observed at 24 hours after processed sulfur administration. This coloration lasted up to 48 hours and is believed to be the effect of the administration of test substances. Weight measurement indicated that weight was lost 72 hours after administration in three cases, but this is considered an accidental weight change. Normal weight gain was observed in the remaining subjects. In all animals, no skin irritation toxicity was observed, and the primary irritation index (P.I.I) was calculated as 0.0 according to Draize's evaluation method. Conclusion: The above findings suggest that it is relatively safe to apply a processed sulfur to the skin. Further research on this topic is needed to provide more specific evidence.

• 대한한의학방제학회지
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• 제24권4호
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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.

• 한국산업보건학회지
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• 제25권3호
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• pp.322-327
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• 2015

Objectives: The major objective of this study is the oral dose toxicity test and skin irritation test of eco-friendly plasticizer using crude glycerol derived from the biodiesel process. Methods: Glyceroldiacetate laurate(GDL) was synthesized from glycerol monolaurat(GML) and acetic acid. The synthesis of the GDL plasticizer was measured with nuclear magnetic resonance spectroscop(NMR) and FT-IR(Fourier Transform Infrared Spectrometer). To provide information on the safety of GDL, we carried out an oral dose toxicity test for GDL in Sprague-Dawley rats. Also, we carried out a skin irritation test for GDL in New Zealand White rabbits. Results: The oral dose toxicity test in Sprague-Dawley rats showed that GDL is a non-toxic material. The result of the skin irritation test on New Zealand White rabbits showed that GDL is non-irritating. Conclusions: From the results of oral dose toxicity test and skin irritation test, we concluded that the developed plasticizer showed excellent eco-friendly property. Based on our results, we confirmed the development of an eco-friendly non-phthalate plasticizer. Applicability for PVC toys and food and drug packaging materials was found.

• Toxicological Research
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• 제34권4호
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• pp.355-361
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• 2018

Methylisothiazolinone (MIT) has been used in combination with methylchloroisothiazolinone (CMIT) for cosmetic products such as shampoo, body lotion, and skin care products. The mixture of CMIT/MIT has been found to cause allergic contact dermatitis and is thus no longer permitted for use as a preservative in leave-on cosmetics. However, MIT itself was approved as a stand-alone preservative at a maximum concentration of 100 ppm as the toxicity was derived from CMIT rather than MIT. However, in many countries, allergic skin irritation caused by MIT remains a social concern. In this study, skin irritation was assessed for the presence of MIT, propylene glycol, and their mixture using a 3D human skin model $EpiDerm^{TM}$. Although non-diluted MIT causes serious skin toxicity, skin irritation was not observed at a concentration of 100 ppm, the maximum permissible level for cosmetics and personal care products according to European regulations. Propylene glycol, the most widely used vehicle for MIT, did not cause skin irritation in the 3D skin model. The results are expected to provide information for regulatory policies and guidelines on the use of biocides in consumer products.

• Toxicological Research
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• 제18권1호
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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.

• 농약과학회지
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• 제14권4호
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• pp.339-346
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• 2010

본 연구는 생리활성이 높은 식물오일의(라벤더, 레몬유칼립투스 및 계피 오일) 친환경 살충소재의 활용가능성을 탐색하고자 급성독성(급성경구독성, 급성경피독성, 피부자극성 및 안점막자극성)시험을 수행하였다. 랫드를 이용한 급성경구독성시험결과 라벤더, 레몬 유칼립투스 및 계피 오일의 $LD_{50}$은 2,000 mg/kg bw 이상이었고, 급성경피독성시험결과 모든 시험물질의 $LD_{50}$이 4,000 mg/kg bw으로 나타났다. 피부자극성시험결과 라벤더와 레몬 유칼립투스 오일은 자극성이 없었고, 계피 오일은 중도의 자극성을 나타냈다. 안점막자극성시험결과 라벤더, 레몬 유칼립투스 오일은 자극성이 없었고, 계피오일은 중도의 자극성을 나타냈으나 세척시험 결과 자극성은 없었다. 따라서, 라벤더 및 레몬 유칼립투스 오일은 독성이 낮았으나, 계피 오일은 중도의 피부자극성 및 안점막자극성을 갖는 것으로 평가되었다.

• 농약과학회지
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• 제15권4호
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• pp.383-388
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• 2011

본 연구는 새롭게 개발된 제초제인 methiozolin의 인체 안전성을 평가하기 위해 급성독성시험을 수행하였다. 랫드를 이용한 급성 독성 시험에서 2,000 mg/kg의 용량을 고용량으로 하여 단계적으로 투여한 결과 methiozolin의 $LD_{50}$은 2,000 mg/kg bw 이상이었다. 급성 경피독성시험결과 시험물질을 고용량 4,000 mg/kg을 투여한 결과 별다른 사망동물이 발생하지 않아 시험물질의 $LD_{50}$이 4,000 mg/kg bw 이상으로 나타났다. 피부자극성 시험결과 시험물질의 약한 자극성이 나타났으며, 안점막 자극성 시험결과 약한 자극성이 있었다. 이상의 연구 결과 경구 독성의 경우 methozolin은 GHS 카테고리 IV에 해당하는 물질로 판단된다. 이러한 결과를 바탕으로 methiozolin은 안전한 제초제로서 추후 만성 독성 연구가 필요하다고 판단된다.

• 대한약침학회지
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• 제3권1호
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• pp.53-63
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• 2000

Carthami tinctorii Fructus is known for its good effect on diseases such as fracture, menorrhalgia, menoschesis, puerperium aneilema and so on. The study of irritation and toxicity of Carthami oil aquapuncture solution applied topically to the skin and the eye mucous membrane were carried out to prove the safety of Carthami oil aquapuncture solution in clinical use. Animal for the research was the rabbit and the solution for the test was made from Carthami semen. 6 animals were used for the skin test and 9 animals were used for the eye mucous membrane test. In results, both tests proved that Carthami oil aquapuncture solution 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 Carthami oil aquapuncture solution in clinical use.

• 농약과학회지
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• 제15권3호
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• pp.231-237
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• 2011

본 연구는 후추출물, 클로브버드, 로즈마리 및 오리가늄오일의 친환경 살충소재의 활용가능성을 탐색하고자 급성경구독성, 급성경피독성, 피부자극성 및 안점막자극성시험을 수행하였다. 랫드를 이용한 급성경구독성시험결과 후추추출물, 클로브버드, 로즈마리 및 오리가늄오일의 $LD_{50}$은 2,000 mg/kg bw이상이었고, 급성경피독성시험결과 모든 사험물질의 $LD_{50}$이 4,000 mg/kg bw으로 나타났다. 피부자극성시험결과 후추추출물, 클로브버드 및 로즈마리오일은 자극성이 없었고, 오리가늄오일은 중도의 자극성을 나타냈다. 안점막자극성시험결과 후추추출물과 로즈마리오일은 자극성이 없고, 클로브버드오일은 경도의 자극성을 나타냈으며, 오리가늄오일은 중도의 자극성을 나타냈다. 따라서, 후추와 로즈마리오열은 독성이 낮았으나, 클로브버드오일은 경도의 안점막자극성을 갖고, 오리가늄오일은 중도의 피부자극성과 안점막자극성이 있는 것으로 구분되었다.