• Toxicological Research
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• 제35권2호
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• pp.119-129
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• 2019

As the use of cosmetics has greatly increased in a daily life, safety issues with cosmetic ingredients have drawn an attention. Drometrizole [2-(2'-hydroxy-5'-methylphenyl)benzotriazole] is categorized as a sunscreen ingredient and is used in cosmetics and non-cosmetics as a UV light absorber. No significant toxicity has been observed in acute oral, inhalation, or dermal toxicity studies. In a 13-week oral toxicity study in beagle dogs, No observed adverse effect level (NOAEL) was determined as 31.75 mg/kg bw/day in males and 34.6 mg/kg bw/day in females, based on increased serum alanine aminotransferase activity. Although drometrizole was negative for skin sensitization in two Magnusson-Kligman maximization tests in guinea pigs, there were two case reports of consumers presenting with allergic contact dermatitis. Drometrizole showed no teratogenicity in reproductive and developmental toxicity studies in which rats and mice were treated for 6 to 15 days of the gestation period. Ames tests showed that drometrizole was not mutagenic. A long-term carcinogenicity study using mice and rats showed no significant carcinogenic effect. A nail product containing 0.03% drometrizole was nonirritating, non-sensitizing and non-photosensitizing in a test with 147 human subjects. For risk assessment, the NOAEL chosen was 31.75 mg/kg bw/day in a 13-week oral toxicity study. Systemic exposure dosages were 0.27228 mg/kg bw/day and 1.90598 mg/kg bw/day for 1% and 7% drometrizole in cosmetics, respectively. Risk characterization studies demonstrated that when cosmetic products contain 1.0% of drometrizole, the margin of safety was greater than 100. Based on the risk assessment data, the MFDS revised the regulatory concentration of drometrizole from 7% to 1% in 2015. Under current regulation, drometrizole is considered to be safe for use in cosmetics. If new toxicological data are obtained in the future, the risk assessment should be carried out to update the appropriate guidelines.

• 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.

• 대한본초학회지
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• 제39권3호
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• pp.107-114
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• 2024

Objective : Cicadae Periostracum (CP), which is the discarded shell of the Cryptotympana atrata (Fabricius, 1775), is a recognized component of oriental medicine for treatment sore throat, itching, shock, sedation, edema. However, the safety and toxicity of CP have not yet been established. It has been reported that symptoms of addiction or side effects may occur in patients who take high doses of CP or who are hypersensitive to it. Therefore, we investigated the acute toxicity of an CP extracts in Sprague-Dawley (SD) rats. Methods : To study acute toxicity, five SD rats of each sex per group were treated with CP extracts at single doses of 0, 500, 1000, or 2000 mg/kg administrated by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. At the end of 14-day observation period, all animals were sacrificed and complete hematological and macroscopic examinations were performed. Results : There were no dead animal and test article-related effects on body weight change or the gross finding. No toxicologically significant results were observed between control and treated groups in hematology. Although salivation related to stress at the highest dose was observed in clinical signs immediately after administration, it is considered to have no toxicological significance. Conclusion : As the results, we did not find any adverse effect at the dose levels of 500, 1000, or 2000 mg/kg in rats. The minimal lethal dose was considered to be over 2000 mg/kg body weight in rats.

• 한국산업보건학회지
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• 제24권3호
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• pp.330-335
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• 2014

Objectives: To evaluate the mutagenicity of lithium carbonate, a bacterial reverse mutation(Ames) test was carried out using four strains of S. typhimurium(TA1535; TA1537; TA98; and TA100) and one strain of E. coli(WP2uvrA). Materials: This was carried out in a dose range from 312.5 to $5,000{\mu}g/plate$ in triplicate with and without S9 activation, which is the most commonly used metabolic activation system supplemented by a post-mitochondrial fraction prepared from the livers of rodents treated with enzyme-inducing agents such as Aroclor 1254 or a combination of phenobarbitone and ${\beta}$-naphthoflavone. Results: No significant increases in the number of revertants were observed under the conditions examined in this study. Conclusions: Based on the above observations, it can be concluded that lithium carbonate has no mutagenic activity. Despite the results, it can have an effect by inducing acute oral toxicity, eye irritation and acute aquatic toxicity. Based on this study, we suggest that future studies should be directed toward chronic, carcinogenic testing and other related areas.

• 대한화장품학회지
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• 제25권4호
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• pp.145-154
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• 1999

A novel retinol derivative, polyethoxylated retinamide(Medimin A) was synthesized, as an anti-aging agent. Collagen synthesis, skin permeation, stability, and toxicity of Medimin A were evaluated and compared with those of retinol and retinyl palmitate. In vitro collagen synthesis was evaluated by quantitative assay of $[^3H]-proline$ incorporation into collagenase sensitive protein in fibroblast cultures. For in vitro skin permeation experiments, Franz diffusion cells(effective diffusion area: 1,766 $cm^2$) and the excised skin of female hairless mouse aged 8 weeks were used, The stabilities of retinoids were evaluated at two different temperature($25^{\circ}C\;and\;40^{\circ}C$) and under UV in solubilized state and in O/W emulsion. To estimate the safety, acute oral toxicity, acute dermal toxicity, primary skin irritation, acute eye irritation and human patch test were performed. The effect of Medimin A on collagen synthesis was similar to that of retinol. The skin permeability of Medimin A was higher than those of retinol and retinyl palmitate. The Medimin A was more stable than retinol and retinyl palmitate. Medimin A was nontoxic in various toxicological tests. These results suggest that Medimin A would be a good anti-aging agent for enhancing bioavailability and stability.

• 대한한의학방제학회지
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• 제21권1호
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• pp.186-199
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• 2013

Objectives : The objectives of this study was to obtain acute information (single oral dose toxicity) of Red-Koji (Monascus purpureus 12002) Fermented Scutellariae Radix Aqueous Extracts (fSR), has been traditionally used in Korean medicine for treating various diseases including inflammatory diseases. Methods : In order to observe the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, fSR powders were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14days after single oral treatment of fSR with organ weights and histopathological observations of 12 types of principle organs. Results : After single oral treatment of fSR, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents, on the body and organ weights, clinical signs, gross and histopathological observations, except for some accidental findings. Conclusions : The results obtained in this study suggest that the LD50 and ALD of fSR in both female and male mice after single oral treatment were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg and can be safety used in clinics.

• Toxicological Research
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• 제21권4호
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• pp.361-365
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• 2005

This study was conducted to obtain the acute information of the oral dose toxicity of Polycan - originated from Aureobasidium pullulans SM-2001 (half of the dry material is -1,3/1,6-glucans), a UV induced mutant of A. pullulans, having various pharmacological effects, in male and female mice. In order to calculate $50\%$ lethal dose $(LD_{50})$, approximate LD and target organs, test article was administered twice by oral gavage to male and female ICR mice at total 1000, 500 and 250mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing. As the results, we could not find any mortalities, clinical signs, changes in the body weight and gross findings. The results obtained in this study suggest that the Polycan is non-toxic in mice and is therefore likely to be safe for clinical use. The L050 and approximate $(LD_{50})$ in mice after single oral dose of Polycan were considered over 1000 mg/kg, respectively.

• Journal of Periodontal and Implant Science
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• 제34권2호
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• pp.425-448
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• 2004

A bioactive and degradable poly(epsilon -caprolactone)/silica nanohybrid(PSH) was synthesized for the application as a bone substitute. PSH was manufactured by using silica and polycaprolacton. PSH was manufactured in some composition after low crystaline apatite had been formed in simulated body fluid and, was used this study. The safety of the PSH was established by test of acute, and subacute toxicity, sensitization cytotoxicity and sterility. In order to assess activity of osteoblast, the test for attaching osteoblast, proliferation test for osteoblast, differentiating gene expression test are performed in vitro. And bone substitutes were grafted in rabbit's calvarium, during 8 weeks for testing efficacy of bone substitutes. Degree of osteogenesis and absorption of substitutes were evaluated in microscopic level. In result, it was not appeared that acute and subacute toxicity, sensitization in intradermal induction phase, topical induction phase and challenge phase. It was shown that the test can not inhibit cell proliferation. adversely, it had some ability to accelerate cell proliferation. The result of sterility test described bacterial growth was not detected in most test tube. The attaching and proliferation test of osteoblast had good results. In the result of differentiating gene expression test for osteoblast, cbfa1 and, alkaline phosphatase, osteocalcin and GAPDH were detected with mRNA analysis. In the PSH bone formation test, ostgeoblastic activity would be different as material constitution but it had good new bone formation ability except group #218. futhermore, some material had been absorbed within 8 weeks. Above studies, PSH had bio-compatibility with human body, new bone formation ability and accelerate osteoblastic activity. So it would be the efficient bone substitute material with bio-active and biodegradable.

• Archives of Pharmacal Research
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• 제19권5호
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• pp.337-341
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• 1996

Propolid (bee-glue), known as a folk medicine, is a lipo;hilic material found in honeybee hives. In the present study on the anti-inflammatory effect of Korean propolis, it was extracted with ethanol, and used as a test material. The $LD_{50}$ value with the oral administration of ethanolic extract of Korean propolis (EEKP) was higher than 2g/kg in mice. The oral administration of the propolis extract (100mg/kg) significantly inhibited the development of hind paw edema induced by carrageenin in rats. the oral pretreatment of the propolis extract markedly inhibited the increase in vascular permeability and the number of writhing induced by acetic acetic acid in mice. Propolis extract, 50 and 100 mg/kg p.o. per day for 7 days, produced a significant inhibitory effect on granuloma and exudate formation in rats. This inhibitory effect was enhanced with the concomitant use of prednisolone (2.5 mg/kg). These results suggest that Korean propolis apparently has a strong anti-inflammatory activity.

• 농약과학회지
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• 제5권4호
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• pp.57-61
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• 2001

영농에서 노동력 절감을 위해 $2{\sim}3종$ 농약을 혼용하여 살포하는 것은 흔한 농약살포 방법이다. 과수 재배시 널리 사용되고있는 4종 살충제의 상호혼합 및 혼용이 인체에 미치는 영향을 구명하고 안전성을 확보할 목적으로 급성독성시험, 유기인계 및 카바메이트계 농약의 주 저해효소인 콜린에스테라제의 활성에 미치는 영향을 평가하였다. 포스팜액제, 디디브이피 유제, 피레스 유제 및 푸라치오카브 유제의 단제 및 혼합제에 대한 급성독성 및 콜린에스트라제의 활성에 미치는 영향을 시험한 결과 포스팜 액제 및 디디브이피 유제의 급성경구독성 $LD_{50}$은 랫드에서 각각 30 mg/kg, 93 mg/kg로 고독성이었으며 나머지는 보통독성이었다. 혼합에 의한 급성경구 및 경피독성 시험결과, $LD_{50}$이 이론치보다 $0.29{\sim}1.0$ 배정도 낮은 상승독성이 발현되었다. 혼용에 의한 급성경구독성 시험결과 포스팜+디디브이피 조합의 경우, $LD_{50}$이 16 mg/kg로 맹독성 농약으로 구분되었으며, 그 외의 조합은 모두 고독성 농약으로 구분되었다. 급성경피독성시험의 경우도 경구와 동일한 결과로 독성발현이 전체적으로 상승되었다. 농약의 혼합에 의한 혈장내 cholinesterase 의 $ID_{50}$의 변화는 약제처리 30분에는 이론치보다 현저한 효소억제가 인정되었으나, 60분에는 이론치와 큰 차이가 없었다.