• Journal of Society of Preventive Korean Medicine
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• v.20 no.1
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• pp.125-144
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• 2016

Objectives : About 13% of the medicines used by traditional korean medicines(TKM), are called animal medicines and are derived from non-herbal sources such as animals and insects. However, the clinical use of these preparations from animal medicines is often based on tradition and belief, rather than on evidence of toxicity and efficacy. As a result, animal medicines containing toxin have caused serious problems from injecting patients with venom. Here, various venoms frequently used as TKM were reviewed in terms of their instinct toxity and tried to estimate their safety classification. Methods : The estimation of safety classification was based on human equivalent dose(HED)-based MOS (margin of safety) and clinical dose applied for patients. Results and Conclusions : Except that of snake venom due to no clinical dose, they were evaluated as class 3 for bee venom, class 4 for cantharidin, toxin from blister beetle, and class 1 for venom from scolopendrid. In conclusion, animal medicines showed a wide range of safety classification from class 1 to class 4. This wide range is estimated to result from extremely limited applications of each venom for patients because of their strong toxicity. However, it should be cautious for application in clinics since animal medicines can produce anaphylactic reactions particularly after veinous administration even with a tiny amount of venom.

• The Journal of Korean Medicine
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• v.35 no.1
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• pp.114-123
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• 2014

Objectives: Evidence-based medicine(EBM) advocates the use of up-to-date "best" scientific evidence from health care research as the basis for making medical decisions. EBM also has been applied to traditional Korean medicine(TKM), especially in the field of safety. Recently, the standard prescription for TKM by Korea Institute of Oriental Medicine was published based on toxic index from various toxicity tests. However, there are some limitations when the results from the study based on EBM are applied in clinics. To overcome these imitations, the term "evidence-based practical medicine" was developed and defined as clinically applicable results from the study based on EBM. And safety classification for TKM was suggested as an example of evidence-based practical medicine. Methods: For safety classification for TKM, the data for $LD_{50}$(50% lethal dose), which was transformed to theoretical $LD_1$(1% lethal dose), was analyzed as one of tools for EMB study and divided by maximum dose used in clinics. Results and Conclusions: As a result, human equivalent dose(HED)-based MOS(margin of safety) for korean traditional medicine was calculated and used for safety classification with 5 categories. These categories would be helpful for oriental medicine clinicians to decide the increase and decrease of dosage according to various factors such as patient's sensitivity, potential toxicity of herbal medicines, clinician's experience for better cure. Thus, this safety classification provides some evidences enough that evidence-based practical medicine should be not the same with EBM and defined differently from EBM.

• Environmental Analysis Health and Toxicology
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• v.15 no.1_2
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• pp.31-37
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• 2000

Acetanilide may be released into the environment through air and wastewater from its production and use sites and exposed to human. Acetanilide is known to produce an analgesic effect and may pose adverse effects on human health by overly exposure. According to the EUSES system, acetanilide showed a high MOS (Margin of safety) value exceeding 6$\times$10$^4$ on a regional exposure, which is safe enough for public health. Whereas the lowest MOS value in dermal exposure was estimated as 3$\times$10$^{-4}$ on a local basis (workplace), the risk could be partly counteracted by taking preventive measures such as using mask and globes and good ventilation in the work places. Acetanilide may pose a potential risk for workers by dust inhalation. For the sake of health protection in the work places, additional data should be accumulated with respect to repeated dose toxicity, reproduction toxicity and developmental toxicity, etc. It is, therefore, recommended that acetanilide should be a candidate for further work to supplement the lacking data until it is proved to be safe in the occupational health aspects.

• The Korean Journal of Pesticide Science
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• v.16 no.4
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• pp.343-349
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• 2012

Exposure and risk assessments were conducted to evaluate the relative safety of mixing/loading work of indoxacarb between wettable powder (WP) and water dispersible granule (WG). Hand exposure was monitored using cotton gloves while inhalation exposure was measured using personal air monitor. Method validation for the exposure monitoring was established successfully through several experiments. Limit of determination and limit of quantitation were 0.25 and 1 ng, respectively. $R^2$ of calibration curve linearity was more than 0.9999 and reproducibility was 0.7-6. Recovery of indoxacarb from gloves, solid sorbent and glass fiber filter at three different levels was 81.5-108.8%. Trapping efficiency and breakthrough tests gave 981.5-108.8% of recovery. During mixing/loading procedure, hand exposure amount (75 percentile of 30 repetitions) for indoxacarb WP was 6 folds (459.8 mg/kg a.i) than that of WG (81.4 mg/kg a.i). This result indicates that WG has less drift than WP thanks to its granular type of formulation. Inhalation amount was $10^{-8}-10^{-7}%$ of spray mixture prepared and $10^{-4}-10^{-3}%$ of hand exposure. In inhalation case, no significant differences were observed between two formulations. Margin of safety was calculated for risk assessment using male Korean average body weight and acceptable operator exposure level as the important exposure factors. Mixing/loading procedures for both of the formulations were considered to be of least risk because calculated MOS values were more than 1.

• Toxicological Research
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• v.35 no.2
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• pp.103-117
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• 2019

The mixture of 5-chloro-2-methylisothiazol-3(2H)-one (CMIT) and 2-methylisothiazol-3(2H)-one (MIT), CMIT/MIT, is a preservative in cosmetics. CMIT/MIT is a highly effective preservative; however, it is also a commonly known skin sensitizer. Therefore, in the present study, a risk assessment for safety management of CMIT/MIT was conducted on products containing 0.0015% of CMIT/MIT, which is the maximum MIT level allowed in current products. The no observed adverse effect level (NOAEL) for CMIT/MIT was 2.8 mg/kg bw/day obtained from a two-generation reproductive toxicity test, and the skin sensitization toxicity standard value for CMIT/MIT, or the no expected sensitization induction level (NESIL), was $1.25{\mu}g/cm^2/day$ in humans. According to a calculation of body exposure to cosmetics use, the systemic exposure dosage (SED) was calculated as 0.00423 mg/kg bw/day when leave-on and rinse-off products were considered. Additionally, the consumer exposure level (CEL) amounted to $0.77512{\mu}g/cm^2/day$ for all representative cosmetics and $0.00584{\mu}g/cm^2/day$ for rinse-off products only. As a result, the non-cancer margin of safety (MOS) was calculated as 633, and CMIT/MIT was determined to be safe when all representative cosmetics were evaluated. In addition, the skin sensitization acceptable exposure level (AEL)/CEL was calculated as 0.00538 for all representative cosmetics and 2.14225 for rinse-off products; thus, CMIT/MIT was considered a skin sensitizer when all representative cosmetics were evaluated. Current regulations indicate that CMIT/MIT can only be used at concentrations 0.0015% or less and is prohibited from use in other cosmetics products. According to the results of this risk assessment, the CMIT/MIT regulatory values currently used in cosmetics are evaluated as appropriate.

• Journal of agricultural medicine and community health
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• v.29 no.2
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• pp.249-263
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• 2004

Objectives: The objectives of the present study were to establish the exposure monitoring method of chlorpyrifos and chlorothalonil application to pear and field red pepper by vehicle-mounted sprayer, hand-held sprayer and to assess the risk. Methods and Results: Chlorpyrifos met all of requirements of sampling and analysis method(U.S. EPA), but chlorothalonil met only dermal patch method. Potential dermal and inhalation exposure was evaluated in 42 farmers. Compared with the hand-held sprayer application, vehicle mounted sprayer demonstrated producing relatively lower dermal exposure levels with statistical significance. In dermal exposure during hand-held application, there is no significant difference between pear and red pepper. Conclusions: This results show that application method is the main factor of dermal exposure. There was no statistically significant difference between each group of respiratory exposure level. The margin of safety (MOS) was calculated to assess the risk of pesticide exposure. All Chlorpyrifos MOS values are lower than 0.2, which mean working conditions are unsafe. In order to protect farmers, big efforts to control exposure are needed.

• Toxicological Research
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• v.35 no.2
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• pp.137-154
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• 2019

Triclosan (TCS) is an antimicrobial compound used in consumer products. The purpose of current study was to examine toxicology and risk assessment of TCS based on available data. Acute toxicities of oral, transdermal and inhalation routes were low, and phototoxicity and neurotoxicity were not observed. Topical treatment of TCS to animal caused mild irritation. TCS did not induce reproductive and developmental toxicity in rodents. In addition, genotoxicity was not considered based on in vitro and in vivo tests of TCS. It is not classified as a carcinogen in international authorities such as International Agency for Research on Cancer (IARC). No-observed-adverse-effect level (NOAEL) was determined 12 mg/kg bw/day for TCS, based on haematoxicity and reduction of absolute and relative spleen weights in a 104-week oral toxicity study in rats. Percutaneous absorption rate was set as 14%, which was human skin absorption study reported by National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (2009). The systemic exposure dosage (SED) of TCS has been derived by two scenarios depending on the cosmetics usage of Koreans. The first scenario is the combined use of representative cosmetics and oral care products. The second scenario is the combined use of rinse-off products of cleansing, deodorants, coloring products, and oral care products. SEDs have been calculated as 0.14337 mg/kg bw/day for the first scenario and 0.04733 mg/kg bw/day for the second scenario. As a result, margin of safety (MOS) for the first and second scenarios was estimated to 84 and 253.5, respectively. Based on these results, exposure of TCS contained in rinse-off products, deodorants, and coloring products would not pose a significant health risk when it is used up to 0.3%.

• Toxicological Research
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• v.35 no.2
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• pp.131-136
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• 2019

Ethylhexyl dimethyl para-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl dimethyl PABA is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5-2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that ethylhexyl dimethyl PABA is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that ethylhexyl dimethyl PABA inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of ethylhexyl dimethyl PABA following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of ethylhexyl dimethyl PABA in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% ethylhexyl dimethyl PABA, which is the maximum level allowed by the relevant domestic authorities.

• The Korean Journal of Pesticide Science
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• v.20 no.3
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• pp.271-279
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• 2016

To evaluate exposure characteristics of the insecticide imidacloprid to apple orchard workers during treatment on orchard fields and evaluate its potential risk using a whole body dosimetry (WBD) method, 1,000-time diluted acephate+imidacloprid 25(20+5)% solutions were sprayed on 10 apple orchard fields in Cheongju with a speed sprayer at a rate of 3,000 L/ha/person, after put on clothes such as inner/outer clothes, personal air pump with a IOM sampler, nitrile glove and mask. Exposure test included mixing, loading and application steps. The test pesticide imidacloprid residues in the collected samples were analyzed with a HPLC-DAD. Recoveries ranged from 81.5 to 108.6% for analytical method validation and from 73.8 to 86.7% for field recovery. Total exposed amounts to mixer/loader and applicator were found to be 0.0014-0.0279% of total applied active ingredient of imidacloprid. Glove exposure of both mixer/loader and applicator was higher than the other parts. Margins of safety of mixer/loader and applicator were calculated to be 97-355 and 46-196, respectively, indicating that exposure risk of imidacloprid to apple orchard workers by spraying with a speed sprayer was very low.

• Journal of Korean Society of Forest Science
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• v.107 no.2
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• pp.229-236
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• 2018

Pesticides are widely sprayed by the growers in street trees and planting areas which include urban forests, community forests and city parks to control pests. Spraying pesticides not only affect the people who sprayed but also affect the unspecified citizens who's are exposed to pesticides sprayed trees by contact or inhalation. A few studies have been conducted to measure the amount of pesticides in forest area but no studies have been conducted to measure the pesticide amount in tree in public living space. So, in our study, we investigated the amount of pesticides in cotton gloves, in leaf residue, and respiratory exposure for a certain period of time after applying Fenitrothion EC to Korean boxweed tree (Buxus Koreana) to know the safety time of pesticides after spraying. We found that, up to 4d, there was no significant difference of the amount of Fenitrothion on leaves. But the amount of pesticides on gloves was significantly higher on 1h ($510.1{\mu}g$) and 24h ($405.4{\mu}g$) than 48h ($45.0{\mu}g$) after spraying. The amount of pesticides on inhalation was also significantly higher in 1 h ($0.2{\mu}g$) and 24 h ($0.1{\mu}g$) than 48 h after spraying. After 48h, we did not find pesticides amount in inhalation. Thus, we was considered necessary to pay attention to 48h after spraying of pesticide Fenitrothion.