• Title/Summary/Keyword: OECD test guidelines

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Aquatic Toxicity Assessment of Phosphate Compounds

  • Kim, Eunju;Yoo, Sunkyoung;Ro, Hee-Young;Han, Hye-Jin;Baek, Yong-Wook;Eom, Ig-Chun;Kim, Hyun-Mi;Kim, Pilje;Choi, Kyunghee
    • Environmental Analysis Health and Toxicology
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    • v.28
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    • pp.2.1-2.7
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    • 2013
  • Objectives Tricalcium phosphate and calcium hydrogenorthophosphate are high production volume chemicals, mainly used as foodstuff additives, pharmaceuticals, lubricants, synthetic resin, and disinfectants. Phosphate has the potential to cause increased algal growth leading to eutrophication in the aquatic environment. However, there is no adequate information available on risk assessment or acute and chronic toxicity. The aim of this research is to evaluate the toxic potential of phosphate compounds in the aquatic environment. Methods An aquatic toxicity test of phosphate was conducted, and its physico-chemical properties were obtained from a database recommended in the Organization for Economic Cooperation and Development (OECD) guidance manual. An ecotoxicity test using fish, Daphnia, and algae was conducted by the good laboratory practice facility according to the OECD TG guidelines for testing of chemicals, to secure reliable data. Results The results of the ecotoxicity tests of tricalcium phosphate and calcium hydrogenorthophosphate are as follows: In an acute toxicity test with Oryzias latipes, 96 hr 50% lethal concentration ($LC_{50}$) was >100 (measured:>2.14) mg/L and >100 (measured: >13.5) mg/L, respectively. In the Daphnia test, 48 hr 50% effective concentration ($EC_{50}$) was >100 (measured: >5.35) mg/L and >100 (measured: >2.9) mg/L, respectively. In a growth inhibition test with Pseudokirchneriella subcapitata, 72 hr $EC_{50}$ was >100 (measured: >1.56) mg/L and >100 (measured: >4.4) mg/L, respectively. Conclusions Based on the results of the ecotoxicity test of phosphate using fish, Daphnia, and algae, $L(E)C_{50}$ was above 100 mg/L (nominal), indicating no toxicity. In general, the total phosphorus concentration including phosphate in rivers and lakes reaches levels of several ppm, suggesting that phosphate has no toxic effects. However, excessive inflow of phosphate into aquatic ecosystems has the potential to cause eutrophication due to algal growth.

OECD High Production Volume Chemicals Program: Ecological Risk Assessment of Copper Cyanide (대량생산화학물질 초기위해성평가: 시안화구리의 초기 생태위해성평가)

  • Baek, Yong-Wook;Kim, Eun-Ju;Yoo, Sun-Kyoung;Ro, Hee-Young;Kim, Hyun-Mi;Eom, Ig-Chun;Kim, Pil-Je
    • Korean Journal of Ecology and Environment
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    • v.44 no.3
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    • pp.272-279
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    • 2011
  • Copper cyanide is a chemical produced in large quantities with 2,500 tonnes being produced in 2006. It is mainly used for electroplating copper, particularly alkali-Cu plate and brass plating. The purpose of this study is to reassess the physicochemical properties and environmental fate of copper cyanide based on reliable data and and to conduct an ecotoxicity test according to the OECD test guidelines as an initial environmental risk assessment (need to state where this was done). Metal containing inorganic substances are not subject to degradation, biodegradation or hydrolysis. Aquatic toxicity tests of copper cyanide were conducted according to OECD test guideline 201, 202 and 203 for green algae, daphnia, and fish, respectively. The following acute toxicity test results were obtained for aquatic species: 0.089 mg $L^{-1}$ (Algae, 72 Hr-$EC_{50}$); 0.21 mg $L^{-1}$ (flea, 48 Hr-$LC_{50}$); 0.62 mg $L^{-1}$ (Fish, 96 Hr-$ErC_{50}$). The chemical possesses properties indicating a hazard for the aquatic environment (acute toxicity in fish, daphnia and algae below 1.0 mg $L^{-1}$). As a result of this study, copper cyanide has become a candidate for detailed risk assessment. Countries that produce this chemical in significant quantities are recommended to perform specific assessments.

Guidance on Estimating Soil Persistence and Degradation Kinetics from Environmental Fate Studies on Veterinary Pharmaceuticals for Environmental Risk Assessment (동물용의약품의 환경 중 위해성 평가를 위한 토양 잔류성 시험법 가이드라인)

  • Kwon, Jin-Wook
    • Korean Journal of Environmental Agriculture
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    • v.30 no.1
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    • pp.68-75
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    • 2011
  • BACKGROUND: To assess and prevent the environmental impacts and risks by veterinary pharmaceuticals, Guidance on Estimating Soil Persistence and Degradation Kinetics from Environmental Fate Studies on Veterinary Pharmaceuticals for Environmental Risk Assessment was proposed. METHODS AND RESULTS: Proposed guidance was coined by VICH, EU guideline, OECD guideline and soil dissipation studies for the purpose of international harmonizing. Guidance was also modified from pesticide soil persistence testing guidelines of US, EU, and Korea, with practical approaches adopting in-use test guideline for Korea. CONCLUSION(S): Proposed guidance are consisted of three parts; Laboratory Soil Experiment, Field Soil Dissipation Study, and Estimation of $DT_{50}/DT_{90}$. Proposed guidance is to be available for the requirement for registration of veterinary pharmaceuticals with fit for purpose in Korea.

The First Report to Evaluate Safety of Cyanobacterium Leptolyngbya sp. KIOST-1 for Use as a Food Ingredient: Oral Acute Toxicity and Genotoxicity Study

  • Lee, Youngdeuk;Kim, Taeho;Lee, Won-Kyu;Ryu, Yong-Kyun;Kim, Ji Hyung;Jeong, Younsik;Park, Areumi;Lee, Yeon-Ji;Oh, Chulhong;Kang, Do-Hyung
    • Journal of Microbiology and Biotechnology
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    • v.31 no.2
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    • pp.290-297
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    • 2021
  • Leptolyngbya sp. KIOST-1 (LK1) is a newly isolated cyanobacterium that shows no obvious cytotoxicity and contains high protein content for both human and animal diets. However, only limited information is available on its toxic effects. The purpose of this study was to validate the safety of LK1 powder. Following Organisation for Economic Co-operation and Development (OECD) guidelines, a single-dose oral toxicity test in Sprague Dawley rats was performed. Genotoxicity was assessed using a bacterial reverse mutation test with Salmonella typhimurium (strains TA98, TA100, TA1535, and TA1537) and Escherichia coli WP2 uvrA, an in vitro mammalian chromosome aberration test using Chinese hamster lung cells, and an in vivo mammalian erythrocyte micronucleus test using Hsd:ICR (CD-1) SPF mouse bone marrow. After LK1 administration (2,500 mg/kg), there were no LK1-related body weight changes or necropsy findings. The reverse mutation test showed no increased reverse mutation upon exposure to 5,000 ㎍/plate of the LK1 powder, the maximum tested amount. The chromosome aberration test and micronucleus assay demonstrated no chromosomal abnormalities and genotoxicity, respectively, in the presence of the LK1 powder. The absence of physiological findings and genetic abnormalities suggests that LK1 powder is appropriate as a candidate biomass to be used as a safe food ingredient.

Genotoxicity Study of Litsea japonica Fruit Flesh Extract (까마귀쪽나무열매추출물의 유전독성 평가)

  • Yun, Ji-Hyun;Park, In-Jae;Park, Sung-Hwan;Choi, Goo-Hee;Kim, Hyun-Jung;Cho, Ju-Hyun
    • Journal of Food Hygiene and Safety
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    • v.33 no.3
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    • pp.207-213
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    • 2018
  • This study aimed to evaluate the genotoxicity of Litsea japonica fruit-hexane extract (LJF-HE). In order to examine the genotoxicity, we carried out bacterial reverse mutation assay, chromosome aberration assay, and a micronucleus induction (MN) test according to the OECD and the Korea Ministry of Food and Drug Safety (MFDS) toxicity test guidelines. In the bacterial reverse mutation assay, no significant increase in revertant colonies, nor bacterial toxicity, was observed in the LJF-HE treatment group, regardless of the absence or presence of metabolic activation by the S9 mixture. However, in the positive control group, revertant colony counts were shown to be more than twice that of the negative control group. The chromosome aberration test showed that the repetition rate of abnormal chromosome aberration was less than 5%, regardless of the treatment time, and with or without the S9 mixture. No significant change was observed when (p < 0.05) compared with the negative control group. The micronucleated polychromatic erythrocytes (MNPCE) repetition rate of the polychromatic erythrocytes (PCE) showed no significant changes when compared with the negative control group (p < 0.05). The PCE portion of total erythrocytes also showed no significant changes (p < 0.05). These results showed that LJF-HE had no significant genotoxic effects.

Single Oral Dose Toxicity Test of Standardized Cornus officinalis and Psoralea corylifolia L. Extracts in Sprague-Dawley Rat (산수유, 보골지 복합추출물의 Sprague-Dawley rat를 이용한 단회경구투여 독성시험)

  • Jin, Bo-Ram;Kang, Hyun-Ae;Cominguez, Divina C.;Kim, Myoung-Seok;Lee, Kwang-Ho;Yoon, Il-Joo;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.34 no.3
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    • pp.31-36
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    • 2019
  • Objectives : In this animal study, we performed the single oral dose toxicity test of Standardized Cornus officinalis Sieb. et Zucc. and Psoralea corylifolia L. 30% ethanol extract (SCP) in Sprague-Dawley (SD) rats owing to aims for verifying approximate lethal dose (ALD). Methods : According to OECD guidelines for the testing of chemicals section 4 health effects test No. 420 acute oral toxicity study - fixed dose procedure (17 December 2001), single oral dose toxicity test was performed. Animals were divided into two groups: Group 1, vehicle-treated rats (Control); Group 2, SCP 5000 mg/kg treated rats. SCP is composed of two medicinal herbs: Cornus officinalis Sieb. et Zucc. (650 g) and Psoralea corylifolia L. (350 g) in 30% ethanol. SCP was once orally administered to female and male SD rats at dose levels of 5000 mg/kg. Animals were monitored on the mortality, clinical signs, body weight changes and necropsy findings for 14 days. Results : After single oral treatment of SCP, we could not find any mortality up to 5000 mg/kg. Compared with the control group, there were also no significant differences in clinical sign, weight change, weight gain and gross abnormalities in SCP 5000 mg/kg-treated group. Conclusions : Taken together, these results suggest that the ALD of SCP in both female and male SD rats were considered as over 5000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

Single-Dose Oral Toxicity Test of Woohwangchungshim-won in Mice (우황청심원의 마우스 단회 경구투여 독성시험 연구)

  • Lee, Je Won;Baek, Kyung Min;Chang, Woo Seok
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.28 no.2
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    • pp.186-194
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    • 2014
  • The object of this study was to obtain acute toxicity information (single-dose oral toxicity) of Woohwangchungshim-won (WHCSW), a pill type herbal medicine used in Korean Medicine (KM) for treating stroke. In order to obtain the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, WHCSW 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.) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines (Notification No. 2009-116). The mortality and changes in the body weight, clinical signs and gross observation were monitored for 14 days after single-dose oral administration of WHCSW according to KFDA Guidelines with organ weights and histopathological changes were observed in 12 principle organs. After single-dose oral administration of WHCSW, we could not find any mortality and toxicological evidences up to 2,000 mg/kg-administered group, except for some accidental findings and dose-independent increases of body weight gains in female 1,000 and 500 mg/kg-administered female mice. The results obtained in this study suggest that the LD50 and ALD of WHCSW in both female and male mice after single-dose oral administration were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development (OECD), and can be safely used in clinics.

A Study on GHS Classification of 3-Methylpentane by Subacute Inhalation Toxicity (아급성흡입독성시험을 이용한 3-Methylpentane의 GHS 분류·표시)

  • Chung, Yong Hyun;Han, Jeong Hee;Shin, Seo Ho
    • Journal of the Korean Institute of Gas
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    • v.21 no.1
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    • pp.6-17
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    • 2017
  • Objectives : The purpose of this study was to obtain information regarding Globally Harmonized System(GHS) classification and health hazards that may result from a 4 weeks inhalation exposure of 3-Methylpentane in Sprague-Dawley rats. Methods : The testing method was conducted in accordance with OECD guidelines for the testing of chemicals No. 412(Subacute Inhalation Toxicity). The Rats were divided into 4 groups(5 male and 5 female rats in each group) and exposed to 0 ppm, 284 ppm, 1,135 ppm, 4,540 ppm 3-Methylpentane in each exposure chamber for 6 h/day, 5 days/week, for 4 weeks. After two weeks, the test animals were autopsied and carried out blood test and biochemical tests and histopathological examination. We used PRISTIMA (Toxicology data management system) to confirm the system and to have confidence of the raw data. Results : No death and particular clinical presentation including weight change and change of feed rate was observed. Relationship between dose, gender and response was also not significantly changed in hematologic examination, biochemical examination of blood and blood coagulation time. The histopathologic lesions caused by the test substance did not appear. Conclusions : NOAEL(No Observable Adverse Effect Level) of 3-Methylpentane is more than 4,540 ppm in male group and female group and the Ministry of Employment and Labor Guidance Announcement No. 2013-37(criteria for the classification marks and Safety of Chemicals) Specific target organ toxicity(repeated exposure) was determined with a substance that is not the separator material.

Single Oral Dose Toxicity Study of Aqueous Extracts of Binso-san in ICR Mice

  • Park, Kyung;Kim, Dae-Jun;Byun, Joon-Seok
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.24 no.1
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    • pp.134-142
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    • 2010
  • Although BinSo-San(BSS), a mixed herbal formula consisted of 11 types of medicinal herbs and have been used as anti-inflammatory agent, In the present study, the acute toxicity (single oral dose toxicity) of lyophilized BSS aqueous extracts was monitored in male and female mice after oral administration according to Korea Food and Drug Administration (KFDA) Guidelines (2005-60, 2005). In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2000, 1000, 500, 250 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines (2005-60, 2005). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines (2005-60, 2005) with organ weight and histopathology of 12 types of principle organs. We could not find any mortality, clinical signs and changes in the body weights except for dose-independent increases of body weight and gains restricted in 1000 mg/kg of BSS extracts-dosing female group. Hypertrophic changes of lymphoid organs.thymus, spleen and popliteal lymph nodes were detectedat postmortem observation with BSS extracts dose-dependent increases of lymphoid organ weights, and hyperplasia of lymphoid cells in these all three lymphoid organs at histopathological observations. These changes are considered as results of pharmacological effects of BSS extracts or their components, immunomodulating effects, not toxicological signs. In addition, some sporadic accidental findings such as congestion spots, cyst formation in kidney, atrophy of thymus and spleen with depletion of lymphoid cells, and edematous changes of uterus with desquamation of uterus mucosa as estrus cycles were detected throughout the whole experimental groups including both male and female vehicle controls. The significant (p<0.01) increases of absolute weights of kidney and pancreas detected in BSS extracts 1000 mg/kg-treated female group are considered as secondary changes from increases of body weights. The results obtained in this study suggest that the BSS extract is non-toxic in mice and is therefore likely to be safe for clinical use. The LD50 and ALD of BSS aqueous extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. In addition, the MTD of BSS extracts was also considered as over 2000 mg/kg because no BSS extracts-treatment related toxicological signs were detected at histopathological observation except for BSS or their component-related pharmacological effects, the immunomodulating effects detected in the present study.

Suitability Assessment of Domestic Natural Waters as a Culture Medium for Daphnia magna (Daphnia magna의 배양배지로서 국내 자연수의 적절성 평가)

  • Yeom, Dong-Hyuk;Jeon, Chan-Sig
    • Korean Journal of Ecology and Environment
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    • v.45 no.3
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    • pp.271-277
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    • 2012
  • The present study was conducted to assess the suitability of domestic natural waters as a Daphnia magna culture medium. In order to assess survival rate and reproductive output, young female daphnids (parent animals), aged less than 24 hours at the start of the test and produced in the Elendt M4 medium, were exposed to Elendt M4 medium, de-chlorinated tap water, and natural mineral water for 21 days. D. magna cultured in Elendt M4 medium (reference medium) and natural mineral water met the criteria of OECD No. 211, Daphnia magna Reproduction Test Guidelines in terms of percent adult survival, first day of reproduction, and average young production. However, the mortalities of adult daphnids observed in de-chlorinated tap water were more than 20% in two reproduction tests for 21 days. Mortality was observed on exposure days 13, 15, and 18 in de-chlorinated water. The use of D. magna is recommended in water of hardness >80 mg $CaCO_3\;L^{-1}$. However, the hardness of de-chlorinated tap water used in the present study was 50~53 mg $CaCO_3\;L^{-1}$. Therefore, it is judged that the delayed mortalities observed in de-chlorinated tap water were caused by a rapid decreased in hardness when the medium was changed from Elendt M4 to de-chlorinated tap water. When D. magna is cultured using domestic natural waters (underground water, surface water, and de-chlorinated water), the quality-control (QC) data should be maintained through a standardization for health assessment method, toxicity test method using reference chemical, test intervals of reference toxicant toxicity test, and data treatment and interpretation. In the long term, national research programs are needed for the development of test species which are representative of domestic aquatic environmental conditions among indigenous daphnids.