• Title/Summary/Keyword: Guidelines for the Testing of Chemicals

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Subchronic Inhalation Toxicity Study of n-pentane in Rats

  • Kim, Jong-Kyu;Cho, Hae-Won;Han, Jeong-Hee;Lee, Sung-Bae;Chung, Yong-Hyun;Rim, Kyung-Taek;Yang, Jeong-Sun
    • Safety and Health at Work
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    • v.3 no.3
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    • pp.224-234
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    • 2012
  • Objectives: This study was conducted in order to obtain information concerning the health hazards that may result from a 13 week inhalation exposure of n-pentane in Sprague-Dawley rats. Methods: This study was conducted in accordance with the Organization for Economic Co-operation and Development (OECD) guidelines for the testing of chemicals No. 413 'Subchronic inhalation toxicity: 90-day study (as revised in 2009)'. The rats were divided into 4 groups (10 male and 10 female rats in each group), and were exposed to 0, 340, 1,530, and 6,885 ppm n-pentane in each exposure chamber for 6 hour/day, 5 days/week, for 13 weeks. All of the rats were sacrificed at the end of the treatment period. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, locomotion activity, urinalysis, hematology, serum biochemistry, gross findings, organ weights, and histopathology were assessed. Results: During the period of testing, there were no treatment related effects on the clinical findings, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross findings, relative organ weight, and histopathological findings. Conclusion: The no-observable-adverse-effect level (NOAEL) of n-pentane is evaluated as being more than 6,885 ppm (20.3 mg/L) in both male and female rats. n-pentane was not a classified specific target organ toxicity in the globally harmonized classification system (GHS).

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.

Recent Advanced Toxicological Methods for Environmental Hazardous Chemicals (환경 오염물질의 진보된 독성 평가 기법)

  • 류재천;최윤정;김연정;김형태;방형애;송윤선
    • Environmental Analysis Health and Toxicology
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    • v.14 no.1_2
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    • pp.1-12
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    • 1999
  • Recently, several new methods for the detection of genetic damages in vitro and in vivo based on molecular biological techniques were introduced according to the rapid progress in toxicology combined with cellular and molecular biology. Among these methods, mouse lymphoma thymidine kanase (tk) gene forward mutation assay, single cell gel electrophoresis (comet assay) and transgenic animal and cell line model as a target gene of lac I (Big Blue) and lac Z (Muta Mouse) gene mutation are newly introduced based on molecular toxicological approaches. The mouse lymphoma tk$\^$+/-/ gene assay (MOLY) using L5178Y tk$\^$+/-/ mouse lymphoma cell line is one of the mammalian forward mutation assays, and has many advantages and more sensitive than hprt assay. The target gene of MOLY is a heterozygous tk$\^$+/-/ gene located in 11 chromosome, so it is able to detect the wide range of genetic changes like point mutation, deletion, rearrangement, and mitotic recombination within tk gene or deletion of entire chromosome 11. The comet assay is a rapid, simple, visual and sensitive technique for measuring and analysing DNA breakages in mammalian cells, Also, transgenic animal and cell line models, which have exogenous DNA incorporated into their genome, carry recoverable shuttle vector containing reporter genes to assess endogenous effects or alteration in specific genes related to disease process, are powerful tools to study the mechanism of mutation in vivo and in vitro, respectively. Also in vivo acridine orange supravital staining micronucleus assay by using mouse peripheral reticulocytes was introduced as an alternative of bone marrow micronucleus assay. In this respect, there was an International workshop on genotoxicity procedure (IWGTP) supported by OECD and EMS (Environmental Mutagen Society) at Washington D. C. in March 25-26, 1999. The objective of IWGTP is to harmonize the testing procedures internationally, and to extend to finalization of OECD guideline, and to the agreement of new guidelines under the International Conference of Harmonization (ICH) for these methods mentioned above. Therefore, we introduce and review the principle, detailed procedure, and application of MOLY, comet assay, transgenic mutagenesis assay and supravital staining micronucleus assay.

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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.

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.

A 13-Week Repeated Oral Dose Toxicity Test and a 4-Week Recovery Test of Standardized Cornus officinalis and Psoralea corylifolia L . in Sprague-Dawley Rats (산수유(山茱萸)와 보골지(補骨脂) 복합추출물의 Sprague-Dawley 랫드를 이용한 13 주 반복경구투여 독성시험 및 4 주 회복시험)

  • Sim, Seo-Ah;Kang, Sung-Chul;Jin, Bo-Ram;Kim, Min-jeong;Yeo, Sujung;Park, In-hwa;Jerng, Ui Min;Cha, Yun-yeop;Ahn, Ji-Hye;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.36 no.6
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    • pp.27-37
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    • 2021
  • Objectives : In the current study, we performed the 13-week repeated oral dose toxicity test and a 4-week recovery 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 no observed adverse effect level (NOAEL). Methods : The animal study was performed according to OECD guidelines for the testing of chemicals section 4 health effects test No.408 repeated dose 90-day oral toxicity study in rodents (03 October 2008). In the repeated dose toxicity study, SCP was orally administered to female and male rats at dose levels of 1,000, 2,000, and 4,000 mg/kg/day for 13-week. The control group and high dose (4,000 mg/kg/day) group were then monitored for 4 extra weeks to determine recovery time after the study period. 1) Results : Compared with the control group, there were no treatment-related adverse effects in clinical signs, body weight, hematology, serum biochemistry (Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, 𝛾-Glutamyl transpeptidase, Blood urea nitrogen, Creatinine, Glucose, Total cholesterol, Total protein, Creatine phosphokinase, Albumin, Total bilirubin, Triglyceride, Inorganic phosphorus, Albumin/Globulin ratio, Calcium ion, Sodium ion, Potassium ion, Chloride ion), necropsy findings and organ weight (Ovary, Adrenal gland, Pituitary, Thymus, Prostate, Testis, Epididymis, Spleen, Kidney, Heart, Lung, Brain, Liver) at any dose tested. Conclusions : Taken together, these results suggest that the NOAEL of SCP in both genders was considered as over 4,000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

A Study on the Characteristics of Ion, Carbon, and Elemental Components in PM2.5 at Industrial Complexes in Ansan and Siheung (안산·시흥 산업단지 지역 PM2.5 중 이온, 탄소, 원소성분의 특성 연구)

  • Lee, Hye-Won;Lee, Seung-Hyeon;Jeon, Jeong-In;Lee, Jeong-Il;Lee, Cheol-Min
    • Journal of Environmental Health Sciences
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    • v.48 no.2
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    • pp.66-74
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    • 2022
  • Background: The health effects of particulate matter (PM2.5) bonded with various harmful chemicals differ based on their composition, so investigating and managing their concentrations and composition is vital for long-term management. As industrial complexes emit considerable quantities of pollutants, higher PM2.5 concentrations and chemical component effects are expected than in other places. Objectives: We investigated the concentration distribution ratios of PM2.5 chemical components to provide basic data to inform future major emissions control and PM2.5 reduction measures in industrial complexes. Methods: We monitored five sites near the Ansan and Siheung industrial complexes from August 2020 to July 2021. Samples were collected and analyzed twice per week in spring/winter and once per week in summer/autumn according to the National Institute of Environmental Research in the Ministry of Environments' Air Pollution Monitoring Network Installation and Operation Guidelines. We investigated and compared composition ratios of 29 ions, carbon, and elemental components in PM2.5. Results: The analysis of PM2.5 components at the five sites revealed that ion components accounted for the greatest total mass at approximately 50% while carbon components and elemental components contributed 23~28% and 8~10%, respectively. Among the ionic components, NO3- occupies the greatest proportion. OC occupies the greatest proportion of the carbon components and sulphur occupies the greatest proportion of elemental components. Conclusions: This study investigated the concentration distribution ratios of PM2.5 chemical components in industrial complexes. We believe these results provide basic chemical component concentration ratio data for establishing future air management policies and plans for the Ansan and Siheung industrial complexes.

Single Oral Dose Toxicity Test of Lythri Herba Water Extracts in Sprague-Dawley Rat (털부처꽃 물 추출물의 Sprague-Dawley 랫드를 이용한 단회경구투여 독성시험)

  • Kim, Hee-Young;Park, Yea-Jin;Shin, Su;Choi, Min-Woo;Hong, Eun-Jin;Shin, Young Woo;Cha, Yun-Yeop;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.37 no.3
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    • pp.21-27
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    • 2022
  • Objectives : Single oral dose toxicity test of Lythri Herba water extracts (LHWE) in Sprague-Dawley (SD) rat was performed to determine approximate lethal dose (ALD) of LHWE. Methods : This test was progressed according to OECD Guidelines for the Testing of Chemicals : acute oral toxicity. After adaptation of 7 days, SD rats were divided into 2 groups : vehicle control and 5000 mg/kg LHWE-treated group. Each group consisted of 5 female rats and 5 male rats. Vehicle or 5000 mg/kg LHWE was orally administrated once a day. Survival rates, general toxicity, and changes of body weight were investigated for 14 days after administration. On the last day of examination, the weight of all animals was measured and an autopsy was performed. All internal organ abnormalities were checked macroscopically and their findings were recorded. Results : In both groups, dead animals were not observed. During 14 days of administration, abnormal clinical signs were not detected. There was also no significant difference in weight gains between each group. Autopsy analysis showed that one case of the LHWE-treated female group had retention of clear fluid in the uterus; however, it was not considered to be affected by LHWE administration. Moreover, abnormal findings were not discovered in the control male group and the LHWE-treated male group. Conclusions : These results suggest that the ALD of LHWE exceed 5000 mg/kg and single oral administration of LHWE below 5000 mg/kg is nontoxic.

Biodegradation test of the alternatives of perfluorooctanesulfonate (PFOS) and PFOS salts (PFOS salts 및 PFOS 대체물질에 대한 미생물분해시험)

  • Choi, Bong-In;Na, Suk-Hyun;Son, Jun-hyo;Shin, Dong-Soo;Ryu, Byung-taek;Chung, Seon-yong
    • Journal of Environmental Health Sciences
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    • v.42 no.2
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    • pp.112-117
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    • 2016
  • Objectives: In this study, we investigated the biodegradation rates of 8 perfluorooctanesulfonate (PFOS) alternatives synthesized at the at Changwon National University in comparison to those of PFOS potassium salt and PFOS sodium salt. Methods: A biodegradability test was performed for 28 days with microorganisms cultured in the good laboratory practice laboratory at the Korea Environment Corporation following the OECD Guidelines for the testing of chemicals, Test No. 301 C Results: While $C_5H_8F_3SO_3K$, $C_8F_{17}SO_3K$ and $C_8F_{17}SO_3Na$ were not degraded after 28 days, the 3 alternatives were biodegraded at the rates of 31.4% for $C_8H_8F_9SO_3K$, 25.6% for $C_{10}H_8F_{13}SO_3K$, 23.6% for $C_{25}F_{17}H_{32}S_3O_{13}Na_3$, 20.9% for $C_{15}F_9H_{21}S_2O_8Na_2$, 15.5% for $C_{23}F_{18}H_{28}S_2O_8Na_2$, 8.5% for $C_{17}F_9H_{25}S_2O_8Na_2$ and 4.8% for $C_6H_8F_5SO_3K$. When the concentration was the same(500 mg/L), $C_{23}F_{18}H_{28}S_2O_8Na_2$ had the lowest tension with 20.94 mN/m, which was followed by $C_{15}F_9H_{21}S_2O_8Na_2$ (23.36 mN/m), $C_{17}F_9H_{25}S_2O_8Na_2$ (27.31 mN/m), $C_{25}F_{17}H_{32}S_3O_{13}Na_3$ (28.17 mN/m), $C_{10}H_8F_{13}SO_3K$ (29.77 mN/m) and $C_8H_8F_9SO_3K$ (33.89 mN/m). Having higher surface tension of 57.64 mN/m and 67.57 mN/m, respectively, than those of the two types of PFOS salts, $C_6H_8F_5SO_3K$ and $C_5H_8F_3SO_3K$ were found valueless as substitute for PFOS. Conclusion: The biodegradation test suggest that 6 compounds could be used as substitutes for PFOS. $C_{23}F_{18}H_{28}S_2O_8Na_2$ and $C_{15}F_9H_{21}S_2O_8Na_2$ were found to be the best substitutes based on biodegradation rate and surface tension, followed by $C_{25}F_{17}H_{32}S_3O_{13}Na_3$, $C_8H_8F_9SO_3K$ and $C_{10}H_8F_{13}SO_3K$. $C_{17}F_9H_{25}S_2O_8Na_2$ was found to have relatively low value as an alternative but it still had a potential to substitute the conventional PFOS.

A Comparison of Sensitivity of Four Freshwater Algae to Five Pesticides (5종 농약에 대한 4종 담수조류(freshwater algae)의 감수성 비교)

  • Park, Yeon-Ki;Kim, Byung-Seok;Bae, Chul-Han;Kim, Yeon-Sik;Park, Kyung-Hoon;Lee, Jea-Bong;Shin, Jin-Sup;Hong, Soon-Sung;Lee, Kyu-Seung;Lee, Jung-Joon
    • The Korean Journal of Pesticide Science
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    • v.12 no.1
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    • pp.50-56
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    • 2008
  • The purpose of the study was to determine the effects of isoprothiolane, diazinon, butachlor, dimethametryn and molinate in Selenastrum capriconurtum, Scenedesmus subspicatus, Chlorella vufgaris and Nitzschia palea during an exposure period of 72 hours. The study was carried out in according with the OECD Guidelines for Testing of Chemicals No 201 Alga, Growth Inhibition Test. The toxicological responses of isoprothiolane to S. capriconutum, S. subspicatus, C. vulgaris and N. palea expressed as in individual $ErC_{50}$ (Median Effective Concentration by growth rate) value, were 5.87, 9.91, $18.55 and 38.79\;mg\;L^{-1}$, respectively. Diazinone to S. capriconutum, S. subspicatus, C. vulgaris and palea expressed as in individual $ErC_{50}$ value, were 10.31, 11.44, >32 and $14.32\;mg\;L^{-1}$, respectively. Butachlor to S. capriconutum, S. subspicatus, C. vulgaris and N. plaea expressed as in individual $ErC_{50}$ value, were 0.002, 0.019, 8.67 and $4.94\;mg\;L^{-1}$, respectively. Dimethamelryn to S. subspicatus, C. vulgaris and N. palea expressed as in individual $ErC_{50}$ value, were 0.0071, 0.011, 0.0065 and $0.009\;mg\;L^{-1}$, respectively. Molinate to S. capriconutum, S. subspicatus, C. vulgaris and N. palea expressed as in individual $ErC_{50}$ value, were 0.44, 1.26, 48.84 and $28.52\;mg\;L^{-1}$, respectively. The sensitivities of five pesticides were different depending on freshwater alga in the order of S. capriconutum > S. subspicatus > C. vulgaris, N. palea. Highly significant correlation (r=0.9677) based on $ErC_{50}$ were found between S. capriconutum and S. subspicatus.