• Title/Summary/Keyword: OECD SIDS program

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Risk Assessment in OECD High Production Volume Chemicals Program and its Countermeasure (OECD 대량생산화학물질 위해성평가 및 대책)

  • Kim, Myungjin;Bae, Heekyung;Choi, Yeonki;Kim, Mi Kyoung;Koo, Hyun-Ju;Song, Sang-Hwan;Choi, Kwang-Soo
    • Journal of Environmental Impact Assessment
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    • v.14 no.5
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    • pp.347-353
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    • 2005
  • The risk assessment is the qualitative or quantitative evaluation of the risk posed to human health and the environment by the actual or potential presence or release of hazardous substances, pollutants or contaminants. The environmental impact assessment (EIA) is assessed by the environmental criteria, and risk assessment is assessed by the risk rate. Risk rate based on dose-response values may not be easy to apply on regulatory basis like EIA for uncertainty. Internationally there is an example of OECD program. Risk assessment of High Production Volume (HPV) Chemicals has started since the OECD Program with the 1990 Council Act on the Co-operative Investigation and Risk Reduction of Existing Chemicals. These HPV chemicals include all chemicals produced or imported at levels greater than 1,000 tonnes per year in at least one Member country or in the European Union region. The SIDS called the Screening Information Data Set is regarded as the minimum information needed to assess an HPV chemical to determine whether any further work should be carried out or not. All the data elements of SIDS including assessment for environment and health are prepared as three formats of the full SIDS Dossier, the SIDS Initial Assessment Report (SIAR), and the SIDS Initial Assessment Profile (SIAP) of an HPV chemical. In 1998 the global chemical industry through the International Council of Chemical Associations (ICCA) has joined to work with OECD. The OECD has assessed approximately 1,000 chemicals from 1991 through 2004 with ICCA. Till the February of 2005, 592 chemicals of those chemicals completed SIDS reports. Member countries have been targeted the goal of 1,000 new chemicals from 2005 to 2010 and Korea shared 36 chemicals from the 1,000 new chemicals. Currently Korea has completed SIDS reports of 7 chemicals among sponsored 24 chemicals. In conclusion SIDS project will be linked to national program for outputs application with more reliable production. Both the OECD and industry will carry out their commitment to complete assessments for more and the remaining chemicals assessment. The major outputs will contribute to cope with international chemical management.

Assessment on combined repeated dose and reproduction/developmental toxicity of benzoyl peroxide

  • Sanghwan Song;Kim, Su-Hyon;Heekyung Bae;Lee, Moon-Soon;Park, Kwangsik
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2002.11b
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    • pp.171-171
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    • 2002
  • This study was carried out by an Korean GLP laboratory to assess the combined repeated dose, reproduction and developmental toxicity of benzoyl peroxide for OECD SIDS(Screening Information Data Set) program. Male and female Sprague Dawley rats were exposed to benzoyl peroxide at levels of 0, 250, 500 and 1,000 mg/kg/day for 29 days for male and for 41-51 days for female.(omitted)

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Initial Risk Assessment of Disodium Disulphite in OECD High Production Volume Chemical Program

  • Sanghwan Song;Park, Yoonho;Park, Hye-Youn;Kwon, Min-Jeoung;Koo, Hyun-Ju;Jeon, Seong-Hwan;Na, Jin-Gyun;Park, Kwangsik
    • Toxicological Research
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    • v.18 no.1
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    • pp.23-29
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    • 2002
  • Disodium disulphite, the HPV chemical, was assigned to Korea in order to implement OECD SIDS program in 1999. It was produced about 3,200 ton/year in 1998. This report evaluates the toxic potency of disodium disulphite based on the environmental and mammalian effects as well as human exposure. Oral $LD_{50}$ in rats is 1,540 mg/kg b.w. and effects was observed to the stomach, liver and the GI track that was filled with blood. For repeated dose toxicity, the predominant effect was the induction of stomach lesion due to local irritation. The no observed adverse effect lever for local (stomach irritation) was about 217 mg/kg bw/day. There is no evidence that disodium disulphite is genotoxic in vivo. No reproductive or developmental toxicty of disodium disulphite was observed for the period up to 2 yr and over three generation. In humans, urticaria and asthma with itching, edema, rhinitis, and nasal congestion were reported. Disodium disulphite is unlikely to induce respiratory sensitization but may enhance symptom of asthma in sensitive individuals. This chemical would be mainly transported to water compartment when released to environmental compartments since it is highly water soluble (470 g/l at 20). Low K oc (2.447) indicates disodium disulphite is so mobile in soil that it may not stay in the terrestrial compartment. The chemical has been tested in a limited number of aquatic species. hem acute toxicity test to fish, 96 hr-$LC_{50}$ was > 100 mg/1. For algae, 72 hr-$XC_{50}$ was 48.1 mg/1. For daphnid, the acute toxicity value of 48 hr-$EC_{50}$ was 88.76 mg/1, and chronic value of 21day-NOEC was > 10 mg/1. Therefore, PNEC of 0.1 mg/l for the aquatic organism was obtained from the chronic value of daphnid using the assessment factor of 100. Based on these data the disodium disulphite was recommended as low priority for further post-SIDS work in OECD.

Initial Risk Assessment of Acetanilide in OECD High Production Volume Chemical Program

  • Park, Hye-Youn;Park, Yoonho;Sanghwan Song;Kwon, Min-Jeoung;Koo, Hyun-Ju;Jeon, Seong-Hwan;Na, Jin-Gyun;Park, Kwangsik
    • Toxicological Research
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    • v.18 no.1
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    • pp.13-22
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    • 2002
  • In Korea, 2,320 tonnes of acetanilide were mostly wed as intermediates for synthesis in phar-maceuticals or additives in synthesizing hydrogen peroxide, varnishes, polymers and rubber. Only small amount of 120 kg were wed as a stabilizer for hydrogen peroxide solution for hair colouring agents in 1998. Readily available environmental or human exposure data do not exist in Korea at the present time. However, potential human exposures from drinking water, food, ambient water and in work places are expected to be negligible because this chemical is produced in the closed system in only one company in Korea and the processing factory is equipped with local ventilation and air filtering system. Acetanilide could be distributed mainly to water based on EQC model. This substance is readily biodegradable and its bioaccumulation is low. Acute toxicity of acetanilide is low since the L $D_{50}$ of oral exposure in rats is 1,959 mg/kg bw. The chemical is not irritating to skin, but slightly irritating to the eyes of rabbits. horn repeated dose toxicity, the adverse effects in rats were red pulp hyperplasia of spleen, bone marrow hyperplasia of femur and decreased hemoglobin, hematocrit and mean corpuscular hemoglobin concentration. The LOAEL for repeated dose toxicity in rats was 22 mg/kg/day for both sexes. Acetanilide is not considered to be genotoxic. In a reproductive/developmental toxicity study, no treatment-related changes in precoital time and rate of copulation, impregnation, pregnancy were shown in all treated groups. The NOAELs for reproduction and developmental toxicity (off-spring toxicity) are considered to be 200 mg/kg bw/day and 67 mg/kg bw/day, respectively. Ecotoxicity data has been generated in a limited number of aquatic species of algae (72 hr- $E_{b}$ $C_{50}$; 13.5 mg/l), daphnid (48hr-E $C_{50}$ > 100 mg/l) and fish (Oryzias latipes, 96hr-L $C_{50}$; 100 mg/l). Form the acute toxicity values, the predicted no effect concentration (PNEC) of 0.135 mg/1 was derived win an assessment factor of 100. On the basis of these data, acetanilide was suggested as currently of low priority for further post-SIDS work in OECD.in OECD.D.

Combined Repeated Dose and Reproductive/Developmental Toxicities of Benzoyl Peroxide (Benzoyl Peroxide의 반복투여 독성과 생식 및 발생독성)

  • 송상환;김수현;배희경;김미경;구현주;박광식;이상균;박중훈;최은실
    • Toxicological Research
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    • v.19 no.2
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    • pp.123-131
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    • 2003
  • This study was carried out to assess the combined repeated dose, reproduction and developmental toxicities of benzoyl peroxide for OECD SIDS (Screening Information Data Set) program. Male and female Sprague-Dawley rats were exposed to benzoyl peroxide at dose levels of 0, 250, 500 and 1,000 mg/kg/day for 29 days for males and for 41-51 days for females. No deaths were found in all animals including control group during exposure period. No hematological effects attributable to benzoyl peroxide were observed in all treated groups. Significant decrease in the weight of testes and epididymis were observed in males at 1,000 mg/kg/day. In females at 1,000 mg/kg/day, slight histopathological effects in uterus such as epithelial vacuolation or hyperplasia were observed. No treatment-related changes in precoital time and rate of copulation, fertility and gestation period were noted in all treated groups. There was no evidence of teratogenic effect of benzoyl peroxide, but body weight of pups at 1,000 mg/kg/day was significantly decreased. NOAEL for combined repeated dose and reproduction/developmental toxicity was 500 mg/kg/day.

Estimated Photodegradation Properties of Acetanilide Using AOPWIN (AOPWIN을 이용한 Acetanilide의 광부해 특성 평가)

  • 권민정;최윤호;송상환;박혜연;구현주;전성환;나진균;박광식
    • Environmental Analysis Health and Toxicology
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    • v.16 no.3
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    • pp.139-142
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    • 2001
  • Acetanilide is a High Production Volume Chemical, which is produced about 2,300 tons/year in Korea as of 1998 survey. Most is used as an intermediate for synthesis of pharmaceuticals and dyes, and the chemical is one of seven chemicals of which human and environmental risk are being assessed by National Institute of Environmental Research under the frame of OECD SIDS program. The Atmospheric Oxidation Program for Microsoft Windows (AOPWIN) is used to estimates the rate constant for the atmospheric, gas-phase reaction between photochemically produced hydroxyl radicals and organic chemicals. It is also used to estimates the rate constant for the gas-phase reaction between ozone and olefinic/acetylenic compounds. The rate constants estimated by the program are then used to calculate atmospheric half-lives for organic compounds based upon average atmospheric concentrations of hydroxyl radicals and ozone. AOPWIN requires only a chemical structure to make these predictions. Structures are entered into AOPWIN by SMILES (Simplified Molecular Input Line Entry System) notations. In this study, one of environmental fate/distribution of the chemical elements, photodegradation of acetanilide was estimated using AOPWIN model based on SMILES notation and chemical name data.

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Estimated Environmental Distribution of Acetanilide Using EQC Model (EQC모델을 이용한 Acetanilide의 환경중 분포예측)

  • 박광식;권민정;최윤호;송상환;박혜연;구현주
    • Environmental Analysis Health and Toxicology
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    • v.16 no.3
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    • pp.133-137
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    • 2001
  • Acetanilide is a High Production Volume Chemical, which is produced about 2,300 tons/year in Korea as of 1998 survey. Most is used as an intermediate for synthesis of pharmaceuticals and dyes and the chemical is one of seven chemicals of which human and environmental risks are being assessed by National Institute of Environmental Research under the frame of OECD SIDS program. The chemical is water soluble (4 g/1 at 20$\^{C}$) and readily biodegradable (68.7%). Partition coefficiency (Log Pow) is 1.16 at 23$\^{C}$ so that the chemical has a low potential for bioaccumulation. The acute toxicities of algae, daphnia and fish are not high. The 72 hr-EbC50 of algae is 13.5 mg/1,48 hr-EC50 of daphnia is over 100 mg/1 and 96 hr-LC50 of Oryzias latipes is over 100mg/1. Regarding the exposure, levels in air, water, soil or sediment have not been monitored or estimated so that risk evaluation of acetanilide was not possible. In this study, distribution of the chemical among environmental media was estimated using EQC model based on the chemical-physical properties. In Level I and IIof which the chemical are hypothesized in equilibrium and no transfer through the media, more than 98% of acetanilide are estimated to be distributed in water. However, in Level Ⅲ of which non-equilibrium and intermedia transfer could be occurred, the chemical is estimated to distributed to soil as 51.8% and water as 47.8% as of total amount.

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Estimated Bioaccumulation properties of Acetanilide using BCFWIN (BCF WIN을 이용한 Acetanilide의 생물농축특성 평가)

  • Kwon, Min-Jeong;Choi, Yoon-Ho;Song, Sang-Hwan;Park, Hye-Youn;Koo, Hyun-Ju;Park, Kwang-Sik
    • Environmental Analysis Health and Toxicology
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    • v.16 no.4
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    • pp.223-226
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    • 2001
  • Acetanilide is a High Production Volume Chemical, which is produced about 2,300 tons/year in Korea as of 1998 survey. Most is used as an intermediate for synthesis of pharmaceuticals and dyes. The chemical is one of seven chemicals, which are under the frame of OECD SIDS program sponsored by National Institute of Environmental Research of Korea. Regarding the information on the environmental fate. bioconcentration is one of important factor to estimate the environmental tranfer. However, measurement of bioconcentration needs high expense and time. For this reason, OECD recommends to use BCFWIN model to estimate bioconcentration of organic chemicals, BCFWIN estimates the bioconcentration factor (BCF) of an organic compound using the log octanol-water partition coefficient (Kow) of the compound. Structures are entered into BCFWIN through SMITES (Simplified Molecular Input Line Entry System) notations. The BCFWIN method classifies a compound as either ionic or non-ionic. ionic compounds include carboxylic acids, sulfonic acids and salts of sulfonic acids, and charged nitrogen compounds (nitrogen with a + 5 valence such as quaternary ammonium compounds). All other compounds are classified as non-ionic. In this study, bioaccumulation of acetanilide was estimated using BCFWIN model based on SMIIES notation, chemical name data and partition coefficient as one of environmental fate/distribution of the chemical elements.

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Risk Assessment of Iron dichloride in OECD High Production Volume Chemicals Program (염화제일철에 대한 인체 및 생태 위해성평가)

  • Bae Hee Kyung;Kim Mi Kyoung;Ahn Kyung Sook;Choi Yeon Ki;Koo Hyun Ju;Kim Hyun Mi;Na Jin Gyun;Choi Kwang Soo;Kim Myung Jin
    • Environmental Analysis Health and Toxicology
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    • v.20 no.4 s.51
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    • pp.375-383
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    • 2005
  • 염화제일철은 2004년 OECD SIDS 프로그램으로 한국에서 위해성평가가 수행된 대량생산 화학물질로 1998년 화학물질 유통량조사에 의하면 우리나라에서 연간 100,000톤이 생산되었다. 본 연구에서는 염화제일철의 인체 및 환경적 영향에 대한 독성잠재성을 평가하기 위하여 OECD테스트가이드라인에 따라 독성시험을 수행하였다. 인체영향을 확인하기 위한 급성경구독성시험과 급성경피독성시험에서 랫드의 반수치사량은 각각 300$\sim$2,000 mg/kg b.w.과 >2,000mg/kg b.w.이었다. 반복독성시험의 무유해용량 (NOAEL)은 수컷 랫드는 125mg/kg b.w./day, 암컷 랫드는 250mg/kg b.w./day였고, 생식 및 발생독성시험에서 무유해용량은 암수 랫드 모두 500mg/kg b.w./day로 관찰되었다. 약한 피부자극성을 보였으며, 안부식성 물질임이 관찰되었다. S. typhimurium과 E. coli 균주를 이용한 복귀돌연변이시험에서 최고 농도인 5,000$\mu$g/plate에서 유전독성을 보이지 않았으며, 마우스를 이용한 생체내 (in vivo)소핵시험에서도 최고 농도인 50mg/kg bw/day에서 소핵유발빈도의 증가를 보이지 않아 본 시험물질은 돌연변이 유발 물질이 아닌 것으로 평가되었다. 어류(Oryzis latipes), 물벼룩 (Daphnia magna), 조류 (Pseudokirchneriella subcapitata)를 이용한 수생생물에 대한 급성독성시험 결과, 96시간 Oryzias latires의 반수치사농도는 46.6 mg/L이었고, 48시간 Daphnia magna의 반수영향농도는 19.0 mg/L이었다. 또한 Pseudokirchneriella subcapitata의 72시간 반수영향농도는 성장률을 이용한 계산법으로 6.9mg/L이었으며, 면적계산법으로는 3.8mg/L의 성장저해가 관찰되었다. 어류와 조류의 경우는 부분적으로 pH의 변화에 따른 영향으로 평가할 수 있는데 어류시험에서 pH중성시험용액에서는 100mg/L이상의 독성값을 나타내었고, 조류에서는 농도 12mg/L이상에서 pH 7아래로 떨어짐을 확인할 수 있었다. 염화제일철은 생산 및 사용공정에서 작업자에게 흡입 혹은 피부로 노출될 가능성이 있으나 밀폐공간에서 사용되므로 노출이 적은 것으로 평가되었다. 3종의 수생생물의 독성결과로부터 염화제일철은 수생환경에서 중간정도의 해가 있으며, 우리나라에서는 직접적인 염화제일철의 소비자 노출은 없으나 환경중 노출이 우려됨에 따라 제19차 OECD대량생산화학물질 초기위해성평가회의에서 환경 분야에 대해서는 추가연구 후보물질로 권고되었고, 인체 분야에서는 인체에 대한 유해성과 사용 패턴을 고려하여 추가연구 우선순위가 낮은 물질로 권고되었다.