• Toxicological Research
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• v.19 no.1
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• pp.21-27
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• 2003

A teratogenic study of dimethyl dimethoxy biphenylate derivative (DDB-S) was carried out on Sprague-Dawley rats. DDB-S dissolved in saline was administered to male and female rats by intravenously injection at daily doses of 50 mg/kg, 75 mg/kg, and 100 mg/kg. A half of dams were sacrificed at 20th day of gestation to scrutinize the pregnant performances and fetal development. And the remaining dams were allowed to deliver. The growth, reflex, behaviour and reproductive function of F1 offsprings were examined. There was no treatment-related difference in body weight, food consumption and necropsy findings of dams. No gross, skeletal and visceral abnormalities was observed in F1 fetuses from dams treated with DDB-S. F1 offsprings did not show any treatment-related difference in growth, reflex, behaviour and reproductive performance. At caesarean section of F1 dams, no growth retardation and gross abnormality was observed in F2 fetuses. In conclusion, DDB-S did not show any potential teratogenic effect in rats.

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.280.1-280.1
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• 2002

Mancozeb. a polymeric complex of zinc and manganese salts of ethylean bisdithiocarbamate(EBDC). is used widely in agriculture as fungicides. and herbicides. Macozeb has been reported to induce teratogenic and carcinogenic effect. But the immunomodulating effects of Mancozeb exposure have not been systemically evaluated. The purpose of this study was to investigate the effects of Mancozeb on immunoglobulin production. (omitted)

• Environmental Mutagens and Carcinogens
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• v.21 no.2
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• pp.118-121
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• 2001

The predictive screening of various molecular descriptors for predicting carcinogenic, mutagenic, teratogenic and alkylation activity of chlorinated disinfection byproducts (DBPs) has been investigated for the application of quantitative structure-activity relationships (QSAR). The toxicity index for 29 compounds were computed by the PASS program and active values were employed in this study. Studies show that different descriptors account for the model equation of each genotoxic endpoint and that thermodynamic descriptors significantly played a major role on prediction of endpoints of chlorinated aliphatic compounds.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.114.1-114.1
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• 2003

Mancozeb is a protective fungicide on plants and a polymeric complex of ethylene bisdithiocarbamate manganese with zinc salt. It is reported to induce teratogenic and carcinogenic effect in laboratory animals. But the immunomodulating effects of Mancozeb exposure have not been systemically evaluated. The purpose of this study was to investigate the effects of Mancozeb on cell-mediated immunity in mice. For ex vivo assessment, mice were orally exposed to Mancozeb dissolved in distilled water as concentrations of 2,500, 5,000, 10,000 mg/kg for single occasion (acute exposure) or 250, 1,000, 1,500 mg/kg/day 5 days a week for 30days(subacute). (omitted)

• Korean Journal of Veterinary Research
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• v.31 no.4
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• pp.411-418
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• 1991

This study was carried out to investigate the amino acid and protein concentrations in amniotic fluid and the potency of the teratogenic effect of ethylenethiourea(2-imidazolidinethione, ETU) in the fetuses due to different dose amounts of this compound. The S.P.F. Sprague-Dawley female rats(10 weeks) were used in this study and these animals were divided into four groups; control group(25pregnant female rats), group I (dosed ETU from day 7 to day 17 of gestation at 10mg/kg/day), group II (dosed ETU from day 7 to day 17 of gestation at 30mg/kg/day), group III (dosed ETU from day 7 to day 17 of gestation at 50mg/kg/ day). 250mg/100mg ETU in group I, 750mg/100ml ETU in group II and 1,250mg/100ml ETU in group III were administered 4ml/kg 13.W by oral route. The results obtained were summarized as follows; 1. The anomalies of the external examination werf meningocele in the head, kinky tail, clubfoot and sharp tail.(Meningocele, in group III, significantly increased from control value at p<0.001). 2. The skeletal variations and delayed ossification were Lumbar ribs, asymmetric sternebrae, asymmetric 13th rib and delayed ossification of skull. Asymmetric sternebrae(group III ) was significantly increased from control value at p<0.05 and delayed ossification of skull (group II and III ) were significantly increased from control value at p<0.05 and p<0.01, respectively. 3. The internal soft tissue anomalies were hydroencephaly of 3th lateral ventricle, dilatation of ureter, dilatation of renal pelvis and cleft palate. (Hydroencephaly, 28.1% in group I, 88.3% in group II and 100% in group III ). 4. Protein values in amniotic fluids are not significantly decreased in 10mg/kg group but significantly(p<0.05) decreased in 30mg/kg group and 50mg/kg group from control group. 5. In the levels of amino acid in amniotic fluids, the levels of glntamic acid, iso-lencine, leucine, tyrosine and phenylalanine of 10mg/kg group are significantly decreased from control group. In 50mg/kg group, except for glycine, valine and methionine, all amino acid levels are significantly(p<0.05) decreased from control group.

• Toxicological Research
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• v.17 no.1
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• pp.27-32
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• 2001

Korean ginseng products have been fumigated with ethylene oxide (EO) for sterilization and prolongation of storage periods. However, there had been controversies indicating that consumption of EO treated foods might cause harmful effects in human. In Korea, the use EO gas for food treatment was banned in 1991. Since then, irradiation technique has been developed as an alternative. This study was carried out to evaluate the safety of irradiated ginseng on embryo and fetal developmental toxicity effects in rats. Either EO gas fumigated or $\gamma$-irradiated ginseng was administered to pregnant Wistar rats by oral gavage from gestational day 7 to 17. The amount of irradiation used in this study was 5, 10 and 30 kGy, respectively. There were no treatment related changes of dams in deaths, clinical signs, food consumption and body/organ weight. No treatment related changes in implantation ratio, litter size, sex ratio and body/organ weight of fetuses were observed. Also, no F1fetuses with external, visceral, head and skeletal mal-formation were observed. The results of this study showed that $\gamma$-irradiated ginseng, up to 30 kGy, has no adverse effects on fetal development of rats.

• Proceedings of the Korea Society of Environmental Toocicology Conference
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• 2002.10a
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• pp.107-116
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• 2002

GLP regulations were initially “promulgated to address assuring the validity of data in the wake of investigations by EPA and FDA during the mid -1970's which revealed that some studies submitted to the agencies had not been conducted in accordance with acceptable laboratory practices.” [1] In the early 1970s, results of an investigation by the FDA in about 40 laboratories revealed many cases of badly managed studies, poor training of personnel and some cases of deliberate fraud. The general findings were that there were poorly trained study directors and study personnel, poorly designed protocols, protocols not followed, procedures not conducted as described, raw data badly collected, data not correctly identified, data without traceability, data not verified and approved by responsible persons, lack of standardised procedures, poor animal husbandry, inadequate characterisation of test items and test systems, inadequate resources, equipment poorly calibrated or otherwise qualified, reports not sufficiently verified, not an accurate account of the actual study, not a proper reflection of raw data and inadequate archiving of data. These problems are not just past history, since they resurface time and time again, even in quite recent times as the experience of GLP inspectors shows [1]. The GLPs specify minimum practices and procedures in order to ensure the quality and integrity of data submitted in accordance with a regulatory requirement

• Toxicological Research
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• v.13 no.1_2
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• pp.167-173
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• 1997

LBD-001, a recombinant human interferon $\gamma$ produced by genetically engineered yeast as a host system, was intravenously administered to pregnant female rabbits (New Zealand White strain) from day 6 to 18 of gestation at dose levels of $0.35 \times 10^6$, $0. 69 \times 10^6$, and $1.38 \times 10^6$ I.U./kg/day. Hydrocortisone sodium succinate (0.3 mg/kg/day) was also given in the same way. Teratological effects of the test agents on the organogenesis of fetuses and the development of offsprings (F1 rabbits) were investigated. The results were as followings: (1) No significant changes by the treatment of LBD-001 or hydrocortisone sodium succinate were observed in the body weights, the food and water consumption, the lactating or nurshing behaviors, and the autopsy of the pregnant rabbits. (2) No significant changes in the resorption rate, the fetal organogenesis, and the normal develpoment of offsprings (F1) by the treatment of LBD-001 or hydrocortisone sodium succinate were detected. The results show that LBD-001 at the dose of $1.38 \times 10^6$ I.U./kg/day or less and hydrocortisone sodium succinate at the dose of 0.3 mg/kg/day are neither teratogenic in the organogensis of the fetuses and the development of the offsprings (F1) nor toxic to the mother rabbits.

• Environmental Mutagens and Carcinogens
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• v.21 no.2
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• pp.113-117
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• 2001

The screening of various molecular descriptors for predicting carcinogenic, mutagenic and teratogenic activities of chlorinated aliphatic compounds as drinking water disinfection byproducts (DBPs) has been investigated for the application of quantitative structure-activity relationships (QSAR). The present work embodies the study of relationship between molecular descriptors and toxicity parameters of the genotoxicity endpoints for the screening of relevant molecular descriptors. The toxicity Indices for 29 compounds constituting the testing set were computed by the PASS program and active values were chosen. We investigate feasibility of screening descriptors and of their applications among different genotoxic endpoints. The correlation to teratogenicity of all 29 compounds was significantly improved when the same analysis was done with 20 alkanes only without alkene compounds. The HOMO (highest occupied molecular orbital) energy and number of Cl parameters were dominantly contributed.

• 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.