• Toxicological Research
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• v.23 no.2
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• pp.173-177
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• 2007

The GLP contains specific language concerning characterization of the test, control and reference substances used in toxicity studies. This paper will describe and discuss what types of documents are required to support test/reference substance characterization under GLP system. The purpose of this article is to present an overview of data needed in the characterization package that will adequately define the substance. Most sponsors use a certificate of analysis (COA) to communicate the test sub-stance characterization status information to the contracting research organizations. The COA should provide the test $material^{\circ}{\phi}s$ characterization results, substance storage requirements, expiration dates, verification of the collection of the retention sample, archival location of the data to support the characterization and GLP compliance status of the characterization.

• Korean Journal of Social Welfare
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• v.48
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• pp.243-270
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• 2002

The purpose of this study was to test the effectiveness of cognitive-behavioral therapy to prevent relapse of substance abuse. A total of 8 substance abusing adult clients participated in the program. All the clients were charged with substance use at the time of implementing the program. Two master's level social workers operated the program, which was implemented in a probation office in Seoul. This study included Beliefs about substance use, abstinence self-efficacy, and coping skills as dependent variables in order to investigate the effectiveness. Cognitive-behavioral therapy emphasizes the enhancement of these cognitive and behavioral skills to prevent relapse of substance use. Research hypotheses were partially supported. That is, clients participated in the program had more negative attitude toward substance use and had more effective problem-focused coping skills. Although a research hypothesis of the enhancement of clients' self efficacy was not supported, their mean scores at the final post test were lower than scores at pretest. This study suggests that more studies be needed to in order to confirm the effectiveness of cognitive-behavioral therapy with substance abusing clients.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

• Journal of Pharmacopuncture
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• v.26 no.4
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• pp.348-356
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• 2023

Objectives: Neuralgia-pharmacopuncture (NP) was recently developed as a water-soluble type of pharmacopuncture inspired by CS (care special pain)-pharmacopuncture. I aimed to evaluate the toxic response and approximate lethal dose of when NP when administered intramuscularly to Sprague Dawley rats. Methods: The experimental group was divided into the NP test substance group and the saline control group and administered at a dose of 1.0 mL/animal to the posterior thigh muscles on both sides using a 1 mL syringe; each group consisted of five males and five females. Each rat was monitored for clinical signs and changes in body weight for 14 days after a single intramuscular injection. After completing observation, necropsy findings and localized tolerance at the injection site were assessed via gross necropsy and histopathological examination. Results: No deaths occurred in the NP or control group, regardless of sex. During the observation period, no changes (such as general symptoms, weight change, or visual observation results at the time of autopsy) were judged to be due to the test substance. Histopathological examination showed no changes at the administration site judged to be caused by the test substance in either the male or female test substance administration groups. In addition, mononuclear cell infiltration of the outer membrane of the femoris muscle at the administration site was observed at the same frequency and extent in the control and NP groups, and was judged to be caused by physical stimulation by the injection needle; therefore, it had no toxicological significance. Conclusion: Based on the above results, the approximate lethal dose for a single intramuscular administration of the test substance NP in Sprague-Dawley rats was judged to be > 1.0 mL/animal, and there were no findings that were judged to be due to the test substance at the administration site.

• Environmental Analysis Health and Toxicology
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• v.21 no.2 s.53
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• pp.173-184
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• 2006

From the harmfulness expectation test conducted through a toxicity anticipation program, methylcyclohexane turned out to be harmful and simulative, but no carcinogenicity was anticipated. In a four-hour acute inhalation toxicity test, the result showed that lethal concentration ($LC_{50}$) was 3,750 ppm (15,054 mg/L), which was identified as a harmful substance on the basis of the harmful substance classification standard $2 of the Industrial safety and health law. methylcyclohexane fell under the category $4(2,500 substance from the GHS standard acute toxicity harmfulness classification. Also, from subchronic inhalation toxicity test that included 6 hours a day, five days a week, and for 13 weeks, we could observe weight, activity, long term weight, blood and blood biochemical influence from the exposure of test substance. No-observed effect level (NOEL) was determined below $100{\sim}400ppm$ inboth male and female. This material falls under the Category 2 ($50{\sim}250ppm/6hours/90days$) in the GHS (Globally Harmonized System) standard trace long-term whole body toxicity repeated exposure, and can be classified as a harmful substance in accordance with the Industrial Safety and Health Law harmful substance standard $NOEL{\leq}0.5mg/L/6hr/90day$ (rat).

• YAKHAK HOEJI
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• v.58 no.1
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• pp.62-70
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• 2014

A 28-day repeated-dose oral toxicity test was performed to determine the no-observed-effect level (NOEL) and establish an optimum dose of the highly toxic Aconiti Ciliare Tuber (ACT) used as a folk remedy. Repeated oral doses of 1,250, 2,500, and 5,000 mg/kg/day of the hot water extract of ACT were administered to five male and five female Sprague-Dawley rats in each group for 4 weeks. The indicators for toxicity included results of examination of common symptoms and changes in weight and feed intake, eye test, urinalysis, hematological and serum biochemical analyses, and post-mortem weight measurement of organs, and visual inspections. All animals survived at the end of the experiment; in addition, we observed no specific test substance-mediated symptoms. We observed no test substance-mediated changes in body weight and feed intake. We observed statistically significant changes in male OB and pH levels (p<0.05). Further, the biochemical test showed statistically significant changes in the IP value of male rats and $CL^-$valueoffemalerats (p<0.05). However, all changes were within historical data. The post-mortem examinations showed no test substance-mediated changes. Moreover, statistically significant changes under the test conditions were confirmed to have been caused by factors other than the test substance. Thus, the maximum NOEL of ACT extract in rats was estimated to be 5,000 mg/kg/day.

• Korean Journal of Health Education and Promotion
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• v.20 no.3
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• pp.61-76
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• 2003

Substance abuse among teenagers has been spreading widely and become a serious social problem. However, teachers hardly realize its importance. Recently, substance abuse prevention programs show a tendency towards one time education. This study aims to research the effect of substance abuse prevention on high school students using the Life Skills Training Program. Two classes(36 students in the experimental group, 35 in the control group) at W High School in Daejeon were randomly sampled for this study from May to June 2002. Substance knowledge and attitude, problem solving, and assertiveness were examined as Pre and Post-Tests. The data was analyzed using frequencies, t-test, means, and covariance(ANCOVA). The results of this study were as follows； 1. Compared with the control group, substance knowledge in the experimental group was significantly improved(F＝176.317, P＝.000). And compared with the control group, substance attitudes in the experimental group were improved significantly.(F＝207.682, P＝.000). 2. Compared with the control group, cognitions to problem solving in the experimental group was significantly improved(F＝100.937, P＝.000). 3. Compared with the control group, assertiveness behaviors in the experimental group were increased significantly(F＝207.255, P＝.000). The study showed that Substance Abuse Prevention of High School Students was effective in improving substance knowledge and attitude, cognition to problem solving, and assertiveness behavior. Some suggestions based on the result are as follows； 1. Substance abuse preventive programs must be practiced properly and systematically with high school students in their regular classes. 2. Various preventive education programs must be developed for substance abuse where high school students can join in a community center, such as Community Welfare Center, Alcoholic Counseling Center, and Mental Health Center. 3. For the furthering of substance abuse preventive education, there must be continued research about not only students with problems of substance misuse and abuse, but also students without them. 4. There must be early determination of students with problems of substance misuse to be able provide school social workers with the opportunity for intervention.

• Asian Pacific Journal of Cancer Prevention
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• v.17 no.8
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• pp.4113-4116
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• 2016

Background: Acceptance and commitment therapy (ACT) increases the psychological flexibility of people afflicted with cancer, and consequently improves their adaptability. The present research was conducted with the aim of determining the effectiveness of ACT for people afflicted with cancer. Materials and Methods: The present research was of semi-pilot type with a pre-test and post-test plan for the proof group. The demographics of the community were composed of all the women with cancer who were under treatment in Tehran's Dehshpour therapeutic center in 2015. The sample was composed of 24 people who were selected as available and chosen randomly in two groups of test and proof. All the participants responded to Snyder questionnaire in two pre-test and post-test stages, and the test group participated in treatment sessions after conducting the pre-test. Results: After collecting the information, data analysis was conducted in two description and inferential levels. The test results of covariance analysis showed that the two groups' hope was meaningfully different. Hope in the test group, compared to the proof group, increased meaningfully. Conclusions: The results show that the ACT is effective in increasing hope of patients with cancer.

• Korean Journal of Acupuncture
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• v.39 no.2
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• pp.54-62
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• 2022

Objectives : The purpose of this study was to evaluate the potential of the test substance, SU-Eohyeol Pharmacopuncture (SUEP), to induce micronuclei in bone marrow cells of Sprague-Dawley (SD) Rats. Methods : The dose range preliminary study was performed first. 1 ml/animal was selected as the high dose of this study. Two additional lower dose levels (0.5 and 0.25 ml/animal) were produced by applying a geometric ratio of 2. In addition, the positive and negative control groups were set. Then, after intramuscular administration (1 ml/animal) of SUEP to 8-week-old male SD rats, an in vivo micronucleus test was performed to evaluate the induction of micronuclei in SD rat bone marrow cells. Results : As a result of the main study, the incidence of micronucleated polychromatic erythrocytes (MNPCE) in polychromatic erythrocytes (PCE) in the test substance SUEP groups was not statistically significantly different from the negative control group. In addition, the ratio of PCE to total erythrocytes in the test substance SUEP groups was not statistically significantly different from the negative control group. In the positive control group, the incidence of MNPCE in PCE was statistically significantly increased when compared to the negative control group. The ratio of PCE to total erythrocytes in the positive control group was not statistically significantly different from the negative control group. Conclusions : Based on these results, the test substance, SUEP, did not have any potential to induce micronuclei formation in bone marrow cells of rats under the conditions of this study.

• Journal of Society of Preventive Korean Medicine
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• v.3 no.2
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• pp.91-100
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• 1999

Today, toxicology is used for many purpose, in many fields. Classification of special toxic effect is related next 4 important principles. 1. The chemical substance must move to target organ or tissue that can induce Biological effect. For this movement, we have to understand the physical-chemical characteristic of substance, and the rout of absorption, metabolism, diffusion and excretion of toxic substance. 2. Every biological effect that induced by chemical substance is not harmful. For example, some specific chemical substance is not harmful in liver enzyme system. 3. The strength of biological effect induced by chemical substance is deep related with dose. Nearly all substance is not effective below the specific dose, and it may toxic to death over the specific dose. It is the 'Dose - response relationship' But carcinogen may toxic whether it is law dose or not. 4. The information that was obtained by experimental animal test, could have to adapt in human biology. Because biological effect of chemical substance could be different in every biological species. In past, drugs was obtained by animal or plants. But in the future, it could be obtained by biochemistry, and genome project. Therefore, in Oriental medicine, research and approach is needed at this time, and have to develop new method of experience in toxic method.