• Toxicological Research
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• v.11 no.1
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• pp.157-159
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• 1995

A study on antigenicity of HRccine (formalin inactivated HFRS virus vaccine) was investigated in guinea pigs and mice. As a part of the safety evaluation of the HRccine, antigenicity tests were carried out according to the Estabilish Regulations of National Institute of Safety Research. In active systemic anaphylaxis (ASA) test no sign was detected when sensitized with up to 120 clinical dose and challenged with up to 1200 clinical dose in guinea pigs. In passive systemic anaphylaxis test guinea pigs showed no sign. In passive cutaneous anaphylaxis (PCA) test, HRccine specific IgE antibody was not detected when sensitized and challenged with up to 1200 clinical dose. Conclusively, there was no adverse antigenic potential at the clinical dose of 120 clinical dose alone and 120 clinical dose with Al(OH)3.

• Toxicological Research
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• v.13 no.1_2
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• pp.153-156
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• 1997

The antigenicity of EPO (erythropoietin) was investigated in guinea pig, mice and rats. Antigenicity tests-active systemic anaphylaxis (ASA), passive cutaneous anaphylaxis (PCA) of this materials were performed according to the established Regulation of Korean National Institute of Safety Research (1996, 4, 16). The results were followed: 1. After sensitizaion with EPO emulsified with complete Freund's adjuvant (CFA), guinea pigs didn't show any anaphylatic shock symptom in the ASA test 2. After sensitization with antisera of EPO sensitized mice, blue spots were observed on the hypodermis of back of rats in the PCA test, but diameter of each spot was smaller than 5 mm. From the results of this investigation, the antigenicity of EPO was negative under the present experimental condition.

• Toxicological Research
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• v.8 no.1
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• pp.139-143
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• 1992

Antigenicity tests-ASA(Active Systemic Anaphylaxis), PSA(Passive Systemic Anaphylaxis), PCA(Passive Cutaneous Anaphylaxis)-of CP-2(Green cross Co). were performed according to the established regulations of National Institute of Safety Research. The results were as follows. 1. No specic clinical signs related anaphylaxis were observed, therefore, it was considered that CP-2 had not antigenicity in guinea pigs and rabbits. 2. No blue spots were observed on the back of guinea pig in the PCA test` CP-2 related IgE was not produced.

• Journal of Food Hygiene and Safety
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• v.6 no.3
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• pp.179-183
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• 1991

Antigenicity tests-ASA(Active Systemic Anaphylaxis), PSA(Passive Systemic Anaphylaxis), PCA(Passive Cutaneous Anaphylaxis)- of Bovine Somatotrophine(BST, Lucky Ltd.) were performed according to the established regulations of National Institude of Safety Research. The results were as follows: 1. No specific clinical signs related anaphylaxis were observed. Therefore, it was considered that BST has no antigenicity in guinea pigs and rabbits. 2. No blue spots were observed on the back of guinea pig in the peA test; BST-related IgE was not produced.

• Biomolecules & Therapeutics
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• v.4 no.4
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• pp.334-338
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• 1996

Antigenicity of DA-3285, human recombinant erythropoietin which was produced from mammalian cells, was examined in guinea pigs and mice. In active systemic anaphylactic test, mild anaphylactic signs were observed in guinea pigs sensitized subcutaneously with DA-3285 or DA-3285 incorporated with complete Freund's adjuvant(CFA) when challenged with high dose(1000 IU/Kg) of DA-3285. Other groups showed negative responses. In mouse-rat passive cutaneous anaphylaxis test, 20% sera of mice immunized with DA-3285 or DA-3285 mixed with aluminum hydroxide(alum) showed mild positive responses. In the case of indirect haemagglutination reaction(IHA) test, when sheep red blood cells coated with DA-3285 was incubated with mouse serum, all the serum samples were showed negative responses. These results suggest that DA-3285 has a very weak antigenic potential and probably would not induce systemic allergic reactions in clinical uses.

• Biomolecules & Therapeutics
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• v.4 no.1
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• pp.1-6
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• 1996

In the present study, the antigenic potential of G009, a polysaccharide isolated from Ganoderma lucidum IY009, was determined in BALB/C mice and Hartley guinea pigs. Antigenicity tests, including passive cutaneous anaphylaxis (PCA), active systemic anaphylaxis (ASA) and indirect hemagglutination test (IHA) were performed according to the established guidelines of National Institute of Safety Research. The results were as follows: 1. Mice showed no production of antibodies against G009 sensitized with an adjuvant, aluminum hydroxide gel (alum), when judged by the heterologous PCA test in rats. Meanwhile, antibodies against ovalbumin (OVA) sensitized with alum were clearly detected. 2. In the studies with guinea pigs, both the sensitization of G009 alone and of G009 with complete Freund's adjutant (CFA) did not produce positive reactions in homologous PCA. In the case of ASA, however, G009 alone and G009 with CFA produced positive reactions. 3. No G009 specific reaction was observed in an IHA assay using sera isolated from G009 sensitized mice. These findings suggest that G009 have no antigenicity potential in mice but may have weak antigenicity in guinea pjgs.

• Toxicological Research
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• v.13 no.3
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• pp.203-208
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• 1997

The antigenic potential of M3S tumor necrosis factor-$\alpha$(M3S TNF), which is a mutated form of TNF(TNF mutein) designed to reduce adverse effects of wild type human TNF, was investigated in the present study. The antigenicity of M3S TNF was examined by conducting active systemic anaphylaxis (ASA) test in guinea pigs, heterologous(mouse-rat) passive cutaneous anaphylaxis(PCA) test and passive hemagglutination(PHA) test. The experimental animals were divided into low, medium, high and the highest dose groups and the groups with or without immunoadjuvant, sensitized according to the appropriate schedule and challenged. In ASA test, when challenged with 120 $\mu\textrm{g}$ /animal, moderate to severe positive anaphylactic responses were observed in groups sensitized with 12 $\mu\textrm{g}$ /animal, 120 $\mu\textrm{g}$ /animal and 120 $\mu\textrm{g}$ /animal+Freund's complete adjuvant. In PCA test, positive responses were observed in the group sensitized with the highest dose emulsified with an alum(12 $\mu\textrm{g}$ /animal+alum). In PHA test, positive responses were observed in the group sensitized with 3 $\mu\textrm{g}$ /animal emulsified with an alum. All the other groups in each experiment showed negative responses. Based on these results, M3S TNF is considered to have some antigenic potential.

• Biomolecules & Therapeutics
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• v.2 no.4
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• pp.331-335
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• 1994

As a part of the safety evaluation of Pseudomonas vaccine(CFC-101), antigenicity tests were carried out in guinea pigs and mice. In active systemic anaphylaxis(ASA) test, guinea pigs showed no sign or only moderate sign(1/5) when sensitized and challenged with up to 200 $\mu\textrm{g}$/kg. In homologous passive cutaneous anaphylaxis(PCA) test using guinea pigs, inoculation of CFC-101 alone did not produce CFC-101-specific antibody. When inoculated with 200 $\mu\textrm{g}$/kg plus adjuvant, challenge of 200 $\mu\textrm{g}$/kg produced PCA titer of 32(5/5) but challenge of 20 $\mu\textrm{g}$/kg did not produce CFC-101-specific antibody. In heterologous PCA test using mice, CFC-101-specific antibody was not detected when sensitized with CFC-101 alone. Some animals(3/12) showed positive PCA response when inoculated with 200 $\mu\textrm{g}$/kg plus alum. In passive hemagglutination (PHA) test, although no antibody was detected at 20 $\mu\textrm{g}$/kg, inoculation of 200 $\mu\textrm{g}$/kg alone or with alum produced positive response in all animals. This result has already been predicted because CFC-101 is a vaccine developed for the purpose of immunization. From the above results, it can be concluded that there is no adverse antigenic potential up to 10 times clinical dose of 200 $\mu\textrm{g}$/kg.

• Toxicological Research
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• v.8 no.2
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• pp.255-263
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• 1992

SKI 2053R and SKI 2053R-human serum albumin(HSA) mixture were examined for their antigenicity in Hartley guinea pigs as well as C57BL/6 mice in comparison with distilled water (DW), HSA and DW-HSA conjugate. Several antigenicity tests, including acitive systemic anaphylaxis(ASA), passive systemic anaphylaxis (PSA), passive cutaneous anaphylaxis (PCA) and indirect hamagglutination test (IHA), were performed according to the Established Regulations of National Institute of Safety Research. The results were as follows: 1. When guinea pigs were sensitized with SKI2053R or SKI2053R-HSA emulsified with complete Freund's adjuvant(CFA), these animals showed negative reactions in ASA and PSA. 2.No blue spot was observed on the back skin of guinea pigs in the PCA test. 3. Sera from guinea pigs revealed a negative reaction in IHA. 4.Guinea pigs were sensitized by HSA emulsified with CFA as a positive control, and these animals showed positive reactions in ASA, PSA, PCA, and IHA. As shown above, SKI2053R was considered to possess neither antigenic, nor haptenic properties, and confirmed not to have the haemagglutinating activity.

• Toxicological Research
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• v.16 no.1
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• pp.83-87
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• 2000

This study was carriet out to evaluate the acute intravenous toxicity and antigenicity of Guamerin, newly developed by Mogam Biotechnology Research Institute (MBRI). In acute intravenous toxicity test, ICR mice were administered intravenously with single dose of 1,000mg/kg, and body weights and clinical signs were observed for 14 days. No dead animal, clinical signs, body weight change and abnormal autopsy findings were found in control and Gumerin treated group. Therefore, the 50% lethoal dose (LD50) of Guamerin for ICR mice was more than 1,000mg/kg on intravenous route for male and female. And the antigenic potential of Guamerin was examined by active systemic anaphylaxis(ASA) and passive cutaneous anaphylaxis(PCA) tests. In the ASA test, low and high doses (10 and 100ug/animal, respectiwely) of Guamerin were administed subcutaneously to guinea pigs for 9 times 3 weeks. All experimental groups showed negative responses whereas the positive control group given ovalbumin plus Freunds complete adjuvant (FCA) showed severe anaphylactic responses. PCA test using rats with mice anti-serum against Guamerin, low and high doses(10 and 100 ug/animal, respectively) of Guamerin were administered to mice for 9 times in 3 weeks. The anti-serum against Guamerin was administed intradermally at the back of rats, however, any positive responses were not detected in the experimental groups. These results strongly indicate that Guamerin does not induce IgE production and is not a PCA reaction inducer under these experimental conditions.