• Toxicological Research
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• 제19권1호
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• pp.39-44
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• 2003

Two local irritation and skin sensitization studies of nonspecific immunostimulator, $BARODON^{\circledR}$ were carried out with New Zealand White rabbits and Hartley guinea pigs. In skin irritation test of male New Zealand White rabbits, body weights were not significantly changed and there were no responses after treatment for 24 or 72 hours and the Primary irritation index (P.1.1.) was '0'. And, in the eye irritation test, there were chemosis in some of rabbits. One of 3 rabbits in washing group was detected chemosis after 24 and 72 h following treatment and 2 of 6 rabbits in non-washing group were detected chemosis after 24h and 7 days following treatment. Therefore, total score is '4' after 24 h and '2' after 72 h following treatment by conforming article "some blood vessel are clearly hyperemic" . However evaluation value is non-irritant because M.O.I. (Mean ocular irritation index) score is below during the all experimental period and no significance through individuals and exposure time. In skin sensitization, the score of skin reaction was graded 1 with 0% sensitization rate. Taken together, these results indicate that $BARODON^{\circledR}$ may be non-irritant material. material.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1996년도 춘계학술대회
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• pp.250-250
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• 1996

Eye irritation, primary skin irritation and skin sensitization tests for Aloewhite were tested in New Zealand White rabbits and Hartley guinea pig. In primary skin irritation test of male New Zealand White rabbits, body weights were not significantly changed and primary Irritation Index(PII) was 0.47, indicating Aloewhite as mildly irritating material, In ocular irritation test, any injury on iris, conjunctival membrane, and cornea in New Zealand White rabbits was not observed. No injuries of the ocular mucous membrane were also recorded. Skin sensitization was tested in guinea Peg after intradermal and epicutaneous induction and graded I with zero % sensitization rate. These results indicate that Aloewhite was not considered to be irritant in test organs of animals.

• 한국산업보건학회지
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• 제25권3호
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• pp.322-327
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• 2015

Objectives: The major objective of this study is the oral dose toxicity test and skin irritation test of eco-friendly plasticizer using crude glycerol derived from the biodiesel process. Methods: Glyceroldiacetate laurate(GDL) was synthesized from glycerol monolaurat(GML) and acetic acid. The synthesis of the GDL plasticizer was measured with nuclear magnetic resonance spectroscop(NMR) and FT-IR(Fourier Transform Infrared Spectrometer). To provide information on the safety of GDL, we carried out an oral dose toxicity test for GDL in Sprague-Dawley rats. Also, we carried out a skin irritation test for GDL in New Zealand White rabbits. Results: The oral dose toxicity test in Sprague-Dawley rats showed that GDL is a non-toxic material. The result of the skin irritation test on New Zealand White rabbits showed that GDL is non-irritating. Conclusions: From the results of oral dose toxicity test and skin irritation test, we concluded that the developed plasticizer showed excellent eco-friendly property. Based on our results, we confirmed the development of an eco-friendly non-phthalate plasticizer. Applicability for PVC toys and food and drug packaging materials was found.

• Toxicological Research
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• 제12권1호
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• pp.87-91
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• 1996

LB00013, a newly developed recombinant human Interferon $\beta$, was tested for primary eye and skin irritation in male New Zealand White rabbits. In the primary eye irritation test, 0.1 ml of a solution of LB00013 was instilled into the eye. In the rinsing group, the eye was washed with water at 30 seconds after instillation. No reaction was produced at the cornea, iris and conjunctivae by LB00013. In the primary skin irritation test, LB00013 was applied to the back of rabbits for 24 hours. Primary irritation index was "0" in test and control sites of all animals. Thus LB00013 was evaluated as a non-irritant on the basis of the criteria of Draize et al. (1944).l. (1944).

• Toxicological Research
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• 제13권1_2호
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• pp.161-165
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• 1997

This study was conducted to investigate the skin irritation by transdermal administration of the three dyes. These dyes were originated from onion by using extraction method. By the order of extraction from onion, A-dye was obtained from onion by using water at 90-100$\circ$C. B-dye was extracted from A-dye with ethylacetate. After ethylacetate extraction from A-dye, the lower layer named as C-dye. Twenty-four New Zealand white rabbits were divided into three groups. The each groups was consisted of two subgroups according to high dose (extracted dyes) and low dose (the 100-fold dilutions of A-, Band C-dye). In primary skin irritation test of male New Zealand White rabbits, body temperature and weights were not significantly changed and blood cells were positioned in normal blood cell ranges of health rabbits. Primary irritation index was "0" in the test and control sites of all animals used in this study. By the results obtained in the present test, all dyes were evaluated as a non-irritant on the basis of the criteria of Draize.of Draize.

• Toxicological Research
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• 제9권1호
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• pp.69-72
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• 1993

LBD-005, a newly developed recombinant granulocyte-macrophage colony stimulating factor, was tested for primary skin irritation in male New Zealand White rabbits. In the primary skin irritation test, LBD-005 was applied to intact and abraded skins for 24 hours. Primary irritation index was "0" in test and control sites of all animals' thus LBD-005 was evaluated as a non-irritatant on the basis of the criteria of Draize et al. (1994).l. (1994).

• Biomolecules & Therapeutics
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• 제23권4호
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• pp.379-385
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• 2015

The eye irritation potential of drug candidates or pharmaceutical ingredients should be evaluated if there is a possibility of ocular exposure. Traditionally, the ocular irritation has been evaluated by the rabbit Draize test. However, rabbit eyes are more sensitive to irritants than human eyes, therefore substantial level of false positives are unavoidable. To resolve this species difference, several three-dimensional human corneal epithelial (HCE) models have been developed as alternative eye irritation test methods. Recently, we introduced a new HCE model, MCTT HCE$^{TM}$ which is reconstructed with non-transformed human corneal cells from limbal tissues. Here, we examined if MCTT HCE$^{TM}$ can be employed to evaluate eye irritation potential of solid substances. Through optimization of washing method and exposure time, treatment time was established as 10 min and washing procedure was set up as 4 times of washing with 10 mL of PBS and shaking in 30 mL of PBS in a beaker. With the established eye irritation test protocol, 11 solid substances (5 non-irritants, 6 irritants) were evaluated which demonstrated an excellent predictive capacity (100% accuracy, 100% specificity and 100% sensitivity). We also compared the performance of our test method with rabbit Draize test results and in vitro cytotoxicity test with 2D human corneal epithelial cell lines.

• 대한약침학회지
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• 제25권1호
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• pp.46-51
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• 2022

Objectives: This study was performed to evaluate the skin irritation toxicity of processed sulfur. Methods: All experiments were conducted at Medvill (Korea), an institution authorized to perform non-clinical studies, under the Good Laboratory Practice (GLP) regulations. In order to investigate skin irritation toxicity of processed sulfur, we divided the back of six rabbits into two control sites and two test sites. One of each of the two control and test sites was then designated abraded sites and intact sites. In test sites, 0.5 g of processed sulfur was applied to the back of the rabbit for 24 hours, and in control sites, 0.5 g of sterile distilled water was applied in the same way. We observed and evaluated mortality, weight, general symptoms, and skin irritation toxicity. This study was conducted with the approval of the Animal Ethics Committee (Approval number: IAC2020-1549). Results: In all experiments, no dead animals were observed. In all cases, skin coloration was observed at 24 hours after processed sulfur administration. This coloration lasted up to 48 hours and is believed to be the effect of the administration of test substances. Weight measurement indicated that weight was lost 72 hours after administration in three cases, but this is considered an accidental weight change. Normal weight gain was observed in the remaining subjects. In all animals, no skin irritation toxicity was observed, and the primary irritation index (P.I.I) was calculated as 0.0 according to Draize's evaluation method. Conclusion: The above findings suggest that it is relatively safe to apply a processed sulfur to the skin. Further research on this topic is needed to provide more specific evidence.

• Biomolecules & Therapeutics
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• 제3권1호
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• pp.63-71
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• 1995

The local irritation studies of DA-3002, an authentic recombinant human growth hormone (rhGH), were carried out in rabbits after the following treatment ; application into the conjunctival sac of the eye (single), single subcutaneous and intramuscular injection, 7-day repeated subcutaneous and intramuscular injection. The results obtained were as follows. In the result of ocular irritation test, 0.16% solution of DA-3002 could be considered as a non-irritating material. In single subcutaneous and intramuscular irritation test, the irritancy of 0.16% DA-3002 solution was not so much different from that of saline. The local irritation of DA-3002 by 7-day repeated injection was negligible and similar to that of saline by both subcutaneous and intramuscular routes. These results suggest that DA-3002 has no irritating activity when injected through subcutaneous or intramuscular route for clinical practice as 0.16% solution.

• Biomolecules & Therapeutics
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• 제2권1호
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• pp.71-76
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• 1994

Anti-inflammatory and analgesic activities and skin irritation of piroxicam patch were investigated. Piroxicam patch increased the pain threshold in rat hind paw inflamed by carrageenan and inhibited writhing induced by acetic acid in mice. Piroxicam patch also inhibited the carrageenan-induced edema in rat hind paw as well as the increased vascular permeability induced by histamine in rats. In adjuvant arthritis of rats, piroxicam patch showed anti-inflammatory effects. Skin irritation of piroxicam patch was tested in Newzealand White rabbits and evaluated by Primary Irritation Index of Draize. The results from skin irritation test showed that piroxicam patch seemed practically non-irritating. The result from the present study indicates that piroxicam may be useful without serious side effects as anti-inflammatory analgesics in this patch form.