• Toxicological Research
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• v.12 no.1
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• pp.53-58
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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 O.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 pig after intradermal and epicutaneous induction and graded 1 with zero % sensitization rate. These results indicate that Aloewhite was not considered to be irritant in test organs of animals.

• YAKHAK HOEJI
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• v.45 no.3
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• pp.310-319
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• 2001

To compare skin irritation and cytotoxicity of anti-wrinkle agents, we examined skin irritation of six anti-wrinkle agents (ascorbic acid, glycolic acid, all trans-retinoic acid, ginseng extract, retinol, EB) in New Zealand white rabbit. Cytotoxicity of these agents was determined by MTT [tetrazolium salt 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide] at multi-time points in cultured HaCaT cell, a human immortalized keratinocyte cell. We then analyzed correlation between skin irritation and cytotoxicity by spearman's rank correlation analysis. All trans-retinoic acid showed the highest primary irritation index (0.92) in skin irritation test. Being all the six agents not irritant, retinal showed the most cytotoxic agents. The correlation between skin irritation and cytotoxicity ($IC_{50}$/ at different time point was 0.814, 0.757, 0.814 and 0.7 at 3, 24, 48 and 72 h, respectively. We also fecund that IC$_{20}$ and IC$_{80}$ of these agents showed similar correlation with skin irritation. These results therefore demonstrated that there is close correlation between skin irritation and cytotoxicity $IC_{50}$/ value by MTT in HaCaT cell at early time points by anti-wrinkle agents or IC$_{20}$ value. $IC_{50}$/ at earily time point or IC$_{20}$ values may be reliable alternative determinant of skin irritation.n.

• Toxicological Research
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• v.13 no.1_2
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• pp.149-152
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• 1997

This test was performed to evaluate the ocular and skin irritation of EPO (Erythropoietin). The results as follows: 1. Ocular irritation test There were no observed clinical signs, body weght changes by EPO during experimental period. The acute ocular irritation index(A.O.I.), mean ocular irritation index(M.O.I.) and Day-7 individual ocular irritation index(I.O.I.) of EPO at dose of 1000U and 10, 000U were 0, respectively. Therefore we evaluated that EPO was non-toxic to eyes. 2. Skin irritation test There were no observed clinical signs, body weght changes and gross pathologic findings by EPO during experimental period. There were no observed erythema, eschar formation and edema formation on intact and abraded skin treated by EPO. The primary irritation index(P.I.I.) of EPO at dose of 1000U and 10, 000U were 0, respectively and were evaluated none irritating product about skin irritation.

• Toxicological Research
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• v.17 no.2
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• pp.143-149
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• 2001

In the present study, we examined eye irritation oj six anti-wrinkle agents (ascorbic acid, glycolic acid, all trans-retinoic acid, ginseng extract, retinol, EB). We also compared eye irritation with skin irritation and cytotoxicity in HaCaT cells by these agents. The highest eye irritation was found in glycolic acid, but all trans-retinoic acid showed the highest skin irritation. The rank of eye irritation was not correlated with the cytotoxicity of agents. This result shows that eye irritation potency by these agents were not correlated with skin irritation potency, and cytotoxicity in HaCaT cells.

• Environmental Mutagens and Carcinogens
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• v.22 no.4
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• pp.296-302
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• 2002

In recent years, the safety of sunscreens have been challenged based on the reports of its adverse effects on users; dermatitis, allergic contact dermatitis, photoallergic contact dermatitis. In the toxicological aspect, the need to investigate the safety of sunscreens is steadily increasing. However, there were few studies on the correlation between sun protection factor (SPF) and the safety of sunscreens. The objective of this study was to assess whether there was a correlation between SPF and the skin irritation index of sunscreens. Octyl methoxycinnamate (OMC) was selected, which was the most frequently used (about 92% in korea and about 90% in the world) in sunscreens. In vitro SPF test was performed using the standard samples recommended by KFDA guideline. We examined primary and cumulative skin irritation and eye irritation of OMC standard sample as well as homosalate. As in vitro SPF was increased, skin irritation index was increased in primary skin irritation test ($r^2$=0.986) and cumulative skin irritation test ($r^2$=0.939). In addition, OMC was non-irritating and non-sensitizing. In this results, there was a good correlation between SPF index and skin irritation index.

• Toxicological Research
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• v.16 no.1
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• pp.89-94
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• 2000

Alpha-hydroxy acid(AHA) are used in cosmetic products as a pH adjuster, mild exfoliant and humectant-skin conditioner. Cosmetics containing higher concentration (30%) and lower pH (3.0) of AHA can cause side effects if it is applied without the prescription. For providing information on the safety of AHA and on human risk assessments we studied skin irritation effect of glycolic acid, one of the most commonly used AHA in guinea pigs. The skin irritation by glycolic acid was increased in a dose(10% to 70%), acidity (pH 2.5 to 5.5.) and length of exposure dependent manner (for up to 14 days), respectively. The combination treatment with UVB (0.4 or 3.0 J/$cm^2$) increased glycolic acid-induced skin irritation. Histological examination showed that hyperplasia of non-inflammatory cells in the epidermis of skin treated with high dose of glycolic acid (pH 3.0). There results show that glycolic acid increased skin irritation in a dose, length of exposure and pH dependent manner, respectively, in guinea pig, and the combination with UVB increased glycolic acid-induced skin irritation. The cell proliferation of non-inflammatory cell may be involved in high doses of glycolic acid-induced skin irritation. Long-term application of more than 30% of glycolic acid (pH 3.0) may cause skin irritation.

• Toxicological Research
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• v.19 no.1
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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.

• Toxicological Research
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• v.26 no.1
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• pp.9-14
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• 2010

The evaluation of eye and skin irritation potential is essential to ensuring the safety of human in contact with a wide variety of substances. Despite this importance of irritation test, little is known with respect to the irritation potency of lomefloxacin, a fluoroquinolone antibiotic, which has been known to cause phototoxicity with an abnormal reaction of the skin. Thus, to investigate the tendency of lomefloxacin to cause eye and skin irritation, we carried out in vitro eye irritation test using Balb/c 3T3, and in vitro skin irritation test using $KeraSkin^{TM}$ human skin model system. 3T3 neutral red uptake assay has been proposed as a potential replacement alternative for the Draize Eye irritation test. In this study, the $IC_{50}$ value obtained for lomefloxacin was 375 ${\mu}g$. According to the classification model used for determining in vitro categories, lomefloxacin was classified as moderately irritant. For evaluation of skin irritation, engineered epidermal equivalents ($KeraSkin^{TM}$) were subjected to 10 and 25 mg of lomefloxacin for 15 minutes. Tissue damage was assessed by tissue viability evaluation, and by the release of a pro-inflammatory mediator, interleukin- 1${\alpha}$. Lomefloxacin increased the interleukin-1${\alpha}$ release after 15 minutes of exposure and 42 hours of post incubation, although no decrease in viability was observed. Therefore, lomefloxacin is considered to be moderately irritant to skin and eye.

• YAKHAK HOEJI
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• v.43 no.4
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• pp.542-545
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• 1999

Primary skin irritation tests for Sangmosu were performed in male New Zealand White rabbits. In primary skin irritation test, body weights were not significantly changed and Primary Irritation Index(P.I.I) was 0.25, indicating Sangmosu as barely irritating material. These results indicate that Sangmosu was not considered to be irritant in test animals.

• Biomolecules & Therapeutics
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• v.10 no.4
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• pp.246-252
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• 2002

In recent years, the safety of sunscreens has been challenged based on the reports of their adverse effect on users; dermatitis, allergic contact dermatitis and photo allergic contact dermatitis. The unscientific idea that higher SPF sunsreen is good for health mealeads many users to tend to prefer higher SPF sunscreen. In the toxicological aspect, the need to investigate the safety of sunscreens is steadily increasing. However, there were few studies on the correlation between sun protection factor (SPF) and the safety of sunscreens. The objective of this study was to assess whether there was a correlation between SPF and the safety of sunscreens. We measured in vitro SPF index using homosalate as a standard and examined the toxicity tests such as primary skin irritation tests, ocular irritation test and skin sensitization test. Homosalate (HS), octyl methoxycinnamate (OMC), octyl salicylate (OS), octocrylene (OC) as UVB organic filter and benzophenone-3 (BP3), butyl methoxy dibenzoil methane (BMDM) as UVA organic filter, and titanium dioxide (TD), zinc oxide (ZO) as inorganic filters were used. The skin irritation indexes in rabbits treated with HS, OMC, OS, BP3, and BMDM were significantly increased as SPF indices were increased. Neither ocular irritation in rabbits nor skin sensitization in guinea pigs were increased. It suggests that there might be a good correlation between SPF and the skin irritation indices of organic UV filters and skin irritation might be one of most sensitive index to assess the safety of sunscreens.