렌즈 보존액 CLIWELLTM에 대한 안점막자극성시험 = EYE IRRITATION TEST OF LENS WASHING AGENTS CLIWELLTM ON NEW ZEALAND WHITE RABBITS

국문 초록 (Abstract)

시판중인 렌즈 보존액 중 가장 흔히 사용 또는 유통되고 있는 CLIWELLTM에 대한 안점막자극성시험을 식품의약품 안전청 고시에 따라 Draize법을 이용하여 그 자극성의 정도를 평가하고, 눈에 가해질 수 있는 잠재적인 독성을 평가하기 위하여, 배출물에 대한 도말표본 상에서 염증세포 및 비 염증성 유상피세포가 차지하는 비율과 함께 점안 14일 후 안구 중, 각막, 홍채, 망막 및 공막의 조직병리학적 관찰을 실시한 결과 다음과 같은 결과를 얻었다. 비 세척군에서는 점안 후 1, 2 및 3일에 국한하여, 각막과 결막에 경미한 자극이 관찰되어, 이 기간 동안의 평균 안점막 자극지수 MIOI가 각각 4.50, 1.67 및 0.67로 관찰되었으며, 세척군에서는 점안 후 1 및 2일에 국한하여, 결막에서 경미한 자극성이 인정되었고, 이때 MIOI는 각각 0.67로 관찰되었다. 따라서 CLIWELLTM은 세척군 및 비 세척군 모두에서 MIOI가 모든 관찰 기간에서 4.50이하로 관찰되었으며, IAOI 역시 점안 1일 후 4.50으로 관찰되어 무자극성 물질로 판단되었다. 한편 배출물에 대한 염증성 세포의 비율은 무처치 대조군과 비교하여 점안 1일 후 유의성 있는 염증세포 비율의 증가가 비세척군에 국한하여 인정된 이외에 의미 있는 변화는 인정되지 않았다. 또한 안구의 조직병리학적 검사에서 각막, 홍채, 망막 및 공막 모두에서 무처치 대조군과 비교하여 의미 있는 변화는 인정되지 않았다.

다국어 초록 (Multilingual Abstract)

The eye irritant test of lens washing agent, CLIWELLTM was conducted using Draize methods according to KFDA Guidelines. In addition, to test the potential toxicity of test articles, the ratio of inflammatory cells and non-inflammatory epitheloid cells was also observed using smear cytology methods against ocular discharge. At sacrifice, the histopathological changes on Cornea, Iris, Retina and Sclera were also observed in all animals. Slight irritancy of cornea and conjunctiva was observed at 1, 2 and 3 days after dropping in non-washing group. The MIOI of these points are detected as 4.50, 1.67 and 0.67, respectively. In washing group, slight irritancy of cornea and conjunctiva were observed at 1 and 2 days after dropping with MIOI as 0.67, respectively. Therefore, CLIWELLTM was considered as non-irritating materials because the MIOI is detected below 5.00 throughout the whole experimental periods in both washing and non-washing groups and the IAOI was also detected as 4.50. Except for significant increase of the inflammatory cell ratios in ocular discharge at 1 day after dropping of non-washing group compared to that non-treated intact eyes, no meaningful changes on smear cytology of ocular discharges are observed in this study. In addition, no abnormal histopathological changes on the cornea, iris, retina and sclera were also detected in CLIWELLTM dropping group compared to that of non-treated intact eyes.

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