Interlaboratory Validation of the In Vitro Eye Irritation Tests for Cosmetic Ingredients. (6) Evaluation of MATREXTM

Ohuchi, Junko; Kasai, Yutaka; Sakamoto, Kazutami; Ohnuma, M.; Kitamura, Masaaki; Kawasaki, Yoshiaki; Kakishima, Hiroshi; Suzuki, Kazuko; Kuwahara, Hirofumi; Imanishi, Yasuo; Tatsumi, Hisashi; Kotani, Masaki; Inoue, Kazumi; Okumura, Hirokazu; Kurishita, Akihiro; Kinoshita, Shigemi; Tani, Naoko; Kojima, Hiroshi; Nakamura, Tsuneaki; Ishibashi, Takuya; Hori, Hiroshi; Takahashi, Hidekazu; Nishikawa, T.; Kitano, Yuriko; Ohno, Yasuo

doi:10.1016/s0887-2333(98)00069-1

Cited by 11 publications

(10 citation statements)

References 5 publications

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“…3 ), which we believe to be a form of contact conjunctivitis related to changes in the constituents of peri-ocular cosmetics or the facial wipes used to remove them. Cosmetics have been previously known to cause problems in the eye [ 7 ] and some toxicity testing in the eye is performed in most products on the market, using the Draize eye test and animal-free alternatives [ 8 , 9 ]. This is usually aimed at excluding corneal toxicity, but in this instance it appears that effects on the conjunctiva have produced a clinically well-defined syndrome.…”

Section: Discussionmentioning

confidence: 99%

Chronic tarsal conjunctivitis

Cook¹,

Mushtaq

Leitner

et al. 2016

BMC Ophthalmol

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BackgroundToxicity is rarely considered in the differential diagnosis of conjunctivitis, but we present here a new form of toxic conjunctivitis with unusual clinical features. Between 2010 and 2013, a new clinical presentation of chronic conjunctivitis unresponsive to normal treatment was noted within a Primary Care Ophthalmology Service.MethodsRetrospective review of case records and histopathology results.ResultsA total of 55 adult patients, all females, presented with epiphora and stickiness. They did not complain of itch and had had symptoms for an average of 9 months. Clinical examination showed bilateral moderate to severe upper and lower tarsal conjunctival papillary reaction, without corneal or eyelid changes and mild bulbar conjunctival hyperaemia in a third of cases. Biopsies were taken in 15 cases to exclude an atypical infection or lymphoma. Histologically, there was a variable superficial stromal lymphocytic infiltrate, involving the epithelium in more severe cases. The majority of the cells were CD3 positive T-lymphocytes and follicle formation was not noted. The clinical history in all cases included prolonged use of eye make- up and other facial cosmetic products. Clinical symptoms of epiphora settled with topical steroid drops, but the clinical signs of chronic tarsal inflammation persisted until withdrawal of the facial wipes thought to contain the inciting agent, though the exact nature of this remains unclear.ConclusionThe presentation, appearances, histological features are consistent with a contact allergen-driven chronic conjunctivitis. Steroid treatment provided good relief of symptoms and patients were advised to avoid potential contact allergens. Management remains difficult. Further research into contact allergies of mucous membranes and identification of its allergens is required.Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-016-0294-1) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Chronic tarsal conjunctivitis

Cook¹,

Mushtaq

Leitner

et al. 2016

BMC Ophthalmol

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“…A simplified dose concentration set of 1, 5, and 10%, was evaluated for discriminating between non-irritants and irritants with the three-dimensional LDM (Figure 2). Table 3 compares the results from this three-dose method used alone, with those from previous Japanese validation studies (9), which obtained IC50 values for use as an index of irritancy potential by the standard multiple-dose method. The former results corresponded well with the latter, with respect to the classification of a substance as non-irritant or irritant, when the IC50 value for triethanolamine was used as the cut-off point value.…”

Section: Verification Of the Use Of The Three-dose Methods In The Mtt mentioning

confidence: 99%

“…The LDM, based on a three-dimensional dermal model developed by Bell et al (6) and Gay et al (7), was included on the basis of its expected validity for the identification of non-irritating ingredients and its expected ability to evaluate water-insoluble ingredients. The data used for the preliminary verification of the tier evaluation system were taken from the reports by Ohno et al (4), Tani et al (8) and Ohuchi et al (9). After verification of the tier system, the possibility of simplifying the MTT assay on the LDM for more-practical use, by selecting only three concentration levels to discriminate non-irritants from irritants, was assessed.…”

Section: Introductionmentioning

confidence: 99%

An In Vitro Tier Evaluation for the Identification of Cosmetic Ingredients Which are Not Ocular Irritants

2008

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A tier evaluation system was assessed as an alternative method for the identification of cosmetic ingredients which are not ocular irritants. The system employed monolayer cultures of SIRC cells, an established cell line originally derived from the rabbit cornea, and a three-dimensional living dermal model (LDM), MATREX™, which consists of human dermal fibroblasts in a contracted collagen lattice. Effects on the cell monolayer cultures were determined by using SIRC cell-Crystal Violet staining (SIRC-CVS), and effects on the LDM were assessed by using the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay. A non-irritating ingredient was defined as a compound having a maximal average total score (MAS) of 5 or less in the Draize eye test, as this is the criterion used in the Japanese draft guidance for evaluating cosmetic ingredients. Among 34 test substances with known characteristics, 30 were classified accurately. Based on these encouraging results, the possibility of simplifying the MTT assay on the LDM for more-practical use, by selecting only three concentration levels to discriminate non-irritants from irritants, was assessed. The simplified method, involving a three-dose set (the three-dose method), was confirmed as being suitable for the identification of non-irritating ingredients, with triethanolamine used as a negative reference standard. Finally, the LDM was used to evaluate compounds at similar concentrations to those tested in vivo, aiming to predict the concentration at which an ingredient can be formulated into products without causing eye irritation. On the basis of previous validation data and our additional results, it was found that test samples that resulted in a cell viability of 50% or more in this model, could be classified as non-irritating ingredients. In all, these results indicate that the tier evaluation system may be suitable for the evaluation of ingredients intended to be used in cosmetics and medicated cosmetics in Japan.

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“…10) In Japan, many eŠorts have been made toˆnd reliable, relevant predictive models such as chorioallantoic membrane (CAM) methods, 11) cell-based cytotoxicity methods, 12,13) and reconstituted tissue models. 14) To date, the Draize eye irritation test has not been fully replaced with in vitro methods, in part due to a lack of understanding of the underlying physiologic mechanisms of eye irritation.…”

Section: Introductionmentioning

confidence: 99%

Application of the Reconstructed Rabbit Corneal Epithelium Model to Assess the <i>in Vitro</i> Eye Irritancy Test of Chemicals

Matsuda¹,

Hisama²,

Shibayama³

et al. 2009

YAKUGAKU ZASSHI

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The rabbit corneal epithelium model (RCE model) was developed as a three-dimensional in vitro model to replace animal testing for the assessment of eye irritation. In the model, a stratiˆed culture of rabbit corneal epithelial cells is grown at the air-liquid interface on collagen gel that acts as a parabasal membrane. Histological cross-sections show that the structure of the RCE model closely parallels that of the rabbit corneal epithelium. The eye irritation potency of test samples is estimated from the measurement of viability using the MTT assay in conjunction with the RCE model. A set of 30 chemicals belonging to diŠerent families with known in vivo Draize score was investigated with the in vitro eye irritation test using the RCE model in order to internally validate the protocol. Use of the RCE model at concentrations of 0.05％, 0.50％, and 1.00％ and the calculation of the IC 50 and percentage of viability allowed the irritants to be divided into four classes. The performance of the in vitro eye irritation test at a concentration of 0.50％ using the RCE model was characterized by good sensitivity (92.3％), good speciˆcity (100％), and good accuracy (93.3％) compared with the irritation classiˆcation predicted by in vivo Draize score at concentrations of 10％ and 100％. These results indicate that the RCE model may provide a useful and sensitive in vitro eye irritation test as an alternative method to the Draize test.

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Interlaboratory Validation of the In Vitro Eye Irritation Tests for Cosmetic Ingredients. (6) Evaluation of MATREXTM

Cited by 11 publications

References 5 publications

Chronic tarsal conjunctivitis

Chronic tarsal conjunctivitis

An In Vitro Tier Evaluation for the Identification of Cosmetic Ingredients Which are Not Ocular Irritants

Application of the Reconstructed Rabbit Corneal Epithelium Model to Assess the <i>in Vitro</i> Eye Irritancy Test of Chemicals

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