Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (1) Overview of the validation study and Draize scores for the evaluation of the tests

Ohno, Yasuo; Kaneko, Toyozo; Inoue, Takeshi; Morikawa, Yoshihiro; Yoshida, Tadashi; Fujii, Akiko; Masuda, Mitsuteru; Ohno, Tadao; Hayashi, Makoto; Momma, Junko; Uchiyama, Takashi; Chiba, Kenichi; Ikeda, Naohiro; Imanishi, Yasuo; Itakagaki, H; Kakishima, Hiroshi; Kasai, Yutaka; Kurishita, Akihiro; Kojima, Hiroshi; Matsukawa, K.; Nakamura, Tsuneaki; Ohkoshi, Kenji; Okumura, Hirokazu; Saijo, Kaoru; Sakamoto, Kazutami; Suzuki, Takahiko; Takano, Katsuhiro; Tatsumi, Hisashi; Tani, Naoko; Usami, Masayoshi; Watanabe, R.

doi:10.1016/s0887-2333(98)00064-2

Cited by 60 publications

(31 citation statements)

References 24 publications

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“…SLS, which are classed as severe and extreme level of eye irritation on the Draize scores, decreased the viability of the RCE models in a dose-dependent manner ( ). These results were comparable with those of the Draze test 11,12) , and therefore, the degree of eye irritation caused by chemicals can be simulated using the RCE model as an in vitro eye irritation test.…”

Section: Discussionsupporting

confidence: 76%

In vitro Eye Irritancy Test of Lauryl Derivatives and Polyoxyethylene Alkyl Derivatives with the Reconstructed Rabbit Corneal Epithelium Model

et al. 2009

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Abstract: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 tolerance. In the model, a stratified culture of rabbit corneal epithelial cells is grown at the air-liquid interface on a collagen gel acting as a parabasal membrane. Histological cross-sections show that the structure of RCE model closely parallels that of the rabbit corneal epithelium. The lauryl derivatives, such as sodium lauryl sulfate (SLS), polyoxyethylene (9) lauryl ether (PLE), sodium polyoxyethylene (2) lauryl ether sulfate (SPLE), mono glyceryl laurate (MGL), and sodium N-lauroyl-L-glutaminate (SLG), and polyoxyethylene alkyl derivatives, polyoxyethylene (9) lauryl ether (PLE), polyoxyethylene (10) cetyl ether (PCE), polyoxyethylene (10) stearyl ether (PSE), polyoxyethylene (10) oleyl ether (POE), and polyoxyethylene (10) behenyl ether (PBE), were evaluated for in vitro eye irritation potential using the RCE model by the measurement of viability with MTT assay. SLS, PLE, SPLE, MGL, and SLG inhibited 90.3%, 69.8%, 79.7%, 45.8%, and 32.7% of the viability at a concentration of 0.5%. The IC50 (50% inhibitory concentration) values of SLS, PLE, SPLE, MGL, and SLG were 0.086%, 0.205%, 0.133%, 0.627%, and 0.934%, respectively. These results indicated that a functional group at the end of lauryl chain is an important factor for inhibiting the viability using the RCE model. The polyoxyethylene alkyl derivatives had distinctly different the viability potencies according to their alkyl patterns. PLE inhibited the viability greater than other polyoxyethylene alkyl derivatives. Therefore, the lauryl chain of PLE is an important factor for inhibiting the viability on the RCE model.

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Section: Discussionsupporting

confidence: 76%

In vitro Eye Irritancy Test of Lauryl Derivatives and Polyoxyethylene Alkyl Derivatives with the Reconstructed Rabbit Corneal Epithelium Model

et al. 2009

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“…Generally there are large variations in Draize scores, and the test uses three or six rabbits. 35,37) These results indicated that there is a possibility that prediction errors for the Draize test may be quite high if the tests are conducted according to the OECD guidelines (1987) using three rabbits. This has to be kept in mind when evaluating alternative methods to the Draize test.…”

Section: Discussionmentioning

confidence: 92%

In Vitro Eye Irritancy Test of Polyoxyethylene Alkyl Derivatives Using a Reconstructed Rabbit Corneal Epithelium Model

Matsuda¹,

Hisama²,

Shibayama³

et al. 2009

Biological & Pharmaceutical Bulletin

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“…Based on the Draize scores for each test concentration, a category 1 classification was given to sodium salicylate by GHS. Ohno et al (1999) indicated that the eye irritation caused by the undiluted substance was largely driven by physical stimulation while chemical eye irritation was likely was conducted with particles of sodium salicylate. There--toxicity in the STE test.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, the development of alternative methods is accelerating in the world due to new regulations like the banning of cosmetics in animal eye irritation tests in the EU (Directive 2003/15/EC, 2003. A lot of eye irritation alternative methods that use various cell lines and tissues are being developed around the world (Balls et al, 1999;Ohno et al, 1999;Eskes et al, 2005). In April 2007, European Center for the Evaluation of Alternative Toxi--mittee (ESAC) approved the bovine corneal opacity and permeability assay (BCOP) and isolated chicken eye Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) (ICE) as alternative eye irritation tests which enable evaluation of severe eye irritation potential.…”

Section: Introductionmentioning

confidence: 99%

Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification

et al. 2009

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-Short time exposure (STE) test using rabbit corneal cell line (SIRC) cells was developed as an alternative eye irritation test. STE test uses relative viability as the endpoint after cells are exposed to the test material at constant concentrations for 5 min. In this inter-laboratory study with 3 laboratories, 44 chemicals with a wide range of classes were evaluated for the transferability, between-lab reproducibility and predictive capacity of the STE test as an alternative eye irritation test. Globally harmonized sysin vivo data. Transferability was assessed using standard chemicals (sodium lauryl sulfate, calcium thioglycolate, andThe irritation category (Irritant or Non irritant) at each test concentration (5% and 0.05%) in STE test was --el (PM) based on the relative viability at two concentrations (5% and 0.05%) were highly correlated with the GHS ranks of non-irritant, category 1, and category 2, respectively (accuracy was 75.0% at all laboratories). These results suggest that the STE test possessed easy transferability, reproducibility, good predictive performance.

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Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (1) Overview of the validation study and Draize scores for the evaluation of the tests

Cited by 60 publications

References 24 publications

In vitro Eye Irritancy Test of Lauryl Derivatives and Polyoxyethylene Alkyl Derivatives with the Reconstructed Rabbit Corneal Epithelium Model

In vitro Eye Irritancy Test of Lauryl Derivatives and Polyoxyethylene Alkyl Derivatives with the Reconstructed Rabbit Corneal Epithelium Model

In Vitro Eye Irritancy Test of Polyoxyethylene Alkyl Derivatives Using a Reconstructed Rabbit Corneal Epithelium Model

Inter-laboratory study of short time exposure (STE) test for predicting eye irritation potential of chemicals and correspondence to globally harmonized system (GHS) classification

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