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

Toxicology in Vitro

Volumn 13, Issue 1, 1999, Pages 73-98

  Ohno, Y ^a   Kaneko, T ^b   Inoue, T ^b   Morikawa, Y ^c,d   Yoshida, T ^e   Fujii, A ^c,f   Masuda, M ^c,g   Ohno, T ^h   Hayashi, M ^b   Momma, J ^b   Uchiyama, T ^c,i   Chiba, K ^c,j   Ikeda, N ^c,k   Imanishi, Y ^c,l   Itakagaki, H ^c,d   Kakishima, H ^c,m   Kasai, Y ^c,n   Kurishita, A ^c,o   Kojima, H ^c,p   Matsukawa, K ^c,k   Nakamura, T ^c,g   Ohkoshi, K ^c,q   Okumura, H ^c,r   Saijo, K ^h   Sakamoto, K ^c,s   Suzuki, T ^t   Takano, K ^c   Tatsumi, H ^c,u   Tani, N ^c,f   Usami, M ^c,v   Watanabe, R ^c,w   more..

^a Biol Safety Res Ctr   (Japan)

^b National Institute of Health Sciences   (Japan)

^c Japan Cosmetic Industry Association   (Japan)

^d SHISEIDO RESEARCH CENTER   (Japan)

^e SHOWA UNIVERSITY   (Japan)

^f POLA Corporation   (Japan)

^g LION CORPORATION   (Japan)

^h INST OF PHYS AND CHEMICAL RESEARCH   (Japan)

ⁱ Kaminomoto Co Ltd   (Japan)

^j YAKULT CENTRAL INSTITUTE FOR MICROBIOLOGICAL RESEARCH   (Japan)

^k Club Cosmetics Co Ltd   (Japan)

^l Research Laboratory   (Japan)

^m KANEBO LTD   (Japan)

ⁿ KAO CORPORATION   (Japan)

^o Kobe Technical Center   (Japan)

^p Nippon Menard Cosmetic Co Ltd   (Japan)

^q Ltd 2 28 2 Shinzaike S ^*  (Japan)

^r Noevir Co Ltd   (Japan)

^s AJINOMOTO CO INC   (Japan)

^t Japan Seigiken Res Center Co Ltd   (Japan)

^u Sunstar Inc   (Japan)

^v Hoyu Co Ltd   (Japan)

^w Nippon Shikazai Inc   (Japan)

more..

Author keywords

Alternatives; Cosmetic ingredients; Draize eye irritation test; In vitro; Validation

Indexed keywords

COSMETIC;

ANIMAL CELL; ANIMAL EXPERIMENT; ARTICLE; CHINESE HAMSTER; CYTOTOXICITY; DIAGNOSTIC ACCURACY; EYE IRRITATION; EYE TOXICITY; NONHUMAN; SCORING SYSTEM;

EID: 0033003549     PISSN: 08872333     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0887-2333(98)00064-2     Document Type: Article

References (50)

1. Booman K. A., Cascieri T. M., Demetrulias J., Driedger A., Griffith J. F., Grochoski G. T., Kong B., McCormick Iii W. C., North-Root H., Rosen M. G., Sedlak R. I. In vitro methods for estimating eye irritation of cleaning products. Phase I: Preliminary assessment. Journal of Toxicology-Cutaneous and Ocular Toxicology. 7:1988;173-185.
2. Booman K. A., Demetrulias J., Driedger A., Griffith J. F., Grochoski G. T., Kong B., McCormick Iii W. C., North-Root H., Rosen M. G., Sedlak R. I. The SDA alternative program: Comparison of in vitro data with Draize test data. Journal of Toxicology-Cutaneous and Ocular Toxicology. 8:1989;35-49.
3. Brantom P. G., Bruner L. H., Chamberlain M., De Silva O., Dupuis J., Earl L. K., Lovell D. P., Pape W. J. W., Uttley M. A summary report of the COLIPA international validation study on alternatives to the Draize rabbit eye irritation test. Toxicology in Vitro. 11:1997;141-179.
4. Chiba K., Makino I., Ohuchi J., Kasai Y., Kakishima H., Tsukumo K., Uchiyama T., Miyai E., Akiyama J., Okamoto Y., Kojima H., Okumura H., Tsurumi Y., Usami M., Katoh K., Sugiura S., Ohsawa H., Miyajima A., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (9) Evaluation of cytotoxicity tests on HeLa cells. Toxicology in Vitro. 13:1995;191-200.
5. Dickens A. D., Earl L. K. and Rowson M. J. (1996) A critical analysis of the rabbit eye irritation test variability. Abstract of 2nd World Congress on Alternatives. Utrecht, The Netherlands.
6. Draize J. H. (1959) Dermal toxicity. In Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, Vol. 46. The Association of Food and Drug Officials of the United States, Austin, TX, and Federal Register 1978, 43 (163), 37359.
7. Gay R., Swiderek M., Nelson D., Ernst A. The living skin equivalent as a model in vitro for ranking the toxic potential of dermal irritants. Toxicology in Vitro. 6:1992;303-315.
8. Gay R., Swiderek M., Nelson D., Stephen T. J. The living dermal equivalent as an in vitro model for predicting ocular irritation. Journal of Toxicology-Cutaneous and Ocular Toxicology. 11:1992;47-68.
9. Gettings S. D., Dipasquale L. C., Gabley D. M., Chudkowski M., Demetrulias J. L., Feder P. I., Hintze K. L., Marenus K. D., Pape W., et al. The CTFA evaluation of alternatives program an evaluation of in vitro alternatives to the Draize primary eye irritation test. Phase I: hydro-alcoholic formulations, A preliminary communication. In Vitro Toxicology. 3:1990;293-302.
10. Gettings S. D., Lordo R. A., Hintze K. L., Bagley D. M., Casterton P. L., Chudkowski M., Curren R. D., Demetrulias J. L., Dipasquale L. C., Earl L. K., Feder P. I., Galli C. L., Glanza S. M., Gordon V. C., Janus J., Kurtz P. J., Marenus K. D., Moral J., Pape W. J. W., Renskers K. J., Rheins L. A., Roddy T. T., Rozen M. G., Tedeschi J. P., Zyracki J. The CTFA evaluation of alternatives program: An evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) Surfactant-based formulations. Food and Chemical Toxicology. 34:1996;79-117.
11. Gordon V. C. and Bergman H. C. (1987) Eytex, an in vitro method for evaluation of ocular irritation. In Alternative Methods in Toxicology, Vol. 5. In Vitro Toxicology: Approaches to Validation. Edited by A. Goldberg, pp. 293-302. Mary Ann Liebert, New York.
12. Guillot R. Ocular irritation: Present cell culture models and perspectives. ATLA. 20:1992;471-475.
13. Hagino S., Itagaki H., Kato S., Kobayashi T. Further evaluation of the quantitative chorioallantoic membrane test using trypan blue stain to predict the eye irritation of chemicals. Toxicology in Vitro. 7:1993;35-39.
14. Hagino S., Itagaki H., Kato S., Kobayashi T., Tanaka M. Quantitative evaluation to predict the eye irritation of chemicals: Modification of chorioallantoic membrane test by using trypan blue. Toxicology in Vitro. 5:1991;301-304.
15. Hagino S., Itagaki H., Kinoshita S., Tani N., Nakamura T., Ono N., Konishi K., Kojima H., Ohno Y., Takanaka A. First phase inter-laboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (2) Evaluation of chorioallantoic membrane (CAM) tests. AATEX. 3:1995;137-145.
16. Hagino S., Kinoshita S., Tani N., Nakamura T., Ono N., Konishi K., Iimura H., Kojima H., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (2) Evaluation of chorioallantoic membrane (CAM) test. Toxicology in Vitro. 13:1997;99-113.
17. 2™ dermal model). In Alternative Methods in Toxicology, Vol. 8. In Vitro Toxicology; Mechanism and New Technology. Edited by A. Goldberg, pp. 301-309. Mary Ann Liebert, New York.
18. Hatao M., Murakami N., Sakamoto K., Takino Y., Ohnuma M., Kakishima H., Ogawa T., Matsushige C., Kaneko T., Momma J., Iwabuchi Y., Kojima H., Chiba K., Matsukawa K., Masuda K., Ohno Y. The second phase validation study of alternative methods to the eye irritation test. (4) Evaluation of the haemoglobin denaturation tests. Journal of Toxicological Science. 20:1995;540.
19. Hatao M., Sakamoto K., Ohnuma M., Kakishima H., Ogawa T., Kojima H., Chiba K., Yoshizawa K., Kaneko T., Momma J., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (4) Haemoglobin denaturation test. Toxicology in Vitro. 13:1997;125-137.
20. Hayashi T., Itagaki H., Fukuda T., Tamura U., Kato S. Quantitative evaluation for the prediction of eye irritation using hemoglobin. Alternatives to Animal Testing Experiments. 2:1993;25-31.
21. Hayashi T., Itagaki H., Fukuda T., Tamura U., Kato S. Quantitative structure activity relationship of surfactants on eye irritation predicted by hemoglobin denaturation. Alternatives to Animal Testing Experiments. 2:1993;49-55.
22. Ishidate M., Odashima S. Chromosomal tests with 134 compounds on Chinese hamster cells in vitro: a screening for chemical carcinogens. Mutation Research. 48:1977;337-354.
23. Itagaki H., Hagino S., Kato S., Kobayashi T., Umeda M. An in vitro alternative to the Draize eye-irritation test: Evaluation of the crystal violet staining method. Toxicology in Vitro. 5:1991;139-143.
24. Itagaki H., Hayashi T., Kakishima H., Ogawa T., Kotani M., Matsukawa K., Masuda K., Kojima H., Chiba K., Makino I., Sakamoto K., Takino Y., Kanari M., Kaneko T., Hirose A., Takanaka A. First phase inter-laboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (4) Evaluation of hemoglobin denaturation test. AATEX. 3:1995;154-161.
25. Itagaki H., Shibata M., Tani N., Kinoshita S., Kakishima H., Seyama Y., Ohuchi J., Kasai Y., Okada J., Kojima H., Okamoto Y., Kotani M., Ohno Y., Miyajima A., Takanaka A. First phase inter-laboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (8) Evaluation of cytotoxicity tests on SIRC cells. AATEX. 3:1995;186-192.
26. TM method. AATEX. 3:1995;201-209.
27. Kaneko T. Importance of reevaluation on existing method in validation of alternative method. A case of Draize test. Tissue Culture. 22:1996;218-223.
28. TM. AATEX. 3:1995;168-174.
29. Kay J. H., Calandra J. C. Interpretation of eye irritation tests. Journal of the Society of Cosmetic Chemists. 3:1962;281-289.
30. Kojima H., Ohuchi J., Kasai Y., Okada J., Tsukumo K., Kakishima H., Miyai E., Akiyama J., Okamoto Y., Kotani M., Inoue K., Shibata M., Okumura H., Arashima M., Atsumi T., Makino I., Chiba K., Takanaka A. First phase inter-laboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (9) Evaluation of cytotoxicity tests on HeLa and CHL/IU cells. AATEX. 3:1995;193-200.
31. ®). AATEX. 3:1995;175-185.
32. TM dermal model ZK1100. AATEX. 3:1995;162-167.
33. 2TM ZK1100 and tissue equivalent assay. Toxicology in Vitro. 13:1997;139-151.
34. Leupke N. P. Hen's egg chorioallantoic membrane test for irritation potential. Food and Chemical Toxicology. 23:1985;287-291.
35. TM. Toxicology in Vitro. 13:1997;209-217.
36. Mosmann T. Rapid colorimetric assay for cellular growth and survival; application to proliferation and cytotoxicity assays. Journal of Immunological Methods. 65:1983;55-63.
37. Murphy J. C., Osterberg R. E., Seabaough V. M., Bierbower G. W. Ocular irritancy responses to various pHs of acids and bases with and without irrigation. Toxicology. 23:1982;281-291.
38. OECD (1987) OECD guidelines, Test Guideline No 405, Acute Eye irritation/corrosion, updated and adoped 24 February 1987. OECD, Paris.
39. OECD (1996) Test guidelines programme. Final report of the OECD workshop on harmonization of validation and acceptance criteria for alternative toxicological test methods. OECD, Paris.
40. Ohno Y., Kaneko T., Kobayashi T., Inoue T., Kuroiwa Y., Yoshida T., Momma J., Hayashi M., Akiyama J., Atumi T., Chiba K., Endo T., Fujii A., Kakishima H., Kojima H., Masamoto Y., Masuda M., Matsukawa K., Ohkoshi K., Okada J., Sakamoto K., Takano K., Suzuki T., Takanaka A. First phase inter-laboratory validation of in vitro eye irritation tests for cosmetic ingredients: (I) Overview, organization, and results of the validation study. AATEX. 3:1995;123-136.
41. Ohno Y., Kaneko T., Kobayashi T., Inoue T., Kuroiwa Y., Yoshida T., Momma J., Hayashi M., Akiyama J., Atsumi T., Chiba K., Endo T., Fujii A., Kakishima H., Kojima H., Masamoto K., Masuda M., Matsukawa K., Ohkoshi K., Okada J., Sakamoto K., Takano K., Takanaka A. First phase inter-laboratory validation of the in vitro eye irritation tests for cosmetic ingredients. In Vitro Toxicology. 7:1994;89-94.
42. TM. Toxicology in Vitro. 13:1997;153-162.
43. Okamoto Y., Kanzaki N., Tanaka N. Studies of an in vitro alternative method to the Draize rabbit eye irritation test. Journal of the Society of Cosmetic Chemists of Japan. 23:1990;272-279.
44. Okamoto Y., Ohkoshi K., Itagaki H., Hagino S., Inoue K., Shibata M., Kakishima H., Ogawa T., Konishi K., Sakamoto K., Takino Y., Kanari M., Matsukawa K., Masuda K., Kojima H., Chiba K., Makino I., Kaneko T., Hirose A., Takanaka A. First phase inter-laboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (3) Evaluation of hemolysis test. AATEX. 3:1995;146-153.
45. Okamoto Y., Ohkoshi K., Itagaki Tsuda T., Kakishima H., Ogawa T., Kasai Y., Ohuchi J., Kojima H., Furumoto T., Tanaka T., Kaneko T., Matsushima Y., Iwabuchi Y., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (3) Evaluation of the haemolysis test. Toxicology in Vitro. 13:1997;115-124.
46. Okumura H., Kotani M., Kojima H., Miyajima A., Sunouchi M., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (10) Evaluation of cytotoxicity test on CHL cells. Toxicology in Vitro. 13:1997;199-208.
47. Tani N., Kinoshita S., Okamoto Y. Y., Kotani M., Itagaki H., Usami M., Kato K., Ohno T., Saijo K., Kato M., Ohno Y. Interlaboratory validation of the in vitro eye irritation tests for cosmetic ingredients. (8) Evaluation of cytotoxicity tests on SIRC cells. Toxicology in Vitro. 13:1997;175-187.
48. Torishima H., Arakawa H., Matsui S., Watanabe M. Application of normal human epidermal keratinocytes in serum-free medium as an alternative to the Draize ocular irritating test. Alternatives to Animal Testing Experiments. 1:1990;20-26.
49. ®. Toxicology in Vitro. 13:1999;163-173.
50. Wilcox D. K., Bruner L. H. in vitro alternatives for ocular safety testing: an outline of assays and possible future developments. ATLA. 18:1990;117-128.