ГОСТ Р ИСО 10993-10-2009 Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 10. Исследования раздражающего и сенсибилизирующего действия

[1]

ИСО 10993-6 Оценка биологического действия медицинских изделий. Часть 6. Исследование местного действия после имплантации

ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

[2]

AGNER T. Noninvasive measuring methods for the investigation of irritant patch test reactions. A study of patients with hand eczema, atopic dermatitis and controls. Acta Derm. Venereol. Suppl. Stockh., 173, pp.1-26, 1992

[3]

World Medical Association. Declaration of Helsinki. Recommendation guiding physicians in biomedical research involving human subjects. Adopted by the 18th World Medical Assembly, Helsinki, June 1964, amended by the 29th World Medical Assembly, Tokyo, October 1975, the 35th World Medical Assembly, Venice, October 1983 and 41st World Medical Assembly, Hong Kong, September 1989. Proc. XXVIth Conf., Geneva, 1993

[4]

LEEC. H. and MAIBACH H.I. The sodium lauryl sulfate model: an overview. Contact Dermatitis, 33, pp.1-7, 1995

[5]

MARZULLI F.N. and MAIBACH H.I. (eds.) Dermatotoxicology, 5th edn., Hemisphere Publ. Corp., 1996

[6]

Organization for Economic Cooperation and Development (OECD) Guideline for the testing of chemicals. Acute dermal irritation study in human volunteers. Draft document, Nov. 1997

[7]

Organization for Economic Cooperation and Development (OECD) Guidelines for the testing of chemicals No. 406, Skin sensitization, OECD Publications, 1992

[8]

Organization for Economic Cooperation and Development (OECD) Guidelines for testing of chemicals No. 404, Acute skin irritation/corrosion, OECD Publications, 1992

[9]

Organization for Economic Cooperation and Development (OECD), Guidelines for testing of chemicals No. 405, Acute eye irritation/corrosion, OECD Publications, 1992

[10]

PONEC M. In vitro models to predict skin irritation. In: The Irritant Contact Dermatitis Syndrome. Van der Valk P.G.M. and Maibach H.I. (eds). Boca Raton, CRC Press, pp.335-341, 1996

[11]

RUSSEL W.M.S. and BURCH R.L. The principles of humane experimental technique, 238 pp., London, Methuen, 1959

[12]

SERUP J. and JEMEC G.B.E. Handbook of non-invasive methods and the skin. CRC Press, 1995

[13]

SILVAO. de., BASKETTER D.A., BARRATT M.D. et al. Alternative methods for skin sensitization testing. The Report and Recommendations of ECVAM Workshop 19. ATLA, 24, pp.683-705, 1996

[14]

SIMION F.A. In vivo models to predict skin irritation. In: The Irritant Contact Dermatitis Syndrome. Van der Valk P.G.M. and Maibach H.I. (eds). Boca Raton, CRC Press, pp.329-334, 1996

[15]

SVENDSEN O., GARTHOFF B., SPIELMANN H. et al. Alternatives to the animal testing of medical devices. ALTA, 24, pp.659-670, 1996

[16]

WAHLBERG J.E. Assessment of skin irritancy: measurement of skin fold thickness. Contact Dermatitis, 9, pp.21-26, 1983

[17]

WAHLBERG J.E. and WAHLBERG E.N. Quantification of skin blood flow at patch test sites. Contact Dermatitis, 17, pp.229-233, 1987

[18]

WAHLBERG J.E. and MAILBACH H.I. Nonanoic acid irritation - A positive control at routine patch testing? Contact dermatitis, 6, pp.128-130, 1980

[19]

WAHLBERG J.E., WRANGSJO K. and HIETASOLA A. Skin irritancy from nonanoic acid. Contact dermatitis, 13, pp.266-269, 1985

[20]

WEIL S.C. and SCALA R.A. Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicol. Appl. Pharmacol., 12, pp. 276-360, 1971

[21]

BALLS M., BERG N. and BRUNER L.H. et al. Eye irritation testing: the way forward. ATLA, 27, pp.53-78, 1999

[22]

BASKETTER D.A., WHITTLE E., GRIFFITHS H.A. et al. The identification and classification of skin irritation hazard by a human patch test. Food Chem. Toxicol., 32, pp.769-775, 1994

[23]

BOTHAM P.A., EARL L.K., FENTEM J.H. et al. Alternative methods for skin irritation testing: the current status. ALTA, 26, pp.195-212, 1998

[24]

BRUNER L.H., KAIN D.J., ROBERTS D.A. et al. Evaluation of seven in vitro alternatives for ocular testing. Fundam. Appl. Toxicol., 17, pp.136-149, 1991

[25]

DRAIZE J.H. Dermal Toxicity. Association of food and drug officials of the U.S, FDA, Washington, D.C. pp.46-59, 1955

[26]

DRAIZE J.H. Appraisal of the safety of chemicals in foods, drugs, and cosmetics, Austin, Texas. Association of food and drug officials of the United States, Texas State Department of Health, Texas, 1959

[27]

European Chemical Industry Ecology and Toxicology Centre. Eye irritation testing, Monograph 11, Brussels, Belgium, 1988

[28]

European Chemical Industry Ecology and Toxicology Centre. Skin irritation, Monograph 15, Brussels, Belgium, 1990

[29]

GERNER L., GRAETSCHEL G., KAHL J. et al. Development of a decision support system for the introduction of alternative methods into local irritancy/corrosivity testing strategies. Development of a relational database. ALTA, 26, pp.11-28, 2000

[30]

STEINBERG M., AKERS W.A., WEEKS M. et al. A comparison of test techniques based on rabbit and human skin responses to irritants with recommendations, regarding the evaluation of mildly or moderately irritating compounds. Animal Models in Dermatology. Maibach H.I. (ed.), N.Y., Churchill Livingstone, pp.1-11, 1975

[31]

YORK M., GRIFFITHS H.A., WHITTLE E. et al. Evaluation of a human patch test for the identification and classification of skin irritation potential. Contact Dermatitis, 34, pp. 204-212, 1996

[32]

NILSSON R., FALLAN J.O., LARSSON K.S. et al. Electrical impedance - A new parameter for oral mucosal irritation tests. J. Mater. Science: Materials in Medicine, 3, p.278, 1992

[33]

ROY M. and WHITE H.I. Establishment of an improved technique for hamster mucous membrane irritation testing. J. Dent. Res., 11, pp. 365-375, 1986

[34]

CHVAPIL M., CHVAPIL T.A., OWEN J.A. et al. Reaction of vaginal tissue of rabbits to inserted sponges made of various materials. J. Biomed. Mater. Res., 13, pp.1-13, 1979

[35]

ECKSTEIN P., JACKSON M.C., MILLMAN N. et al. Comparisons of vaginal tolerance tests of spermicidal preparations in rabbits and monkeys. J. Reprod. Fertil., 20, pp.85-93, 1969

[36]

KAMINSKY M. and WILLIGAN D.A. pH and thepotential irritancyof douche formulations to thevaginal mucosa of the albino rabbit and rat. Food Chem. Toxicol., 20, pp.193-196, 1982

[37]

MULLER P., RAABE G., HOROLD J. et al. Action of chronic peracetic acid (wofasteril) administration on the rabbit oral mucosa, vaginal mucosa and skin. Exp. Pathol., 34, pp.223-228, 1988

[38]

ANDERSEN K.E. and MAIBACH H.I. Contact allergy predictive tests in guinea pigs., Curr. Probl. Dermatol., 14,1985

[39]

ANDERSEN K.E. and MAIBACH H.I. Guinea pig sensitization assays. An overview. Curr. Probl. Dermatol., 14, pp.263-290, 1985

[40]

ANDERSEN K.E., . and FRANKILD S. The guinea pig maximization test with a multiple dose design. Acta Derm. Venereol., 75, pp.463-469, 1995

[41]

BUEHLER E.V. Delayed contact hypersensitivity in the guinea pig. Arch. Dermatol., 91, pp.171-175, 1965

[42]

BUEHLER E.V. A rationale for the selection of occlusion to induce and elicit delayed contact hypersensitivity in the guinea pig. A prospective test. Curr. Probl. Dermatol., 14, pp.39-58, 1985

[43]

European Chemical Industry Ecology and Toxicology Centre. Skin sensitization testing, Monograph 14, Brussels, Belgium, 1990

[44]

European Chemical Industry Ecology and Toxicology Centre. Skin sensitization testing for the purpose of hazard identification and risk assessment. Monograph 29, Brussels, Belgium, 2000

[45]

FRANKILD S., BASKETTER D.A. and ANDERSEN K.E. The value and limitations of rechallenge in the guinea pig maximization test. Contact Dermatitis, 35, pp.135-140, 1996

[46]

FRANKILD S., ., WAHLBERG J.E.etal. Comparison of the sensitivities of the Buehler test and the guinea pig maximization test for predictive testing of contact allergy. Acta Derm. Venereol., 80, pp.256-262, 2000

[47]

KANIWA M.A., MOMMA J., IKARASHI Y. et al. A method for identifying causative chemicals of allergic contact dermatitis using a combination of chemical analysis and patch testing in patients and animal groups: application to a case of rubber boot dermatitis. Contact Dermatitis, 27, pp.166-173, 1992

[48]

KOJIMA S., MOMMA J. and KANIWA M.A. Phosgene (chlorophenyl) hydrazones, strong sensitizers found in yellow sweaters bleached with sodium hypochlorite, defined as causative allergens for contact dermatitis by an experimental screening method in animals [published erratum appears in Contact Dermatitis, 23, p.383. Contact Dermatitis, 23, pp.129-141, 1990

[49]

LANDSTEINER K. and CHASE M.W. Studies on the sensitization of animals with simple chemical compounds. J. Exp. Med., 69, p.767, 1939

[50]

MAGNUSSON B. and KLIGMAN A.M. The identification of contact allergens by animal assay. The guinea pig maximization test. J. Invest. Dermatol., 52, pp.268-276, 1969

[51]

NAKAMURA A., MOMMA J., SEKIGNCHI H. et al. A new protocol and criteria for quantitative determination of sensitization potencies of chemicals by guinea pig maximization test. Contact Dermatitis, 31, pp.72-85, 1994

[52]

NEWMANN E.A., BUEHLER E.V. and PARKER R.D. Delayed contact hypersensitivity in the vagina and skin of the guinea pig. Fundam. Appl. Toxicol., 3, pp.521-527, 1983

[53]

POLIKANDRITOU M. Enhancement of the sensitivity of the Buehler method by use of the Hill Top chamber. Soc. Cosmetic Chem., 36, pp.151-168, 1996

[54]

RITZ H.L. and BUEHLER E.V. Planning, conduct and interpretation of guinea pig sensitization patch tests. In DRILL V. and LAZAR P. (eds.) Current concepts in cutaneous toxicity, Academic Press, New York pp.25-40, 1979

[55]

ROBERTS D.W. Structure-activity relationships for skin sensitization potential of diacrylates and dimethacrylates. Contact Dermatitis, 17, pp.281-289, 1987

[56]

ROBINSON M.K., STOTTS J., DANNEMAN P.J. et al. A risk assessment process for allergic contact sensitization. Food. Chem. Toxicol., 27, pp.479-489, 1989

[57]

ROBINSON M.K., NUSAIR T.L., FLETCHER E.R. et al. A review of the Buehler guinea pig skin sensitization test and its use in a risk assessment process for human skin sensitization. Toxicology, 61, pp.91-107, 1990

[58]

ALBERS R., BROEDERS A., VAN DERPIJL A. et al. The use of reporter antigens in the popliteal lymph node assay to assess immonomodulation by chemicals. Toxicol. Appl. Pharmacol., 143, pp.102-109, 1997

[59]

BASKETTER D.A., LEAL. J., COOPER K. et al. Threshold for classification as a skin sensitizer in the local lymph node assay: a statistical evaluation. Food. Chem. Toxicol., 37, pp.1167-1174, 1999

[60]

BASKETTER D.A., ROBERTS D.W., CRONIN M. et al. The value of the local lymph node assay in quantitative structure-activity investigations. Contact Dermatitis, 27, pp.137-142, 1992

[61]

BASKETTER D.A. and SCHOLES E.W. Comparison of the local lymph node assay with the guinea pig maximization test for the detection of a range of contact allergens. Food. Chem. Toxicol., 30, pp.65-69, 1992

[62]

BASKETTER D.A., SCHOLES E.W. and KIMBER I. The performance of the local lymph node assay with chemicals identified as contact allergens in the human maximization test. Food. Chem. Toxicol., 32, pp.543-547, 1994

[63]

DE BAKKER J.M., M.E., MULLER E.S.M. et al. Kinetics and morphology of chemically induced popliteal lymph node reactions compared with antigen-mitogen-, and graft-versus-host-reaction-inducedresponses. Virchows Archiv. B Cell Pathol., 58, pp.279-287, 1990

[64]

DEAN J., TWERDOK L.E., ANDERSEN K.E. et al. The murine local lymph node assay: A test method for assessing the allergic contact dermatitis potential of chemicals/compounds. NIH publication No. 99-494, Research Triangle Park, 1999, available at http://iccvam.niehs.nih/gov/methods/IInadocs/IInarep.pdf

[65]

DEARMAN R.J., BASKETTER D.A. and KIMBER I. Local lymph node assay: use in hazard and risk assessment. J. Appl. toxicol., 19, pp.299-306, 1999

[66]

DESCOTES J., PATRIARCA C., VIAL T. et al. The popliteal lymph node assay in 1996. Toxicol., 119, pp.45-49, 1997

[67]

EDWARDS D.A., SORANOO T.M., AMORUSO M.A. et al. Screening petrochemicals for contact hypersensitivity potential: a comparison of the murine local lymph node assay with guinea pig and human test data. Fundam. Appl. Toxicol., 23, pp.179-187, 1994

[68]

GERBERICK G.F., GRUSE L.W. and RYAN C.A. Local lymph node assay: differentiating allergic and irritant responses using flow cytometry. Methods, 19, pp.48-55, 1999 (a)

[69]

GERBERICK G.F., GRUSE L.W., MILLER C.M. et al. Selective modulation of B-cell activation markers CD86 and I-AK on murine draining lymph node cells following allergen or irritant treatment. Toxicol. Appl. Pharmacol, 159, pp.142-151, 1999 (b)

[70]

IKARASHI Y., OHNO K., MOMMA J. et al. Assessment of contact sensitivity of two thiourea rubber accelerators: comparison of two mouse lymph node assays with the guinea pig maximization test. Food Chem. Toxicol., 32, pp.1067-1072, 1994

[71]

IKARASHI Y., TSUCHIYA T. and NAKAMURA A. Detection of contact sensitivity of metal salts using the murine local lymph node assay. Toxicol.Lett., 62, pp.53-61, 1992

[72]

IKARASHI Y., TSUCHIYA T. and NAKAMURA A. A sensitive mouse lymph node assay with two application phases for detection of contact allergens. Arch. Toxicol., 67, pp.629-636, 1993

[73]

IKARASHI Y., TSUCHIYA T. and NAKAMURA A. Application of sensitive mouse lymph node assay for detection of contact sensitization capacity of dyes. J. Appl. Toxicol., 16, pp.349-354, 1996

[74]

IKARASHI Y., TSUKAMOTO Y., TSUCHIYA T. et al. Influence of irritants on lymph node cell proliferation and the detection of contact sensitivity to metal salts in the murine local lymph node assay. Contact Dermatitis, 29, pp.128-132, 1993

[75]

KIMBER I. and BASKETTER D.A. The murine local lymph node assay: a commentary on collaborative studies and new directions. Food Chem. Toxicol., 30, pp.165-169, 1992

[76]

KIMBER I., HILTON J., DEARMAN R.J. et al. An international evaluation of the murine local lymph node assay and comparison of modified procedures. Toxicol., 103, pp.63-73, 1995

[77]

LEA L.J., WARBRICK E.V., DEARMAN R.J. et al. The impact of vehicle on assessment of relative skin sensitization potency or 1,4-dihydroquinone in the local lymph node assay. Am. J. Contact Dermatitis, 10, pp.213-218. 1999

[78]

LOVELESS S.E., LADICS G.S., GERBERICK G.F. et al. Further evaluation of the local lymph node assay in the final phase of an international collaborative trial. Toxicol., 108, pp.141-152, 1996

[79]

MONTELIUS J., WAHLKVIST H., BOMAN A. et al. Experience with the murine local lymph node assay: inability to discriminate between allergens and irritants. Acta Derm. Venereol., 74, pp.22-27, 1994

[80]

ROBERTS D.W. Structure-activity relationships of skin sensitization potential of diacrylates and dimethacrylates. Contact Dermatitis, 17, pp.281-289, 1987

[81]

VIAL T., CARLEER J., LEGRAIN B. et al. The popliteal lymph node assay: results of a preliminary interlaboratory validation study. Toxicol., 122, pp.213-218, 1997

[82]

WARBRICK E.V., DEARMAN R.J., LEA L.J. et al. Local lymph node assay responses to paraphenylenediamine: intra- and inter-laboratory evaluations. J. Appl. Toxicol., 19, pp.225-260, 1999

[83]

Organization for Economic Cooperation and Development, Guideline for the testing of chemicals No. 429, Skin sensitisation: Local lymph node assay, OECD Publications, 2002