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Corola-website/Law/292696_a_294025

testul nu relevă efecte corozive sau puternic iritante, se efectuează un test de confirmare pe alte două animale. REFERINȚE BIBLIOGRAFICE: (1) OECD (1996) OECD Test Guidelines Programme: Final Report of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods. Held în Solna, Sweden, 22 - 24 January 1996 (http://www.oecd.org/ehs/test/background.htm). (2) OECD (1998) Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances, aș endorsed by

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of the OECD Workshop on Harmonization of Validation and Acceptance Criteria for Alternative Toxicological Test Methods. Held în Solna, Sweden, 22 - 24 January 1996 (http://www.oecd.org/ehs/test/background.htm). (2) OECD (1998) Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances, aș endorsed by the 28th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, November 1998 (http://www.oecd.org/ehs/Class/HCL6.htm). (3) Worth, A.P. and Fentem

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of Chemical Substances, aș endorsed by the 28th Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, November 1998 (http://www.oecd.org/ehs/Class/HCL6.htm). (3) Worth, A.P. and Fentem J.H. (1999). A General Approach for Evaluating Stepwise Testing Strategies. ATLA 27, 161-177. (4) Metodă de testare B.4. Toxicitate acută: iritație/coroziune dermica. (5) Young, J.R., How, M.J., Walker, A.P., Worth W.M.H. (1988) Classification aș Corrosive or Irritant to Skin of Preparations Containing Acidic

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Single pH. J. Toxicol. Cut. Ocular Toxicol. 12, 227 - 231. (7) Fentem, J.H., Archer, G.E.B., Balls, M., Botham, P.A., Curren, R.D., Earl, L.K., Edsail, D.J., Holzhutter, H.G. and Liebsch, M. (1998) The ECVAM internațional validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the Management Team. Toxicology in Vitro 12, pp. 483 - 524. (8) Metodă de testare B.40 Coroziune dermica. (9) Anexă la metoda de testare B.4: O strategie de testare secvențiala pentru iritație

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și ale scheletului, precum și tipurile și incidentele diverselor anomalii, precum și alte modificări relevante. Discutarea rezultatelor. Concluzii. 4. REFERINȚE BIBLIOGRAFICE: (1) Kavlock R.J. et al. (1996) A Simulation Study of the Influence of Study Design on the Estimation of Benchmark Doses for Developmental Toxicity. Risk Analysis 16; 399-410. (2) Kimmel, C.A. and Francis, E.Z. (1990) Proceedings of the Workshop on the Acceptability and Interpretation of Dermal Developmental Toxicity Studies. Fundamental and Applied Toxicology 14; 386-398. (3) Wong, B.A., et al

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1976) Differential Staining of Cartilage and Bone în Fetal Mouse Skeleton by Alcian Blue and Alizarin Red S. Congenital Anomalies 16; 171-173. (8) Igarashi, E. et al. (1992) Frequency Of Spontaneous Axial Skeletal Variations Detected by the Double Staining Technique for Ossified and Cartilaginous Skeleton în Rât Foetuses. Congenital Anomalies 32; :381-391. (9) Kimmel, C.A. et al. (1993) Skeletal Development Following Heat Exposure în the Rât. Teratology 47:229-242. (10) Marr, M.C. et al. (1988) Comparison of Single and Double

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and Cartilaginous Skeleton în Rât Foetuses. Congenital Anomalies 32; :381-391. (9) Kimmel, C.A. et al. (1993) Skeletal Development Following Heat Exposure în the Rât. Teratology 47:229-242. (10) Marr, M.C. et al. (1988) Comparison of Single and Double Staining for Evaluation of Skeletal Development: The Effects of Ethylene Glycol (EG) în CD Rats. Teratology 37; 476. (11) Barrow, M.V. and Taylor, W.J. (1969) A Rapid Method for Detecting Malformations în Rât Foetuses. Journal of Morphology 127:291-306. (12) Fritz

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10) Marr, M.C. et al. (1988) Comparison of Single and Double Staining for Evaluation of Skeletal Development: The Effects of Ethylene Glycol (EG) în CD Rats. Teratology 37; 476. (11) Barrow, M.V. and Taylor, W.J. (1969) A Rapid Method for Detecting Malformations în Rât Foetuses. Journal of Morphology 127:291-306. (12) Fritz, H. (1974) Prenatal Ossification în Rabbits ss Indicative of Foetal Maturity. Teratology 11; 313-320. (13) Gibson, J.P. et al. (1966) Use of the Rabbit în Teratogenicity Studies. Toxicology

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în Rats: Malformations or Variations? Teratology 8; 309-316. (15) Marr, M.C. et al. (1992) Developmental Stages of the CD (Sprague-Dawley) Rât Skeleton after Maternal Exposure to Ethylene Glycol. Teratology 46; 169-181. (16) Monie, I.W. et al. (1965) Dissection Procedures for Rât Foetuses Permitting Alizarin Red Staining of Skeleton and Histological Study of Viscera. Supplement to Teratology Workshop Manual, pp. 163-173. (17) Spark, C. and Dawson, A.B. (1928) The Order and Time of appearance of Centers of Ossification în the

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Limbs of the Albino Rât, with Special Reference to the Possible Influence of the Sex Factor. American Journal of Anatomy 41; 411-445. (18) Staples, R.E. and Schnell, V.L. (1964) Refinements în Rapid Clearing Technique în the KOH-Alizarin Red S Method for Fetal Bone. Stain Technology 39; 61-63. (19) Strong, R.M. (1928) The Order Time and Rate of Ossification of the Albino Rât (Mus Norvegicus Albinus) Skeleton. American Journal of Anatomy 36; 313-355. (20) Stuckhardt, J.L. and Poppe, S.M. (1984) Fresh Visceral

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Staining Techniques în the Evaluation of Pesticide Teratogenicity. Acta Vet. Acad. Sci. Hung. 28; 233-239. (25) Staples, R.E. (1974) Detection of visceral Alterations în Mammalian Foetuses. Teratology 9; 37-38. (26) Van Julsingha, E.B. and C.G. Bennett (1977) A Dissecting Procedure for the Detection of Anomalies în the Rabbit Foetal Head. În: Methods în Prenatal Toxicology Neubert, D., Merker, H.J. and Kwasigroch, T.E. (eds.). University of Chicago, Chicago, ÎL, pp. 126-144. (27) UȘ Environmental Protection Agency (1991) Guidelines for Developmental Toxicity Risk

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A Dissecting Procedure for the Detection of Anomalies în the Rabbit Foetal Head. În: Methods în Prenatal Toxicology Neubert, D., Merker, H.J. and Kwasigroch, T.E. (eds.). University of Chicago, Chicago, ÎL, pp. 126-144. (27) UȘ Environmental Protection Agency (1991) Guidelines for Developmental Toxicity Risk Assessment. Federal Register 56; 63798-63826. (28) Wise, D.L. et al. (1997) Terminology of Developmental Abnormalities în Common Laboratory Mammals (Version 1) Teratology 55; 249-292. ANEXĂ 2G B.35. STUDIU DE TOXICITATE ASUPRA REPRODUCERII PE DURATA A DOUĂ

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of Reproduction and Fertility 54:103-107. (4) Klinefelter, G.R. et al., (1991). The Method of Sperm Collection Significantly Influences Sperm Motion Parameters Following Ethane Dimethanesulfonate Administration în the Rât. Reproductive Toxicology 5:39-44 (5) Seed, J. et al. (1996). Methods for Assessing Sperm Motility, Morphology, and Counts în the Rât, Rabbit, and Dog: a Consensus Report. Reproductive Toxicology 10(3):237- 244. (6) Chapin, R.E. et al., (1992). Methods for Assessing Rât Sperm Motility. Reproductive Toxicology 6:267-273 (7) Klinefelter, G.R.

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Reproductive Toxicology 5:39-44 (5) Seed, J. et al. (1996). Methods for Assessing Sperm Motility, Morphology, and Counts în the Rât, Rabbit, and Dog: a Consensus Report. Reproductive Toxicology 10(3):237- 244. (6) Chapin, R.E. et al., (1992). Methods for Assessing Rât Sperm Motility. Reproductive Toxicology 6:267-273 (7) Klinefelter, G.R. et al., (1992). Direct Effects of Ethane Dimethanesulphonate on Epididymal Function în Adult Rats: an In Vitro Demonstration. Journal of Andrology 13:409-421. (8) Slott, V.L. et al., (1991

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al., (1989) Histological Assessment of Ovarian Follicle Number în Mice Aș a Screen of Ovarian Toxicity. În: Growth Factors and the Ovary, A.N. Hirshfield (ed.), Plenum, New York, pp. 421-426. (17) Manșon, J.M. and Y.J. Kang, (1989). Test Methods for Assessing Female Reproductive and Developmental Toxicology. În: Principles and Methods of Toxicology, A.W. Hayes (ed.), Raven, New York. (18) Smith, B.J. et al,. (1991). Comparison of Random and Serial Sections în Assessment of Ovarian Toxicity. Reproductive Toxicology 5:379-383. (19

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Raven, New York. (18) Smith, B.J. et al,. (1991). Comparison of Random and Serial Sections în Assessment of Ovarian Toxicity. Reproductive Toxicology 5:379-383. (19) Heindel, J.J. (1999). Oocyte Quantitation and Ovarian Histology. În: An Evaluation and Interpretation of Reproductive Endpoints for Human Health Risk Assessment, G. Daston,. and C.A. Kimmel, (eds.), ILSI Press, Washington, DC. (20) Thomas, J. A. (1991). Toxic Responses of the Reproductive System. În: Casarett and Doull's Toxicology, M.O. Amdur, J. Doull, and C.D. Klaassen

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Gerberick, G.F., Kimber, Ț. and Loveless, S.E (1 996). The local lymph node assay- A viable alternative to currently accepted skin sensitisation tests. Food and Chemical Toxicology, 34, 985-997. 7 Basketter, D.A., Gerberick, G.F. and Kimber, I. (1998). Strategies for identifying false positive responses în predictive sensitisation tests. Food and Chemical Toxicology. 36, 327-33. 8 Van Och, F.M.M, Slob, W., De Jong, W.H., Vandebriel, R.J., Van Loveren, H. (2000). A quantitative method for assessing the sensitising potency of

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and Kimber, I. (1998). Strategies for identifying false positive responses în predictive sensitisation tests. Food and Chemical Toxicology. 36, 327-33. 8 Van Och, F.M.M, Slob, W., De Jong, W.H., Vandebriel, R.J., Van Loveren, H. (2000). A quantitative method for assessing the sensitising potency of low molecular weight chemicals using a local lymph node assay: employement of a regression method that includes determination of uncertainty margins. Toxicology, 146, 49-59. 9 Dearman, R.J., Hilton, J., Evans, P., Harvey, P., Basketter, D.A.

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D.A. and Kimber, I. (1998). Temporal stability of local lymph node assay responses to hexyl cinnamic aldehyde. Journal of Applied Toxicology, 18, 281-4. 10 Național Institute of Environmental Health Sciences (1999). The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potențial of Chemicals/Compounds: The Results of an Independent Peer Review Evaluation Coordinated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the Național Toxicology Program Center for the Evaluation of

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A Test Method for Assessing the Allergic Contact Dermatitis Potențial of Chemicals/Compounds: The Results of an Independent Peer Review Evaluation Coordinated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the Național Toxicology Program Center for the Evaluation of Alternative Toxicological Methods (NICETAM). NIH Publication No: 99-4494, Research Triangle Park, N.C. (http://iccvam.niehs.nih.gov). 11 Metodă de testare B.4. 12 Basketter, D.A., Selbie, E., Scholes, E.W. Lees, D. Kimber, I. and Botham

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local lymph node assay dose responses. J. Appl. Toxicology, 19, 261-266. 14 Basketter DA, Blaikie L, Derman RJ, Kimber Ț, Ryan CĂ, Gerberick GF, Harvey P, Evans P, White TR and Rycroft RTG (2000). Use of local lymph node assay for the estimation of relative contact allergenic potency. Contact Dermatitis 42, 344-48. B.43. STUDII DE NEUROTOXICITATE PE ROZĂTOARE 1. METODĂ Această metodă de testare este echivalentă cu OCDE TG 424 (1997). Această metodă de testare a fost elaborată în vederea obținerii

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nu se observă nici un efect advers. Concluzii: - se încurajează furnizarea unei aprecieri privind neurotoxicitatea globală a substanței de testat. 4. REFERINȚE BIBLIOGRAFICE: 1. OECD Guidance Document on Neurotoxicity Testing Strategies and Test Methods. OECD, Paris. În preparation. 2. Test Guideline for a Developmental Neurotoxicity Study. OECD Guidelines for the Testing of Chemicals. În preparation. 3. World Health Organization (WHO) (1986). Environmental Health Criteria Document 60: Principles and Methods for the Assessment of Neurotoxicity Associated with Exposure to Chemicals. 4. Spencer. P.S.

32004L0073-ro (2004) [Corola-website/Law/292696_a_294025]
se încurajează furnizarea unei aprecieri privind neurotoxicitatea globală a substanței de testat. 4. REFERINȚE BIBLIOGRAFICE: 1. OECD Guidance Document on Neurotoxicity Testing Strategies and Test Methods. OECD, Paris. În preparation. 2. Test Guideline for a Developmental Neurotoxicity Study. OECD Guidelines for the Testing of Chemicals. În preparation. 3. World Health Organization (WHO) (1986). Environmental Health Criteria Document 60: Principles and Methods for the Assessment of Neurotoxicity Associated with Exposure to Chemicals. 4. Spencer. P.S. and Schauraburg, H.H. (1980). Spencer, P.S. and

32004L0073-ro (2004) [Corola-website/Law/292696_a_294025]
Testing Strategies and Test Methods. OECD, Paris. În preparation. 2. Test Guideline for a Developmental Neurotoxicity Study. OECD Guidelines for the Testing of Chemicals. În preparation. 3. World Health Organization (WHO) (1986). Environmental Health Criteria Document 60: Principles and Methods for the Assessment of Neurotoxicity Associated with Exposure to Chemicals. 4. Spencer. P.S. and Schauraburg, H.H. (1980). Spencer, P.S. and Schaumburg, H.H. eds., Williams and Wilkins Co., Baltimore/London, 726-742. 5. Tupper D.E. and Wallace, R.B. (1980). Utility of the Neurologic

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1980). Spencer, P.S. and Schaumburg, H.H. eds., Williams and Wilkins Co., Baltimore/London, 726-742. 5. Tupper D.E. and Wallace, R.B. (1980). Utility of the Neurologic Examination în Rats. Acta Neurobiol. Exp., 40, 999-1003. 6. Gad, S.C. (1982). A Neuromuscular Screen for Use în Industrial Toxicology. J. Toxicol. Environ. Health, 9, 691-704. 7. Moser V.C., McDaniel, K.M. and Phillips, P.M. (1991). Rât Străin and Stock Comparisons Using a Funcțional Observațional Battery: Baseline Values and Effects of amitraz. Toxic. Appl, Pharmacol., 108, 267-283

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