stream [5]:5, Following Decision C(97),186/Final of the OECD Council, data generated in the testing of chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries. @�plzPX��/b������ ��Ym��Tm7��~��p3>����p��ִ���(�ɽ]����L qg�Dβ�۱5���/D||NZ�6�E̔q�i���B �xO$2�:nø>��>=�l�v{��l�c�1��Y��d��U��ҿ�N���C�>����h�(h���r�n@-�G�ʖԧ2�׉��0w�c�?+kK�cz�h�3�uDvyغ��φ[��CA�h��m�������;�B��3�7x��P�\� B9J��@��Щ�"T.d�#�� �xZ��v�sv^�E��c!>����@��K|��h� �1r�))Z�O�j��h��]� �i� endobj The original Test Guideline 487 was adopted in 2010; it has been revised in the context of an overall review of the OECD Test Guidelines on genotoxicity and to reflect several years of experience with this test and the interpretation of the data. Directive 2004/10/EC has replaced Directive 87/017/EEC as of 11 March 2004; Directive 2004/9/EC has replaced Directive 88/320/EEC as of 11 March 2004. OECD/OCDE . 1 x cm-1 the chemical … �BtY�,� �R�C\>��K9�Jt�ϣPSp8jKȮ{����n@�`L�;��Dm_�Z�B��x�ql.&�ǁ猍�!vX�G�ٺ��m���`k¾��^�tV593w�C�x0=)%{�YR�:Z�ؘ���%�x H��V�n�0��;�(�l�[�0�M��C.C����m��.Rg?���)۩�F�NCQǖH����Tz�i�7Ų!oߦgMS,��Y����[:��X����uU4�z���_L��|. ��\��hi�������>�s|#?����o� have provided a tutorial for users to quickly embark on and do the job properly. The original Guideline 420 was adopted in July 1992 as the first alternative to the conventional acute toxicity test, described in Test Guideline 401. Since 1987 the European Council had adopted two basic Directives and a Decision relating to the application of the GLP principles. [3] GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. �Z��w�Rr^�L5����eu�p��_#� T���wF�m:����u�M���uN����b���^Ӏ&Ŵ�9�y2�)����Hw�QK���w�$��ލ�����R�r���N��|�f.æ�,�&�a���n���KiV��|��N��J�(�E8Q�!� ~�[{,͐��6E|��|u��Q��j��!�~� The United States FDA has rules for GLP in 21CFR58. <>>> h޼��n�8�_��޴�F`g��i/��)��Bk����dXJӾ}g(R�;V�vA��CrH���0ˆ3�p)�D�$�9h�aGJ8� This Test Guideline is part of a series of Test Guidelines on genetic toxicology. 89/569/EEC Council Decision of 28 July 1989 on the acceptance by the European Economic Community of an OECD decision / recommendation on compliance with principles of good laboratory practice. 2 0 obj <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> An inspection in non-member economies by OECD inspectors will not guarantee that data generated in compliance with GLP will be accepted in other member countries than the one to which they are submitting data and which has thus sent inspectors to verify the accuracy of their compliance statement. The Environmental Protection Agency (EPA) had also encountered similar problems in data submitted to it, and issued its own draft GLP regulations in 1979 and 1980, publishing the Final Rules in two separate parts (40 CFR 160 and 40 CFR 792) in 1983. OECD publishes OECD Guidelines for the Testing of Chemicals, which are guidelines that usually have to be followed for GLP compliance. This directive lays down the obligation of the Member States to designate the authorities responsible for GLP inspections in their territory. OECD/OCDE 106 Adopted : 21st January 2000 1/45 OECD GUIDELINE FOR THE TESTING OF CHEMICALS Adsorption - Desorption Using a Batch Equilibrium Method INTRODUCTION 1. It was published in 1997, by BASF (a chemical company) authors. 1. endstream endobj 958 0 obj <>/Metadata 85 0 R/Pages 955 0 R/StructTreeRoot 142 0 R/Type/Catalog>> endobj 959 0 obj <>/MediaBox[0 0 595.32 841.92]/Parent 955 0 R/Resources<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 960 0 obj <>stream The United States FDA has rules for GLP in 21CFR58. OECD Guidelines for the Testing of Chemicals are a set of internationally accepted specifications for the testing of chemicals decided on by the Organisation for Economic Co-operation and Development (OECD). In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health (including pharmaceuticals) through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.[1][2]. %%EOF ���aw�����!UJ�eD��?aR��,8[I� �ׯ��9}��^|[�t2o����7M�~E���}R��ERm���7�:+�\�Yӗ��tz�\�(z�ϛ��$�N`G�V{�"q暞����Z�E�����j�*�m�j~��ˆ�|z!ן^r&�� ]/>�F�*�C3i¸#)D��&��� [4], These issues were made public in the hearings at the US Congress, which led to the FDA's publication of Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58). OECD Guidelines for Testing of Chemicals are periodically reviewed to ensure that they reflect the best available science. INTRODUCTION . To ease the burden of this management, Webster et al. Based on the ��!/@݁`�܅F�ڒ�A�5V���!���5-��� In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method . Preclinical trials on animals in the United States of America use these rules prior to clinical research in humans. GLP is not limited to chemicals and also applies to medical devices, food additives, food packaging, colour additives, animal food additives, other non-pharmaceutical products or ingredients, biological products, and electronic products. Kevin Robinson for BioPharm International, 1 Aug 2003. OECD/OCDE 221 Adopted : 23 March 2006 1/22 OECD GUIDELINES FOR THE TESTING OF CHEMICALS Lemna sp. If this can include an overarching 'chain of custody' sample history and data flow, combined with adequate SOP's for calibration & linearization of measuring tools, GLP compliance is virtually assured. "��m&Ff�^F����d? Adopted: 24. th. %PDF-1.5 %���� They are widely required by agencies doing risk assessments of chemicals. This Test Guideline is designed to assess the toxicity of substances to freshwater aquatic plants of the genus Lemna (duckweed). �������y3�lfٻ�ݢH�y�3��߽������~�����'쁏����{�����2쁍�u��&�*�?y �*�d���ʴ����p�ۛk"�c���T.ڸ{j*Y(TZ�xoK�Ty�b~6���ySR��ȋ֙�/>��W) V��mԳ�.I~XIv@ݪf��E9۬֨��Ȓ��;8��n��oj6��٬�y:��0 =d��zku��m��Z��*+K�u&rY�J@k��PW?��W�U^BS�r/���QJ���1���ӽ6#�"ò���k���t�)x�?7��8x�����.�\�YS�-��Ɏ+X������Z�T/&�R� Z�3������ˣ�6�:2{]�BM���1�[�I�{TSp�Z����g0����`�F�e��OO�A�Ƽ�xE�u9�2b�=��Y`����_��v^϶t��aG�z��Y��P8��j6~��fiqC��b77S��P����fݰ���o�@n�o�#u%꓈my�ļ['�jP�Q�!