This document directs the reader to OECD standards.
Typical In Vitro genotoxicity tests are listed
OECD 471 http://www.oecd.org/chemicalsafety/risk-assessment/1948418.pdf
OECD 473 http://www.oecd.org/chemicalsafety/risk-assessment/1948434.pdf
OECD 476 http://www.oecd.org/chemicalsafety/risk-assessment/1948426.pdf
And others that have since been deleted
Typical In Vivo Genotoxicity tests are listed
OECD 474 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf
OECD 475 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf
OECD 478 was updated after the ISO document was published http://www.oecd.org/env/ehs/testing/OECD_TG478_Revision_Sept_2013.pdf
OECD 483 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/testing/TG-483-Mammalian-Spermatogonial-Chromosomal-Aberrations-Revision-Sep-23-2013-CLEAN-FM-bis.pdf
OECD 484 was updated after the ISO document was published http://www.oecd.org/env/ehs/testing/TG487%20Oct%202012%20updated%2029oct.pdf
OECD 485 http://www.oecd-ilibrary.org/docserver/download/9748501e.pdf?expires=1465236843&id=id&accname=guest&checksum=2CE62F9561F95CE93AB3BB6B38B2E7DD
Typical Carcinogenicity tests are listed
OECD 451 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745101e.pdf?expires=1465236964&id=id&accname=guest&checksum=B232266A151EA20354D82D1088553DEB
OECD 453 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745301e.pdf?expires=1465237013&id=id&accname=guest&checksum=31427D06039676195EFC0FEF7E875EB9
Typical In Vitro genotoxicity tests are listed
OECD 471 http://www.oecd.org/chemicalsafety/risk-assessment/1948418.pdf
OECD 473 http://www.oecd.org/chemicalsafety/risk-assessment/1948434.pdf
OECD 476 http://www.oecd.org/chemicalsafety/risk-assessment/1948426.pdf
And others that have since been deleted
Typical In Vivo Genotoxicity tests are listed
OECD 474 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/risk-assessment/1948442.pdf
OECD 475 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/risk-assessment/1948450.pdf
OECD 478 was updated after the ISO document was published http://www.oecd.org/env/ehs/testing/OECD_TG478_Revision_Sept_2013.pdf
OECD 483 was updated after the ISO document was published http://www.oecd.org/chemicalsafety/testing/TG-483-Mammalian-Spermatogonial-Chromosomal-Aberrations-Revision-Sep-23-2013-CLEAN-FM-bis.pdf
OECD 484 was updated after the ISO document was published http://www.oecd.org/env/ehs/testing/TG487%20Oct%202012%20updated%2029oct.pdf
OECD 485 http://www.oecd-ilibrary.org/docserver/download/9748501e.pdf?expires=1465236843&id=id&accname=guest&checksum=2CE62F9561F95CE93AB3BB6B38B2E7DD
Typical Carcinogenicity tests are listed
OECD 451 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745101e.pdf?expires=1465236964&id=id&accname=guest&checksum=B232266A151EA20354D82D1088553DEB
OECD 453 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9745301e.pdf?expires=1465237013&id=id&accname=guest&checksum=31427D06039676195EFC0FEF7E875EB9
Typical Reproductive toxicity tests are listed
OECD 414 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9741401e.pdf?expires=1465237113&id=id&accname=guest&checksum=98F76117DDEB0FAE06C8B8CBACB0BE9A
OECD 415 http://www.oecd-ilibrary.org/docserver/download/9741501e.pdf?expires=1465237174&id=id&accname=guest&checksum=A94F6B9C220AC0F3D032D68911136501
A few quick definitions
Genotoxicity test means a test that will determine gene mutations, changes in chromosome stucture or change to the DNA.
Carcinogenicity test means a test that determines the tumorigenic potential of devices, materials or extracts to either single or multiple exposures over the lifespan of an animal.
Reproductive and developmental tests evaluate the potential of devices, materials, or extracts to affect reproductive function, embryonic development and prenatal and postnatal development.
Maximum implantable dose is the largest dose an animal can tolerate without it causing physical or mechanical effects.
Energy depositing devices exert their therapeutic or diagnostic effects by the absorption of electromagnetic, ionic, or ultrasonic radiation.
General Genotoxicity
The battery of tests should contain 3 tests that should cover the 3 levels of genetic mateirals, DNA, gene mutation, and chromosome aberration.
The final finished product should be tested and 2 extracts should be used, one a physiologic medium and one a solvent which is compatible with the test system.
General Carcinogenicity
Conditions that may suggest the need for carcinogenicity include; resorbable materials, when there has been positive genotoxicity tests, permanent internal implants.
The final finished devce should be tested, with 2 dose levels. A maximum implantable dose and half that.
General Reproductive toxicity
Conditions that suggest the need for reproductive toxicity tests include, intrauterine devices, energy depositing devices and permanent reproductive contacting implants. Also unknown resorbable or leachable products.
OECD 414 was updated after the ISO document was published http://www.oecd-ilibrary.org/docserver/download/9741401e.pdf?expires=1465237113&id=id&accname=guest&checksum=98F76117DDEB0FAE06C8B8CBACB0BE9A
OECD 415 http://www.oecd-ilibrary.org/docserver/download/9741501e.pdf?expires=1465237174&id=id&accname=guest&checksum=A94F6B9C220AC0F3D032D68911136501
A few quick definitions
Genotoxicity test means a test that will determine gene mutations, changes in chromosome stucture or change to the DNA.
Carcinogenicity test means a test that determines the tumorigenic potential of devices, materials or extracts to either single or multiple exposures over the lifespan of an animal.
Reproductive and developmental tests evaluate the potential of devices, materials, or extracts to affect reproductive function, embryonic development and prenatal and postnatal development.
Maximum implantable dose is the largest dose an animal can tolerate without it causing physical or mechanical effects.
Energy depositing devices exert their therapeutic or diagnostic effects by the absorption of electromagnetic, ionic, or ultrasonic radiation.
General Genotoxicity
The battery of tests should contain 3 tests that should cover the 3 levels of genetic mateirals, DNA, gene mutation, and chromosome aberration.
The final finished product should be tested and 2 extracts should be used, one a physiologic medium and one a solvent which is compatible with the test system.
General Carcinogenicity
Conditions that may suggest the need for carcinogenicity include; resorbable materials, when there has been positive genotoxicity tests, permanent internal implants.
The final finished devce should be tested, with 2 dose levels. A maximum implantable dose and half that.
General Reproductive toxicity
Conditions that suggest the need for reproductive toxicity tests include, intrauterine devices, energy depositing devices and permanent reproductive contacting implants. Also unknown resorbable or leachable products.
