Appendix B
Testing Protocols

OPPTS HARMONIZED TESTING GUIDELINES1

Series 870 Health Effects

870.1000 Acute toxicity testing-background

870.1100 Acute oral toxicity

870.1200 Acute dermal toxicity

870.1300 Acute inhalation toxicity

870.2400 Acute eye irritation

870.2500 Acute dermal irritation

870.2600 Skin sensitization

870.3050 Repeated dose 28-day oral toxicity study in rodents

870.3100 90-Day oral toxicity in rodents

870.3150 90-Day oral toxicity in nonrodent

870.3200 21/28-Day dermal toxicity

870.3250 90-Day dermal toxicity

870.3465 90-Day inhalation toxicity

870.3550 Reproduction/developmental toxicity screening test

870.3650 Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test

870.3700 Prenatal developmental toxicity study

1  

The EPA OPPTS Harmonized Guidelines can be found online at http://www.epa.gov/opptsfrs/home/guidelin.htm.



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OCR for page 240
Toxicity Testing for Assessment of Environmental Agents: Interim Report Appendix B Testing Protocols OPPTS HARMONIZED TESTING GUIDELINES1 Series 870 Health Effects 870.1000 Acute toxicity testing-background 870.1100 Acute oral toxicity 870.1200 Acute dermal toxicity 870.1300 Acute inhalation toxicity 870.2400 Acute eye irritation 870.2500 Acute dermal irritation 870.2600 Skin sensitization 870.3050 Repeated dose 28-day oral toxicity study in rodents 870.3100 90-Day oral toxicity in rodents 870.3150 90-Day oral toxicity in nonrodent 870.3200 21/28-Day dermal toxicity 870.3250 90-Day dermal toxicity 870.3465 90-Day inhalation toxicity 870.3550 Reproduction/developmental toxicity screening test 870.3650 Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test 870.3700 Prenatal developmental toxicity study 1   The EPA OPPTS Harmonized Guidelines can be found online at http://www.epa.gov/opptsfrs/home/guidelin.htm.

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Toxicity Testing for Assessment of Environmental Agents: Interim Report 870.3800 Reproduction and fertility effects 870.4100 Chronic toxicity 870.4200 Carcinogenicity 870.4300 Combined chronic toxicity/carcinogenicity 870.5100 Bacterial reverse mutation test 870.5140 Gene mutation in Aspergillus nidulans 870.5195 Mouse biochemical specific locus test 870.5200 Mouse visible specific locus test 870.5250 Gene mutation in Neurospora crassa 870.5275 Sex-linked recessive lethal test in Drosophila melanogaster 870.5300 In vitro mammalian cell gene mutation test 870.5375 In vitro mammalian chromosome aberration test 870.5380 Mammalian spermatogonial chromosomal aberration test 870.5385 Mammalian bone marrow chromosomal aberration test 870.5395 Mammalian erythrocyte micronucleus test 870.5450 Rodent dominant lethal assay 870.5460 Rodent heritable translocation assays 870.5500 Bacterial DNA damage or repair tests 870.5550 Unscheduled DNA synthesis in mammalian cells in culture 870.5575 Mitotic gene conversion in Saccharomyces cerevisiae 870.5900 In vitro sister chromatid exchange assay 870.5915 In vivo sister chromatid exchange assay 870.6100 Acute and 28-day delayed neurotoxicity of organophosphorus substances 870.6200 Neurotoxicity screening battery 870.6300 Developmental neurotoxicity study 870.6500 Schedule-controlled operant behavior 870.6850 Peripheral nerve function 870.6855 Neurophysiology Sensory evoked potentials 870.7200 Companion animal safety 870.7485 Metabolism and pharmacokinetics 870.7600 Dermal penetration 870.7800 Immunotoxicity 870.8355 Combined Chronic Toxicity/Carcinogenicity Testing of Respirable Fibrous Particles

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Toxicity Testing for Assessment of Environmental Agents: Interim Report OECD TESTING GUIDELINES Series 4: Health Effects 401 Acute Oral Toxicity (Deleted Guideline, date of deletion: 20th December 2002) 402 Acute Dermal Toxicity (Updated Guideline, adopted 24th February 1987) 403 Acute Inhalation Toxicity (Original Guideline, adopted 12th May 1981) 404 Acute Dermal Irritation/Corrosion (Updated Guideline, adopted 24th April 2002) 405 Acute Eye Irritation/Corrosion (Updated Guideline, adopted 24th April 2002) 406 Skin Sensitisation (Updated Guideline, adopted 17th July 1992) 407 Repeated Dose 28-day Oral Toxicity Study in Rodents (Updated Guideline, adopted 27th July 1995) 408 Repeated Dose 90-Day Oral Toxicity Study in Rodents (Updated Guideline, adopted 21st September 1998) 409 Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents (Updated Guideline, adopted 21st September 1998) 410 Repeated Dose Dermal Toxicity: 21/28-day Study (Original Guideline, adopted 12th May 1981) 411 Subchronic Dermal Toxicity: 90-day Study (Original Guideline, adopted 12th May 1981) 412 Repeated Dose Inhalation Toxicity: 28-day or 14-day Study (Original Guideline, adopted 12th May 1981) 413 Subchronic Inhalation Toxicity: 90-day Study (Original Guideline, adopted 12th May 1981) 414 Prenatal Developmental Toxicity Study (Updated Guideline, adopted 22nd January 2001) 415 One-Generation Reproduction Toxicity Study (Original Guideline, adopted 26th May 1983) 416 Two-Generation Reproduction Toxicity Study (Updated Guideline, adopted 22nd January 2001) 417 Toxicokinetics (Updated Guideline, adopted 4th April 1984) 418 Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure (Updated Guideline, adopted 27th July 1995) 419 Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study (Updated Guideline, adopted 27th July 1995)

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Toxicity Testing for Assessment of Environmental Agents: Interim Report 420 Acute Oral Toxicity - Fixed Dose Method (Updated Guideline, adopted 20th December 2001) 421 Reproduction/Developmental Toxicity Screening Test (Original Guideline, adopted 27th July 1995) 422 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (Original Guideline, adopted 22nd March 1996) 423 Acute Oral toxicity - Acute Toxic Class Method (Updated Guideline, adopted 20th December 2001) 424 Neurotoxicity Study in Rodents (Original Guideline, adopted 21st July 1997) 425 Acute Oral Toxicity: Up-and-Down Procedure (Updated Guideline, adopted 20th December 2001) 427 Skin Absorption: In Vivo Method (Original Guideline, adopted 13th April 2004) 428 Skin Absorption: In Vitro Method (Original Guideline, adopted 13th April 2004) 429 Skin Sensitisation: Local Lymph Node Assay (Updated Guideline, adopted 24th April 2002) 430 In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) (Original Guideline, adopted 13th April 2004) 431 In Vitro Skin Corrosion: Human Skin Model Test (Original Guideline, adopted 13th April 2004) 432 In Vitro 3T3 NRU Phototoxicity Test (Original Guideline, adopted 13th April 2004) 451 Carcinogenicity Studies (Original Guideline, adopted 12th May 1981) 452 Chronic Toxicity Studies (Original Guideline, adopted 12th May 1981) 453 Combined Chronic Toxicity/Carcinogenicity Studies (Original Guideline, adopted 12th May 1981) 471 Bacterial Reverse Mutation Test (Updated Guideline, adopted 21st July 1997) 473 In vitro Mammalian Chromosomal Aberration Test (Updated Guideline, adopted 21st July 1997) 474 Mammalian Erythrocyte Micronucleus Test (Updated Guideline, adopted 21st July 1997) 475 Mammalian Bone Marrow Chromosomal Aberration Test (Updated Guideline, adopted 21st July 1997)

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Toxicity Testing for Assessment of Environmental Agents: Interim Report 476 In vitro Mammalian Cell Gene Mutation Test (Updated Guideline, adopted 21st July 1997) 477 Genetic Toxicology: Sex-Linked Recessive Lethal Test in Drosophila melanogaster (Updated Guideline, adopted 4th April 1984) 478 Genetic Toxicology: Rodent Dominant Lethal Test (Updated Guideline, adopted 4th April 1984) 479 Genetic Toxicology: In vitro Sister Chromatid Exchange Assay in Mammalian Cells (Original Guideline, adopted 23rd October 1986) 480 Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay (Original Guideline, adopted 23rd October 1986) 481 Genetic Toxicology: Saacharomyces cerevisiae, Miotic Recombination Assay (Original Guideline, adopted 23rd October 1986) 482 Genetic Toxicology: DNA Damage and Repair, Unscheduled DNA Synthesis in Mammalian Cells in vitro (Original Guideline, adopted 23rd October 1986) 483 Mammalian Spermatogonial Chromosome Aberration Test (Original Guideline, adopted 21st July 1997) 484 Genetic Toxicology: Mouse Spot Test (Original Guideline, adopted 23rd October 1986) 485 Genetic Toxicology: Mouse Heritable Translocation Assay (Original Guideline, adopted 23rd October 1986) 486 Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo (Original Guideline, adopted 21st July 1997)