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