Guideline

Rejection factor

Developmental Toxicity—Nonrodents (cont.) (83-3(b))

A NOEL was not established

Statistical problems

Reproduction (83-4)

Information missing from laboratory results

Lack of characterization of the test material

Information missing or requiring clarification of laboratory methods or results

Missing historical controls

A NOEL was not established due to effects at the lowest dose tested

Low fertility and/or inadequate number of animals were used per dose level

A NOEL was not established  in the absence of reproductive effects

Metabolism (85-1)

Inadequate or missing data on identification of metabolites

Improper methodology or dosing regimen

Inadequate number of animals were used in the dose groups

No individual animal data

Improper reporting

Inadequate or missing tissue residue analysis data

Testing at only one dose level

Only one sex of animal used

Lack of an intravenous dose group

No collection of 14 CO2

Dermal Penetration (85-2)

Incomplete/missing data evaluation

Improper test material preparation/application

Raw data missing and incomplete summary tables

No signed quality assurance statement

Missing purity or concentration of test material

 

SOURCE: P. Fenner-Crisp, EPA, personal communication, 1992

The additional acute study proposed in guideline number 81-4 is acute neurotoxicity testing in the rat. This study would be required for all pesticide registrations (food and nonfood) and experimental use permits (EUPs), and it would include assessments of function and activity as well as histopathological (microscopic) examination of selected neural tissue. EPA presently requires that this study be conducted by manufacturers wishing to reregister.



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