Table 1

Examples of Organization for Economic Co-operation and Development Test Guidelines for the Developmental and Reproductive Toxicity Assays That Refer to the Adjustment of Litter Size by Elimination of Extra Pups

Test TypeCulling RequirementDescription
Test number 426, developmental neurotoxicity studyRequiredOn or before postnatal day 4, the size of each litter should be adjusted by eliminating extra pups by random selection to yield a uniform litter size for all litters
Test number 443, extended 1-generation reproductive toxicity studyRecommendedOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 5 males and 5 females per litter
Test number 415, 1-generation reproduction toxicity studyOptionalIf standardization is carried out, the following procedure is suggested: on day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by selection to yield, as nearly as possible, 4 males and 4 females per litter
Test number 416, 2-deneration reproduction toxicityOptionalStandardization of litter sizes is optional
Test number 421, reproduction/developmental toxicity screening testOptionalOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 4 or 5 pups per sex per litter depending on the normal litter size in the strain of rats used
Test TypeCulling RequirementDescription
Test number 426, developmental neurotoxicity studyRequiredOn or before postnatal day 4, the size of each litter should be adjusted by eliminating extra pups by random selection to yield a uniform litter size for all litters
Test number 443, extended 1-generation reproductive toxicity studyRecommendedOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 5 males and 5 females per litter
Test number 415, 1-generation reproduction toxicity studyOptionalIf standardization is carried out, the following procedure is suggested: on day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by selection to yield, as nearly as possible, 4 males and 4 females per litter
Test number 416, 2-deneration reproduction toxicityOptionalStandardization of litter sizes is optional
Test number 421, reproduction/developmental toxicity screening testOptionalOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 4 or 5 pups per sex per litter depending on the normal litter size in the strain of rats used
Table 1

Examples of Organization for Economic Co-operation and Development Test Guidelines for the Developmental and Reproductive Toxicity Assays That Refer to the Adjustment of Litter Size by Elimination of Extra Pups

Test TypeCulling RequirementDescription
Test number 426, developmental neurotoxicity studyRequiredOn or before postnatal day 4, the size of each litter should be adjusted by eliminating extra pups by random selection to yield a uniform litter size for all litters
Test number 443, extended 1-generation reproductive toxicity studyRecommendedOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 5 males and 5 females per litter
Test number 415, 1-generation reproduction toxicity studyOptionalIf standardization is carried out, the following procedure is suggested: on day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by selection to yield, as nearly as possible, 4 males and 4 females per litter
Test number 416, 2-deneration reproduction toxicityOptionalStandardization of litter sizes is optional
Test number 421, reproduction/developmental toxicity screening testOptionalOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 4 or 5 pups per sex per litter depending on the normal litter size in the strain of rats used
Test TypeCulling RequirementDescription
Test number 426, developmental neurotoxicity studyRequiredOn or before postnatal day 4, the size of each litter should be adjusted by eliminating extra pups by random selection to yield a uniform litter size for all litters
Test number 443, extended 1-generation reproductive toxicity studyRecommendedOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 5 males and 5 females per litter
Test number 415, 1-generation reproduction toxicity studyOptionalIf standardization is carried out, the following procedure is suggested: on day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by selection to yield, as nearly as possible, 4 males and 4 females per litter
Test number 416, 2-deneration reproduction toxicityOptionalStandardization of litter sizes is optional
Test number 421, reproduction/developmental toxicity screening testOptionalOn day 4 after birth, the size of each litter may be adjusted by eliminating extra pups by random selection to yield, as nearly as possible, 4 or 5 pups per sex per litter depending on the normal litter size in the strain of rats used
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