§1702.9. Relevant experimental data. — Inbound Citations

(2) All reasonably available human experience data, reasonably available relevant experimental data (both human and animal), product and packaging specifications, labeling, and marketing history, in accordance with §§ 1702.8 through 1702.14,

Experimental data are generated in both animals and humans in controlled situations in order to evaluate the biological effects of a substance. Certain toxicological effects cannot generally be evaluated in human beings. This is especially true of those substances which are not normally intended to be used in or on the human body or animal body. Therefore, the Commission considers experimental data obtained in animal studies to be an important supplement to such data as may exist from any experimental studies conducted in humans. The minimum toxicological evaluation necessary for a particular household substance is proportional to the expected exposure of man to that substance. Household substances which are not expected, in normal use, to contact man are subject to less extensive studies than those substances, such as drugs, which are designed to be used in or on man. The Commission has, therefore, separated the requirements of this section into three subsections. Section 1702.9(a) lists minimum acute animal toxicity data which shall be submitted, if reasonably available, for all petitions; § 1702.9(b) lists those additional data which shall be submitted, if reasonably available, for drug products and all other household substances which are normally intended to be used in or on the human body; and § 1702.9(c) lists those additional data which shall be submitted, if reasonably available, by petitioners requesting exemption for substances not intended for use in or on the human or animal body. The Commission emphasizes that, while not absolutely necessary, the types of data outlined in § 1702.9(c) may greatly expedite the Commission's evaluation of a particular exemption request.

Experimental data are generated in both animals and humans in controlled situations in order to evaluate the biological effects of a substance. Certain toxicological effects cannot generally be evaluated in human beings. This is especially true of those substances which are not normally intended to be used in or on the human body or animal body. Therefore, the Commission considers experimental data obtained in animal studies to be an important supplement to such data as may exist from any experimental studies conducted in humans. The minimum toxicological evaluation necessary for a particular household substance is proportional to the expected exposure of man to that substance. Household substances which are not expected, in normal use, to contact man are subject to less extensive studies than those substances, such as drugs, which are designed to be used in or on man. The Commission has, therefore, separated the requirements of this section into three subsections. Section 1702.9(a) lists minimum acute animal toxicity data which shall be submitted, if reasonably available, for all petitions; § 1702.9(b) lists those additional data which shall be submitted, if reasonably available, for drug products and all other household substances which are normally intended to be used in or on the human body; and § 1702.9(c) lists those additional data which shall be submitted, if reasonably available, by petitioners requesting exemption for substances not intended for use in or on the human or animal body. The Commission emphasizes that, while not absolutely necessary, the types of data outlined in § 1702.9(c) may greatly expedite the Commission's evaluation of a particular exemption request.

Experimental data are generated in both animals and humans in controlled situations in order to evaluate the biological effects of a substance. Certain toxicological effects cannot generally be evaluated in human beings. This is especially true of those substances which are not normally intended to be used in or on the human body or animal body. Therefore, the Commission considers experimental data obtained in animal studies to be an important supplement to such data as may exist from any experimental studies conducted in humans. The minimum toxicological evaluation necessary for a particular household substance is proportional to the expected exposure of man to that substance. Household substances which are not expected, in normal use, to contact man are subject to less extensive studies than those substances, such as drugs, which are designed to be used in or on man. The Commission has, therefore, separated the requirements of this section into three subsections. Section 1702.9(a) lists minimum acute animal toxicity data which shall be submitted, if reasonably available, for all petitions; § 1702.9(b) lists those additional data which shall be submitted, if reasonably available, for drug products and all other household substances which are normally intended to be used in or on the human body; and § 1702.9(c) lists those additional data which shall be submitted, if reasonably available, by petitioners requesting exemption for substances not intended for use in or on the human or animal body. The Commission emphasizes that, while not absolutely necessary, the types of data outlined in § 1702.9(c) may greatly expedite the Commission's evaluation of a particular exemption request.