Data and report
(f) Data and report(1) Treatment of results. (i) Data shall be presented in tabular form and shall include the number of animals at risk, the germ cell stage treated, the number of partial steriles and semisteriles (if the fertility test is used), the number of cytogenetically confirmed translocation heterozygotes (if the fertility test is used, report the number of confirmed steriles and confirmed partial steriles), the translocation rate, and either the standard error of the rate or the upper 95 percent confidence limit on the rate. (ii) These data shall be presented for both treated and control groups. Historical or concurrent controls shall be specified, as well as the randomization procedure used for concurrent controls. (2) Statistical evaluation. Data shall be evaluated by appropriate statistical methods. (3) Interpretation of results. (i) There are several criteria for determining a positive result, one of which is a statistically significant dose-related increase in the number of heritable translocations. Another criterion may be based upon detection of a reproducible and statistically significant positive response for at least one of the test points. (ii) A test substance which does not produce either a statistically significant dose-related increase in the number of heritable translocations or a statistically significant and reproducible positive response at any one of the test points is considered nonmutagenic in this system. (iii) Both biological and statistical significance should be considered together in the evaluation. (4) Test evaluation. (i) Positive results in the heritable translocation assay indicate that under the test conditions the test substance causes heritable chromosomal damage in the test species. (ii) Negative results indicate that under the test conditions the test substance does not cause heritable chromosomal damage in the test species. (5) Test report. In addition to the reporting recommendations as specified under 40 CFR part 792, subpart J, the following specific information shall be reported: (i) Species, strain, age, weight and number of animals of each sex in each group. (ii) Test chemical vehicle, route and schedule of administration, toxicity data. (iii) Dosing regimen, doses tested and rationale for dosage selection. (iv) Mating schedule, number of females mated to each male. (v) The use of historical or concurrent controls. (vi) Screening procedure including the decision criteria used and the method by which they were determined. (vii) Dose-response relationship, if applicable.