Abstract:Objective To evaluate whether the Pandanus amaryllifolius Roxb. powder had reproductive toxicity to the SD rat and whether it was teratogenic to theembryo, perform toxicological evaluation of its safety, and provide the basis of the toxicology safety for the development of food additive. Methods Pregnant rats were randomly divided into negative control group, positive control group, Pandanus amaryllifolius Roxb. powder sample high-dose group, middle dose group and low-dose group (2.50,1.25 and 0.60 g/kg BW respectively),using the teratogenic test method in GB 15193.14-2015. The test substance was orally administered on the 6th to 15th day of conception, and was administered by intragastric administration. The vehicle control group was intragastrically administered with the same amount of pure water; the positive control group was intraperitoneally injected with cyclophosphamide 15 mg/kg. The pregnant rats were sacrificed on the 20th day of pregnancy, and the abnormalities of the fetal rats were examined, dissected and recorded. Results The groups intervened with Pandanus amaryllifolius Roxb. powder showed no producematernal toxicity,mbryonic toxicity nor teratogenicity,compared with the negative control group. No significant abnormality was found in the indicators, and the overall analysis did not have a dose-response relationship. The positive control group showed obvious embryonic toxicity and teratogenicity. The no observed adverse effect level (NOAEL) was 2.50 g/kg BW. Conclusion In the dose range of this experimental study, there was no teratogenic effect in the sample of Pandanus amaryllifolius Roxb. powder.