We describe a method of mechanical agitation to determine rates of dialkyl phthalate migration from polyvinyl chloride (PVC) products into saliva simulant. The method consists of rotary shaking of a sample with 30 mL of saliva simulant (pH 7.0) at 35ῌ in a 50 mL glass tube at 300 rpm for 15 min, then measuring the amount of dialkyl phthalate in the saliva simulant by HPLC with a UV detector. The migration rates of diisononyl phthalate (DINP), di-2-ethylhexyl phthalate (DEHP) and di-n-butyl phthalate (DBP) from PVC plates containing about 45῍ (w/w) plasticizer (molded in our laboratory) were identical. However, the migration rates from molded plates containing 13῍ (w/w) DBP were almost double those of DINP and DEHP at the same ratios. In addition, the amounts of DINP that migrated in vitro after rotary shaking for 15 min were equivalent to those in vivo determined in saliva from volunteers who chewed plates for 60 min. The migration rates of dialkyl phthalates from 11 commercially available toys ranged from 15.6 to 85.2 mg/cm 2 /h [relative standard deviation (RSD), 3 to 12῍].Key words: dialkyl phthalate; polyvinyl chloride (PVC) product; saliva simulant; rotation shaking; migration rate Introduction Dialkyl phthalates are widely used as plasticizers to impart softness and flexibility to normally rigid plastics such as polyvinyl chloride (PVC). Medical devices, toys and child-care articles are often made of PVC and contain diisononyl phthalate (DINP), di-2-ethylhexyl phthalate (DEHP) and/or di-n-butyl phthalate (DBP) as the predominant plasticizers 1)ῌ3) . Some dialkyl phthalates have testicular toxicity and other e#ects on the reproductive tracts of male and female animals 4) . The level of toxicity di#ers considerably depending on the nature of the alkyl chain 5) . Wine et al. have identified the testicular toxicity of DBP in rats by reproductive assessment using a continuous breeding protocol 6) . DEHP and DINP are peroxisome proliferators that induce tumors in the rodent liver 7) . Infants are uniquely exposed to dialkyl phthalates, especially DINP, since it is the major plasticizer in toys 3), 8) . The DINP and DEHP migration rates in children chewing or sucking PVC toys has been measured using two types of methods. Adult volunteers have chewed PVC products under controlled conditions (in vivo method) 9)ῌ12) and PVC toys have been shaken or impacted in a saliva simulant in vitro, but the migration rates varied considerably, with poor reproducibility. In addition, large amounts of data are di$cult to obtain in vivo for both practical and ethical reasons. Therefore, a simple and reproducible in vitro migration test is required.We found that the results of a 15-min in vitro migration test of DINP from PVC toys by mechanical agitation, especially rotary shaking, were well correlated with the results of in vivo tests over 60 min 14) . We also evaluated the e#ect of experimental conditions on the dialkyl phthalate migration rates into saliva simulant from PVC products using rotary shaking, and we have established ...