Adopted by the CSTEE during the 41st plenary meeting of 8 January 2004. The CSTEE is of the opinion that the current risk assessment report (Nikiforov, 2003) is of a good quality. From a mouthing study of PVC-disks containing ATBC in human volunteers, a maximum daily oral exposure dose of 227 µg/kg bw has been estimated. A new 13 week study in rats with an in utero exposure has identified a NOAEL of 100 mg/kg bw/day. Since this study is judged to have an adequate design for addressing the potential risk for young children mouthing PVC-toys containing ATBC as a plasticizer, the CSTEE does not see a need for a chronic toxicity study. It is assumed that the risk assessment report is a correct reflection of the study outcome. When comparing the estimated exposure dose with the NOAEL, a Margin of Safety (MOS) of 440 can be calculated. Since the exposure dose clearly is a worst-case estimate, the actual MOS for children up to 36 months of age presumably is considerably larger. Therefore, the CSTEE is of the opinion that the risk assessment has provided sufficient sound scientific evidence to show that toys plasticized with acetyl tributyl citrate (ATBC) can be safely mouthed by children