Risk assessment-based verification of the CertiPUR^TM limit values for toluene diamine and methylene dianiline in...

Flexible polyurethane foams (PUF) are used in many consumer products. PUF may contain trace levels of aromatic diamine impurities that could represent a potential health risk. The risk associated with sleeping on a PUF mattress was evaluated. Toxicity benchmarks for sensitization and non-cancer endpoints were derived from the respective points-of-departure using standard assessment factors. For the cancer endpoints, toxicity benchmarks were derived from the 25th-percentile values of animal studies. Recently published emission and migration data allowed to link exposure with the CertiPUR^TM voluntary quality limits of ≤5 mg.kg^-1 for 2,4-toluene diamine and 4,4'-methylene dianiline in PUF. Using conservative exposure scenarios, lifetime-average daily internal doses from the combined inhalation and dermal exposures were calculated. Margins of safety for non-cancer and sensitization endpoints were >10⁴. The theoretical excess cancer risk was ≤1.5 × 10^-7. It is concluded that sleeping on a mattress that satisfies the CertiPUR limit value does not pose undue risk to consumers.