Conclusion DEHP causes minimal skin irritation in rabbits. Limited data suggest no irritant effects in humans. Eye irritation Previous evaluations Two eye irritation studies in rabbits were performed according to OECD guideline 404 (BASF, 1986*; Hüls, 1987*) and another eye irritation study in rabbits was performed according to FDA recommended methods (Hüls, 1981*). No reaction was observed in the cornea or iris in any of the studies. All three studies reported mild conjuctival redness after one hour. In the earlier study, mild conjunctival redness was observed in five eyes, one hour after dosing and in three eyes, 24 hours after application (Huls, 1981*). Where reported, all reactions resolved at later timepoints. Data not reported in previous evaluations No data. Conclusion DEHP causes minimal eye irritation in rabbits. Respiratory irritation Previous evaluations No studies specifically addressing this issue have been found. One acute toxicity study included examination of the lungs. Exposure to 10 mg/L DEHP for 4 hours induced dark red foci and patches in the lungs of 19/31 rats (Hüls, 1981*; Klimisch et al., 1992*). It is unknown if these effects were reversible. are no adequate human data. In a case report of 3 preterm infants artificially ventilated with PVC respiratory tubes, an unusual lung disorder resembling hyaline membrane disease was observed in two infants, whilst the third died (Roth et al., 1988*). The authors assumed that these findings were causally related to the exposure to high doses of DEHP released from the PVC tubes. Data not reported in previous evaluations No data. Conclusion Data are insufficient to determine the respiratory irritant potential of DEHP.
Conclusion DEHP causes minimal skin irritation in rabbits. Limited data suggest no irritant effects in humans. Eye irritation Previous evaluations Two eye irritation studies in rabbits were performed according to OECD guideline 404 (BASF, 1986*; Hüls, 1987*) and another eye irritation study in rabbits was performed according to FDA recommended methods (Hüls, 1981*). No reaction was observed in the cornea or iris in any of the studies. All three studies reported mild conjuctival redness after one hour. In the earlier study, mild conjunctival redness was observed in five eyes, one hour after dosing and in three eyes, 24 hours after application (Huls, 1981*). Where reported, all reactions resolved at later timepoints. Data not reported in previous evaluations No data. Conclusion DEHP causes minimal eye irritation in rabbits. Respiratory irritation Previous evaluations No studies specifically addressing this issue have been found. One acute toxicity study included examination of the lungs. Exposure to 10 mg/L DEHP for 4 hours induced dark red foci and patches in the lungs of 19/31 rats (Hüls, 1981*; Klimisch et al., 1992*). It is unknown if these effects were reversible. are no adequate human data. In a case report of 3 preterm infants artificially ventilated with PVC respiratory tubes, an unusual lung disorder resembling hyaline membrane disease was observed in two infants, whilst the third died (Roth et al., 1988*). The authors assumed that these findings were causally related to the exposure to high doses of DEHP released from the PVC tubes. Data not reported in previous evaluations No data. Conclusion Data are insufficient to determine the respiratory irritant potential of DEHP.
DEHP-hazard-assessment.docx