Diéthylhexyl Phthalate

5. What health effects can DEHP cause in laboratory animals?

Tests in laboratory animals have shown that if DEHP is swallowed or inhaled, it is rapidly absorbed and metabolised via several pathways. It does not accumulate in the body. The main metabolites are the monoester, MEHP, and an alcohol, ethylhexanol. The metabolites are excreted via the urine. DEHP can be present in breast milk.

A single dose of DEHP which is swallowed or breathed in has low acute toxicity. It is also assumed to have low acute toxicity via the skin. DEHP is slightly irritating to the animal skin and eye but it is not a skin sensitiser.

Repeated oral exposure to DEHP mainly affects the testis (see also below) and the kidney. The highest doses that didn’t cause adverse effect on these organs have been established. No effects were seen on the testis at a dose of 4.8 milligrams/kg bw/day in a rat study, which extended over 3 generations. In a long-term study in rats no effects were seen in the kidney at doses in the range 29-36 milligrams/kg bw/day.

Laboratory tests suggest that DEHP does not cause damage to the inherited genetic materials in cells (chromosomes and DNA).

Adverse effects are also seen in the liver of rats and mice, including liver cancer, but studies have indicated that the mechanism by which phthalates cause liver damage is not relevant for humans. Thus there does not seem to be concern for liver cancer in humans. DEHP also causes tumours in the testis and white blood cells (leukaemia) in rodents but the relevance of these effects for humans is not known.

Adverse effects are also seen in the liver of rats and mice, including liver cancer, but studies have indicated that the mechanism by which phthalates cause liver damage is not relevant for humans. Thus there does not seem to be concern for liver cancer in humans. DEHP also causes tumours in the testis and white blood cells (leukaemia) in rodents but the relevance of these effects for humans is not known. More...