title: PVC in Medical Devices

 

Plasticisers and possible harm

 

Problems with plasticisers - experimental data

Healthcare Without Harm commissioned the University of Massachusetts, USA, to look at the toxic effects of DEHP. This involved reviewing the published experiments which have been carried out on laboratory animals, human cells in tissue culture and evidence from humans where available. The results are summarised in the table:

 

* Exposure levels: to make doses comparable, they are all adjusted according to the weight of the animal tested. Hence mg of DEHP / kg of body weight / day of exposure.

Species tested Toxic effect DEHP exposure levels*

Human neonate

Respiratory distress and cellular changes to membranes in lung.

Up to 4.2mg/hour when new born baby is on lung ventilator for 12-30 days.

Rat

Degeneration of seminiferous tubules in testes.

0.9 and 1.9g/kg/day in diet for 90 days

Rat

Damage to testes in offspring

3.0-3.5mg/kg/day in water from day 1 of gestation to 21 days after birth.

Rat

Reduced or delayed ovulation. Reduced production of oestrogen and formation of cysts in ovaries.

2g/kg/day in food for 3 - 12 days.

Rat

Reduction in heart rate and blood pressure.

20-75mg doses of related phthalate plasticiser.

Rat

Lowering of kidneys' ability to remove creatinine (indicates impaired kidney function).

0.8mg/kg/day in diet for 1 year.

Rat

Cancer of the liver (hepatic adenoma).

146mg/kg/day in diet for 2 years.

Mouse

Abnormal development of embryos: death in uterus, neural tube defect (spina bifida), reduced birth size, exencephaly.

1g/kg/day in diet of mother for 2 days during pregnancy.

Rhesus Monkey

Reduction in liver function. Changes in liver cell structures.

Total dose of 87-290mg intravenous administration over period of 1 year.