Dietilhexil ftalatos

6. Does DEHP pose risks to human health?

• 6.1 Are workers at risk from exposure to DEHP?
• 6.2 Are consumers at risk from exposure to DEHP?
• 6.3 Are people at risk from environmental exposure to DEHP?

The source document for this Digest states:

4.1.3 Risk characterisation

The toxicity to exposure ratio for different human populations and scenarios has been used to derive the MOS. The lowest and most reliable NOAELs established in oral studies in animals have been used. These effects concern: repeated dose toxicity to kidney (NOAEL 29 mg/kg/day) and testes (NOAEL 4.8 mg/kg/day), as well as effects on fertility (NOAEL 20 mg/kg/day) and development (NOAEL 4.8 mg/kg/day). To correct for route-to-route extrapolation, systemic oral NOAELs for kidney and for fertility have been derived from oral NOAELs in rats: this is based on 50% oral bioavailability in adults. This extrapolation has not been necessary for the other end-points, as they are obtained from life-time studies covering phases with different absorption rates (50-100%).

Source & ©: ECB,
 "Bis-(2-Ethylhexyl) Phthalate, DEHP), Summary Risk Assessment report" , 2008. p.15-16.

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6.1 Are workers at risk from exposure to DEHP?

The source document for this Digest states:

Workers

The exposure scenarios considered for workers in this risk assessment concern exposure to DEHP from production of DEHP, industrial use of DEHP and industrial end-use of preparations or materials containing DEHP.

For the scenarios on production and industrial use, monitored data for inhalation exposure and modelled values for dermal exposure have been used as a realistic worst case. For the scenario industrial end-use of products containing DEHP, it is assumed that relatively high work temperatures, aerosol generation and considerable skin contact occur. There is not enough quantitative and qualitative information available on technical control measures and personal protective equipment used during production and processing to establish their effectiveness. There is concern for the testicular effects, fertility, toxicity to kidneys, on repeated exposure and developmental toxicity for workers as a consequence of inhalation and dermal exposure during production, processing and industrial end-use of preparations or materials containing DEHP. There is no concern for the acute toxicity, irritation and sensitising effects, carcinogenicity, and mutagenicity.

Source & ©: ECB,
 "Bis-(2-Ethylhexyl) Phthalate, DEHP), Summary Risk Assessment report" , 2008. p.16.

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6.2 Are consumers at risk from exposure to DEHP?

The source document for this Digest states:

Consumers

Exposure scenarios considered important for adult consumers concern exposure from indoor air, PVC gloves and car interiors. The information used is based on measurements and modelling of DEHP in indoor air, absorption from gloves and car interiors. Exposure scenarios considered important for children consumers concern exposure from toys and baby equipment, from indoor air and from car interiors. The information used is based on measurements of DEHP in artificial and human saliva for toys and baby equipment and modelled data for indoor air.

The result of the consumer assessment for adults is that: There is no concern for exposure from indoor-air, gloves, car interiors and multiple pathways of exposure for all endpoints studied.

The result of the consumer assessment for children is that: There are concerns with regard to testicular effects, fertility and toxicity to kidneys on repeated exposure as a consequence of oral exposure route to toys and child-care articles, and multiple routes of exposure. No risk is identified for exposure from indoor air or car interiors. There is no concern for the acute toxicity, irritation and sensitising effects, carcinogenicity, and mutagenicity.

Concerning exposure of consumers from medical equipment, there is concern for some or all end points: testicular effects, fertility, and toxicity to kidneys, on repeated exposure and developmental (excluding children) for the exposure scenarios

• long term haemodialysis in adults (testicular, fertility, toxicity to kidneys and developmental)
• long term blood transfusion in children (testicular)
• transfusions in neonates (testicular and fertility)

Calculating the MOS values on data from human lifetime exposure from medical equipment during infusions, there is no concern for the endpoints for haemodialysis, infusion of platelets and autopheresis.

Based on a qualitative risk assessment, there is concern for all end points: testicular effects, fertility, and toxicity to kidneys for extracorporal oxygenation in children

Source & ©: ECB,
 "Bis-(2-Ethylhexyl) Phthalate, DEHP), Summary Risk Assessment report" , 2008. p.16-18.

The same information on

6.3 Are people at risk from environmental exposure to DEHP?

The source document for this Digest states:

Humans exposed via the environment

Exposure scenarios considered important for adults and children are:

• Environmental exposure of adults
• Environmental exposure of children
• Exposure of babies/infants from infant formulae
• Exposure of babies from breast milk

Environmental exposure has been estimated by two different approaches; by calculation of daily ‘regional’ intake of DEHP based on the measured excretion of DEHP-metabolites in a general population, and by the EUSES model. Using EUSES, worst-case exposure has been estimated for adults and children. Both environmental monitoring and default values were used in the model. This information was compared with NOAELs derived from oral studies. MOSs for both local and regional exposure have been estimated. The assessment based on measured excretion of DEHP-metabolites is believed to be more reliable (and covering potential contamination of food during handling and processing) than the one based on EUSES, and when it comes to regional exposure, only the conclusion from the former assessment (based on biomonitoring) is presented here. However, the assessment of local exposure is solely based on EUSES.

The result for man exposed indirectly via the environment is that for regional exposure of adults and children: There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

In the local exposure scenarios, there is concern for children with regard to testicular effects, fertility, and toxicity to kidneys, on repeated exposure, as a consequence of exposure via food. There is no concern for adults. The scenarios that give concern for children are generic scenarios based on default emission data for children living in the vicinity of sites: processing polymer products; producing sealants/adhesives, lacquers and paints, or printing ink; municipal STP; and recycling paper. For municipal STP and paper recycling the only concern is for testicular effects. There is no concern for the limited number of sites that have reported emission data. Based on the results for local exposure from food, water and air assessment for children the conclusion is that: There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

For exposure of new-born and infants via infant formulae and breast milk, monitoring data have been used. There is no concern for any end-point for new-borns and infants exposed via infant formulae or breast milk.

Combined exposure

Exposure to DEHP apparently occurs during the entire human life time, from different sources. Exposure may therefore be equated with persistent low dose exposure. New-borns are probably the most sensitive sub-population, exposed via many sources, and perhaps at higher levels than the adults. However, combined exposure is considered in setting conclusions for the most sensitive sub-population, i.e. the new-borns, in the section ‘Human exposed via the environment’, and no conclusion will therefore be drawn specifically in this section on combined exposure.

4.2 HUMAN HEALTH (PHYSICO-CHEMICAL PROPERTIES)

There is at present no need for further information and/or testing and no need for risk reduction measures beyond those which are being applied already.

Source & ©: ECB,
 "Bis-(2-Ethylhexyl) Phthalate, DEHP), Summary Risk Assessment report" , 2008. p.17-18.

The same information on