Diethylhexyl phthalate

7. Are further research and additional risk reduction measures needed?

The source document for this Digest states:

5 RESULTS

5.1 ENVIRONMENT

Atmosphere

Conclusion (ii) 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.

This conclusion is reached because the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.

Aquatic ecosystem

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

This conclusion is reached because of concern for birds consuming mussels exposed to DEHP near sites processing polymers with DEHP or sites producing printing inks, sealants and/or adhesives with DEHP. The scenarios that give concern are generic scenarios based on default emission data. There is no concern for the limited number of sites that have reported measured emission data.

Conclusion (i) There is a need for further information and/or testing.

Further refinement of the assessment may remove some concern. This conclusion is reached because of concern for sediment dwelling organisms as a consequence of exposure to DEHP near sites processing polymers with DEHP or sites producing lacquers, paints, printing inks, sealants and/or adhesives with DEHP. The scenarios that give concern are generic scenarios based on default emission data. There is no concern for the limited number of sites that have reported measured emission data.

Further refinement of the assessment may remove some concern. However implementation of risk management measures to address the risks identified for other environmental spheres will eliminate the need for further information on sediment dwelling organisms.

Terrestrial ecosystem

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

This conclusion is reached because of concern for mammals consuming earthworms exposed to DEHP near sites processing polymers with DEHP or sites producing lacquers, paints, printing inks, sealants and/or adhesives with DEHP. The scenarios that give concern are generic scenarios based on default emission data. There is no concern for the limited number of sites that have reported measured emission data.

Conclusion (i) There is a need for further information and/or testing.

Further refinement of the assessment may remove some concern. However considering that there are other concerns for these scenarios that will require risk management measures, further information will only be requested if needed when risk management measures have been agreed. This conclusion is reached because of concern for soil organisms exposed to DEHP near sites processing polymers with DEHP or sites producing printing inks, sealants and/or adhesives with DEHP. The scenarios that give concern are generic scenarios based on default emission data. There is no concern for the limited number of sites that have reported measured emission data.

Further refinement of the assessment may remove some concern. However implementation of risk management measures to address the risks identified for other environmental spheres will eliminate the need for further information on soil organisms.

Micro-organisms in the sewage treatment plant

Conclusion (ii) 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.

This conclusion is reached because the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.

5.2 HUMAN HEALTH

5.2.1 Human health (toxicity)

The conclusion of the assessment of the risks to

Workers

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

This conclusion is reached because of:

• concerns for testicular effects, fertility, toxicity to kidneys, on repeated exposure and developmental toxicity as a consequence of inhalation and dermal exposure during production, processing and industrial end-use of preparations or materials containing DEHP

Consumers

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

This conclusion is reached because of:

• concerns for children in regard to testicular effects, fertility, and toxicity to kidneys, on repeated exposure, as a consequence of oral exposure from toys and child-care articles, and multiple routes of exposure.
• concerns for children undergoing long-term blood transfusion and neonates undergoing transfusions with regard to testicular toxicity and fertility, as a consequence of exposure from materials in medical equipment containing DEHP.
• concerns for adults undergoing long-term haemodialys with regard to repeated dose toxicity to kidney and testis, fertility, and developmental toxicity, as a consequence of exposure from materials in medical equipment containing DEHP.

Humans exposed via the environment

Conclusion (iii) There is a need for limiting the risks; risk reduction measures which are already being applied shall be taken into account.

This conclusion is reached because of:

• concerns for children with regard to testicular effects, fertility, and toxicity to kidneys, on repeated exposure, as a consequence of exposure via food locally near sites processing polymers with DEHP, or sites producing sealants and/or adhesives, paints and lacquers or printing inks with DEHP. The scenarios that give concern are generic scenarios based on default emission data. There is no concern for the limited number of sites that have reported measured emission data.
• concerns for children with regard to testicular toxicity, as a consequence of exposure via food grown locally near sites recycling paper or municipal sewage treatment plants. The scenarios that give concern are generic scenarios based on default emission data.

5.2.2 Human health (risk from physico-chemical properties

Conclusion (ii) 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.

This conclusion is reached because the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient.

Source & ©: ECB,
 "Bis-(2-Ethylhexyl) Phthalate, DEHP), Summary Risk Assessment report" , 2008. p.19-21.

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