Phthalate Di-isodecyl & Di-isononyl phthalates

6. Do DIDP and DINP pose risks to human health?

• 6.1 Are workers at risk from exposure to DIDP and DINP?
• 6.2 Are consumers at risk from exposure to DIDP and DINP?

Harmful effects to the liver and reproductive effects due to repeated exposure are considered to be the critical health effects in the risk assessment of DIDP and DINP.

Risks are assessed by comparing worst case exposures to the exposures at which no harmful effects were observed in animal studies. The difference between the two is the margin of safety (MOS). More...

6.1 Are workers at risk from exposure to DIDP and DINP?

For workplace exposure, the margins of safety are considered sufficient. It is concluded that exposures to DINP or DIDP are of no concern for workers because they are well below the amounts that would cause harmful effects. The assessment concluded that there is at present no need for further information and/or testing or for further risk reduction measures beyond those being applied already. More...

6.2 Are consumers at risk from exposure to DIDP and DINP?

Consumer exposure from various products containing DIDP or DINP can occur by different routes (inhalation, skin, ingestion) in different situations.

Scenarios were built for three sub-populations:

• For adults and children (3-15 years old) the estimated exposures to DIDP and DINP are well below the doses without effects in animal studies.
• For infants (6 months to 3 years old), if DIDP were to be used as a substitute for other phthalates in toys, the margin of safety would not be considered sufficient to protect infants. In such a case it is concluded that there would be a need to limit the risks, taking into account the risk reduction measures which already apply. However, if DINP were to be used as a substitute for other phthalates in toys, the margin of safety is considered sufficient to protect infants. It is then concluded that there is at present no need for further information and/or testing or for further risk reduction measures beyond those being applied already.
• For newborns (0 to 6 months old), the exposure scenarios and conclusions are the same as for infants. That is, the margins of safety are considered sufficient to protect newborns, except for the scenario with DIDP-containing toys.

(See exposure table, question 4.2)

The environmental exposure assessment of DIDP and DINP has shown that the exposure of adults and infants via the environment is within the margins of safety when considering liver toxicity and developmental effects. It is concluded that there is at present no need for further information and/or testing or for further risk reduction measures beyond those being applied already.

As combined exposure of adults to DIDP and DINP is almost exclusively related to occupational exposure, the margins of safety are considered sufficient for adults. For children 3 to 15 years old, the margins of safety are also considered sufficient. However, if DIDP should be used as a substitute for other phthalates in toys, there would be a need to limit the risks, taking into account the risk reduction measures which already apply. Because DIDP and DINP are not explosive, flammable or oxidizing, these properties are not considered to pose a hazard. For those properties, there is at present no need for further information and/or testing or for further risk reduction measures beyond those being applied already. More...