Survey of Chemical Substances in Consumer Products, 74 – Evaluation of the health risk to animals playing with phthalate containing toys

Evaluation of the health risk to animals playing with phthalate containing toys

5 Conclusion

The risk to animals playing with DEHP and DINP containing toys has been evaluated based on effect assessment in concordance with the EU Risk Assessment Reports on DINP (2001) and DEHP (2001) and assessment of exposure to dogs eating pieces of toy.

The exposure has been estimated for different sizes of dogs (1-40 kg) eating different amounts of toy (1-50 g or 1-50 cm²) and the estimations have been made either by the use of a measured migration rate or by assuming that 10% of the total content migrate while the toy is retained in the gastrointestinal tract.

When DEHP exposure was estimated based on the relatively conservative assumption that 10% of the phthalate migrates while in the gastrointestinal tract, critical exposure levels were derived for all the scenarios, i.e. even the largest dog eating only 1 g of toy/day that contains a mean content of DEHP is exposed to doses of DEHP where toxic effects can occur. Also, when the exposure estimations of DEHP were based on measured migration rates of phthalates into saliva or saliva simulant, the major part of the scenarios results in an exposure level where toxic effects could be expected; not only when using the maximum migration rate but also when using the average migration rate.

The NOAEL for DEHP is established for developmental toxicity. The most critical time of exposure to DEHP is a relatively short period especially during sexual differentiation but also during development.

It seems realistic that dogs (including pregnant and/or nursing dogs) might be exposed to DEHP from toys during the relatively short critical period of exposure at levels, which can affect the reproductive system in dogs. Consequently, there is a concern for reproductive effects in dogs due to the presence of DEHP in toys.

Also for DINP, the major part of the exposure estimations based on 10% migration of total DINP, result in exposures beyond the level where effects could be expected. An exception is the larger dogs (20-40 kg) eating the smallest amount of toy (1g) with an average content of DINP. When based on measured migration rates of DINP, critical exposure levels were only derived for the smaller dogs eating larger areas of toy.

As the NOAEL for DINP is established for liver toxicity in a chronic toxicity study, a longer duration of exposure to DINP is necessary to cause the toxic effects. It does not seem very realistic that dog owners continuously should provide their dogs with toys even though the dogs continuously tear the toy apart. Therefore although possible, it seems less likely that the presence of DINP in toys can cause effects in the liver in dogs.

Recent research has indicated that DINP affects the level of testosterone in the male reproductive system, an effect which is evident for DEHP. The available data are not sufficient in order to evaluate the risk for reproductive effects following exposure to DINP, but DINP seems to be much less potent than DEHP. Consequently, the concern for reproductive effects in dogs due to the presence of DINP in toys is considered as being low.

The exposure via toys may be a major source of phthalate exposure to dogs. However as for humans, animals may also be exposed to phthalates via other sources (environment, food, consumer products). This includes exposure to DEHP and DINP, but also other phthalates e.g DBP where combined actions could be expected.

As an advice to the animal owners, they can reduce the potential health risk to their animals by limiting the animal’s use of toys that potentially contain phthalates especially during pregnancy and as pups.