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Survey, migration and health evaluation of chemical substances in toys and childcare products produced from foam plastic

4 Summary and Conclusions

Based on the survey phase the Danish Environmental Protection Agency selected the following products for testing:

The analysis part, which was an iterative process, was initiated with qualitative and quantitative analyses of 8 products for bromated flame-retardants, TCEP, phthalates and metals. Performed were also tests for content of organic tin compounds, content of colorants and screening for volatile organic compounds in selected products.

Only concentrations of phthalates and organic tin compounds above the detection limit were measured. Based on the phthalate analyses, two products were withdrawn (4 and 7) from the Danish market because the contained amount was higher than the permitted limit value for phthalates in toys intended for children between 0-3 years (0.05%) (3).

5 chemical substances were selected for the health assessment to be performed in phase 3; diisobutylphthalate (DIBP), di-n-butylphthalate (DBP), diisononylphthalate (DINP), monobutyltin (MBT) og dibutyltin (DBT).

The highest amount of DIBP and DBP (0,05%) in the remaining 6 products was measured in product 5 and 5 respectively. The amount was considerably lower than the permitted limit value for phthalates in toys intended for children between 0-3 years (3) and does not give reason for health concern.

The highest amount of DINP (0.05%) in the remaining 6 products was measured in product 1. The amount was higher than the permitted limit value for phthalates in toys intended for children between 0-3 years. However, as the product is intended for children of more than 3 years, it was not withdrawn from the Danish market. The distributor of product 1 has been informed about the content of DINP in the product and is working on eliminating the substance completely from the product.

Foamed toys and childcare products are mainly produced from EVA and PUR foam. Based on this survey, it is recommended to focus on the content of phthalates of these products, as 2 of 8 products contained concentrations above the permitted limit value for phthalates (0.05%) in toys intended for children between 0-3 years, (3). DEHP is furthermore contained in all products. DEHP, DBP and BBP, which have been identified as reproduction toxic substances, will be prohibited in concentrations above 0.1% of all softened toys and childcare articles. DINP, DIDP and DNOP will be prohibited in toys and childcare articles intended for mouthing (4). The prohibition comes into force one year after the proportion is agreed upon in the council.

Testing for organic tin compounds was performed in 2 products (4 and 6). Product 4 has been withdrawn from the Danish market and is not included in the assessment. In product 6 (a fabric book with PUR-stuffing intended for children under 3 years) was measured 1.95 µg MBT/kg and 1.15 µg DBT/kg. An exposure assessment based on a worst-case scenario was made: A newborn child and a child of 1.5 years were exposed and the total concentration of MBT and DBT was released and ingested in one day. As sufficient data was not found on the toxic effects of MBT and DBT in animals and humans, the assessment was based on the content of tin and a Tolerable Daily Intake (TDI) for the two substances which is recommended by Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) (30). The additive effect of MBT and DBT was calculated. A fraction sum < 1 means that the total MBT and DBT in the book do not cause reason for health concern. The additive effect of the substances was calculated to be 0.08 and 0.03 for a newborn child and a child of 1.5 years, respectively. Based on this calculation the content of MBT and DBT in the book should not cause any health concern.

The Margin of Safety (MoS) for the exposure of the two organic tin compounds from the book was calculated by dividing NOAEL with the exposure (under the assumption that the entire amount of MBT (1.95 µg/kg book) and DBT (1.15 µg/kg book) is released in one day. A NOAEL for DBT of 2.5 mg/kg bw/day was used for both MBT and DBT.

A MoS of 86000 and 250000 was calculated for a newborn child and a child of 1.5 years old, respectively. DTC estimates that exposure to organic tin compounds from the book does not cause any health concerns. DTC recommends however that the contribution from other sources is calculated. An estimation of how large an amount of TDI that could be allocated to consumer products would then be possible.

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Version 1.0 March 2006, © Danish Environmental Protection Agency