Survey of chemical substances in consumer products, 70 – Survey, migration and health evaluation of chemical substances in toys and childcare products produced from foam plastic

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

Summary

The objective of Phase 1 was to make a survey of toys and childcare articles on the Danish market produced from foam plastic, including their chemical composition.

Most wholesalers and distributors of toys and childcare articles have been very helpful providing lists of products of their assortment. It has however been difficult to obtain information on consumption and almost impossible to obtain information on the chemical composition of the products.

Foreningen af Legetøjsfabrikanter i Danmark (FLD) (The Association of Toy Manufacturers in Denmark), whose members count seven of the largest manufacturers in Denmark estimates that less than 1% of all toys (by number) are produced from foam plastic (1).

Based on data from the website “Danmarks statistik – www.statistikbanken.dk”, an estimate on toys and childcare articles on the Danish market was made (2). The website contains information on imported and imported products in kilos. Since DTC did not find any toys or childcare articles made from plastic foam produced in Denmark, only the number of imported toys was estimated. As it was not possible to select data on specific materials, a data selection from the statistic base on a superior level was made based on which foam plastic products were specified. The estimated total of imported toys and childcare articles made from foam plastic in 2004 was 171.2 ton.

During the survey, it was not possible to obtain information on the complete chemical composition of the products. DTC obtained information on the use of two basic polymers, ethylene vinyl acetate (EVA) and polyurethane (PUR).

Based on the survey, the Danish Environmental Protection Agency (Danish EPA) has selected the following products for testing:

Product no.	Product	Argumentation
1	Sword	Swords represent a great part of the foam plastic toys on the market
2	Floor puzzle 1	Body contact. For children of > 1 year. May be used as nursing carpet
3	Surf board	Is shaped like a frog and therefore believed to attract attention to children < 3 years.
4	Activity carpet	Body contact. Children may spend a lot of time on it.
5	Mask	Face contact.
6	Book	Children are expected to mouth it.
7	Floor puzzle 2	Body contact when children are lying on the puzzle. Marked for children > 3 years, however, The Danish Safety Technology Authority has decided that the puzzle is for children < 3 years.
8	Ball	The diameter (< 20 cm) indicates use for children < 3 years.

The objective of Phase 2 is to determine the content of hazardous substances in the selected products. The selection of substances was based on knowledge of additives in plastic products as well as knowledge of substances that may be hazardous to humans.

The process of analyses was iterative and initiated with qualitative and quantitative analyses of eight products for bromated flame-retardants, TCEP, phthalates and metals. Testing for content of organic tin compounds and colorants was also performed as well as a screening for volatile organic compounds in selected products. The test results are shown in the following survey.

Pro- duct no.	Product	Phtha- lates	Bro- ma- ted flame retar- dants + TCEP	Me- tals	Orga- nic tin com- pounds	Azo color- ants	Selec- ted color- ants, (speci- fied in table 2.8)	Scree- ning for vola- tile orga- nic com- pounds < C₁₄- C₁₆
1	Sword	B	A	A		A	E	F
2	Floor puzzle 1	A	A	A		A	E	F
3	Swim board	A	A	A
4	Activity Carpet	C	A	A	D
5	Mask	A	A	A				F
6	Book	A	A	A	B
7	Floor puzzle 2	C	A	A
8	Ball	A	A	A				F
A Not measured in concentrations of concern B Concentrations requiring safety assessment C Concentrations exceeding the permitted limit D Not assessed. The products were withdrawn from the Danish market because of the total content of phthalates) E Assessment not possible. The detection limit is higher than the limit value due to the complexicity of the polymer materials F The analyses was a screening without quantification or qualification of the substances. The GC-MS-spectrum of the ball contained a signal equal to C₁₀-C₁₄ hydrocarbons.

The content of phthalates in two products (4 and 7) were higher than the limit value for phthalates in toys intended for children between 0-3 years of 0.05%, and the two products were ordered withdrawn from the Danish market (3). 5 chemical substances were selected for the safety assessment in phase 3; diisobutylphthalate (DIBP), di-n-butylphthalate (DBP), diisononylphthalate (DINP), monobutyltin (MBT) and dibutyltin (DBT).

The purpose of phase 3 was to set up toxicological profiles for the above 5 substances and perform an exposure assessment of MBT and DBT in product 6. Based on the safety assessment in phase 3, the below assessments were performed.

The highest DIBP measured in the remaining 6 products, was 6.5 mg/kg in product 5 (corresponding to 0.00065%). The amount is lower than the above limit value (3), and does not cause any health concern.

The highest DBP measured in the remaining 6 products was 11.9 mg/kg in product 6 (corresponding to 0.00119%). The amount is lower than the above limit value (3), and does not cause any health concern.

The highest amount of DINP measured in the remaining 6 products was 935 mg/kg in product 1 (corresponding to 0.0935%). The amount is higher than the above limit value (3), but as the product is intended for children > 3 years it was not withdrawn from the Danish market. The distributor of product 1 was informed of the content of DINP in the product and is working on eliminating the substance 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.

2 products (4 and 6) were analysed for organic tin compounds. Product 4 was withdrawn from the Danish market and consequently it was not assessed. 1.95 µg MBT/kg and 1.15 µg DBT/kg was measured in product 6 (a fabric book with PUR stuffing intended for children under 3 years).

Sufficient data was not found on MBT and DBT’s toxic effects in animals and humans. The substances were assessed based on a Tolerable Daily Intake (TDI) for the two substances recommended by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) (4).

The assessment was based on a worst-case scenario under the assumption of a release of the total amount of MBT and DBT in one day and exposure of a newborn child and a child of 1.5 years of age. The average weight in Denmark of a newborn child is 3,450 g (5) and a child of 1.5 years weighs 9,850 g (6). An additive effect of the two substances is expected. A fraction sum < 1 means that the total content of MBT and DBT in the book does not cause any health concern.

The fraction sum of the exposure of a newborn child and a child of 1.5 years old is 0.08 and 0.03, respectively. This means that there is no reason for health concerns based on the content of MBT and DBT in the book.

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, which is assumed to be sufficient for the protection of children. The used NOAEL for MBT and the assumption of a release of the total content of the organic tin compounds in one day underestimates the MoS. DTC estimates that exposure to organic tin compounds from the book does not cause any health concerns. Because of the large amount of organic tin compounds found in dust from European households, and the potential to ingest organic tin compounds through breast milk and food and from a number of other consumer products, DTC recommends that the contribution from other sources is calculated. An estimation of how large an amount of TDI that could be allocated to consumer products is then possible.