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Migration of phthalates from PVC toys into saliva simulant by dynamic extraction
1Inspectorate for Health Protection and Veterinary Public Health, PO Box 465, 9700 AL Groningen, The Netherlands. krista.bouma@kvw.nl
Insights
Phthalates in soft PVC toys pose health risks, leading to EU restrictions. A Dutch study found common phthalates like DINP and DEHP, with some exceeding migration limits, highlighting the need to regulate alternative plasticizers.
Area of Science:
- Materials Science
- Toxicology
- Consumer Product Safety
Background:
- Soft PVC children's products often contain phthalates, which can migrate when children suck or chew them.
- Some phthalates are linked to adverse health effects, including kidney and liver damage, and testicular issues.
- European regulations restrict certain phthalates in soft PVC toys for children under three.
Purpose of the Study:
- To analyze the plasticizers used in soft children's products.
- To assess compliance with European regulations regarding phthalate content.
- To evaluate the migration levels of plasticizers from PVC toys.
Main Methods:
- Market surveillance of 62 soft toys in The Netherlands.
- Analysis of plasticizers, primarily Diisononylphthalate (DINP) and di(2-ethylhexyl)phthalate (DEHP).
- Migration testing using saliva simulant and the 'Head over Heels' agitation method.
Main Results:
- 47 out of 62 toys contained plasticized PVC, with DINP and DEHP being predominant.
- One teething ring exceeded the regulatory limit for phthalate content.
- DEHP migration exceeded guidance values in six toys, though all complied with general release limits.
Conclusions:
- While most toys met migration standards, some exceeded specific DEHP limits, indicating potential risks.
- Alternative plasticizers are used, but their safety and migration behavior require further investigation.
- Regulation of alternative plasticizers is recommended to ensure the overall safety of PVC toys.
Abstract:
Soft PVC children's products are usually plasticized with phthalates. As young children suck and chew on toys, they extract and ingest certain quantities of the plasticizers. Some phthalates are suspected to affect the kidneys and liver and cause testicular damage. Therefore, the EC has prohibited the sale of toys and childcare articles intended to be placed in the mouth by children <3 years of age made of soft PVC containing >0.1% by weight of six phthalates (1999/815/EC). The aim was to study the materials and plasticizers used in soft children's products. In February 2001, a market surveillance was performed in The Netherlands and 62 soft toys were sampled. Forty-seven of these toys contained plasticized PVC. Diisononylphthalate (DINP) and di(2-ethylhexyl)phthalate (DEHP) were the predominant plasticizers and were usually found in concentrations between 30 and 45% by weight. One teething ring was made of PVC plasticized with 45% by weight of DINP and was not in compliance with Decision 1999/815/EC. The DINP and DEHP migration was determined in saliva simulant using the 'Head over Heels' agitation method. All toys complied with the Scientific Committee on Toxicity, Ecotoxicity and the Environment (SCTEE) guidance release value of 6.7 microg min(-1) 10 cm(-2). The DEHP migration of six toys exceeded the SCTEE guidance release value of 1.7 microg min(-1) 10 cm(-2). Substitutes found for phthalates plasticizers are acetyltributylcitrate, tributylcitrate and diisononyladipate. In addition, other plasticizers and additives were found in minor amounts. The toxicity and the migration behaviour of these substances is less known and requires more attention. To ensure the safety of PVC toys, these substances should also be regulated.
