Survey of Chemical Substances in Consumer Products, No. 60 – Migration and health assessment of chemical substances in surface treated wooden toys

Migration and health assessment of chemical substances in surface treated wooden toys

1 Introduction

1.1 Background
1.2 Purpose
1.3 Product description
1.4 Target group
1.5 Project development

1.1 Background

The purpose of the study is an analysis of the migration of heavy metals and organic chemical substances from surface treated wooden toys and a health assessment of selected chemical substances migrating from surface treated wooden toys.

The project specifically targets wooden toys aimed at children less than 3 years of age and that is surface coated with paint, wood stain, lacquers or similar. Particularly for young children/toddlers a risk of exposure exists when the children places the toy in the mouth.

The study is a follow-up of a previous project by the Danish Environmental Protection Agency (Survey no. 33, 2003). The conclusion of the survey was that the release of health hazardous substances from the surface treated wooden toys was difficult to evaluate since the migration was not examined in that project.

The manufacturer or the importer has an obligation to evaluate whether the toy is hazardous. Furthermore, additional requirements in relation to current standards are set. The current regulation sets threshold limit values for the migration of 8 metals from all types of toys: The metals are antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium. These metals are considered to be of most essential health concern/relevance.

In the Statutory Order on toys (Bkg. 1116, 2003) is further noted that toys to children must not contain substances or preparations as defined in Directive 67/548/EEC and 88/378/EEC may be hazardous to the health of children using it.

Therefore, some of the detected substances that might pose a health problem are evaluated.

1.2 Purpose

The study aims to show whether a migration of health hazardous substances takes place from surface treated toys intended for children below 3 years of age and whether this may cause a potential health problem.

1.3 Product description

The products included in the study are primarily wooden toys labelled suitable to children 0 to 3 years of age. Wooden toys surface treated with paint, colorants and lacquers are intentionally selected. A further description of the selected toys is presented in section 2.6.

1.4 Target group

Consumers of surface treated toy products are usually young children / toddlers. Because the group of children aged between 0 and 3 years may be especially sensitive to chemical influences toys for this particular group are the ones focused on in selection and analyses.

1.5 Project development

The project is divided into 2 phases:

Phase 1

Based on the survey in the survey report no. 33 the apparently most problematic toy categories from the information on the preparations used for surface treatment/coating are selected. A selection of 15 toys for children less than 3 years of age is sampled. The toy is selected among toys, which based on appearance, size or function might be expected to be put into the mouth, e.g. rattles, wooden blocks, pieces of puzzles. Toys stained, oiled, lacquered or painted were focused on.

The migration of heavy metals was determined according to the EN71-3 standard where the simulant is 0.07 M HCl (simulating artificial saliva).

The migration of organic chemical substances from the toys was determined qualitatively by a screening analysis in relation to the preliminary standards on toys (EN 71-9, -10 and –11, cf ref.list). In these standards the migration takes place in the simulant at 37°C for 120 minutes. Pretreatment of the test samples was performed according to standard prEN 71-10.

In an EU-report (CEN/TC 52, 2003) prepared by the working group on safety of toys, the migration from a plastic film was measured using several extraction media (artificial saliva, hydrochloric acid (0.07 M HCl), distilled water at pH 7, distilled water containing 10% ethanol, and albumin protein in a sodium chloride solution. The conclusion was that in most instances water was better or as good as any other of the saliva, perspiration or gastric acid simulants for the extraction of organic substances from the plastic matrice. Based on this report the migration examinations could be performed using deionised water as requested in prEN 71-10.

However, according to agreement with the Danish Environmental protection Agency and following a severe criticism of the CEN report from the Scientific Committee (SCTEE 2003) the migration examinations were performed using artificial saliva prepared according to Amtliche Sammllung von Untersuchungsverfahren nach § 35 LMBG nr. 82.10 1, copied from DIN no. 53 160.

The identified substances were compared to the regulation in the Statutory Order on toys (Bkg. 1116, 2003) concerning regulated substances.

Phase 2

The second phase concerns the screening of potential health hazardous effects from substances released (migrated) from the surface treated wooden toys.

A literature screening on the identified substances in the qualitative migration analyses is performed. The screening/literature search is based on literature information and has the purpose to ensure that the substances focused on in the quantitative analyses are the most relevant.

Some substances are evaluated in the CEN/TG 52 (2003) report and these informations are included in the final assessments. Following the qualitative analyses the appeared results are evaluated. Data on the individual substances such as NOAEL, LOAEL or other relevant data are used when available. Alternatively QSAR is used for substances where no data were found. A comparison is performed to the EU classification criteria.