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Survey and Health Assement of the exposue of 2-year-olds to chemical substances in Consumer Product 6 Chemical analyses
6.1 AnalysesThe purpose of the analysis in this project was to establish whether the product groups selected contained chemical substances that are potentially endocrine disruptors or allergens. The analysis programme consists of three elements: Screening analyses, quantitative analyses and migration analyses with different exposure scenarios. The screening analyses were performed to identify the ingredients in the products selected. Further studies were performed on some of the products based on the results of the screening analyses. The product groups selected contained chemical substances that are potentially endocrine disruptors or allergens. Various exposure scenarios simulate contact with the skin and mouth using artificial sweat and saliva. Simulated inhalation was used to study release. The reasons for choosing these scenarios are described in Chapter 7. Quantitative content analyses of selected substances and products were made to compare the total content of a product with that a child can be expected to be exposed to through contact with the product. The results were used to perform a risk assessment, including a comparison with previous quantitative studies that did not include exposure scenarios. 6.1.1 Product groups selected for analysis.On the basis of the knowledge collected in Chapter 3 on previously studied substances and products, 12 product groups were selected for surveying. The following 12 product groups were surveyed, see Chapter 3:
Of these 12 product groups, the following 10 were selected for analyses:
Moisturising creams/oil-based creams/ lotions and sunscreens were not selected because, as agreed with DEPA, risk assessment was to be performed based on maximum permitted amount of the declared content of the products. Each product group belongs to an arena of use, described in more detail in Chapter 3. Table 6.1 presents a list of the product groups by arena. Table 6.1 Relationship between arenas of use and product groups analysed
Diapers fall into all arenas, which is to be expected as most 2-year-olds wear diapers day and night. 6.1.2 Analysis programme compositionThe structure of the analysis programme is justified below. First an overall description is provided, followed by a summary of the conclusions of all analyses. The product groups are described individually in the following chapters. The description includes methods and results of screening analyses, quantitative analyses and migration analyses, including reasons for selection of substances and products for more detailed studies. A range of substances or substance groups have been selected and described in Chapter 3. Initially, there were more under consideration, but some were excluded. The analyses focused on the following substances and substance groups:
Table 6.2 presents the analysis methods used in the project. The initial screening programme was based on knowledge from the survey as to which products could contain the substances. All the products selected were extracted with dichloromethane and analysed using GC/MS to determine the content of extractable organic substances. In cases where the material composition is not stated on the product nor the accompanying packaging, and where the product was suspected of being made of polycarbonate or PVC, an FTIR analysis has been performed in order to determine the material type. The aim was to provide information to consumers on the relationship between material composition and the presence of bisphenol A and phthalates. The studies were not weighted, which gives the total material composition of the product. Table 6.2 Analysis methods
The screening methods used are described under each product group, as there are variations between methods due to the different material composition of the products. Results and details of which part(s) of the products were used for analysis are also given under each product group. Based on the results of the screening analyses, products and substances were selected for quantitative analyses and exposure scenarios. The grounds for such choices are given under each product group and described in more detail in Chapter 3. The exposure scenarios used are described in the following section, whilst the methods of quantitative determination of migrating substances and results are given under each product group. Section 6.11 contains a list of the results of quantitative analyses and results of the migration studies. 6.2 Exposure scenariosChoice of relevant exposure scenarios was based on the possible use of the products by 2-year-olds. This project focused on skin contact (sweat) and mouth contact (saliva) plus inhalation of perfume and aromatic compounds where relevant. The scenarios (including the simulant used and exposure time) were selected in consultation with DEPA. Further grounds and references concerning the exposure scenarios are given in Chapter 7, Table 7.1. Analysis results are given under each product group in the following section and in Table 6.82. Risk assessment of the analysis results is given in Chapter 7. 6.2.1 Exposure scenariosTable 6.3 describes the various exposure scenarios used in this project. Table 6.3 Exposure scenarios used
Studies were made for certain substances deemed to be relevant to risk assessment. 6.2.2 Artificial sweat, saliva simulants and temperatures usedSimulants for sweat and saliva migrations were selected based on whether they had previously been used for comparable analyses of toys and textiles, for example. Furthermore, these migration fluids were selected because they only contain organic substances, and thus minimise the risk of interference of the organic substances being analysed. The artificial sweat simulant used is described in DS/EN ISO 105-E04, as used for ØKO-TEX certification (Öko-Tex Standard 100). The sweat simulant in DS/EN ISO 105-E04 consists of 1-histidine-monohydrochloride-1-hydrate, sodium chloride, sodium dihydrogen phosphate, and sodium hydroxide for adjustment of pH to pH 5.5. The artificial saliva simulant is described in an EU project (Simoneau et al, 20001 EUR 19826 EN). It consists of calcium chloride, magnesium chloride, potassium carbonate, potassium chloride, potassium phosphate, sodium chloride, and hydrochloric acid for adjustment of pH to pH 6.8. The migration tests were performed at 37°C, which is close to body temperature and is used in DS/EN-71-3, DS/EN ISO 105-E04 and the aforementioned EU report. The simulant was heated before being applied to the products for the migration tests. The samples were placed in a temperature-controlled oven (37+/- 3°C) for the number of hours stated in the analysis programme. Where sample quantity was sufficient, approx. 2.5 g material to 50 ml simulant was used, which is the amount used in DS/EN ISO 105-E04. The samples were cut into as few pieces as possible to maximally simulate use situations. 6.3 Outdoor clothes (jackets and mittens)Outdoor clothing comes under the Good Day arena: Playing outside. The project focussed on outdoor clothes marketed as being waterproof, water resistant, or dirt resistant. 6.3.1 Summary of resultsScreening the exterior part of the textile materials in the products provided evidence for the presence of a large number of organic substances. Some of these organic substances are suspected of being harmful or potential endocrine disruptors. For example, isocyanates (potential allergens) were found in several of the products. Migration studies on artificial saliva showed that only a fraction of the content migrates. In addition to the product textiles, certain labels, straps and a reflector that were made of soft polymer materials and deemed to represent a risk of phthalate content, were selected for analysis for phthalates. Phthalates were found in labels printed with product names on two mittens, in a loose-hanging reflector and in a strap on a jacket zip. To test for impregnating agents containing perfluoride compounds all the products were screened for fluoride. The analysis revealed fluoride in all of them apart from product nos. 1-4. Closer investigation of certain jackets and mittens revealed the content of various perfluoride compounds. It was not possible to perform migration studies on these substances. Formaldehyde was found in the lining of all products. Migration studies of a mitten lining showed that a large proportion of the content migrated to artificial sweat. 6.3.2 Description of product typeJackets and mittens consist of an inner part which can come in contact with the child's skin and an outer part, which the child can suck on. It was therefore deemed to be important that both the outside and inside of the products were tested. Products with straps attached to zips were of interest, as 2-year-olds tend to suck on the strap. The project focussed on outdoor clothes marketed as being waterproof and/or water resistant. To achieve these properties, the clothes can have:
Impregnation compounds can contain fluoride, but silicon compounds can also be used to provide a water resistant effect. The most common fluoride compounds used for this purpose are fluorocarbons, but fluorotelomers can also occur. It is also likely that membranes contain fluoropolymer compounds. Plastic linings can be polyurethane or polyvinylchloride and possible other types of polymers – it cannot be excluded that they can contain fluoride compounds. 6.3.3 Selected productsTable 6.4 and Table 6.4 list the products selected for analysis. The reasons for choosing these products are described in the survey. Table 6.4 Selected products, jackets
Table 6.5 Selected products, mittens
6.3.4 Analyses methodsThe following sections explain the screening methods and quantitative Analysis methods applied. The migration analyses have been carried out as described in Chapter 6.2, and have subsequently been analysed using quantitative analyses. The procedures are described below. 6.3.4.1 X-ray analysisX-ray screening analyses (WEXRF) were performed on the outer material of jacket arms and mittens for elementary substances that could indicate impregnation using poly and perfluorinated compounds (Fluoride) and flame-inhibitors (Sb, Br). 6.3.4.2 GC/MS analysis, extractable organic substancesA GC/MS analysis is used to test for the presence of extractable volatile and semi-volatile organic components. The outer material and other textile parts that are easily accessible to the child were analysed, e.g. zip straps and Velcro tapes. If mittens were made of different materials on the back and palm, both were analysed. A single analysis was performed. The analysis method is described in Table 6.6. Some jackets and mittens have labels, straps and reflectors easily accessible to the child, and made of soft polymer materials deemed to represent a risk of phthalate content. These parts were analysed quantitatively for phthalates. A single analysis was performed due to limited samples. Table 6.6 GC/MS screening of textiles and quantitative determination of phthalates in other materials
6.3.4.3 Spectrophotometer analysis of formaldehyde.Spectrophotometer analysis was used to identify formaldehyde. The analysis was performed according to Japanese law no. 112 (1973). This determines the content of formaldehyde which is not bound. The result is quantitative. Dual analyses were performed on mittens, whereby the analysis was accredited. Single analyses were performed on jackets, whereby the analysis was not accredited. Priority was given to obtaining maximum knowledge of the product's formaldehyde content, as the jacket linings consisted of several different materials, making it relevant to take samples on several places on the product. The analysis method is described in Table 6.7. Table 6.7 Spectrophotometer analysis
Sweat migration was performed according the methods described in Chapter 6.2 Exposure scenarios for a set of bed linen and a mitten. The migration fluid was then analysed as described above, as extraction with water was avoided. A dual analysis was performed. 6.3.4.4 ICP-MS and GC/MS for organotin compoundsThe products were analysed for organotin compounds using migration to artificial sweat. The sweat was then ICP-MS analysed to screen for tin content. In the event of positive findings, GC/MS was performed to identify and quantify the organic tin compounds (mono-, di- and tributyltin. A single analysis was performed. The analysis method is described in Table 6.8. Table 6.8 ICP/MS and GC/MS analyses
6.3.4.5 Quantitative GC/MS analysis for perfluorous compoundsAnalysis performed by Rosanna Bossi, Danmarks Miljøundersøgelser. The analysis method is described in Table 6.9. External standards were used for quantification of the substances found. Quantitative analysis of the perfluorous compounds in the migration fluids was attempted, but it was not possible to optimise the method to achieve satisfactory detection. Table 6.9 Quantitative GC/MS analysis for perfluorous compounds
Table 6.10 List of abbreviations and names for perfluorous compounds
6.3.4.6 GC/MS analysis, migration studies for organic compoundsSaliva migration was performed in accordance with the methods described in Chapter 6.2 of selected jackets and mittens for phthalates, triphenylphosphate, diglycidylbisphenol A and o-toluidine. A dual analysis was performed. The migration fluid was then extracted and analysed as described in Table 6.11. Table 6.11 GC/MS analysis of migration fluids
6.3.4.7 HPLC analyses and migration studies for TDI and MDISaliva migration was performed in accordance with the methods described in Chapter 6.2 Exposure scenarios of selected jackets and mittens for isocyanates 2.4-TDI, 2.6-TDI and MDI. The migration fluid was then extracted and analysed as described in Table 6.12. Table 6.12 HPLC analysis of migration fluids for TDI and MDI
6.3.5 Results of initial analysesThe results of the screening analyses and other preliminary analyses are presented in the sections below. 6.3.5.1 Results of X-ray screening analysesTable 6.13 and Table 6.14 list the results of X-ray screening analysis of the product surfaces. Results are given in % weight. Table 6.13 Results of X-ray screening analyses of jackets, % weight
-: Below the detection threshold Table 6.14 Results of X-ray screening analyses of mittens, % weight
-: Below the detection threshold Fluoride was found in all products except nos. 1-4. Further analyses were therefore performed to establish if the fluoride found came from impregnating agents containing fluorotelomers. The presence of bromide and antimony could indicate that the products were impregnated with flame-retardants. However, the values are so low that they do not support this. 6.3.5.2 Results of GC/MS analysesThe tables below contain the results of the GC/MS analyses Table 6.15 and Table 6.16 present the results for outer materials on jacket arms. The results are from screening analyses and stated in µg/g. The results are semi-quantitative as the substances are estimated according to internal standards. Table 6.15 Results for the GC/MS-analysis of jacket outer material, µg/g Table 6.16 Results for the GC/MS-analysis of jacket outer material, µg/g
-: Below the detection threshold Table 6.17 presents results for other jacket textile parts. The results are semi-quantitative since the substances are estimated according to internal standards. Table 6.17 Results for the GC/MS analysis of other jacket parts, µg/g Table 6.18 presents results of analyses for phthalates in labels and reflectors from jackets. These components are made of soft polymer materials, deemed to represent a risk of phthalate content. Analyses were performed as single analysis and quantitative content analysis. Table 6.18 Results for the GC/MS analysis of jacket labels and reflectors*, µg/g
-: Below the detection threshold < 10 µg/g *: Analyses were run for the following phthalates: DMP, DEP, DIBP, BBP, DOP, DIDeP and DINP, which were not detected. Table 6.19 presents the results for mitten outer material. The results are semi-quantitative since the substances are estimated according to internal standards. Table 6.19 Results for the GC/MS analysis of mitten outer material, µg/g Table 6.20 presents the results of analysis of Velcro fastener on mittens. The results are semi-quantitative since the substances are estimated according to internal standards. Table 6.20 Results for the GC/MS analysis of Velcro fasteners on mittens, µg/g
-: Below the detection threshold <1-10 µg/g Table 6.21 presents the results of analysis for phthalates in mittens. These components are made of soft polymer materials, deemed to represent a risk of phthalate content. Analyses were performed as single analysis and quantitative content analysis. Table 6.21 Results for the GC/MS analysis of mitten labels and reflectors*, µg/g
-: Below the detection threshold < 10 µg/g *: Analyses were run for the following phthalates: DBP, DMP, DEP, DIBP, BBP, DOP and DIDeP, which were not detected. Analyses of jackets and mittens revealed the presence of a large number of organic compounds. Phthalates, triphenylphosphate (a softener), o-toluidine (a primary aromatic amine, carcinogen), and a number of isocyanates were found in the outer material and Velcro fastenings of some of the mittens. Phthalates were found in loose-hanging reflectors and a strap on a jacket zip. Phthalates were also found in labels on the back of mittens made of a non-textile material printed with a product name. 6.3.5.3 Results of analyses for formaldehydeTable 6.22 and Table 6.23 present the results of spectrophotometer analysis for formaldehyde. Results are given in units of µg/g. The results are quantitative (single analysis) and state the content of free formaldehyde in the product. Table 6.22 Results for formaldehyde analysis of jackets, individual analyses, µg/g
-: Below the detection threshold < 2 µg/g * n/r = not relevant. Table 6.23 Results for formaldehyde analysis of mittens, average of dual analyses, µg/g
-: Below the detection threshold < 2 µg/g Formaldehyde was found in jackets and mittens. 6.3.5.4 Results of analyses for organotin compoundsTable 6.24 and Table 6.25 present the results of analyses for organotin compounds. Results are given in units of µg/g. Table 6.24 Results for total tin in jackets, µg/g
Below the detection threshold < o.02 µg/g Table 6.25 Results for total tin in mittens, µg/g
-: Below the detection threshold < o.02 µg/g Tin was found in the outer material of jacket product nos.1-5 and mitten product nos.2-2 and 2-5, which could stem from the content of organotin compounds. GC/MS analysis for organotin subsequently showed that there were no organotin compounds in the 3 products in which tin had been detected. 6.3.6 Quantitative analyses and migration studies6.3.6.1 Selection of products and substancesIn collaboration with the Danish Environmental Protection Agency, a series of products and substances were selected to undergo further examinations based on screening tests. Selection of products was based on high content of the selected substances, and presentation of cheap and expensive products. Table 6.26 Overview of products and substances selected for analysis
*: See list of analysed compounds in Table 6.10. Unfortunately, it was impossible to perform migration with sweat for FTOH due to problems retrieving the substances in the analytic method. 6.3.6.2 Results of quantitative and migration analysesResults of the examinations are shown in the table below. Table 6.27. Results of quantitative and migration analyses for phthalates.
n.a.: Not analysed Table 6.28 Results of quantitative analysis for content of perfluorous compounds
n.d.: Not detected by analysis Table 6.29. Results of quantitative and migration analyses for isocyanates.
n.a.: Not analysed 2.6-TDI, CAS no. 91-08-7 was not shown in any of the tests. Table 6.30 presents the results of migration analyses of other organic substances.
n.a.: Not analysed Table 6.31. Results of quantitative and migration analyses for formaldehyde.
GC/MS analysis for organotin showed that there were no organotin compounds in the 3 products in which tin had been detected. The analyses show that only a small number of the phthalates migrate from the products surveyed under the specified conditions. Formaldehyde, isocyanates, triphenylphosphate, diglycidylbisphenol and o-toluidine did not migrate. All products analysed contained perfluorinated compounds. 6.4 FootwearFootwear comes under the arnea Good Day: Playing outside. The survey focused on rubber boots and rubber clogs. 6.4.1 Summary of resultsIn three of the five rubber clogs a quantifiable phthalate content was detected (product nos. 3-1, 3-3 and 3-4). Migration studies on artificial sweat showed that only a fraction of the phthalate content migrated from the products. Only a few organic substances were found in the rubber boots, and one type of phthalate was found in one of the boots (product no. 4-4). Therefore, no further analyses were performed on these products. 6.4.2 Description of product typeThe rubber clogs selected consist of the same material on the outside and inside. They are expected to be worn with socks, but can be used without resulting in skin contact. Some of the boots consist of the same material on the outside and inside, whilst other products have a thin textile lining on the inside. Children were expected to have most skin contact with the upper edge of the boots analysed. 6.4.3 Selected productsTable 6.32 and Table 6.33 list the products selected for analysis. The reasons for choosing these products are described in the survey. Table 6.32 Selected products, rubber clogs
Table 6.33 Selected products, rubber boots
6.4.4 Analsyis methodsThe following sections describe the screening methods and quantitative analysis methods used. The migration analyses have been carried out as described in Chapter 6.2 and have subsequently been analysed using quantitative analyses. The procedures are described below. 6.4.4.1
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| Sampling | Textile band at top of boot |
| Spectrophotometer | ESEM, EDX |
| Detection threshold | 0.1% |
| Analysis margin of uncertainty | 5%* |
*: Depends on concentration range
A GC/MS analysis is used to test for the presence of extractable organic components. Samples were taken from the top edge of the boots or uppers of the rubber clogs. A single analysis was performed during the initial screening followed by a dual analysis for products selected for quantitative analyses. External standards were applied for calculating quantitative content of selected phthalates.
The analysis method is described in Table 6.35.
Table 6.35 GC/MS method
| Sampling | Rubber boots: Upper edge Rubber clogs: Uppers Sample quantity for extraction: 1.5 g |
| Extraction | Extraction agent: Dichloromethane, 15 ml (boots)/25 ml (clogs). Extraction: Overnight extraction as a minimum, performed at room temperature. Thereafter 1.5 ml of extraction fluid withdrawn, adding 13.5 ml of methanol to precipitate any dissolved polymeric material. |
| Internal standards | Hexachlorobenzene (HCB) and Butylbenzenephthalate (BBP) |
| GC/MS instrument | Varian 3800 GC/MS |
| GC parameters | Column RTX-5sil MS, 30 m x 0.25 mm id., 0.25 µm phase film Carrier gas: Helium, constant flow at 1 ml/min. Oven settings: 80 ºC for 2 min., 20 ºC/min. until 200 ºC, 8 ºC/min. until 320 ºC Injection: 325 ºC, split 20 |
| MS-parameters | Scan mode: 35-650 m/z Solvent delay: 5 min. |
| Detection threshold (estimated) | 100 µg/g |
A 2.5 g sample (cut into as few pieces as possible and with the surface area estimated) was placed in 50 ml of preheated artificial sweat or saliva with BBP as internal standard and left at 37°C for 0.5-7.75 hours. The liquid phase was decanted from the sample pieces and examined using GC/MS, with solid-phase micro-extraction (SPME) of substances migrated to the liquid phase with 7 µm PDMS-fibre after the addition of 25% w/v NaCl.
The results of the screening analyses are given in the sections below.
No fluoride traces over 0.1% were found in the textile edge at the top of product 4.2, thus there is no evidence that this product had been impregnated with an agent containing per- or polyfluorous compounds.
Table 6.36 and Table 6.37 contain the results of the GC/MS screening analysis. Results are given in units of µg/g. The results are semi-quantitative since the substances are estimated according to internal standards.
Table 6.36 Results of the GC/MS analysis of rubber clogs, µg/g
| Product no. | ||||||
| 3-1 | 3-2 | 3-3 | 3-4 | 3-5 | ||
| Substance name | CAS no. | |||||
| Diisobutylphthalate | 84-69-5 | 3000 | - | - | - | - |
| DEHP | 117-81-7 | 50000 | - | - | 800 | - |
| Dibutyl phthalate | 84-74-2 | - | - | 51000 | - | - |
| Unidentifiable aliphatic hydrocarbons | N/A | - | - | + | - | + |
’-’ = Below the detection threshold
'+' = shown to contain the substance
Table 6.37 Results of the GC/MS analysis of rubber boots, µg/g
| Product no. | |||||||
| 4-1 | 4-2 | 4-2, textile edge | 4-3 | 4-4 | 4-5 | ||
| Substance name | CAS no. | ||||||
| 2.4-bis (1-phenylethyl)-phenol | 2769-94-0 | 1500 | - | - | - | - | - |
| Butylisobutyl phthalate | 17851-53-5 | - | - | - | - | 400 | - |
’-’ = Below the detection threshold
Phthalate was detected in three of the five rubber clogs, (product nos. 3-1, 3-3 and 3-4), and in one of the boots (product 4-4).
In collaboration with the Danish Environmental Protection Agency, a series of products and substances have been selected to undergo further examinations based on screening tests.
Table 6.38 Overview of selected products and substances
| Product no. | Description | Components analysed for | Analyses | Reason |
| 3-1 | Rubber clogs | DEHP, DIBP | Quantitative sweat migration: 7,75 hours | Used without socks in the summer. Quantitative analyses and migration analyses performed to compare with results in literature. |
| 3-3 | Rubber clogs | DBP | Quantitative sweat migration: 7,75 hours | See product 3-1 |
Analysis results are shown in Table 6.39.
Table 6.39 Results of quantitative and migration analyses for phthalates
| Substance (CAS no.) | Product type + no. | Screening analysis, ug/g | Quantitative analysis, ug/g | Migration analysis, ug/g | Migration period, hours | Migration fluid |
| DIBP (84-69-5) | 3-1, Clogs | 3000 | 670* (431-901) |
84* (32-136) |
6 | Sweat |
| DBP (84-74-2) | 3-3, Clogs | 51000 | 25603 | 249 | 6 | Sweat |
| DEHP (117-81-7) | 3-1, Clogs | 50000 | 15658 | n.d. | 6 | Sweat |
| 3-3, Clogs | n.d. | 137 | n.d. | 6 | Sweat |
*: Relatively large spread of these results (interval stated in brackets)
i.a.: n.d.: Not detected at analysis
Pacifiers come under the arena Good Night: Bed
2.4-bis (1-phenylethyl)phenol was found in the teat of one product, no. 5-3. Siloxane compounds were found in products 5-4 and 5-5, made of silicon rubber.
The coverage of all the pacifiers analysed were made of polycarbonate; they all contained bisphenol A. Phthalates were found in the coverage of product no. 5-1 and 5-3. Migration studies showed that the substances did not migrate to artificial sweat or saliva.
2-mercaptobenzothiazole was not found in the teat of the pacifiers analysed.
A pacifier comprises a teat and a coverage of various shapes and combinations. The coverage can also bear printed decorations. The teat was analysed, along with a pooled sample of coverages.
Table 6.40 displays those products selected for analysis. The reason for choosing these products is described in the survey.
Table 6.40 Selected products
| Product no. | Description | Information stated on the packaging or product (direct transcript) |
| 5-1 | Pacifier with red coverage, white knob, blank handle. Drawing of a golden crown on the white knob. Anatomic, 3-36 mths (2) | Non-allergen pacifier. Anatomic |
| 5-2 | Pacifier with blank handle. Blue line drawing of two yellow teddies. Anatomic natural rubber. | Natural rubber pacifier, shatterproof polycarbonate coverage. |
| 5-3 | Blue pacifier, round coverage. Shiny blue with silver hue. Natural rubber (latex), round vent hole, 6 mths.+ | Polycarbonate coverage and ring: Teat made of natural rubber. |
| 5-4 | White pacifier with own name (MST 2-year-olds) engraved | Teat: Natural rubber (latex/silicon). Coverage and ring: Polycarbonate |
| 5-5 | 2 pacifiers with clear pink open coverage. Pink knob on one, white on the other. No ring. Ultra soft silicon. Air anatomic, extra skin-friendly (4m+) |
Anatomic. Extra skin-friendly |
The following sections describe the screening methods and quantitative analysis methods used. The migration analyses have been carried out as described in Chapter 6.2 and have subsequently been analysed using quantitative analyses. The procedures are described below.
In the case of products 5-1 and 5-5, the material composition was not stated on the product nor on the accompanying packaging. Thus, a FTIR analysis has been performed in order to determine the type of material.
A GC/MS analysis is used to test for the presence of extractable organic components. All pacifiers were scalded with boiling water before analysis as agreed with DEPA, and as instructed on their user instructions (scalding or boiling). A sample was taken from the teat, along with a pooled sample of coverages. A single analysis was performed.
The analysis method is described in Table 6.41.
Table 6.41 GC/MS-screening
| Sampling | 1) Teat 2) Shield /knob (equal parts of each) Sample quantity: 1.5 g |
| Extraction | Extraction agent: Dichlormethane, 15 ml. Extraction: Overnight extraction as a minimum, performed at room temperature. Thereafter 1.5 ml of extraction fluid withdrawn, and 13.5 ml methanol added to precipitate any dissolved polymeric material. |
| Internal standards | BBP, HCB |
| GC/MS instrument | Varian 3800 GC/MS |
| GC parameters | Column RTX-5sil MS, 30 m x 0.25 mm id., 0.25 µm phase film Carrier gas: Helium, constant flow at 1 ml/min. Oven settings: 80ºC for 2 min., 20ºC/min. until 200ºC, 8ºC/min. until 320ºC Injection: 325ºC, split 20 |
| MS parameters | Scan mode: 35-650 m/z Solvent delay: 5 min. |
| Detection threshold (estimated) | 100 µg/g (DINP 500 µg/g) |
A 2.5 g sample (cut into as few pieces as possible and with the surface area estimated) was placed in 50 ml of preheated artificial sweat or saliva with BBP as internal standard and left at 37°C for 0.5-7.75 hours. The liquid phase was decanted from the sample pieces and examined using GC/MS, with solid-phase micro-extraction (SPME) of substances migrated to the liquid phase with 7 µm PDMS-fibre after the addition of 25% w/v NaCl.
The results of the screening analyses are presented in the sections below.
The FTIR analyses showed that both the pacifier coverages analysed (5-1 and 5-5) were manufactured from polycarbonate.
Table6.42 and Table6.43 present the results of the GC/MS-screening analysis. Results are given in units of µg/g. The results are semi-quantitative as the substances are estimated according to internal standards.
Table 6.42 Results for the GC/MS analysis, teat, µg/g
| Product no. | ||||||
| 5-1 (teat) |
5-2 (teat) |
5-3 (teat) |
5-4 (teat) |
5-5 (teat) | ||
| Substance name | CAS no. | |||||
| 2.4-bis (1-phenylethyl)-phenol | 2769-94-0 | - | - | 4400 | - | - |
| Cyclosiloxane compound (several) | 556-71-8 18772-36-6 |
- | - | - | + | + |
-: Below the detection threshold
+: Shown to contain the substance
2-mercaptobenzothiazole was not found in the teat of the pacifiers analysed.
Table 6.43 Results for the GC/MS analysis, coverage, µg/g
| Product no. | ||||||
| 5-1, (coverage) | 5-2, (coverage) | 5-3, (coverage) | 5-4, (coverage) | 5-5, (coverage) | ||
| Substance name | CAS no. | |||||
| DEHP | 117-81-7 | - | - | 300 | - | - |
| DINP | 28553-12-0 | 500* | - | 1600 | - | - |
| Bisphenol A | 80-05-7 | 1900 | 1700 | 1600 | 1000 | 1000 |
| Tert. Butylphenol | 98-54-4 | 1600 | 1500 | - | 2200 | - |
| 2-(4-(1,1-dimethylethyl)-2-methylphenoxyethanol | 54934-87-1 | 250 | 500 | - | 500 | - |
-: Below the detection threshold
+: Shown to contain the substance *: Result close to the detection threshold.
The coverages of all the pacifiers analysed were made of polycarbonate; they all contained bisphenol A. Phthalates were found in the coverage of two of the products, but in such low concentrations that the phthalates cannot have been added as softeners.
Pacifiers are defined as articles for infants as the product is intended to make it easier for the child to sleep or relax by sucking it. REACH, annex XVII, entry 51 and 52 continued the prohibition to use, import or sell toys and childcare articles containing certain phthalates (including DEHP and DINP) in concentrations above 0.1% expressed per mass of the softened material (equivalent to 1,000 µg/g, i.e. 1,000 ppm). This means that the DINP content in the coverage of pacifier 5-3 is above this limit. It may be that the coverage is not intended to be put in the mouth, but the pacifier can be turned the wrong way accidentally. The DEPA Chemical Inspection Service has considered the case.
In collaboration with the Danish Environmental Protection Agency, a series of products and substances have been selected to undergo further investigations based on screening tests.
Table 6.44 Overview of selected products and substances
| Product no. | Description | Components analysed for | Analyses | Reason |
| 5-1 | Pacifier, coverage | Bisphenol A, Tert. Butylphenol | Quantitative sweat migration: 7.75 hours Saliva migration: 7.75 hours |
Quantitative analyses and migration analyses performed to compare with results in literature. High contents of bisphenol A and content of phthalates. The child's mouth and hands are in contact. |
| 5-3 | Pacifier, coverage | DEHP, DINP Bisphenol A, Tert. Butylphenol |
Quantitative sweat migration: 7.75 hours Saliva migration: 7.75 hours |
See 5-3. |
Analysis results are shown in Table 6.45. The results of the screening analyses are single determinations. Unless otherwise specified, the results of the quantitative and migration analyses are averages of dual analyses.
Table 6.45 Results for quantitative and migration analyses for bisphenol A and tert. butylphenol
| Substance (CAS no.) | Product type + no. | Screening analysis, ug/g | Quantitative analysis, ug/g | Migration analysis, ug/g | Migration period, hours | Migration fluid |
| Bisphenol A (80-05-7). | 5-1, Pacifier (coverage) | 1900 | 106 | n.d. | 7,75 | Sweat |
| n.d. | 7,75 | Saliva | ||||
| 5-3, Pacifier (coverage) | 1600 | 280 | 7* | 7,75 | Sweat | |
| n.d. | 7,75 | Saliva | ||||
| Tert. Butylphenol | 5-1, Pacifier (coverage) | 1600 | 1264 | n.d. | 7,75 | Sweat |
| n.d. | 7,75 | Saliva | ||||
| 5-3, Pacifier (coverage) | 1900 | 1003 | n.d. | 7,75 | Sweat | |
| n.d. | 7,75 | Saliva |
*: Only found in one of the samples.
n.d. Signifies that the substance has not been detected.
Table 6.46 Results of quantitative analyses and migration analyses for phthalates.
| Substance (CAS-no.) | Product type + no. | Screening analysis, ug/g | Quantitative analysis, ug/g | Migration analysis, ug/g | Migration period, hours | Migration fluid |
| DEHP (117-81-7) | 5-1, Pacifier (coverage) | n.d. | n.d. | n.d. | 7,75 | Sweat |
| n.d. | 7,75 | Saliva | ||||
| 5-3, Pacifier (coverage) | 300 | 275 | n.d. | 7,75 | Sweat | |
| n.d. | 7,75 | Saliva | ||||
| DINP (28553-12-0) | 5-3, Pacifier (coverage) | 1600 | 1047 | n.d. | 7,75 | Sweat |
n.d. Signifies that the substance has not been detected.
Despite high quantitative levels of phthalates and bisphenol A, the results show that these substances do not migrate with the use of artificial saliva or sweat for the stated number of hours.
Soap packaging comes under the arena Good Night: Bath.
All the soap packaging analysed was made of PVC and large quantities of phthalates were found in all the products analysed. The phthalates found were DEHP, DINP, DNOP and DEP. Migration studies showed that the some of the phthalates migrated to artificial sweat and saliva, whilst the heavier DINP did not.
All the soap packaging analysed contained DEHP, DINP and/or DNOP exceeding the permitted threshold of 0.1% in accordance with the statutory order on phthalates in toys (BEK 855, 2009). The Danish Safety Technology Authority subsequently determined that these products can be considered toys. Sales of these products were therefore stopped.
The products are shaped as colourful figures. They are soft products and focus was placed on the container, which represents the largest surface of the product. The packaging was rinsed thoroughly with water prior to analysis, but allowance has to be made for the contents of the product, e.g. perfume residue, that could affect the analysis results.
Table 6.47 presents those products selected for analysis. The reason for choosing these products is described in the survey.
Table 6.47 Selected products
| Product no. | Description | Information stated on the packaging or product (direct transcript) |
| 6-1 | Foam bath with lid shaped as a head | Product Ref. 50381. Information about chemicals, including methylparaben, butylparaben and perfume. Plastic code 3 = PVC |
| 6-2 | Small product – fits in your hand. Colour of soap: blue. | Information about chemicals, including methylparaben, ethylparaben, propylparaben and perfume. |
| 6-3 | Small product – fits in your hand. Approximate length: 8 cm. Colour of soap: orange. | Information about chemicals, including methylparaben, ethylparaben, propylparaben and perfume. |
| 6-4 | Small product, max. 12 cm in length Colour of soap: pink. | |
| 6-5 | Small product – fits in your hand. Maximum length: 8 cm. Colour of soap: red. |
The following sections describe the screening methods and quantitative analysis methods used. The migration analyses have been carried out as described in Chapter 6.2 and have subsequently been analysed as quantitative analyses. The procedure is described below.
In cases where the material composition is not stated on the product nor on the accompanying packaging (products 6-2, 6-3, 6-4, 6-5), an FTIR analysis has been performed in order to determine the type of material.
A GC/MS analysis is used to test for the presence of extractable organic components. Samples have been taken from the product packaging (6-1: From the lid/head. From the rest a sample was extracted from the packaging, which includes valves). A single analysis was performed.
The analysis method is described in Table 6.48.
Table 6.48 GC/MS screening
| Sampling | 6-1 (head/lid), with the rest: The entire packaging, including the soap valve. Sample quantity: 1.5 g |
| Extraction | Extraction method: Dichloromethane, 15 ml (product 6-1) - 25 ml (other). Extraction: Overnight extraction as a minimum, performed at room temperature. Thereafter 1.5 ml of extraction fluid withdrawn, and 13.5 ml methanol added to precipitate any dissolved polymeric material. |
| Internal standards | BBP, HCB |
| GC/MS-instrument | Varian 3800 GC/MS |
| GC-parameters | Column RTX-5sil MS, 30 m x 0,25 mm id., 0,25 µm phase film Carrier gas: Helium, constant flow at 1 ml/min. Oven settings: 80 ºC for 2 min., 20 ºC/min. until 200 ºC, 8 ºC/min. until 320 ºC Injection: 325 ºC, split 20 |
| MS-parameters | Scan mode: 35-650 m/z Solvent delay: 5 min. |
| Detection threshold (estimated) | 100 µg/g |
A 2.5 g sample (cut into as few pieces as possible and with the surface area estimated) was placed in 50 ml of preheated artificial sweat or saliva with BBP as internal standard and left at 37 oC for 0.5-7.75 hours. The liquid phase was decanted from the sample pieces and examined using GC/MS, with solid-phase micro-extraction (SPME) of substances migrated to the liquid phase with 7 µm PDMS-fibre after the addition of 25% w/v NaCl.
The results of the screening analyses are given in the sections below.
The FTIR analyses showed that all the examined packagings (6-2, 6-3, 6-4, 6-5) consist of PVC softened with phthalates.
Table 6.49 presents the results of the GC/MS screening analysis Results are given in units of µg/g. The results are semi-quantitative since the substances are estimated according to internal standards.
Table 6.49 Results for the GC/MS analysis of soap packagings, µg/g
| Product no. | ||||||
| 6-1 | 6-2 | 6-3 | 6-4 | 6-5 | ||
| Substance name | CAS no. | |||||
| DEHP | 117-81-7 | - | - | - | 190000 | 200000 |
| DINP | 28553-12-0 | - | - | - | 100000 | 200000 |
| DNOP | 117-84-0 | 120000 | 150000 | 150000 | - | - |
| DEP | 84-66-2 | - | 6000 | 11000 | 300 | 300 |
-: Below the detection threshold
+: Shown to contain the substance
Phthalates were found in all examined soap packagings.
In collaboration with the Danish Environmental Protection Agency, a series of products and substances have been selected to undergo further investigations based on screening tests.
Table 6.50 Overview of selected products and substances
| Product no. | Description | Components being analysed for | Analyses | Reason |
| 6-1 | Soap packaging | DNOP | Quantitative sweat migration: 0.5 hours | The material is stated to be PVC and is hard compared to the other soap packagings, which are soft. Has been selected to test whether migration is different. |
| 6-2 | Soap packaging | DNOP, DEP | Quantitative sweat migration: 0.5 hours Saliva-migration: 0.5 hours |
6-2 and 6-5 contain various phthalates and were therefore both selected. The products are deemed tempting for a child to play with and suck on. |
| 6-5 | Soap packaging | DEHP, DINP, DEP | Quantitative sweat migration: 0.5 hours Saliva-migration: 0.5 hours |
See product 6-2 |
Results of the examinations are shown in the table below. The results of the screening analyses are single determinations. Unless otherwise specified, the results from the quantitative and migration analyses are averages of dual analyses.
Table 6.51 Results of quantitative and migration analyses for phthalates.
| Substance (CAS-no.) | Product type + no. | Screening analysis, ug/g | Quantitative analysis, ug/g | Migration analysis, ug/g | Migration period, hours | Migration fluid | ||
| DEHP (117-81-7) | 6-1, Soap packaging | n.d. | 133 | n.d. | 0.5 | Sweat | ||
| 6-2, Soap packaging | n.d. | 206 | n.d. | 0.5 | Sweat | |||
| n.d. | 0.5 | Saliva | ||||||
| 6-5, Soap packaging | 200000 | 80130 | 2 | 0.5 | Sweat | |||
| n.d. | 0.5 | Saliva | ||||||
| DINP (28553-12-0) | 6-5, Soap packaging | 200000 | 87692 | n.d. | 0.5 | Sweat | ||
| n.d. | 0.5 | Saliva | ||||||
| DNOP (117-84-0) | 6-1, Soap packaging | 120000 | 57740 | n.d. | 0.5 | Sweat | ||
| 6-2, Soap packaging | 150000 | 64595 | n.d. | 0.5 | Sweat | |||
| n.d. | 0.5 | Saliva | ||||||
| DEP (84-66-2) | 6-2, Soap packaging | 6000 | 11357 | 34 | 0.5 | Sweat | ||
| 34 | 0.5 | Saliva | ||||||
| 6-5, Soap packaging | 300 | 1092 | 5 | 0.5 | Sweat | |||
| 7 | 0.5 | Saliva | ||||||
n.d. means that the substance was not detected above the detection threshold.
Despite high quantitative levels in these projects, the results show that only a small amount of the phthalate contents migrates under the specified conditions. Results also show that the higher molecular weight phthalates DINP and DNOP are not detected in the migration fluids.
Non-slip figures and mats for bathtubs belong to the arena “Go´nat”: Bath.
The phthalates DEHP and DINP were detected in three of the products. Migration studies show that DEHP migrates to artificial sweat while DINP is not detected.
Non-slip figures and mats often consist of a smooth or structured surface and an underside with suction capabilities. When the child is sitting on the product, the greatest exposure will be from the top surface. However, when the child plays with the product, it may come into contact with both sides. Both sides of the product have been examined (at the edge).
Table 6.52 presents those products selected for analysis. The reason for choosing these products is described in the survey.
Table 6.52 Selected products
| Product no. | Description | Information stated on the packaging or product (direct transcript) |
| 7-1 | White mat with print | PVC |
| 7-2 | Toy figures | 100% TPE |
| 7-3 | Toy figures in various colours | PVC-free |
| 7-4 | Bright green shower mat | PVC |
| 7-5 | White mat |
The following sections describe the screening methods and quantitative snalysis methods used. The migration analyses have been carried out as described in Chapter 6.2 and have subsequently been analysed using quantitative analyses. The procedures are described below.
In case of products 7-3 and 7-5, the material composition was not stated on the product nor on the accompanying packaging. Thus, an FTIR analysis has been made in order to determine the type of material.
GC/MS is used to examine for organic components. Samples have been extracted from the edge of the mats. Product 7-3 consists of figures of various colours and a sample has been analysed from all three colours. A single analysis was performed.
The analysis method is described in Table 6.53.
Table 6.53 GC/MS-screening
| Sampling | At the edge of the mats. In product 7-3 equal amounts have been sampled (weight wise) from each of the 3 colours. Sample quantity: 1.5 g |
| Extraction | Extraction method: Dichloromethane, 20 ml (product 7-1) - 15 ml (other). Extraction: Overnight extraction as a minimum, performed at room temperature. Thereafter 1.5 ml of extraction fluid withdrawn, and 13.5 ml methanol added to precipitate any dissolved polymeric material. |
| Internal standards | BBP, HCB |
| GC/MS-instrument | Varian 3800 GC/MS |
| GC-parameters | Column RTX-5sil MS, 30 m x 0,25 mm id., 0,25 µm phase film Carrier gas: Helium, constant flow at 1 ml/min. Oven settings: 80 ºC for 2 min., 20 ºC/min. until 200 ºC, 8 ºC/min. until 320 ºC Injection: 325 ºC, split 20 |
| MS-parameters | Scan mode: 35-650 m/z Solvent delay: 5 min. |
| Detection threshold (estimated) | 100 µg/g |
A 2.5 g sample (cut into as few pieces as possible and with the surface area estimated) was placed in 50 ml of preheated artificial sweat or saliva with BBP as internal standard and left at 37 oC for 0.5-7.75 hours. The liquid phase was decanted from the sample pieces and examined using GC/MS, with solid-phase micro-extraction (SPME) of substances migrated to the liquid phase with 7 µm PDMS-fibre after the addition of 25% w/v NaCl.
The results of the screening analyses are given in the sections below.
Products 7-3 and 7-5 were analysed using FTIR. The analyses have shown that both products are made from poly(ethylene-propylene).
Table 6.54 contains the results of the GC/MS screening analysis Results are given in units of µg/g. The results are semi-quantitative as the substances are estimated according to internal standards.
Table 6.54 Results for the GC/MS analysis, µg/g
| Product no. | ||||||
| 7-1 | 7-2 | 7-3 | 7-4 | 7-5 | ||
| Substance name | CAS-no. | |||||
| DEHP | 117-81-7 | 220000 | - | - | - | - |
| DINP | 28553-12-0 | - | - | - | Large quantities* | - |
| Tributyl Acetylcitrate | 77-90-7 | 10000 | - | - | - | - |
| Phthalic acid, diisooctyl ester | 1330-91-2 | 3100 | - | - | - | - |
| Phthalic acid, 2-methylpropylbutyl ester | 17851-53-5 | - | - | 14000 | - | - |
| Butyl octyl phthalate | 84-78-6 | 200 | ||||
| Non-identifiable hydrocarbons | + | + | + | |||
-: Below the detection threshold +: Shown to contain the substance
*: Dilution necessary for a usable result
In collaboration with the Environmental Protection Agency, a series of products and substances have been selected to undergo further investigations based on screening tests.
Table 6.55 Overview of selected products and substances
| Product no. | Description | Components analysed for | Analyses | Reason |
| 7-1 | Shower mat | DEHP | Quantitative sweat migration: 0.5 hours | The child sits on the mat |
| 7-4 | Shower mat | DINP | Quantitative sweat migration: 0.5 hours | The child sits on the mat |
Analysis results are shown in Table 6.56 .
Table 6.56 Results of quantitative and migration analyses for phthalates
| Substance (CAS no.) | Product type + no. | Screening analysis, ug/g | Quantitative analysis, ug/g | Migration analysis, ug/g | Migration period, hours | Migration fluid |
| DEHP (117-81-7) | 7-1, Shower mat | 220000 | 128625 | 25 | 0.5 | Sweat |
| DINP (28553-12-0) | 7-4, Shower mat | 800000 | 146330 | n.d. | 0.5 | Sweat |
n.d.: Not detected
Despite large quantities in these products, results show that only a fraction of the contents of the DEHP phthalate migrates and that the higher molecular weight phthalate DINP is not detected in the migration fluids.
Soft toys come under the arena Good Night: The bed
Two of the soft toys are designed for heating and they release several fragrances consistent with the constituents of lavender oil, both before and after heating. No fragrances were found in the remaining three products.
No trace of formaldehyde was found during analysis of the selected soft toys.
A soft toy may consist of many parts. For example, the fur, the eyes and the nose may be made from different materials such as textiles and polymers, and it may be equipped with a bowtie or be clothed. It was decided to pool the various materials used in the soft toys. Two of the selected soft toys are designed to be heated in the microwave and both these soft toys give off a lavender scent.
Table 6.57 presents those products selected for analysis. The reason for choosing these products is described in the survey.
Table 6.57 Selected products
| Product no. | Description | Information stated on the packaging or product (direct transcript) |
| 8-1 | Soft toy with scent. | Microwavable. Gentle relaxing aroma. Washable outer cover. Toy standard EN71 approved*. CE-marked |
| 8-2 | Small soft toy, approx. 40 cm in length. | Machine washable at 30 degrees C. Produced in China CE-marked |
| 8-3 | Soft toy | 100% polyester both filling and external material. CE-marked |
| 8-4 | Soft toy in a cow outfit. | 100% polyester - both filling and external material. CE-marked |
| 8-5 | Soft toy with scent. | Microwave for two minutes max. Microwave Heating Times: 600-700 watts 150 seconds 800-1000 watts 120 seconds Complies with BS EN71-1/2/3 and ASTM-F963 safety standards. CE-marked |
* The information is misleading since it is not made clear exactly which of the standards the product is analysed against.
The following sections describe the screening methods and quantitative analyses used. Examination of exposure through inhalation is also conducted.
GC/MS is used to examine for organic components. Samples have been extracted from the surface of the soft toys (equal weight samples of each type of fabric on the soft toys). A single analysis was performed.
The analysis method is described in Table 6.58.
Table 6.58 GC/MS screening
| Sampling | In total 1.5 g, equal amounts of each fabric on the soft toys |
| Extraction | Extraction agent: Dichloromethane 15 ml. Extraction: Overnight extraction as a minimum, performed at room temperature. Thereafter 1.5 ml of extraction fluid withdrawn, and 13.5 ml methanol added to precipitate any dissolved polymeric material. |
| Internal standards | BBP, HCB |
| GC/MS instrument | Varian 3800 GC/MS |
| GC parameters | Column RTX-5sil MS, 30 m x 0.25 mm id., 0.25 µm phase film Carrier gas: Helium, constant flow at 1 ml/min. Oven settings: 80 ºC for 2 min., 20 ºC/min. until 200 ºC, 8 ºC/min. until 320 ºC Injection: 325 ºC, split 20 |
| MS parameters | Scan mode: 35-650 m/z Solvent delay: 5 min. |
| Detection threshold (estimated) | 100 µg/g |
A GC/MS-headspace analysis is used to test for the presence of volatile organic components. The soft toys (the entire soft toy) are placed in a closed chamber (in an exsiccator) and volatile substances are then collected using Radiello-tubes (white diffusive body + cartridge code 130) for 16 hours with and without prior heating of the scented bears in the microwave (8-1 and 8-5 respectively). Microwave heating has been conducted according to the instructions on the soft toys, meaning that soft toy 8-1 (just the inside bag) was heated at 650 watts for 45 seconds. Soft toy 8-5 (the entire bear) was heated at 650 watts for 150 seconds. A single analysis was performed.
The analysis method is described in Table 6.59.
Table 6.59 GC/MS-screening
| GC/MS instrument | Varian 3800 GC/MS |
| GC parameters | Column RTX-5sil MS, 30 m x 0.25 mm id., 0.25 µm phase film Carrier gas: Helium, constant flow at 1 ml/min. Oven settings: 40 ºC for 5 min., 5 ºC/min. until 80 ºC, 20 ºC/min. until 250 ºC Injection: 250 ºC, split 30 |
| MS parameters | Scan mode: 35-650 m/z Solvent delay: 2 min. |
| Detection threshold (estimated) | 1 µg absolute |
Spectrophotometric analysis was used to identify formaldehyde. The analysis was performed according to Japanese law no. 112 (1973). This determines the content of formaldehyde that is not bound. The result is quantitative and a single analysis was performed from two different places on each soft toy, for instance including ribbons. The analysis method is described in Table 6.60.
Table 6.60 Spectrophotometer analysis
| Sampling | 2.5 g |
| Extraction | Japanese law no. 112 (1973) Extracted at 40°C using 100 ml water in 1 hour. Filtered, with acetyl acetone reagent added and incubated for 30 minutes in a water bath at 40°C. |
| Spectrophotometer | Absorption maximum 412-415 nm |
| Detection threshold | 2 µg/g |
The results of the screening analyses are presented in the sections below.
Table 6.61 contains the results of the GC/MS-screening analysis. Results are given in units of µg/g. The results are semi-quantitative since the substances are estimated according to internal standards.
Table 6.61 Results for the GC/MS-analysis, µg/g
| Product no. | ||||||
| 8-1 | 8-2 | 8-3 | 8-4 | 8-5 | ||
| Substance name | CAS no. | |||||
| 1,2-Benzenedicarboxylic acid, 2-methylpropylbutyl ester, |
17851-53-5 | - | 1600 | - | 160 | - |
| Dibutyl phthalate | 84-74-2 | - | - | - | 130 | - |
-: Below the detection threshold
Very few organic substances were detected during analysis of the soft toys.
Tabel 6.62 contains the results of the GC/MS-screening analysis. The collected substances are comparable to substances found in lavender oil. The results for the total amount of lavender oil are given in
Tabel 6.62. The results are semi-quantitative since the substances are estimated according to internal standards. Tablel 6.63 presents the substances identified using the GC/MS NIST database, but the identification is rather uncertain due to the complex composition of structurally similar compounds found in lavender oil.
Tabel 6.62 Results for GC/MS analysis, ug absolute over 16 hours
| Product no. | ||||||||
| 8-1 | 8-1* | 8-2 | 8-3 | 8-4 | 8-5 | 8-5* | ||
| Collected/degassed total amount | ug | 70 | 4800 | - | - | - | 100 | 11000 |
*: Heated in microwave as instructed on the product
-: Not detected in the product
Tablel 6.63 Resultatd for GC/MS analysis, identified substances at headspace analysis, µg absolute over 16 hours
| Product no. | ||||||||
| 8-1 | 8-1** | 8-2 | 8-3 | 8-4 | 8-5 | 8-5** | ||
| Substance name | CAS no. | |||||||
| Linalool | 78-70-6 | 15 | 650 | - | - | - | 17 | 1580 |
| Linalool acetate | 115-95-7 | 16 | 800 | - | - | - | 15 | 1460 |
| Camphene | 79-92-5 | - | 22 | - | - | - | - | 79 |
| Eucalyptol | 470-82-6 | 24 | 2400 | - | - | - | 48 | 6430 |
| Camphor | 76-22-2 | 8 | 370 | - | - | - | 11 | 630 |
| Linalyl oxide | 5989-33-3 | + | 260 | - | - | - | + | 830 |
| a-Cumylalcohol | 617-94-7 | + | + | - | - | - | + | + |
| Camphol | 507-70-0 | + | + | - | - | - | + | + |
| ß-pinene | 127-91-32 | - | 31 | - | - | - | - | 120 |
| m-cymol | 535-77-3 | - | + | - | - | - | - | + |
| Limonene | 138-86-3 | - | + | - | - | - | - | - |
| Terpineol | 7299-41-4 | - | + | - | - | - | - | + |
| 4-terpineol | 562-74-3 | - | + | - | - | - | - | + |
| Bornyl acetate or isobornylacetate |
76-49-3 125-12-2 |
- | 100 | - | - | - | - | 170 |
| Limonene oxide | 1195-92-2 | - | + | - | - | - | - | + |
| a-pinene | 7785-70-8 | - | + | - | - | - | - | + |
**: Heated in microwave as instructed on the product
+: Detected in the product - : Not detected in the product
Two of the soft toys are designed for heating and these give off several fragrances, both before and after heating. No fragrances were found in the remaining three products.
Stuffing, bows, laces and pouch (depending on product) were analysed for formaldehyde, which was not detected above the detection threshold of 2 µg/g.
Headspace analyses were performed, which correspond to exposure through inhalation. The results can be found in section 6.8.5.2.
It was decided not to select more products and fabrics for further analysis in this product category.
The diapers come under the arena Go´morgen: Clothing, but may come under all arenas if the 2-year-old child wears them for 24 hours a day.
Screening analyses have been performed on the extractable organic compounds in various parts of the diapers. The analyses showed that most of the organic substances found are aliphatic hydrocarbons and polymers which could not be identified using the applied method.
Five of the organic compounds appear in all the products. These are all additives (antioxidants) which may have been used in the production of the polymers that comprise the diapers.
Limonene, which is a perfume substance, was detected in three of the products.
The analysis showed that three of the analysed diapers contained low levels of formaldehyde. However, these levels were so low that they were close to the detection threshold of this method.
No organotin compounds or rosin were detected in the diapers.
A diaper consists of many parts in close contact with the child’s skin. The filling material which provides suction capability is a large component of the product. The diapers’ upper edge and leg edges are also in close contact with the skin and may be made from a different material than the rest of the diaper in order to give a good fit. On selected diapers there is a strip of adhesive for fitting the diaper. This is not in direct contact with the skin. The screening methods below clarify which parts of the diapers have been analysed.
Table 6.64 presents those products selected for analysis. The reason for choosing these products is described in the survey.
Table 6.64 Selected products
| Product no. | Description | Information stated on the packaging or product (direct transcript) |
| 9-1 | Diaper with stretch closure. Print on the front side of diaper. Junior/5 11-25. kg | - Latex free. Contains no lotion or perfume - Contains: Cellulose, bleached without chlorine, polypropylene, polyethylene, polyurethane, synthetic rubber. |
| 9-2 | Trouser diaper, print on the front side of diaper. 13.20 kg | - Anti leak technology - All-round soft fit |
| 9-3 | Diaper with stretch closure. Print on the front and back sides of the diaper. Junior 11-25. kg |
- Non-stop fit - Stretch & Hold - Contains: Petrolatum, stearyl alcohol, paraffinum liquidum, aloe barbadensis extract. |
| 9-4 | Diaper with stretch closure. Print on the front side of diaper. Junior 12-22. kg |
- Perfume and lotion free |
| 9-5 | Diaper with stretch closure. Print on the front side of diaper. |
- 100% free of chlorine - Contains over 50% “renewable resources”. - Compostable packaging. - Dermatologically and clinically tested - Breathable foil 100% biodegradable |
In the following sections, the applied screening methods are explained.
A GC/MS analysis is used to test for the presence of extractable volatile and semi-volatile organic components. Samples have been extracted from the filling material, the elastic/rim around the legs, the waistband and, if present, frontal prints and adhesive strips. A single analysis was performed.
The analysis method is described in Table 6.65.
Table 6.65 GC/MS-screening
| Sampling | Samples were collected from 4-5 different places on the diapers. The samples have been analysed individually. |
| Extraction | Extraction agent: Dichloromethane and acetone (3:1), 20-40 ml. Extraction: 60 min. in ultrasound followed by 60 min. of mechanical shaking |
| Internal standards | DEHP-d4, Pyrene-d10, Naphthalene-d8. |
| GC/MS instrument | Agilent GC/MS |
| GC parameters | Column Phenomenex ZB-5 MS, 30 m x 0.5 mm id., 0.25 µm phase film Carrier gas: Helium, constant flow at 1.9 ml/min. Oven settings: 40 ºC for 0.5 min., 20 ºC/min. to 320 ºC for 15 mins. Injection: 280 ºC, splitless |
| MS parameters | Scan mode: 29-550 m/z Solvent delay: 3 min. |
| Detection threshold | 1 µg/g |
5 ml of the extract from the GC/MS analysis was reduced to dryness after which 2 ml of BF3 in methanol was added. See Table 6.65 After heating, the sample was cooled and water plus hexane were added. The hexane phase was analysed using GC/MS using the same method as that for screening. Two samples were taken from each diaper, one from the filling and one from the inside lining. The detection threshold is estimated to be 1-2 µg/g.
A spectrophotometric analysis was employed for the identification of formaldehyde. The analysis was performed according to Japanese law no. 112 (1973). This determines the content of formaldehyde that is not fixed. The result is quantitative and a single analysis was performed. The analysis method is described in Table 6.66.
Table 6.66 Spectrophotometer analysis
| Sampling | 2.5 g |
| Extraction | Japanese law no. 112 (1973) Extracted at 40 °C using 100 ml water in 1 hour. Filter, add acetylacetone reagent and leave for 30 minutes in a water bath at 40 °C. |
| Spectrophotometer | Absorption maximum 412-415 nm |
| Detection threshold | 2 µg/g |
The products were analysed for organotin compounds using migration to artificial sweat. The sweat was then ICP-MS analysed to screen for tin content. A positive finding meant that a GC/MS analysis was performed to identify and quantify the organotin compounds. A single analysis was performed.
The analysis method is described in table 6.67.
Table 6.67 ICP/MS-analysis
| Sampling | 2.5 g of filling material and elastic rim around legs |
| Extraction | Extraction agent: Artificial sweat at 40 ºC and concentrated nitric acid 0.14 M added. Extraction volume: 100 ml for padding and 50 ml interfacing/elastic |
| ICP-MS equipment | ion 118 and 120 |
| Internal standard | Rh |
| Detection threshold | 0.03 µg/g for filling material and02 µg/g for elastic rim |
The results of the screening analyses are given in the sections below.
Several different parts of the diapers were analysed. Filling material, elastic leg rims, stretch closures, inner lining and imprints were all analysed.
GC/MS-analyses showed that most of the organic substances found are aliphatic hydrocarbons and polymers which could not be identified using the applied method.
Analysing the filling material of the diapers revealed no other organic substances in addition to those mentioned - except for Irganox 245 (an additive - antioxidant) found in product no. 9-2, see Table 6.68. The result is given in units of µg/g. The result is semi-quantitative since the substance is estimated according to an internal standard.
Table 6.68 Results for GC/MS-Analysis, filling material in diapers, µg/g
| Substance name | CAS no. | Product no. | ||||
| 9-1 | 9-2 | 9-3 | 9-4 | 9-5 | ||
| Irganox 245 | 36443-68-2 | - | 160 | - | - | - |
-: Below the detection threshold
Table 6.69 contains an overview of the organic substances found in other parts of the diaper. The organic substances are not from the filling material, but from the waistband, the elastic, the stretch closures, the inner lining and the frontal print.
Table 6.69 Results of screening for extractable organic substances
| Name | CAS no. | Product no. | ||||
| 9-1 | 9-2 | 9-3 | 9-4 | 9-5 | ||
| Limonene | 138-86-3 | + | + | + | ||
| 3.6-Dimethyl-1.4-dioxan-2.5-dione | 95-96-5 | + | ||||
| Caprolactam | 105-60-2 | + | + | |||
| 2.4-bis (1,1-dimethylethyl)-phenol | 96-76-4 | + | + | + | + | + |
| Butylhydroxytoluene (BHT) | 128-37-0 | + | + | + | + | + |
| 1-Octadecanol | 112-92-5 | + | ||||
| Unknown ester | N/A | + | ||||
| 2-methylpropyl hexadecanoic acid ester | 110-34-9 | + | ||||
| 2-methylpropyl octadecanoic acid ester | 646-13-9 | + | + | |||
| Octadecyl oleate | 17673-49-3 | + | ||||
| 13-Docosenamide | 112-84-5 | + | ||||
| Naugard 524 /Irgafos 168 | 31570-04-4 | + | + | + | + | + |
| Unknown phthalate with large alkyl groups | N/A | + | ||||
| Oxidated Irgafos 168 (phosphite to phosphate) | N/A | + | + | + | + | + |
| Irganox 1076 | 2082-79-3 | + | + | + | + | + |
+: Detected in the product N/A: Not available
The results of the GC/MS analyses are presented below, grouped by the part of the diaper that was analysed. Results are given in units of µg/g. The results are semi-quantitative as the substances were calculated using internal standards for hydrocarbons C10-C24.
Tabel 6.70 Results for the GC/MS-analysis, inner waist lining, µg/g
| Name | CAS no. | Product no. | ||||
| 9-1 | 9-2 | 9-3 | 9-4 | 9-5 | ||
| Limonene | 138-86-3 | - | - | - | - | 33 |
| 3.6-Dimethyl-1.4-dioxan-2.5-dion | 95-96-5 | - | - | - | - | 220 |
| Butylhydroxytoluene (BHT) | 128-37-0 | 18 | 7 | 8 | - | 10 |
| Naugard 524 /Irgafos 168 | 31570-04-4 | 430 | 890 | 550 | 380 | 220 |
| Unknown phthalate with large alkyl groups | N/A | - | - | - | - | 100 |
| Oxidated Irgafos 168 (phosphite to phosphate) | N/A | 98 | 61 | 67 | 180 | 41 |
| Irganox 1076 | 2082-79-3 | 92 | - | 55 | 50 | - |
-: Below the detection threshold N/A: Not available
Table 6.71 Results for the GC/MS-analysis, elastic rim*, µg/g
| Name | CAS no. | Product no. | ||||
| 9-1 | 9-2 | 9-3 | 9-4 | 9-5 | ||
| Limonene | 138-86-3 | - | - | - | - | 140 |
| 3.6-dimethyl-1.4-dioxane-2.5-dione | 95-96-5 | - | - | - | - | 160 |
| 2.4-bis (1,1-dimethylethyl)-phenol | 96-76-4 | 14 | 14 | 8 | 7 | 6 |
| Butylhydroxytoluene (BHT) | 128-37-0 | 100 | 9 | 11 | 8 | 8 |
| 1-Octadecanol | 112-92-5 | - | - | 4800 | - | - |
| Naugard 524 /Irgafos 168 | 31570-04-4 | 480 | 1200 | 550 | 560 | 260 |
| Unknown phthalate with large alkyl groups | N/A | - | - | - | - | 170 |
| Oxidated Irgafos 168 (phosphite to phosphate) | N/A | 200 | 180 | 240 | 150 | 130 |
| Irganox 1076 | 2082-79-3 | 180 | - | 280 | 76 | - |
-: Below the detection threshold N/A: Not available
*: The sample was extracted near the legs in products 9-1, 9-3, 9-4 and 9-5. The sample from product no. 9-2 was extracted at the inner lining, since it is a trouser diaper with elastic bands both around the waist and legs.
Table 6.72 Results for the GC/MS-analysis, stretch closures*, µg/g
| Name | CAS no. | Product no. | |||
| 9-1 | 9-3 | 9-4 | 9-5 | ||
| Limonene | 138-86-3 | - | 42 | 60 | 210 |
| 2.4-bis (1,1-dimethylethyl)-phenol | 96-76-4 | 19 | 11 | 10 | 25 |
| Butylhydroxytoluene (BHT) | 128-37-0 | 29 | 9 | 10 | 41 |
| 13-Docosenamide | 112-84-5 | - | - | 82 | - |
| Naugard 524 /Irgafos 168 | 31570-04-4 | 1000 | 300 | 210 | 830 |
| Oxidated Irgafos 168 (phosphite to phosphate) | N/A | 180 | - | 89 | 100 |
| Irganox 1076 | 2082-79-3 | - | 500 | 480 | 62 |
-: Below the detection threshold N/A: Not available Product 9-2 is a trouser diaper which means that there are no stretch closures to analyse.
Table 6.73 Results for the GC/MS-analysis, frontal print, µg/g
| Name | CAS no. | Product no. | ||||
| 9-1 | 9-2 | 9-3 | 9-4 | 9-5 | ||
| Limonene | 138-86-3 | - | - | - | 41 | 92 |
| Caprolactam | 105-60-2 | - | - | - | 610 | 240 |
| 2.4-bis (1,1-dimethylethyl)-phenol | 96-76-4 | - | 8 | 8 | 7 | - |
| Butylhydroxytoluene (BHT) | 128-37-0 | 25 | 7 | 10 | 6 | - |
| Unknown ester | N/A | - | - | - | 1200 | |
| 2-methylpropyl hexadecanoic acid ester | 110-34-9 | - | - | - | 210 | - |
| 2-methylpropyl octadecanoic acid ester | 646-13-9 | - | - | - | 560 | 1200 |
| Octadecyl oleate | 17673-49-3 | - | - | - | 210 | - |
| Naugard 524 /Irgafos 168 | 31570-04-4 | 130 | 960 | 430 | - | 390 |
| Oxidated Irgafos 168 (phosphite to phosphate) | N/A | 81 | 160 | 140 | - | - |
| Irganox 1076 | 2082-79-3 | 110 | 150 | - | - | |
-: Below the detection threshold N/A: Not available
Five of the organic substances such as Irgafos 168 and BHT are present in all products. These substances are additives (antioxidants) which may have been used in the production of the polymers that are used in the diapers.
In three of the products the fragrance limonene was detected, although not in the filling material used for most of the diaper.
An analysis was performed for rosin, which is sometimes used as an adhesive in paper products. No rosin was detected above the 2 µg/g detection threshold in the filling material of the diaper or in the waistband.
Table 6.74 presents the results of the spectrophotometric analysis for formaldehyde. Results are given in units of µg/g. The results are quantitative (single analysis) and state the content of free formaldehyde in the product. It was not possible to finish the analysis for the filling material in the diapers.
Tabel 6.74 Results for spectrophotometric analyses, formaldehyde, µg/g
| Product no. | |||||
| 9-1 | 9-2 | 9-3 | 9-4 | 9-5 | |
| Outer lining with print and inner lining | 4 | - | - | 4 | 2 |
| Top rim, tape, flaps and elastic waistband | - | n/r. | - | - | - |
| Top rim by stomach and elastic rim by legs (inside) | - | n/r. | - | - | - |
| Elastic rim by stomach and legs | n/r. | - | n/r. | n/r. | n/r. |
-: Below the detection threshold < 2 µg/g. n/r: Not relevant. Depending on whether it is a trouser diaper.
The diaper analyses showed that three diapers contained low levels of formaldehyde. However, these levels were so low they were close to the detection threshold of this method.
The diapers were analysed for organotin compunds by screening for tin. No tin was detected above the detection threshold (0.02-0.03 µg/g) in the diaper’s filling material, nor in the elastic bands near the legs.
In collaboration with the Danish Environmental Protection Agency, it was decided not to select any more products and fabrics for further analysis in this product category.
Bed linen comes under the arena Good Night: The bed
A large number of organic compounds have been detected in the examined bed linens; some will disappear after washing while others will remain detectable.
A number of substances suspected to be a health risk were detected in products no. 12-3 and 12-4, and which are subject to the requirements in the Eco-Tex Standard 100, such as dichlorobenzene, o-toluidine, aniline and dichloroanilines. The highest concentrations of organic substances were found in product no. 12-4.
At analysis of the bed linen, formaldehyde was detected in 3 types of bed linen. Contents decrease after washing. Product no. 12-4 has the highest detected levels both before and after washing.
One set of bed linen consists of a main pillowcase and a duvet cover. In this product, the sole focus has been on the duvet cover. All of the selected products are patterned, and the analyses have attempted to sample from as many of the colours as possible.
Table 6.75 presents those products selected for analysis. The reason for choosing these products is described in the survey.
Table 6.75 Selected products
| Product no. | Description | Information stated on the packaging or product (direct transcript) |
| 12-1 | Printed teal stripes, floral vine and picture of a prince on a white fabric | - 2 piece bed linen - Duvet case: 70x100 cm - Pillow case: 40x45 cm - Material. 100% cotton Washed at 60 °C |
| 12-2 | Lots of colours, dominant ones being red and black | - 100% cotton - 100x140 cm duvet case, 40x45 cm pillow case Washed at 60 °C |
| 12-3 | Large and small numbers of various colours printed on white material | Bed sheet: 140x240 cm Duvet case: 150x200 cm Pillow case: 50x60 cm Material: 100% cotton Shrinkage 4% Washed at 60 °C |
| 12-4 | Red print on orange fabric | Style: 82-007 Colour: 05 Size: Junior |
| 12-5 | Bright gray-ish green and red/orange brown symmetrical pattern printed on white fabric | Material: 100% organic cotton, certified according to international SKAL-standards. GOTS-certified. Eco-sustainable licensed textiles. Eco-tex colour standards. PVC and phthalate free packaging Washed at 60 °C |
All bed linens were analysed both before and after washing. Each set of bed linen was washed separately according to the instructions provided on the packing material or on the product, 60°C or 30°C, respectively. A standard washing procedure was performed in a washing machine of the brand Wascator, using a standard ECE-detergent without added perborate. No bulking agent was used and thus no standard wash fabric filling. “Blind-sample” washing was performed at 60°C, in which a 1 m cotton standardized fabric of full width (zig-zag cut at the ends) was washed by itself with ECE detergent. Both the blinded sample and the bed linen were then hung-dried.
The following sections explain the screening methods and quantitative analysis methods used. The migration analyses have been carried out as described in Chapter 6.2 and have subsequently been analysed as quantitative analyses. The procedures are described below.
A GC/MS analysis is used to test for the presence of extractable volatile and semi-volatile organic components. Sampling of the bed linen was conducted in such a way that as many colours as possible were represented in the samples.
The analysis method is described in Table 6.76.
Table 6.76 GC/MS-screening
| Sampling | Between 1.0 – 1.3 grams extracted before and after washing |
| Extraction method | ASE with acetone Dichloromethane was added to selected samples due to unsolved substances |
| Internal standards | Pyrene-d10 |
| GC/MS instrument | Agilent GC/MS |
| GC parameters | Column Phenomenex ZB-5 MS, 30 m x 0.5 mm id., 0.25 µm phase film Carrier gas: Helium, constant flow at 1.9 ml/min. Oven settings: 40 ºC for 0.5 min., 20 ºC/min. to 320 ºC for 15 mins. Injection: 280 ºC, splitless |
| MS parameters | Scan mode: 29-550 m/z Solvent delay: 3 min. |
| Detection threshold | 10 µg/g |
Spectrophotometric analysis was used to identify formaldehyde. The analysis was performed according to Japanese law no. 112 (1973) – this is an accredited method. This determines the content of formaldehyde, which is not fixed. The result is quantitative and dual analyses were performed. The analysis method is described in Table 6.77.
Table 6.77 Spectrophotometer analysis
| Sampling | 2.5 g |
| Extraction | Japanese law no. 112 (1973) Extracted at 40 °C using 100 ml water in 1 hour. Filter, add acetyl acetone reagent and 30 minutes in a water bath at 40 °C. |
| Spectrophotometer | Absorption maximum 412-415 nm |
| Detection threshold | 2 µg/g |
The results of the screening analyses are given in the sections below.
Table 6.78 presents the results of the GC/MS analysis. The results are given in µg/g and are semi-quantitative since the substances are estimated according to internal standards.
Table 6.78 Results for the GC/MS-analyse, µg/g – before and after washing
A large number of organic compounds have been detected in the surveyed bed linens; some disappear on washing. A few substances appear in larger quantities after washing. The reason for this is that interfering substances made it impossible to identify those substances before washing. Some of these interfering substances are removed in the wash, resulting in better identification and quantification of other substances (semi quantitatively).
A number of substances were found in products no 12-3 and 12-4, including arylamines such as aniline, o-toluidine, dichloroanilines and dichlorobenzenes, which are regulated through the Eco-Tex Standard 100 (Eko-Tex Standard 100, 2009). The arylamines may be the decomposed products from an azo colouring agent and the dichlorobenzenes may result from chemicals used to aid fabric colouring. The highest concentrations of organic substances were found in product no. 12-4.
Tabel 6.79 presents the results of the spectrophotometric analysis for formaldehyde. Results are given in units of µg/g. The results are quantitative (average of dual analyses) and state the content of free formaldehyde in the product.
Tabel 6.79 Results for spectrophotometric analyses, formaldehyde, µg/g
| Product number | 12-1 | 12-2 | 12-3 | 12-4 | 12-5 |
| Before washing | - | 16 | 7 | 182 | - |
| After washing | - | 4 | 3 | 34 | - |
“-“ : Below the detection threshold < 2 µg/g.
Formaldehyde has been detected in 3 of the products both before and after washing.
A series of products and substances have been selected to undergo further examinations based on screening tests.
Table 6.80 Overview of selected products and substances
| Product no. | Description | Components analysed for | Analyses | Reason |
| 12-4 | Bed linen, before washing | Formaldehyde | Sweat migration: 16 hours | A quantitative result is found by extraction in water, 1 hour, 40 degrees. The child sleeps during the day and night. |
| 12-4 | Bed linen, after washing | Formaldehyde | Sweat migration: 10 hours | In order to calculate exposure with and without washing |
The set of bed linen containing the highest levels of formaldehyde during screening studies was selected for further analysis.
Results of the investigations are shown in the table below.
Table 6.81. Results of quantitative analyses and migration analyses for formaldehyde.
| Product type + no. | Quantitative analysis | Migration analysis | Migration period | Migration fluid |
| Bed linen no. 12-4 before washing | 182 ug/g | 307 ug/g | 10 hours | Sweat |
| Bed linen no. 12-4 after washing | 34 ug/g | 121 ug/g | 10 hours | Sweat |
A larger content of formaldehyde has been found following the migration analysis compared to the quantitative analysis using a standardized method for the detection of formaldehyde in fabric. The quantitative analysis is performed followed by 1 hour extraction with water, whereas the migration analysis is performed for 10 hours with artificial sweat, which is a watery fluid containing salts. It would therefore appear that the applied standardized method does not determine the total amount of formaldehyde present in a given product. The standardized method determines the amount of free formaldehyde, and it is possible that the artificial sweat releases more formaldehyde due to its composition, or due to the prolonged liquid exposure.
The results of the quantitative analyses and the migration studies are found in the chapters pertaining to the specific products. The most important results are summarized in Table 6.82.
Table 6.82. Analytical results of quantitative analyses and migration analyses
| Substance (CAS-no.) | Product type + no. | Screening analysis, ug/g | Quantitative analysis, ug/g | Migration analysis, ug/g | Migration period, hours | Migration fluid |
| Formaldehyde | Mitten no. 2-3 | n.s. | 11 | 5 | 3 | Sweat |
| Bed linen no. 12-3 before washing | n.s. | 16 | n.a. | n.a. | n.a. | |
| Bed linen no. 12-3 after washing | n.s. | 4 | n.a. | n.a. | n.a. | |
| Bed linen no. 12-4 before washing | n.s. | 7 | n.a. | n.a. | n.a. | |
| Bed linen no. 12-4 after washing | n.s. | 3 | n.a. | n.a. | n.a. | |
| Bed linen no. 12-4 before washing | n.s. | 182 | 307 | 10 | Sweat | |
| Bed linen no. 12-4 after washing | n.s. | 34 | 121 | 10 | Sweat | |
| Jacket no. 1-1 | n.s. | 5 | n.a. | n.a. | n.a. | |
| Jacket no. 1-2 | n.s. | 6 | n.a. | n.a. | n.a. | |
| Jacket no. 1-3 | n.s. | 5 | n.a. | n.a. | n.a. | |
| Jacket no. 1-4 | n.s. | 5 | n.a. | n.a. | n.a. | |
| Jacket no. 1-5 | n.s. | 5 | n.a. | n.a. | n.a. | |
| Mitten no. 2-1 | n.s. | 6 | n.a. | n.a. | n.a. | |
| Mitten no. 2-2 | n.s. | 7 | n.a. | n.a. | n.a. | |
| Mitten no. 2-3 | n.s. | 11 | 5 | 3 | Sweat | |
| Mitten no. 2-4 | n.s. | 8 | n.a. | n.a. | n.a. | |
| Mitten no. 2-5 | n.s. | 9 | n.a. | n.a. | n.a. | |
| DIBP (84-69-5) | jacket no. 1-2, outer material | 18 | n.a. | 0,04 | 3 | Saliva |
| Clog no. 3-1 | 3000 | 670 | 84 | 6 | Sweat | |
| DBP (84-74-2) | Jacket no. 1-4, zipper strap | 43 | n.a. | 0,51 | 3 | Saliva |
| Jacket no. 1-5, loose reflector piece | n.s. | 120 | n.a. | n.a. | n.a. | |
| Clog no. 3-3 | 51000 | 25603 | 249 | 6 | Sweat | |
| DEHP (117-81-7) | Jacket no. 1-4, zipper strap | 74 | n.a. | <0.1 | 3 | Saliva |
| Jacket no. 1-5, loose reflector piece | n.s. | 213000 | n.a. | n.a. | n.a. | |
| Mittens no. 2-3, label* | n.s. | 124000 | 0.56 | 3 | Saliva | |
| Mittens no. 2-4, label* | n.s. | 147000 | 0.68 | 3 | Saliva | |
| mitten no. 2-4, outer material | n.s. | 417 | < 0,01 | 3 | Saliva | |
| Mitten no. 2-2, outer material | 320 | n.a. | 0.27 | 3 | Saliva | |
| Clog no. 3-1 | 50000 | 15658 | n.d. | 6 | Sweat | |
| Clog no. 3-3 | n.d. | 137 | n.d. | 6 | Sweat | |
| Pacifier (coverage) nr. 5-3 | 300 | 275 | n.d. | 7.75 | Sweat | |
| n.d. | 7.75 | Saliva | ||||
| Soap packaging no. 6-1 | n.d. | 133 | n.d. | 0.5 | Sweat | |
| Soap packaging no. 6-2 | n.d. | 206 | n.d. | 0.5 | Sweat | |
| n.d. | 0.5 | Saliva | ||||
| Soap packaging no. 6-5 | 200000 | 80130 | 2 | 0.5 | Sweat | |
| n.d. | 0.5 | Saliva | ||||
| Shower mat no. 7-1 | 220000 | 128625 | 25 | 0.5 | Sweat | |
| DINP (28553-12-0) | Mittens no. 2-3, label* | n.s. | 86000 | n.d. | 3 | Saliva |
| Mittens no. 2-4, label* | n.s. | 78000 | n.d. | 3 | Saliva | |
| Pacifier no. 5-3 (coverage) | 1600 | 1047 | n.d. | 7.75 | Sweat | |
| n.d. | 7.75 | Saliva | ||||
| Soap packaging no. 6-5 | 200000 | 87692 | n.d. | 0.5 | Sweat | |
| n.d. | 0.5 | Saliva | ||||
| Shower mat no. 7-4 | 800000 | 146330 | n.d. | 0.5 | Sweat | |
| DNOP (117-84-0) | Soap packaging no. 6-1 | 120000 | 57740 | n.d. | 0.5 | Sweat |
| Soap packaging no. 6-2 | 150000 | 64595 | n.d. | 0.5 | Sweat | |
| n.d. | 0.5 | Saliva | ||||
| DEP (84-66-2) | Soap packaging no. 6-2 | 6000 | 11357 | 34 | 0.5 | Sweat |
| 34 | 0.5 | Saliva | ||||
| Soap packaging no. 6-5 | 300 | 1092 | 5 | 0.5 | Sweat | |
| 7 | 0.5 | Saliva | ||||
| 2.4-TDI (584-84-9) | Jacket no. 1-2 | 190 | n.a. | 0,24 | 3 | Saliva |
| Mitten no. 2-2 | 870 | n.a. | 0,20 | 3 | Saliva | |
| MDI (101-68-8) | Jacket no. 1-2 | 130 | n.a. | n.d. | 3 | Saliva |
| Mitten no. 2-2 | 2900 | n.a. | n.d. | 3 | Saliva | |
| Mitten no. 2-3 | 1600 | n.a. | 3,4 | 3 | Saliva | |
| Bisphenol A (80-05-7). | Pacifier (coverage) nr. 5-1 | 1900 | 106 | n.d. | 7.75 | Sweat |
| n.d. | 7.75 | Saliva | ||||
| Pacifier (coverage) nr. 5-3 | 1600 | 280 | 7 | 7.75 | Sweat | |
| n.d. | 7.75 | Saliva | ||||
| Tert. Butylphenol (98-54-4) | Pacifier (coverage) nr. 5-1 | 1600 | 1264 | n.d. | 7.75 | Sweat |
| n.d. | 7.75 | Saliva | ||||
| Pacifier (coverage) nr. 5-3 | 1900 | 1003 | n.d. | 7.75 | Sweat | |
| n.d. | 7.75 | Saliva | ||||
| Triphenylphosphate (115-86-6) | Mitten no. 2-2 | 66 | n.a. | 1.1 | 3 | Saliva |
| Mitten no. 2-3 | 23 | n.a. | 1.1 | 3 | Saliva | |
| Diglycidylbisphenol A (1675-54-3) | Mitten no. 2-3 | 150 | n.a. | 3.2 | 3 | Saliva |
| o-toluidine (95-53-4) | Mitten no. 2-3 | 64 | n.a. | 4,5 | 3 | Saliva |
| 6:2 FTOH (647-42-7) | Jacket 1-1 | 0.41 % by weight F | 0.02 | n.p. | 3 | Saliva |
| Jacket 1-2 | 1.4 % by weight F | 0.02 | n.p. | 3 | Saliva | |
| Jacket 1-3 | 0.68 % by weight F | 0.01 | n.p. | 3 | Saliva | |
| Mitten 2-1 | 2 % by weight F | 0.09 | n.p. | 3 | Saliva | |
| Mitten 2-3 | 1,3 % by weight F | 0.14 | n.p. | 3 | Saliva | |
| 8:2 FTOH (678-39-7) | Jacket 1-2 | 1.4 % by weight F | 0.48 | n.p. | 3 | Saliva |
| Jacket 1-3 | 0.68 % by weight F | 1.09 | n.p. | 3 | Saliva | |
| Mitten 2-1 | 2 % by weight F | 2.82 | n.p. | 3 | Saliva | |
| Mitten 2-3 | 1,3 % by weight F | 1.54 | n.p. | 3 | Saliva | |
| 10:2 FTOH (865-86-1) | Jacket 1-1 | 0.41 % by weight F | 0.02 | n.p. | 3 | Saliva |
| Jacket 1-2 | 1.4 % by weight F | 0.34 | n.p. | 3 | Saliva | |
| Jacket 1-3 | 0.68 % by weight F | 0.57 | n.p. | 3 | Saliva | |
| Mitten 2-1 | 2 % by weight F | 1.47 | n.p. | 3 | Saliva | |
| Mitten 2-3 | 1,3 % by weight F | 0.97 | n.p. | 3 | Saliva | |
| N-Me-FOSA | Jacket 1-1 | 0.41 % by weight F | 0.002 | n.p. | 3 | Saliva |
| Jacket 1-3 | 0.68 % by weight F | 0.002 | n.p. | 3 | Saliva | |
| Mitten 2-1 | 2 % by weight F | 0.002 | n.p. | 3 | Saliva | |
| Mitten 2-3 | 1,3 % by weight F | 0.002 | n.p. | 3 | Saliva | |
| Me-FOSE | Jacket 1-3 | 0.68 % by weight F | 0.004 | n.p. | 3 | Saliva |
| Mitten 2-1 | 2 % by weight F | 0.008 | n.p. | 3 | Saliva | |
| Mitten 2-3 | 1,3 % by weight F | 0.006 | n.p. | 3 | Saliva | |
| Et-FOSE (1691-99-2) | Mitten 2-1 | 2 % by weight F | 0.007 | n.p. | 3 | Saliva |
n.a.: Product or fabric was not selected for analysis
n.s.: A screening result was not calculated
n.d.: The substance was not detected above the detection threshold, as indicated earlier in this report
n.p.: The analysis was not possible due to problems retrieving the frabrics
Substances and product groups have been selected based on these results, and subjected to risk assessment.
The results from the migration studies are highly dependant on the substance in question:
Risk assessment of selected substances is described in Chapter 7.
Version 1.0 November 2009, © Danish Environmental Protection Agency