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Survey and Health Assement of the exposue of 2-year-olds to chemical substances in Consumer Product

Summary and conclusions

Since 2001 an extensive series of projects have been carried out to evaluate the risks inherent in use of various product groups. These projects focused primarily on peoples’ exposure to chemical substance from individual products. The primary objective in the current project has been to look at the total exposure of the 2 year-old child to chemical substances over the course of one day.

Two-year-olds are exposed to many chemical substances in daily life. Furthermore, they are particularly susceptible due to their physical size (large surface area/small volume). The primary focus will be on consumer products, but because the 2 year-old’s exposure to chemical substances involves not only food products but also food contact materials and articles, focus has also been placed on these sources. Exposure from indoor air and dust has also been evaluated based on existing measurements.

The project will result in an information campaign intended to disseminate the report’s conclusions and provide active advice. The primary target group for the campaign is parents and grandparents who are in daily contact with 2 year-olds, but the project is also expected to have a knock-on effect on Danes in general, raising awareness of their chemical exposure in daily life and generating an understanding that it is possible to reduce unnecessary exposure to chemicals.

Several substances were selected and focussed on in the risk assessment. They were selected for their known endocrine disrupting effects in animal studies, and an anticipated exposure of 2 year-old children to these substances through food products, indoor air and dust, or consumer products. The following substances were selected:

Antiandrogens (androgen antagonists):

• DEHP (di-ethyl-hexyl-phthalate) (117-81-7)
• DINP (di-iso-nonyl-phthalate) (68515-48-0)
• DBP (di-butyl-phthalate) (84-74-2)
• DIBP (di-iso-butyl-phthalate) (84-69-5)
• BBP (butyl-benzyl-phthalate) (85-68-7)
• Prochloraz (67747-09-5)
• Tebuconazole (107534-96-3)
• Linuron (330-55-2)
• Vinclozolin (50471-44-8)
• Procymidone (32809-16-8)
• PCBs (poly-chlorinated-biphenyls)
• Dioxins
• DDTs/DDDs (dichloro-diphenyl-trichlorethane/dichloro-diphenyl-dichloroethene).

Oestrogen-like:

• Propylparaben (94-13-3)
• Butylparaben (94-26-8)
• Isobutylparaben (4247-02-3)
• Bisphenol A (80-05-7).

Initially the following substances were investigated in addition to the abovementioned priority substances; DEP (diethyl phthalate), propiconazole, perfluorinated and polyfluorinated compounds, organotin compounds and the UV filters, 3-benzylidene camphor and 2-ethylhexyl-4-methoxycinnamate were all excluded during the selection phase. For DEP and propiconazole no animal studies revealed sufficient evidence for endocrine disrupting effects. And for perfluorated and polyfluorated compounds insufficient data on migration of these substances (these analyses could not be performed) led to exclusion. Furthermore organotin compounds were excluded, as they were not identified in the migration analyses of the selected products. The two UV filters were excluded, as they were only used in two sunscreen lotions for children purchased in the autumn of 2008. The two manufacturers involved in the manufacturing of these sunscreen products have informed that the UV filters will not be a component of the products for sale in 2009.

In addition to performing quantitative risk assessments for the above potential endocrine disruptors, the aim was to achieve a more detailed profile of children's total exposure to substances posing a potential health hazard. Therefore, a review of available literature on substances with potential endocrine disrupting and allergenic effects was carried out, and a series of consumer products was screened for content of organic substances. The substances identified in the screening were subsequently reviewed for any endocrine disrupting and allergenic effects and for classification of other health hazards. A preliminary rough exposure assessment (Tier 1) was carried out for all substances. The screening was also used to select substances for quantitative analysis of content and migration, which was subsequently used in a more detailed exposure assessment.

The screening included the following 12 product groups:

1. Outdoor clothes in the form of impregnated textiles (jackets), i.e. jackets marked as waterproof or water-resistant (PVC-rainwear was also a selection criterion but was not found).
2. Mittens of the same material as all-in-one suits.
3. Footwear in the form of rubber clogs.
4. Footwear in the form of unlined rubber boots.
5. Pacifiers, primarily pacifiers in which the plastic coverage is polycarbonate.
6. Bath soap packaging formed as various figures/animals, but also other containers manufactured from PVC for children's soap.
7. Non-slip figures and non-slip mats for bathtubs.
8. Soft toys with fragrance to be warmed in a microwave oven.
9. Diapers.
10. Sunscreen lotion.
11. Moisturising cream/lotion/oil-based cream.
12. Bed linen (junior bed linen).

Sunscreen lotions and moisturising creams/lotion/oil-based creams have been mapped, and ingredients have been registered based on packaging and information from the manufacturer/importer/retailer.

The route of exposure relevant for the individual product will depend on the product type and the chemical substance in question. Assessment of exposure is based on ingestion, skin exposure and inhalation of volatile substances from the product. For example, the 2 year-old may be affected via inhalation of substances from bed linen and clothing, and from substances that evaporate from soft toys, etc. Skin exposure (dermal exposure) must, on the other hand, be considered relevant, as children have direct skin contact with all these products. Ingestion, resulting from a 2 year-old sucking a product, is also pertinent for all product groups with the exception of footwears and diapers. The framework for the exposure period and other data for use in the exposure scenarios are presented below.

Summary of analysis results

Outdoor clothes (jackets and mittens), footwear (rubber clogs and rubber boots), pacifiers, bath soap packaging, non-slip figures and mats, soft toys, diapers and bed linen were analysed.

Below follows a summary of the analysis results, including the results for potential endocrine disruptors. A quantitative risk assessment for the selected substances is presented in Chapter 7.

Endocrine disruptors

Phthalates

The content of phthalates has been quantified in a series of products and several concentrations have been detected that indicate that the phthalates have been added as a softener. Examination of exposure scenarios with sweat and saliva simulators, however, demonstrated that only a small amount of the phthalates DIBP, DBP, DEHP and DEP migrate out of the products, and that the highest molecular weight phthalates, DINP and DNOP, do not migrate under the applied conditions.

Phthalates are found in the following product types (the figure in parentheses indicates the number of products with detected phthalate content)

• Jackets - Outer material (1 - DIBP) and in reflectors (1 - DEHP) and in the zip strap (1 - DBP, DEHP)
• Mittens - Outer material (1 - DEHP) and label with product name on the back of the hands (2 - DEHP, DINP)
• Rubber clogs (3 - DIBP, DBP, DEHP)
• Rubber boots (1 - 1-Butyl-2-isobutyl phthalate)
• Soap packaging (5 - DEHP, DINP, DNOP, DEP) - All products manufactured from PVC
• Bath mats (3 - DEHP, DINP) - Highest content in products made from PVC
• Soft toys (2 - DBP, 1-Butyl-2-isobutyl phthalate).

In five out of five soap packagings, the content of DEHP, DINP and/or DNOP exceeded the permitted limit of 0.1% stipulated in the Statutory Order on the ban on phthalates in toys and childcare articles. The Danish Safety Technology Authority subsequently determined that these products can be considered toys. Sale of these products has therefore been stopped.

Low concentrations of phthalates were also detected in the coverage of all inspected pacifiers (5 products - DEHP, DINP), but the migration analyses showed no migration from the materials to the saliva and sweat simulators under the applied conditions. The coverage from one product has a DINP content slightly over the threshold value of 0.1% as indicated in the statutory order on the ban on phthalates in toys and childcare articles.

Bisphenol A

Bisphenol A has been detected in the coverage of pacifiers made of polycarbonate, but the analyses revealed no migration from the materials to the saliva and sweat simulators.

Allergens

Formaldehyde

Formaldehyde was detected in jackets (5 products), mittens (5 products), diapers (3 products, low content at the detection threshold) and bed linen (3 products, both before and after washing). The highest content was detected in bed linen. Ten-hour sweat migration tests of a set of bed linen showed higher content than the quantitative analyses, which involved water extraction for 1 hour.

Isocyanates

Various isocyanates were found in all jackets (5 products) and mittens (5 products) investigated. Studies of select products for MDI and 2,4-TDI with saliva simulators revealed that only a minor amount of isocyanates migrate.

Fragrances

Two soft toys designed to be warmed in the microwave contained numerous fragrances. These soft toys were examined before and after warming. Higher concentrations and more fragrances were detected after than before warming.

Other results

Analysis of jackets, mittens and bed linen revealed a large number of organic compounds. Studies of triphenylphosphate, diglycidylbisphenol and o-toluidine in exposure scenarios with saliva simulators demonstrated that these migrate.

There are no indicators that jackets and mittens have been impregnated with flame retardants.

Washing textiles

Bed linen were analysed before and after washing. The results show that many of the organic substances cannot be detected after washing the products. Several substances can, however, still be found in low concentrations after 1 wash. The remaining textiles (jackets and mittens) were not examined before and after washing, but it is assumed that the same would apply.

Summary of risk assessment

The project’s risk assessments focused on the 2 year-old child’s total exposure to selected endocrine disruptors in consumer products, foods, indoor air and dust. Exposure calculations are based on the present project; the analysis results from previous survey projects; and on estimates of exposure from cosmetic products, indoor air, dust and food.

The risk to which a 2 year-old is exposed was calculated for both the summer and winter periods. In these calculations the summer scenario included:

• Contact with sunscreen lotion
• Contact with rubber clogs
• Dermal contact with toys for 9 hours in the summer
• Ingestion of 50 mg dust.

The winter scenario included:

• Dermal contact with toys for 6 hours in the winter
• Contact with jackets/mittens for 3 hours
• Ingestion of 100 mg dust.

Common to both scenarios were:

• Ingestion of foods
• Contact with objects other than toys, i.e. moisturising cream, bath articles and other textiles other than winter clothing (jackets/mittens).

The results show that regardless of whether calculations are based on the summer scenario or the winter scenario, the RCR values (Risk Characterisation Ratio = Exposure/DNEL = Exposure/(NOAEL/AF)) are greater than 1 for the substances DBP and dioxins and dioxin-like PCBs. This means that at each exposure to each of these substances there will be a risk for endocrine disrupting effects, and there will also be a risk for these affects based on the other assumptions in this report. For DBP and dioxins and dioxin-like PCBs, the highest amounts are contributed by foods, indoor air and dust.

For propylparabens, the RCR is above 1 for the summer scenario, while RCR is 0.83 for the winter scenario. For the summer scenario RCR is high (0.7) for butylparaben but nevertheless under 1. The parabens originate from use of lotions, including sunscreens, and is the reason that their contribution is greatest in the summer scenario.

The concentrations used in the risk assessment of the parabenes are based on a small survey of the concentration used in products on the Danish Market. If the highest allowed in the cosmetics directived were used, RCR would be far above 1.

By grouping the substances into anti-androgenic, oestrogen-like substances, and substances that may have both effects, the cumulative RCR is calculated and stated in Table 0.1.

Table 0.1 Cumulative RCR for oestrogenic and anti-androgenic substances

The results show that cumulative RCR for the anti-androgenic substances and the oestrogen-like substances is above 1 for both the summer and winter scenarios. DBP and dioxins and dioxin-like PCBs contribute most to the RCR for anti-androgenic effect. These contributions originate from their presence in foods, indoor air and dust. Propyl and butylparaben contribute most to the RCR for oestrogen-like effect. These contributions originate from their presence in sunscreen lotions and oil-based creams.

The present investigation, however, is based on random samples of individual consumer products and product groups. There may therefore be other chemical substances with suspected endocrine disrupting effects and other products on the market that add to this risk. In addition to the exposure contribution covered by these calculations, there may be other contributing factors that could increase the overall risk; for example, any presence of the prioritised substances in medicine and medical devices has not been included. In addition to this, there could be substances that the child already has in their body from earlier exposures, such as those passed from mother to child during the foetal period and nursing.

In addition, there may be a greater contribution from some of the consumer products, as some values (such as for toys) may be underestimated because it has been necessary to estimate the weight of the products in the calculations. In addition, the actual number of products used by the 2 year-old may further contribute to the calculated risk; for example, it should be expected that pacifiers are changed more often than mittens and jackets.

It should also be noted that the project's calculations also include many parameters that are based on estimates. This is due to the fact that there is no clear documentation for the areas concerned. Such types of estimates can produce distorted results and may mean that overall exposure is estimated at a higher level than is actually the case.

For propyl- and butylparaben in particular, which are included in the cumulative risk assessments, the selected LOAEL-based effects have been found in only a few studies conducted by a Japanese group (Oishi et al 2001, and Oishi et al 2002 in SCCP opinion; SCCP (2005)). In the SCCP opinion from 2005, doubt is raised concerning the validity of these results, and SCCP has asked the industry to provide results from developmental toxicity studies that can determine whether propyl, butyl and isobutylparaben have endocrine disrupting effects in animals. SCCP is, however, still awaiting the information from the industry which could decide whether the parabens induce endocrine disrupting effects or not. In addition, skin absorption for parabens is estimated at 10%. There is currently no documentation for skin absorption, metabolism and excretion of parabens. The EU’s Scientific Committee for consumer products has stated that the documentation will be available shortly, after which a more exact risk assessment of parabens can be performed. The estimate at 10% is based on worst-case scenarios and may produce distorted results, as results in cumulative exposure are being estimated at a higher level than actually occurs.

Based on the assumptions made in the report, it can be concluded that:

• A few exposures to a high content of an endocrine disruptor, such as that of DBP in rubber clogs may result in a critical risk for the 2 year-old.
• The amounts that 2 year-olds absorb, in particular from the phthalate DBP (mostly from foods) and dioxins and dioxin-like PCBs (mostly from foods, and partly from indoor air and dust), constitute a risk for anti-androgen disruptions to the endocrine system.
• The amounts that 2 year-olds absorb from the parabens propylparaben and butylparaben, in particular, can constitute a risk for oestrogen-like disruptions of the endocrine system. This contribution originates predominantly from cosmetic products such as oil-based creams/moisturising creams/lotions and sunscreen.

In summary, it can be concluded that not only is there a need to reduce exposure to anti-androgens and oestrogen-like substances from food products, indoor air and dust, but also to reduce exposure to the studied product groups, as these contribute to both indoor air and dust and to direct exposure, based on the assumptions made in this report. A reduction of the potential cumulative risk requires knowledge of the sources of the contents of food products, indoor air and dust. However, there is also a need to reduce possible contributions from other sources, such as propyl-, butyl- and isobutyl paraben in cosmetics, and phthalates in footwear (such as light-weight sandals and rubber boots).

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Version 1.0 November 2009, © Danish Environmental Protection Agency