Health impacts of regulative policies on use of di-n-butylphthalate (DBP) in consumer products
Scope
Purpose of this assessment was to evaluate the effect of two regulative policies on the exposure levels and health risks/impacts caused by di-n-butylphthalate when using consumer products. The regulative policies in question were targeted on toys and cosmetics, which were selected as sources of exposure. In addition indoor air, indoor dust and food were considered as background sources. Exposure was aggregated from all considered sources and through different exposure routes (inhalation, ingestion and dermal). The data used represent different European countries, which provide results that are applicable to Europe in average. Sub-populations selected are young children and adult women. The most relevant health end-point for DBP and selected for this assessment is reproductive effects resulting from chronic exposure. See appended causal diagram.
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Type of assessment |
Prognostic |
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Scenario(s) |
1. The business as usual (BAU) situation, where exposure calculations and risk/impact assessment are made for the situation without any specific policy measure 2. The action of two European directives: a) ban on use of DBP in cosmetics (Commission Directive 2004/93/EC of 21 September 2004 amending Council Directive 76/768/EEC), b) limiting the use of DBP as substance or as constituent of preparations at concentrations of greater than 0.1 % by mass of the plasticized material in toys and childcare articles (Commission Directive 2005/84/EC amending Council Directive 76/769/EEC) |
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Study area(s) |
Europe |
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Dates/time periods |
BAU situation before year 2005, policy situation after year 2006 |
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Study population(s) |
European population, sub-groups of young children (0-12 months) and adult women (18-80 years) |
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Exposures/risk factors |
Chronic exposure to Di-n-butylphthalate in consumer products |
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Health outcomes |
Reproductive effects |
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Stakeholders |
National public health agencies, consumer product safe authorities, health ministries, poison control centre, consumer product NGO’s |
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Stakeholder participation |
At the screening stage of the assessment some stakeholders were contacted via e-mail asking them to list possible chemicals in consumer products that are the most interesting ones in relation to consumer exposure and health effects. Contacted stakeholders represented the following groups: Public Health Institutes, consumer product safe authorities, poison control centre |
Assessment Methods
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Source-exposure variables |
- Amount of DBP in toys, cosmetics, indoor air, indoor dust, food - Use habits of cosmetics
- General exposure factors
- Mouthing behaviour of young children - Migration rate of DBP from toys - Amount of dust ingested - Uptake fraction of DBP through ingestion, inhalation and dermal pathways - General housing factors
- Chemical information
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Exposure metrics |
Intake dose of DBP as µg/kg bw/day |
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Sources and emissions |
The main data sources when defining the sources of exposure were: - ECB 2003 European Union Risk Assessment Report for dibutyl phthalate. http://ecb.jrc.it/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/dibutylphthalatereport003.pdf - ECHA 2009. Data on manufacture, import, export, uses and releases of Dibutyl phthalate (DBP) as well as information on potential alternatives to its use, contract ECHA/2008/02/SR5/ECA.227 http://echa.europa.eu/doc/consultations/recommendations/ tech_reports/tech_rep_dbp.pdf |
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Concentrations/hazard intensity |
Concentrations from: - Household products database: http://householdproducts.nlm.nih.gov/ - Hazardous chemicals in consumer products – Sept 2003 – TNO http://www.greenpeace.org.uk/MultimediaFiles/Live/FullReport/6043.pdf - Survey of Chemical Substances in Consumer Products, No. 60, 2005. Migration and health assessment of chemical substances in surface treated wooden toys. http://glwww.mst.dk/udgiv/publications/2005/87-7614-712-6/html/helepubl_eng.htm - Pretty nasty – phthalates in European cosmetic products, 2002 http://safecosmetics.org/downloads/PrettyNastyReport_HCWH.pdf - Anne Kirstine Müller, Elsa Nielsen, Ole Ladefoged. Human exposure to selected phthalates in Denmark. Institute of Food Safety and Nutrition. http://gl.foedevarestyrelsen.dk/FDir/Publications/2003015/Rapport.pdf - Clausen, P. O., Wolkoff, P. and Svensmark, B. (1999). Preliminary study of semivolatile organic compounds in some Danish indoor environments. Proceedings of the 8th International Conference on Indoor Air Quality and Climate. Edinburgh, Scotland. - Fromme H, Lahrz T, Piloty M, Gebhart H, Oddoy A, Ruden H. (2004). Occurrence of phthalates and musk fragrances in indoor air and dust from apartments and kindergartens in Berlin (Germany). Indoor Air 14, 188-195. Modelled concentrations - Concentrations resulting from the use of cosmetics were modelled with ConsExpo |
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Exposures |
Exposures were modelled with following procedure - Cosmetics: 1) Exposure for each product separately with ConsExpo, 2) ConsExpo results fed in to the Analytica and aggregated with probabilistic Median latin hypercube method to result total exposure distribution from use of cosmetics - Toys, indoor air and dust: Probabilistic Median latin hypercube method with Analytica - Food: Probabilistic Median latin hypercube method in Analytica by using food exposure information from the article by Wormuth et al. (Wormuth, M., Scheringer, M., Vollenweider, M., Hungerbuhler, K. 2006 What Are the Sources of Exposure to Eight Frequently Used Phthalic Acid Esters in Europeans? Risk Analysis 26, 803-824) - Total exposure: Intake dose modelled with probabilistic Median latin hypercube method in Analytica by aggregating the results of all sources produced with above listed methods |
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Exposure-health effect variables |
* LOAEL (2 mg/kg bw/day) * derived effect level (DEL) (20 µg/kg bw/day) * tolerable daily intake (TDI) value (10 µg/kg bw/day) |
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Health metrics |
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Exposure-response functions |
Not available, not appropriate |
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Impact metrics |
Percentage of people exceeding tolerable daily intake (TDI) values, percentage of people exceeding derived effect level (DEL) |
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Impact assessment methods |
Impact assessment was performed by comparing the percentage of people exceeding the DEL and TDI values before and after the policy measures. |
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Main sources of uncertainty |
Lack of input data (amount of DBP in the sources, size of population actually using products containing DBP) |
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Methods for uncertainty analysis |
Probabilistic Median latin hypercube method was used for modelling of exposures. |
Results
Exposure assessment: The average level of the total exposure was decreased from 7.79 µg/kg bw/day to 6.77 µg/kg bw/day (15% decrease) in the group of adult women and from 7.88 µg/kg bw/day to 7.79 µg/kg bw/day (1% decrease) in the group of young children after the policy measure. Exposure levels with distribution information are presented for all sources in more detail in appended Table 1 (adult women) and in appended Table 2 (young children).
Risk assessment: The TDI is not exceeded by the average levels of exposure that have been estimated for both situations before and after the policy measure in both target groups. However, examination of the cumulative probabilities shows that around 26% of adult women population and 30% of young children population might be exposed to levels above the TDI level.
Health effect assessment: Based on the results calculated here, both target populations are below this level with average levels of exposure and it can be concluded that health effects can not be expected. Nevertheless, when examining the cumulative probabilities of the exposure estimates, it can be seen that around 9% of the adult female population and 7% of the infant population might be exposed to levels above the DEL value and may be subject to productive health effects caused by aggregate exposure to DBP.
Impact assessment: After the policy measure the percentage of adult women population exceeding TDI value was lowered from 26% to 24% and in the young children population from 30% to 29%. This indicates that the direct effect of the policy measures, specifically for DBP alone, on health risk levels was very small.
Appraisal
In both target groups TDI and DEL values were still exceeded after the policy measures with the highest level of exposure. The main reason for this is the fact that toys and cosmetics are not the main sources contributing to the exposure of DBP, it is food. The main dietary contribution is estimated to be root crops and leaf crops. DBP present in food is coming from DBP as an environmental contaminant, but might also result from the use of DBP in food and water contact materials. Policy measures that have more effect to the production amount of DBP and as consequence lower the environmental concentrations of DBP or policy measures that lower the concentrations of DBP in food packaging materials might result in a more noticeable decrease of human exposure levels than the policy measures considered here.
The main limitations of this study are 1) Only repeated (chronic) exposure is considered, 2) only women and very young (0-12 month) children are considered, because they are assumed to have the highest exposures from cosmetics and toys, and 3) the possible effect of the use of alternatives (with their possible own adverse health effects) is not taken into account. However, this assessment provides some new aspects compared to previous risk assessments performed at European level. The main advantage is the use of aggregate exposure, providing more realistic exposure values. Furthermore, in previous risk assessments, exposure from cosmetics has been evaluated only for one or two products, whereas much more products have been taken into account in this case study. Another advantage of this approach is that it allows the comparison of different sources of exposure and in this case, it showed that food was the main contributor in the exposure profiles and that future policy measures may need to be focused on this source of exposure in order to limit the exposure of the populations to DBP.
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