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

Contents

Foreword

Summary and conclusions

1 Introduction

• 1.1 Project background
• 1.2 Project purpose
• 1.3 The project’s target group
• 1.4 Report structure

2 Definitions

• 2.1 2-year-olds
• 2.2 Toys for 2 year-olds
• 2.3 Relevant substances
• 2.4 Relevant products
• 2.5 Endocrine disrupters
  • 2.5.1 Oestrogenic substances or oestrogen-like substances
  • 2.5.2 Anti-androgenic substances
• 2.6 Combination effects
• 2.7 Allergens

3 Selected substances and products

• 3.1 Quantitative risk assessment of potential endocrine disruptors
• 3.2 Exposure to other substances with potentially harmful effects
• 3.3 Literature review
• 3.4 Selection of products for screening
  • 3.4.1 Reporting arenas
• 3.5 Screening results
• 3.6 Tier 1 exposure assessment
• 3.7 Identified substances with potential endocrine disrupting properties
• 3.8 Literature review of endocrine disruptors
• 3.9 (Q)SAR predictions for substances with potential endocrine disrupting effects
  • 3.9.1 Procedure
  • 3.9.2 Results
  • 3.9.3 Oestrogen-like effects
  • 3.9.4 Antiandrogenic effects
  • 3.9.5 Conclusion on (Q)SAR predictions
• 3.10 Conclusion on the identification of substances with potentially endocrine disrupting effects
• 3.11 Identified substances with allergenic effects
• 3.12 Literature review of allergens12
• 3.13 Chemical substances identified in the screening with classification for other effects harmful to health

4 Legislation

• 4.1 Toys
  • 4.1.1 Safety requirements for toys
  • 4.1.2 Ban on phthalates in toys
  • 4.1.3 REACH
• 4.2 Textiles
• 4.3 Statutory order on cosmetics
  • 4.3.1 List of ingredients
  • 4.3.2 Substances with restrictions on use in cosmetic products
    • Substances which are not permitted in cosmetic products
    • Colouring agents permitted in cosmetic products
    • Preservatives permitted in cosmetic products
    • UV filters permitted in cosmetic products
• 4.4 Pacifiers
• 4.5 General regulations for limitations on use of certain substances
• 4.6 Foodstuffs, assessment of pollution from EFSA (European Food Safety Authority)

5 Survey

• 5.1 Delimitation
• 5.2 General conditions of the survey
  • 5.2.1 Contacts
  • 5.2.2 Sizes
• 5.3 Outdoor clothes
  • 5.3.1 Legislation
  • 5.3.2 Delimitation
  • 5.3.3 Description of product type in use
  • 5.3.4 Survey of the range of outdoor clothing
    • 5.3.4.1 Procedure
  • 5.3.5 Survey results
    • 5.3.5.1 Products
    • 5.3.5.2 Results of surveying via trade associations and large retail chains
    • 5.3.5.3 Result of surveying via the web
    • 5.3.5.4 Results of shop visits
    • 5.3.5.5 Product list
    • 5.3.5.6 Product prices
    • 5.3.5.7 Selected products
    • 5.3.5.8 Product prices
    • 5.3.5.9 Selected products
• 5.4 Footwear
  • 5.4.1 Legislation
  • 5.4.2 Delimitation
  • 5.4.3 Description of product type in use
  • 5.4.4 Survey of the range of footwear
    • 5.4.4.1 Procedure
  • 5.4.5 Results of survey
    • 5.4.5.1 Products
    • 5.4.5.2 Results of survey via trade associations and large retail chains
    • 5.4.5.3 Result of surveying via the web
    • 5.4.5.4 Results of shop visits
    • 5.4.5.5 Product list
    • 5.4.5.6 Product prices
    • 5.4.5.7 Selected products
• 5.5 Pacifiers[13]
  • 5.5.1 Legislation
  • 5.5.2 Delimitation
  • 5.5.3 Description of product type in use
  • 5.5.4 Survey of the range of pacifiers
    • 5.5.4.1 Procedure
  • 5.5.5 Results of survey
    • 5.5.5.1 Products
    • 5.5.5.2 Results of surveying via trade associations and large retail chains
    • 5.5.5.3 Result of surveying via websites
    • 5.5.5.4 Results of shop visits
    • 5.5.5.5 Product list
    • 5.5.5.6 Product prices
    • 5.5.5.7 Selected products
• 5.6 PVC bath soap packaging
  • 5.6.1 Legislation
  • 5.6.2 Delimitation
  • 5.6.3 Description of product type in use
  • 5.6.4 Identifying the range of bath soap packaging
    • 5.6.4.1 Procedure
  • 5.6.5 Results of the survey
    • 5.6.5.1 Products
    • 5.6.5.2 Result of surveying large retail chains
    • 5.6.5.3 Result of surveying via the web
    • 5.6.5.4 Result of surveying via shops
    • 5.6.5.5 Product list
    • 5.6.5.6 Product prices
    • 5.6.5.7 Selected products
• 5.7 Non-slip figures and bath mats
  • 5.7.1 Legislation
  • 5.7.2 Delimitation
  • 5.7.3 Description of product types in use
  • 5.7.4 Survey of the range of non-slip figures and mats for bath tubs
    • 5.7.4.1 Procedure
  • 5.7.5 Results of survey
    • 5.7.5.1 Products
    • 5.7.5.2 Results of surveying via trade associations and large retail chains
    • 5.7.5.3 Result of surveying via websites
    • 5.7.5.4 Results of shop visits
    • 5.7.5.5 Product list
    • 5.7.5.6 Product prices
    • 5.7.5.7 Selected products
• 5.8 Soft toys
  • 5.8.1 Legislation
  • 5.8.2 Delimitation
  • 5.8.3 Description of product type in use
  • 5.8.4 Survey of the range of soft toys
    • 5.8.4.1 Procedure
  • 5.8.5 Results of the survey
    • 5.8.5.1 Results of surveying via trade associations and large retail chains
    • 5.8.5.2 Result of surveying via websites
    • 5.8.5.3 Results of shop visits
    • 5.8.5.4 Product list
    • 5.8.5.5 Selected products
• 5.9 Diapers
  • 5.9.1 Legislation
  • 5.9.2 Delimitation
  • 5.9.3 Description of the product group in use
  • 5.9.4 Survey of the range of diapers
    • 5.9.4.1 Procedure
  • 5.9.5 Results of the survey
    • 5.9.5.1 Products
    • 5.9.5.2 Results of surveying via trade associations and large retail chains
    • 5.9.5.3 Result of surveying via websites
    • 5.9.5.4 Results of shop visits
    • 5.9.5.5 Product list
    • 5.9.5.6 Product prices
    • 5.9.5.7 Selected products
• 5.10 Sunscreens
  • 5.10.1 Legislation
  • 5.10.2 Delimitation
  • 5.10.3 Description of product type in use
  • 5.10.4 Survey of the range of sunscreens
    • 5.10.4.1 Procedure
  • 5.10.5 Results of the survey
    • 5.10.5.1 Products
    • 5.10.5.2 Results of surveying via trade associations and large retail chains
    • 5.10.5.3 Product list
    • 5.10.5.4 Exctracts from the Access database
    • 5.10.5.5 Selected products
• 5.11 Moisturising creams/ oil-based creams/lotions.
  • 5.11.1 Legislation
  • 5.11.2 Delimitation
  • 5.11.3 Description of product types in use
  • 5.11.4 Survey of the range of moisturising creams, oil-based creams and lotions
    • 5.11.4.1 Procedure
  • 5.11.5 Results of the survey
    • 5.11.5.1 Products
    • 5.11.5.2 Results of surveying via trade associations and large retail chains
    • 5.11.5.3 Product list
    • 5.11.5.4 Extracts from the Access database
• 5.12 Bed linen
  • 5.12.1 Legislation
  • 5.12.2 Delimitation
  • 5.12.3 Description of product types in use
  • 5.12.4 Survey of the range of bed linen
    • 5.12.4.1 Procedure
  • 5.12.5 Results of the survey
    • 5.12.5.1 Results of surveying via trade associations and large retail chains
    • 5.12.5.2 Result of surveying via websites
    • 5.12.5.3 Result of surveying via shop visits
    • 5.12.5.4 Product list
    • 5.12.5.5 Product prices
    • 5.12.5.6 Selected products

6 Chemical analyses

• 6.1 Analyses
  • 6.1.1 Product groups selected for analysis.
  • 6.1.2 Analysis programme composition
• 6.2 Exposure scenarios
  • 6.2.1 Exposure scenarios
  • 6.2.2 Artificial sweat, saliva simulants and temperatures used
• 6.3 Outdoor clothes (jackets and mittens)
  • 6.3.1 Summary of results
  • 6.3.2 Description of product type
  • 6.3.3 Selected products
  • 6.3.4 Analyses methods
    • 6.3.4.1 X-ray analysis
    • 6.3.4.2 GC/MS analysis, extractable organic substances
    • 6.3.4.3 Spectrophotometer analysis of formaldehyde.
    • 6.3.4.4 ICP-MS and GC/MS for organotin compounds
    • 6.3.4.5 Quantitative GC/MS analysis for perfluorous compounds
    • 6.3.4.6 GC/MS analysis, migration studies for organic compounds
    • 6.3.4.7 HPLC analyses and migration studies for TDI and MDI
  • 6.3.5 Results of initial analyses
    • 6.3.5.1 Results of X-ray screening analyses
    • 6.3.5.2 Results of GC/MS analyses
    • 6.3.5.3 Results of analyses for formaldehyde
    • 6.3.5.4 Results of analyses for organotin compounds
  • 6.3.6 Quantitative analyses and migration studies
    • 6.3.6.1 Selection of products and substances
    • 6.3.6.2 Results of quantitative and migration analyses
• 6.4 Footwear
  • 6.4.1 Summary of results
  • 6.4.2 Description of product type
  • 6.4.3 Selected products
  • 6.4.4 Analsyis methods
    • 6.4.4.1
    • 6.4.4.2 GC/MS analysis, extractable organic substances
    • 6.4.4.3 SPME analysis of migrating fluids
  • 6.4.5 Results
    • 6.4.5.1 Results of X-ray analyses
    • 6.4.5.2 Results of the GC/MS screening analyses
  • 6.4.6 Quantitative analyses and migration studies
    • 6.4.6.1 Selection of products and substances
    • 6.4.6.2 Results of quantitative and migration analyses
• 6.5 Pacifiers
  • 6.5.1 Summary of results
  • 6.5.2 Description of product type
  • 6.5.3 Selected products
  • 6.5.4 Analysis methods
    • 6.5.4.1 FTIR analysis of the material composition
    • 6.5.4.2 GC/MS screening, extractable organic substances
    • 6.5.4.3 SPM analysis of migrating fluids
  • 6.5.5 Results
    • 6.5.5.1 Results of FTIR analyses
    • 6.5.5.2 Results of the GC/MS screening analyses
  • 6.5.6 Quantitative analyses and migration studies
    • 6.5.6.1 Selection of products and substances
    • 6.5.6.2 Results of quantitative and migration analyses
• 6.6 Soap packaging
  • 6.6.1 Summary of the results
  • 6.6.2 Description of product type
  • 6.6.3 Selected products
  • 6.6.4 Analysis methods
    • 6.6.4.1 FTIR analysis of the material composition
    • 6.6.4.2 GC/MS screening, extractable organic substances
    • 6.6.4.3 Quantitative SPME analysis of migrating fluids
  • 6.6.5 Results
    • 6.6.5.1 Results of FTIR analyses
    • 6.6.5.2 Results of the GC/MS-screening analyses
  • 6.6.6 Quantitative analyses and migration studies
    • 6.6.6.1 Selection of products and substances
    • 6.6.6.2 Results of quantitative and migration analyses
• 6.7 Non-slip figures and mats
  • 6.7.1 Summary of the results
  • 6.7.2 Description of product type
  • 6.7.3 Selected products
  • 6.7.4 Analysis methods
    • 6.7.4.1 FTIR analysis of the material composition
    • 6.7.4.2 GC/MS screening, extractable organic substances
    • 6.7.4.3 SPME analysis of migrating fluids
  • 6.7.5 Results
    • 6.7.5.1 Results of FTIR analyses
    • 6.7.5.2 Results of the GC/MS screening analyses
  • 6.7.6 Quantitative analyses and migration studies
    • 6.7.6.1 Selection of products and substances
    • 6.7.6.2 Results of quantitative and migration analyses
• 6.8 Soft toys
  • 6.8.1 Summary of results
  • 6.8.2 Description of product type
  • 6.8.3 Selected products
  • 6.8.4 Analysis methods
    • 6.8.4.1 GC/MS screening, extractable organic substances
    • 6.8.4.2 GC/MS-screening, headspace analysis
    • 6.8.4.3 Spectrophotometric analysis of formaldehyde.
  • 6.8.5 Results
    • 6.8.5.1 Results of the GC/MS analyses, extractable organic substances
    • 6.8.5.2 Results of the GC/MS analyses, headspace
    • 6.8.5.3 Results of analyses for formaldehyde
  • 6.8.6 Quantitative analyses and migration studies
• 6.9 Diapers
  • 6.9.1 Summary of the results
  • 6.9.2 Description of product type
  • 6.9.3 Selected products
  • 6.9.4 Screening methods
    • 6.9.4.1 GC/MS screening, extractable organic substances
    • 6.9.4.2 GC/MS analysis, derivatised from rosin
    • 6.9.4.3 Spectrophotometer analysis of formaldehyde.
    • 6.9.4.4 ICP-MS for organotin compounds
  • 6.9.5 Results
    • 6.9.5.1 Results of GC/MS analyses
    • 6.9.5.2 Results of analyses for rosin
    • 6.9.5.3 Results of analyses for formaldehyde
    • 6.9.5.4 Results of analyses for organotin compounds
  • 6.9.6 Quantitative analyses and migration studies
• 6.10 Bed linen
  • 6.10.1 Summary of results
  • 6.10.2 Description of product type
  • 6.10.3 Selected products
  • 6.10.4 Washing procedure
  • 6.10.5 Analysis methods
    • 6.10.5.1 GC/MS screening, extractable organic substances
    • 6.10.5.2 Spectrophotometric analysis of formaldehyde
  • 6.10.6 Results
    • 6.10.6.1 Results of GC/MS analyses
    • 6.10.6.2 Results of analyses for formaldehyde
  • 6.10.7 Quantitative analyses and migration studies
    • 6.10.7.1 Selection of products and substances
    • 6.10.7.2 Results of quantitative and migration analyses
• 6.11 Overview of quantitative analyses and migration analyses
  • 6.11.1 Conclusions from migration studies

7 Risk Assessment

• 7.1 Selection of dose factors (NOAELs and LOAELs)
• 7.2 Use of assessment factors
• 7.3 Exposure scenarios - Method
  • 7.3.1 Route of exposure
    • 7.3.1.1 Inhalation
    • 7.3.1.2 Dermal uptake
    • 7.3.1.3 Daily ingestion
  • 7.3.2 Previous relevant product surveys
  • 7.3.3 Exposure scenarios
    • 7.3.3.1 Exposure times used
    • 7.3.3.2 Use of summer and winter scenarios
    • 7.3.3.3 Anatomic data
  • 7.3.4 Methods for the calculation of exposure
    • 7.3.4.1 Calculation of exposure
• 7.4 Calculation of risk - method
  • 7.4.1 Combination effects
• 7.5 Significant sources of exposure
  • 7.5.1 Indoor climate
    • Gunnersen et al. (2009) state that the greatest exposure to PCB used in building joints occurs due to realease to the indoor air. Gunnersen et al. (2009) conclude that although primarily non-dioxin-like PCBs are released to the indoor air, there will also be exposure to dioxin-like PCBs. The relevance of this finding should be considered in view of the fact that there is always more or less concomitant exposure to non-dioxin-like PCBs and dioxin-like PCBs.
    • The present report focusses on the dioxin-like PCBs because there is documented evidence of their endocrine disrupting effects.
  • 7.5.2 Other sources of exposure
    • 7.5.2.1 Phthalates, generally
    • 7.5.2.2 Parabens in general 99-96-7
• 7.6 Calculation of exposure
  • 7.6.1 Exposure calculations for the selected substances via the indoor climate
    • 7.6.1.1 Dust
    • 7.6.1.2 Air
    • 7.6.1.3 Comparison of dust and air
    • 7.6.1.4 Total contribution from the indoor climate
• 7.7 Risk assessment of the individual substances
  • 7.7.1 DIBP, di-isobutyl phthalate, 84-69-5
    • 7.7.1.1 NOAEL, AF and DNEL
    • 7.7.1.2 General exposure
    • 7.7.1.3 Exposure to DINP from foods
    • 7.7.1.4 Exposure from consumer products
    • 7.7.1.5 Exposure from indoor climate
    • 7.7.1.6 Combined exposure and risk
  • 7.7.2 DBP, dibutyl phthalate, 84-74-2
    • 7.7.2.1 NOAEL, AF and DNEL
    • 7.7.2.2 General exposure
    • 7.7.2.3 Exposure to DBP from foods
    • 7.7.2.4 Exposure from consumer products
    • 7.7.2.5 Exposure from indoor climate
    • 7.7.2.6 Combined exposure and risk
  • 7.7.3 BBP, benzyl butyl phthalate, 85-68-7
    • 7.7.3.1 NOAEL, AF and DNEL
    • 7.7.3.2 General exposure
    • 7.7.3.3 Exposure to BBP from foods, etc.
    • 7.7.3.4 Exposure from consumer products
    • 7.7.3.5 Exposure from indoor climate
    • 7.7.3.6 Combined exposure and risk
  • 7.7.4 DEHP, diethylhexyl phthalate, 117-81-7
    • 7.7.4.1 NOAEL, AF and DNEL
    • 7.7.4.2 General exposure
    • 7.7.4.3 Exposure from foods
    • 7.7.4.4 Exposure from consumer products
    • 7.7.4.5 Exposure from indoor climate
    • 7.7.4.6 Combined exposure and risk
  • 7.7.5 DINP, di-isononyl phthalate, 28553-12-0
    • 7.7.5.1 NOAEL, AF and DNEL
    • 7.7.5.2 General exposure
    • 7.7.5.3 Exposure to DINP from foods
    • 7.7.5.4 Exposure from consumer products
    • 7.7.5.5 Exposure from indoor climate
    • 7.7.5.6 Combined exposure and risk
  • 7.7.6 Prochloraz, 67747-09-5
    • 7.7.6.1 NOAEL, AF and DNEL
    • 7.7.6.2 Exposure from food
    • 7.7.6.3 Combined exposure and risk
  • 7.7.7 Tebuconazole, 107534-96-3
    • 7.7.7.1 NOAEL, AF and DNEL
    • 7.7.7.2 Exposure from food
    • 7.7.7.3 Combined exposure and risk
  • 7.7.8 Linuron, 330-55-2
    • 7.7.8.1 NOAEL, AF and DNEL
    • 7.7.8.2 Exposure from food
    • 7.7.8.3 Combined exposure and risk
  • 7.7.9 Vinclozolin
    • 7.7.9.1 NOAEL, AF and DNEL
    • 7.7.9.2 Exposure from foods
    • 7.7.9.3 Combined exposure and risk
  • 7.7.10 Procymidone
    • 7.7.10.1 NOAEL, AF and DNEL
    • 7.7.10.2 Exposure from foods
    • 7.7.10.3 Combined exposure and risk
  • 7.7.11 Dioxins and dioxin-like PCBs
    • 7.7.11.1 NOAEL, AF and DNEL
    • 7.7.11.2 Exposure from foods
    • 7.7.11.3 Combined exposure and risk
  • 7.7.12 Non-dioxin-like PCBs
    • 7.7.12.1 Risk assessment
  • 7.7.13 DDT
    • 7.7.13.1 NOAEL, AF and DNEL
    • 7.7.13.2 Exposure from foods
    • 7.7.13.3 Combined exposure and risk
  • 7.7.14 Propyl-, butyl-, and isobutylparaben
    • 7.7.14.1 Propylparaben, 94-13-3
    • 7.7.14.2 NOAEL, AF and DNEL
    • 7.7.14.3 Butylparaben, 94-26-8
    • 7.7.14.4 Isobutylparaben, 4247-02-3
    • 7.7.14.5 Exposure to parabens from consumer products
    • 7.7.14.6 Exposure from indoor climate
    • 7.7.14.7 Combined exposure and risk
  • 7.7.15 Bisphenol A, 80-05-7
    • 7.7.15.1 Exposure from foods etc.
    • 7.7.15.2 Exposure from consumer products
    • 7.7.15.3 Exposure from indoor climate
    • 7.7.15.4 Combined exposure and risk
• 7.8 Cumulative risk assessment of potential endocrine-like substances
  • 7.8.1 Risk assessment, overview summary
    • 7.8.1.1 Summer scenario
    • 7.8.1.2 Winter scenario
  • 7.8.2 Risk assessment, total for antiandrogenic substances
  • 7.8.3 Risk assessment, total for oestrogenic substances
  • 7.8.4 Risk assessment totalled for oestrogenic and antiandrogenic substances
  • 7.8.5 Discussion and conclusion

8 References:

Appendix A: Chemical substances in sunscreens

Appendix B: Chemical substances in moisturising creams, oil-based creams and lotions

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Version 1.0 November 2009, © Danish Environmental Protection Agency