Exposure of Pregnant Consumers to Suspected Endocrine Disruptors
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Exposure of pregnant consumers to suspected endocrine disruptors Survey of chemical substances in consumer products no. 117 Title: Contributors/editors: Exposure of pregnant consumers to suspected Dorthe Nørgaard Andersen, Lise Møller and Helle Buchardt Boyd, endocrine disruptors DHI Julie Boberg, Marta Axelstad Petersen, Sofie Christiansen and Ulla Hass, Food DTU Pia Brunn Poulsen, Maria Strandesen and Daniela Bach, FORCE Technology Publisher: Photo: Miljøstyrelsen Strandgade 29 1401 København K Illustration: www.mst.dk Year: Map: 2012 ISBN no. 978-87-92903-02-0 Disclaimer: The Danish Environmental Protection Agency will, when opportunity offers, publish reports and contributions relating to environmental research and development projects financed via the Danish EPA. Please note that publication does not signify that the contents of the reports necessarily reflect the views of the Danish EPA. The reports are, however, published because the Danish EPA finds that the studies represent a valuable contribution to the debate on environmental policy in Denmark. May be quoted provided the source is acknowledged. 2 Exposure of pregnant consumers to suspected endocrine disruptors Contents 1 INTRODUCTION 11 1.1 PROJECT BACKGROUND 11 2 SELECTION OF SUBSTANCES AND PRODUCT GROUPS FOR ANALYSIS 17 2.1 SELECTION OF SUBSTANCES 17 2.2 MATERIALS IN WHICH THE SELECTED SUBSTANCES ARE EXPECTED TO OCCUR 20 2.3 CRITERIA FOR SELECTION OF PRODUCTS FOR FURTHER EXAMINATION 21 2.4 SELECTION OF PRODUCT GROUPS 22 3 SURVEY 28 3.1 CELL PHONE COVERS 29 3.2 SLEEPING MATS 37 3.3 WORK GLOVES/HOUSEHOLD GLOVES 42 3.4 SNEAKERS 47 3.5 ANTIBACTERIAL CLOTHING 53 3.6 HANDBAGS MADE OF SYNTHETIC LEATHER 60 3.7 PREGNANT BELLY CREAMS/PREGNANCY OILS AND MOISTURISING CREAMS/LOTIONS 67 3.8 SUNSCREEN 76 4 EXPOSURE CONSIDERATIONS 82 4.1 RELEVANT DATA FOR USE IN THE MIGRATION ANALYSES AND THE EXPOSURE CONSIDERATIONS 82 5 ANALYSES 85 5.1 QUANTITATIVE ANALYSES 85 5.2 MIGRATION ANALYSES 91 6 HAZARD ASSESSMENT 93 6.1 SELECTION OF NO AND LOWEST OBSERVED ADVERSE EFFECT LEVELS (NOAELS AND LOAELS) 93 6.2 ASSESSMENT OF ENDOCRINE DISRUPTING EFFECTS 93 6.3 APPLICATION OF ASSESSMENT FACTORS 95 6.4 CONVERSION TO INTERNAL DOSE 96 6.5 DATA SELECTED FOR HAZARD ASSESSMENT 97 6.6 PHTHALATES 106 6.7 DIOXINS AND DIOXIN-LIKE PCBS 108 6.8 BISPHENOL A 109 6.9 NONYLPHENOL 110 6.10 TETRABROMOBISPHENOL A (TBBPA) 111 6.11 PERFLUORO OCTANOATE (PFOA) 111 6.12 PERFLUORO OCTANE SULFONATE (PFOS) 111 6.13 OCTAMETHYLCYCLOTETRA-SILOXANE (D4) 112 6.14 PARABENS 112 6.15 UV-FILTERS 114 6.16 TRICLOSAN 115 6.17 RESORCINOL 115 6.18 PESTICIDES 116 7 EXPOSURE ASSESSMENT 121 7.1 METHOD FOR CALCULATION OF EXPOSURE 121 7.2 ANATOMIC DATA USED IN EXPOSURE CALCULATIONS 124 7.3 DERMAL AND ORAL ABSORPTION RATES AND INHALATION FRACTIONS127 7.4 EXPOSURE VIA FOOD 128 7.5 EXPOSURE VIA INDOOR AIR 133 7.6 EXPOSURE VIA CONSUMER PRODUCTS 161 8 RISK ASSESSMENT 188 8.1 METHOD FOR CALCULATION OF RISK 188 8.2 EXPOSURE SCENARIOS 190 8.3 RESULTS 192 8.4 DISCUSSION 211 8.5 SIGNIFICANCE OF UNCERTAINTIES 223 8.6 OTHER SUBSTANCES, WHICH MAY CONTRIBUTE TO ENDOCRINE DISRUPTING EFFECTS 224 9 CONCLUSION 229 10 REFERENCES 233 3 Introduction The project on exposure of pregnant consumers to suspected endocrine disruptors was carried out during the period July 2011 to March 2012. This report describes the results of the project, including selection of substances, review of existing knowledge in this area (incl. previous surveys from the Danish EPA), a survey of new products selected for chemical analyses, exposure scenarios, and risk assessment of the overall exposure to suspected endocrine disruptors of pregnant women and women who want to become pregnant. The results of the report will be followed up by an information campaign mainly targeting pregnant women in Denmark and women who want to become pregnant. The information campaign is launched in March 2012. The project was carried out in cooperation between DHI, Food DTU, FORCE Technology, Institute for Environment and Health, and Operate. Project management was managed generally by DHI, by head of projects, MSc. Dorthe Nørgaard Andersen. The survey was carried out by Pia Brunn Poulsen and Maria Strandesen, FORCE, and Lise Møller, Tina Haugaard Stephansen and Dorthe Nørgaard Andersen, DHI. Daniela Bach, FORCE, has been responsible for the analyses The risk assessments were carried out by Julie Boberg, Marta Axelstad Petersen, Sofie Christiansen, Ulla Hass, Food DTU, Pia Brunn Poulsen and Maria Strandesen, FORCE, and Lise Møller, Helle Buchardt Boyd and Dorthe Nørgaard Andersen, DHI Communication consultant Torben Clausen, Operate, has the overall responsibility for the information campaign. The project was overseen by a focus group consisting of Shima Dobel, the Danish Environmental Protection Agency Louise Fredsbo Karlsson, the Danish Environmental Protection Agency Marie Louise Holmer; the Danish Environmental Protection Agency Christel Søgaard Kirkeby; the Danish Environmental Protection Agency Dorthe Nørgaard Andersen, DHI The project is funded by the Danish Environmental Protection Agency. Summary and Conclusions In daily life, all humans are exposed to chemical substances from various sources such as food, medical products, indoor environment, cosmetics and other consumer products surrounding us at home, in connection with hobbies, and at work. Among the thousands of chemical substances one could possibly be exposed to in daily life, some have been shown to act as endocrine disruptors in laboratory animals. These substances are also suspected of being endocrine disruptors to humans and to contribute to e.g. cryptorchidism (undescended testicles to scrotum) or hypospadias (birth defect of the penis) in baby boys, premature puberty in girls and low semen quality, increased occurrence of testicular cancer and reduced levels of the male sex hormones in men. In this project the exposure of women in the child-bearing age to a number of selected suspected endocrine disruptors was investigated. Some of the most sensitive periods of human life are the fetal stage and childhood, because the human being and its organs during these stages undergo a significant development which requires balance in the hormonal systems that are involved in regulating the various stages of the development. The pregnant woman was in focus in this project, because her exposure to suspected endocrine disruptors can give an impression of what her fetus may be exposed to in sensitive stages of its development. Women who wish to become pregnant are included in the target group for the subsequent information campaign, because they are typically pregnant two weeks before they know it, and because some suspected endocrine disruptors accumulate in the body and are only released very slowly. Exposure even a long time before pregnancy may therefore have an impact on the exposure of the fetus. The project forms the basis for an information campaign which includes the conclusions of the report and gives advice to pregnant women and women who want to become pregnant. A number of chemical substances suspected of being endocrine disruptors were selected. The endocrine disrupting effects included are antiandrogenic (reduce production of or block effect of male sex hormones), estrogenic (affects the balance of female sex hormone) and/or thyroid disrupting (disrupts the balance or effects of the thyroid gland’s hormones). The criteria for including a substance in the project were as follows: substances from group 1 and group 2a according to the criteria for identification of endocrine disruptors made by the Danish Centre for Endocrine Disruptors (CEHOS) for The Danish EPA (Danish EPA 2011), substances, where the endocrine disrupting effect is related to an antiandrogenic, estrogenic or thyroid hormone disrupting mode of action, substances, for which there is sufficient knowledge in animal studies to calculate the doses of the substance, which may be assumed to be safe for humans (with regard to the specific endocrine effect), substances expected to be present in products commonly used by the pregnant women, substances expected to contribute with a significant exposure, 5 finally, it was considered that the selected substances should cover several different product groups and several different materials within the selected exposure situations/activities The focus is thus on substances with antiandrogenic, estrogenic and thyroid disrupting mode of action. It should be noted that some substances have multiple modes of action and that it is not always possible to categorise, whether, for example, changes in the reproductive system are due to an antiandrogenic or estrogenic mode of action. The Selected substances are: Substance name (CAS No.) Antiandro- Estrogenic thyroid genic disrupting Phthalates DEHP (di-ethyl-hexyl-phthalate) (117-81-7) X X DiNP (di-iso-nonyl-phthalate) (28553-12-0) X DBP (di-butyl-phthalate) (84-74-2) X DiBP (di-iso-butyl-phthalate) (84-69-5) X BBP (butyl-benzyl-phthalate) ( 85-68-7) X DPP (dipentyl phthalate) (131-18-0) X DnHP (di-n-hexyl phthalate) ( 84-75-3) X X DnOP (Di-n-octyl phthalate) (117-84-0) X X Other environmentally hazardous chemical substances Dioxin and dioxin-like PCBs X X Bisphenol A (80-05-7) X Nonylphenol (25154-52-3) X TBBPA (Tetrabromobisphenol A) (79-94-7) X X Perfluorooctanoate (PFOA) (335-67-1) X X Perfluorooctane sulfonate (PFOS) (1763-23-1) X X Octamethylcyclotetrasiloxane (D4) (556-67-2) X Substances in cosmetic products Propylparaben (94-13-3) X Butylparaben (94-26-8) X Isobutylparaben (4247-02-3) X Octyl methoxycinnamate, 2-ethylhexyl-4- X X methoxycinnamate (OMC) (5466-77-3) 3-Benzylidene camphor (3-BC) (15087-24-8) X 4-Methylbenzylidene camphor (4-MBC) (36861-47-9) X Benzophenone 3 (BC-3) (131-57-7) X Triclosan (3380-34-5) X X Resorcinol (108-46-3) X Pesticides Chlorpyrifos (2921-88-2) X X Dithiocarbamates: X X - Mancozeb (8018-01-7) - Maneb (12427-38-2) - Propineb (12071-83-9) Imazalil (35554-44-0) X Iprodione (36734-19-7) X Pirimiphos-methyl (29232-93-7) X Procymidon(32809-16-8) X Propamocarb (24579-73-5) X Tebuconazole (107534-96-3) X Thiabendazole (148-79-8) X X The selection of the 35 substances reflects the knowledge available today.