«Exposure of pregnant consumers to suspected endocrine disruptors Survey of chemical substances in consumer products no. 117 Title: ...»
Exposure of pregnant
Survey of chemical substances in consumer
products no. 117
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
Miljøstyrelsen Strandgade 29 1401 København K Illustration:
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 FORANALYSIS 17
2.1 SELECTION OF SUBSTANCES 17
2.2 MATERIALS IN WHICH THE SELECTED SUBSTANCES ARE EXPECTED TOOCCUR 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
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, 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.
Based upon knowledge from previously completed surveys of consumer products from the Danish EPA, as well as a behaviour analysis focussing on the target group’s use of consumer products, which might contain substances from the above table, new product groups were chosen for survey and analysis. A total of 8 product groups were included in this survey: cell phone covers, sleeping mats, work gloves, hand bags made of synthetic leather, sneakers, antibacterially treated clothes, moisturisers for full body/pregnant belly creams and sunscreens.
The survey gave insight into the number of products within the 8 product groups, types of material used in the product groups and for cosmetics the content of the selected substances. Within these 8 groups, products were selected for quantitative analyses of a number of the selected substances depending on the type of material of the product. For certain products in de different groups also migration analyses were performed.
The quantitative analyses gave the following results:
Phthalates were identified by a content analysis in the following product groups (the number between brackets indicates the number of products with detected
content of the substance in question):
20 cell phone covers tested (DEHP in 5 products, DiNP in 1 product) 11 work gloves tested (DEHP in 1 product, DiNP in 2 products) 10 sleeping mats tested (DEHP in 1 product) 9 sneakers tested (DEHP in 1 product) 10 handbags tested (DEHP in 2 products, DBP in 1 product) Content analyses identified traces of bisphenol A (i.e. concentrations under quantification limit) in 6 cell phone covers made of polycarbonate plastic, also known as PC.
The content of triclosan and nonylphenol were analysed in antibacterial clothes and sneakers. No triclosan or nonylphenol were identified in the analyses (including nonylphenolethoxylates with up to approx. 4 ethoxylate units in the chain).
The content of octamethylcyclotetrasiloxane (D4) was analysed in cell phone covers, work gloves, sneakers, antibacterial clothes and cosmetic products. The substance was only identified in cosmetic products. In 10 out of 15 cosmetic products a content of D4 above the detection limit was identified.
Migration tests with sweat simulators were performed. None of the phthalates DEHP or DiNP, or bisphenol A migrated out of the products under the used conditions – not even in trace amounts. Migration analyses were not performed for triclosan and nonylphenol/nonylphenolethoxylates, as the quantitative analyses did not find any content of these substances. Migration analyses were not performed for D4, as no products apart from cosmetic products contained D4. For the cosmetic products a migration analysis is irrelevant, as the products are applied directly onto the skin. A dermal absorption factor is used instead in the subsequent exposure assessement, to estimate the amount of D4 expected to be absorbed through the skin.
A hazard assessment of the selected chemical substances was performed in order to determine the no or lowest adverse effect levels (NOAELs or LOAELs) of the substances based on their endocrine disrupting effect in laboratory animals. These were used both to assess the risk from exposure to each substance, and to calculate the combined risk from exposure to a group of substances with the same mode of action.
The exposure of pregnant women to the selected substances was assessed using a basis scenario, and with different other inputs to exposure such as a holiday scenario and a work scenario. The scenarios were divided into a medium and a maximum exposure respectively, with the approach that the exposure is evened out over a week’s exposure, as the project assesses exposure for pregnant women. In the pregnancy period it is important to focus on a very short exposure period because of the several short critical windows of exposure, where the fetus is very vulnerable to endocrine disrupting effects, as shown in animal studies.
Medium exposure describes a situation, which many in the target group is expected to experience, i.e. a realistic scenario, whereas the maximum exposure describes a situation expected to be experienced by fewer in the target group, i.e. a realistic worst case scenario.
The starting point has been the available information and an estimate of which products a pregnant woman is expected to use during a week. A lot of women may use the products in other ways than described here, but the assumptions are made to be able to calculate an estimated exposure. Even though some of the assumptions in the scenarios may not cover all the women in the target group, it should be kept in mind that other women in the target group may also use other products not included here, but which may contain the selected substances and thereby add to the total exposure.
The basis scenario includes exposure to food, indoor environment and the activities normally practiced in daily life, and includes contributions from toothbrushing, footwear/clothing, use of cream (including pregnant belly cream and body lotions), sex toys, bath soaps, bath mats etc. as well as sport, leisure and shopping. The exposure assessments are based on available data, i.e. for the consumer products, contributions from products with available migration data are included (e.g. oilcloth, pilates ball, rucksack, bath soap packaging and plastic sandal). Consequently, the exposures do not cover the contribution from all consumer products, which the target group is expected to be in contact with in daily life.
Apart from the basis scenario, an exposure in connection to a holiday scenario is estimated, where mainly the contribution from sunscreens is included in the assessment, a work scenario, where a risk of exposure from a few consumer products, such as hand cream and plastic sandals used by health staff and cashiers in work scenarios, is estimated. Also a risk from indoor environment in cars is estimated in a transport scenario.