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

3 Selected substances and products

This chapter explains the inclusion and exclusion of the substances and products which will be the focus of the rest of the project. In addition, a 2 year-old’s possible exposure to other potential endocrine disrupters, allergens and substances with classifications for other harmful health effects. This is performed through a literature review, screening analyses of consumer products, and use of (Q)SAR models.

3.1 Quantitative risk assessment of potential endocrine disruptors

Focus for the quantitative risk assessment in this project is the 2 year-old’s total exposure to substances with potential endocrine disruptive properties, including anti-androgenic substances and oestrogen-like substances. Cumulative risk assessment of substances with endocrine disruptive properties is, according to the Danish Environmental Protection Agency, both possible and necessary (Kortenkamp, 2009). The report also points out that the dose addition method can be used to calculate cumulative effects. This method is used in this project and described in greater detail in Chapter7. In order to utilise this method, it is necessary to know the substances’ NOAEL (No Observed Adverse Effect Level) or LOAEL (Lowest Observed Adverse Effect Level) values. It is therefore a prerequisite that there are reliable animal studies on anti-androgens or oestrogen-like effects for substances included in the quantitative risk assessment. One of the criteria for selection of substances for risk assessment in this project has been a known endocrine disrupting effect of the substances from animal studies. Another criterion has been anticipated exposure of the 2 year-old child to the substances through food products, indoor climate or consumer products. The substances selected are the following:

Antiandrogens:

  • 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)
  • Tebuconazol (107534-96-3)
  • Linuron (330-55-2)
  • Vinclozoline (50471-44-8)
  • Procymidon (32809-16-8)
  • PCBs (poly-chlorinated-biphenyls)
  • Dioxins
  • DDTs/DDDs (dichloro-diphenyltrichloroethane/dichloro-diphenyldichloroethane).

Oestrogen-like:

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

These substances were selected because they are believed to account for a significant part of the 2 year-old’s exposure to potential endocrine disruptors. It has also been a condition that there is data concerning the exposure/migration of these substances from consumer products, food products and/or indoor climate.

The phthalates DEHP, DINP, DBP, DIBP and BBP occur in consumer products. They have been identified in screenings of consumer products in this project and in the Danish Environmental Protection Agency’s previous surveying projects. In addition, some phthalates are used in materials and objects that come into contact with food products. They are also found in food products as a result of environmental pollution. The pesticides prochloraz, tebuconazole, linuron, vinclozoline and procymidone may occur as food product contaminants. PCBs, dioxins and DDTs occur in food products as a result of environmental pollution. PCBs are also found in our indoor climate. Parabens occur in cosmetics, and finally, bisphenol A is found in products of the plastic type polycarbonate, and also exists as an environmental contaminant.

In addition to the substances prioritised above, DEP (diethylphthalate), propiconazol, perfluorinated and polyfluourinated compounds, organotin compounds and the UV filters 3-benzylidene camphor and 2-ethylhexyl-4-methoxycinnamate were also studied initially, but were deselected during the surveying process. DEP and propiconazole were excluded because no animal studies revealed sufficient evidence for their endocrine disruptor effects. Perfluorated and polyfluorated compounds were identified in the analyses in this project, but were excluded due to insufficient data for migration of these substances (these analyses could not be performed). Organotin compounds were excluded because they were not identified in the migration analyses of the selected products, and the two UV filters were excluded as these UV filters were only used in two sunscreen lotions for children purchased in the autumn of 2008. Furthermore, the two manufacturers of these sunscreen lotions state that they would not use these UV filters in the products to be sold in 2009.

3.2 Exposure to other substances with potentially harmful effects

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.

3.3 Literature review

The Danish Environmental Protection Agency’s previous surveying projects and certain other sources have been reviewed for potential endocrine disruptors and allergens. The results of these reviews are described in sections 0 and 3.11.

3.4 Selection of products for screening

Selection of products for survey and chemical analysis was made on the basis of the following criteria:

  • There must be a frequent/lasting use of the product for the 2 year-old (the results from CASA’s working paper for the Danish Environmental Protection Agency are included).
  • There is an assumption that there are potential endocrine disruptors in the products.
  • The 2 year-old must be exposed to these substances (through ingestion, inhalation, or contact).
  • There is something to report for each individual reporting arena (see below).

3.4.1 Reporting arenas

In the following, reference is made to a series of reporting arenas. The arenas mentioned below are those that were used as a starting point for the selection of product groups for survey. The arenas used in the information campaign, etc. are therefore not identical with those mentioned here.

Review of previously completed investigations of consumer products divided by arena is given in Table 3.1.

Table 3.1 Overview of number of products studied by the Ministry of the Environment’s survey projects and related arenas of reporting

Arena of reporting Number of products investigated distributed by arenas of reporting1 Number of products investigated - containing relevant substances only2
1: Good morning - child is dressed, eats breakfast and brushes teeth etc. 22 15
2: On the way to day-care 14 13
3: Day-care - inside 82 59
4: Day-care - outside 17 17
5: Back home - playing in the child's room 101 69
6: Children’s TV programmes in sitting room 18 15
7: Evening meal in kitchen 14 12
8: Bathtub 25 21
9: Goodnight - bed in the child’s room 25 18

112 products fit into all arenas.
211 products fit into all arenas.

This illustrates that it is largely only reporting arenas 3 and 5, the indoor arenas which include use of toys that are well covered, in that there were many products that were investigated.

Previous surveys were used as the starting point, with the understanding that some of the results will be out of date as a result of new legislation. This applies to toys, for example, where 6 phthalates are now prohibited. Results that are not in compliance with applicable legislation were sorted out if possible when processing the results further.

If we are able to conclude something on all of these reporting arenas, it is therefore also important that the new product types that are mapped cover these slightly “weaker” reporting arenas:

  • 2: On the way to day-care
  • 4: Day-care - outside
  • 6: Children’s TV programmes in sitting room
  • 7: Evening meal in kitchen.

The final 12 products were selected for study based on the selection criteria. Many toy products in particular were ruled out, as there has been an EU ban on 6 of the most commonly used phthalates in toys and childcare articles since 2007. It is therefore expected that children are not exposed to phthalates with endocrine disrupting effects from toys and childcare articles.

Screening analyses were performed on 10 of the 12 product groups that were investigated further. The 12 selected product groups are:

  • Jackets
  • Mittens
  • Rubber clogs
  • Rubber boots
  • Pacifiers
  • Soap containers
  • Non-slip figures and bath mats
  • Soft toys
  • Diapers
  • Bed linen
  • Sunscreen
  • Moisturising cream/oil-based cream/lotion.

No analyses were performed for the last two product groups, namely sunscreen and moisturising cream/oil-based cream/lotion. Instead a list of ingredients and permitted use of the selected substance in the products were used in exposure assessments.

3.5 Screening results

Screening analysis of the 10 product groups identified more than 175 different substances. For 21 of these substances it was not possible, based on the screening, to perform a unique identification of the substances, i.e. the substances were not identified with a CAS number. Some of the individual substances also cover, for example, the total of aliphatic hydrocarbons or similar, and for some substances more than one possible CAS number was identified.

Table 3.2 presents the substances identified in the screening analyses in this project. The table indicates whether the substances are classified on the List of hazardous substances (List of Harmonised Classification, which is currently (March 2009) identical to the List of Hazardous Substances), the Danish Environmental Protection Agency’s guidelines list to self-classification of hazardous substances (Danish Environmental Protection Agency, 2001) or the EU candidate list of potential endocrine disruptors. A Tier 1 exposure calculation was then performed using the procedure described in REACH.

The table presents the substances sorted by the worst case exposure concentration (Tier 1) to which the 2 year-old could be exposed from the products examined.

3.6 Tier 1 exposure assessment

A Tier 1 exposure assessment is based on the measured values and the assumption of full migration and full absorption, i.e. 100%.In all cases it is assumed that all the substance in the product migrates instantaneously and is absorbed into the body (whether by sucking or through dermal contact). In other words, the Tier 1 calculations are an expression of the maximum possible exposure to which the two year-old may be subject under the given conditions. For individual products it is, however, assumed that the child sucks on or has contact with a small part of the product, such as bath mats and soap containers, for example. This factor fandel is therefore included in the calculation. Allowance is also made for the fact that far more diapers than jackets are used in a year, for example. A multiplication factor n is therefore used (n=number of products used per day). On this basis, a worst case exposure is calculated as mg/kg body weight per day.

The calculations are made using the following formula:

Click here to see The Calculations

For highly volatile substances, such as formaldehyde, which can be inhaled, the same formula is used, as it is assumed that all the substance in the product is instantaneously evaporated and inhaled by the 2 year-old.

For each substance, the values for all the different products are summated, because the two year-old is exposed to DEHP via jackets, mittens, rubber clogs, pacifiers, soap containers and bath mats.

The parameters and assumptions that are used in the Tier 1 calculations are stated in the report segment on analyses and reproduced here:

  • The weight of a 2 year-old is as the worst case set to 10.3 kg (minimum weight for 2 year-old girls).
  • Jackets: The maximum measured value for each substance is used, and an estimate is made of how large a part of the total weight of the product, the outer material or a zipper strap, for example, would constitute. Two jackets per year were used and it was assumed that 100% of the measured values from the jacket were absorbed:
  • Mittens: The maximum measured value for each substance is used and an estimate is made of how large a part of the total weight of the product, the outer material or a Velcro strap, for example, would constitute. 2 pairs of mittens per year were used and it was assumed that 100% of the measured values from the mittens were absorbed:
  • Rubber clogs: The maximum measured value for each substance was used and the total weight for a pair of rubber clogs was used, (i.e. the weight of one shoe was doubled). Two pairs of clogs per year were used and it was assumed that 100% of the measured values from the clogs were absorbed:
  • Rubber boots: The maximum measured value for each substance was used and the total weight for a pair of rubber boots was used, (i.e. the weight of one boot was doubled). 2 pairs of rubber boots per year were used and it was assumed that 100% of the measured values from the boots were absorbed
  • Pacifiers: The maximum measured value for each substance is used and it is estimated that the nipple constitutes 20% of the pacifier’s total weight. 12 pacifiers per year were used and it was assumed that 100% of the measured values from the pacifier were absorbed:
  • Soap containers: The maximum measured value for each substance was used and it was assumed that the two year-old touches or sucks on a maximum of 10% of the product. An exposure of only 10% of the content in the products is therefore calculated. Two soap containers per year were used.
  • Bath mats: The maximum measured value for each substance was used and it was assumed that the two year-old touches or sucks on a maximum of 10% of the product. 1 bath mat was used every 2 years.
  • Soft toys: The maximum value for each substance was used and it was assumed that all the evaporated material is inhaled and everything that was in the soft toy was absorbed (2 year-old sucks, squeezes and touches the soft toy over the entire object). 5 soft toys per year were used and it was assumed that 100% of the measured values from the soft toys were absorbed:
  • Diapers: The maximum measured value for each substance was used and it was assumed that primarily the materials from the filling, elastic/vlieseline and interior waistband were absorbed. Values that are only measured in the stretch closure and the print edge are, however, also included if the substance is not measured in other parts of the diaper. Five diapers per day were used and it was assumed that 100% of the measured values from the diapers were absorbed:
  • Bed linen: The maximum measured value for each substance was used and it was assumed that all the substance in the bed linen was absorbed, even if the bed linen has two sides and not all the substance came into contact with the skin. Area of the pillowslip was also included. Two sets of bed linen per year were used and it was assumed that 100% of the measured values from the bed linen were absorbed

In other words, the Tier 1 calculations accounted for the amount of the substance in the product, how often the 2 year-old is in contact with the product, and how great a part of the product the 2 year-old is in contact with. The substance with the highest Tier 1 exposure amount is DINP, which is therefore listed first in Table 3.2.

Table 3.2 Substances identified in the screening analyses performed for the 10 consumer products in this project. It is stated if the substances are classified in accordance with the list of hazardous substances or the Danish Ministry of the Environment’s self-classification, and if the substances are on the EU candidate list of potential endocrine disruptors

Click here to see Table 3.2

3.7 Identified substances with potential endocrine disrupting properties

Eleven of the substances identified in the product screening are on the EU’s candidate list of suspected endocrine disruptors because they have shown signs of endocrine disrupting effects or are suspected of having such effects. These are:

  • DINP (Group 2[9], DG Environment, 2007)
  • DEHP (Group 1[10], DG Environment, 2007)
  • DBP (Group 1, DG Environment, 2007)
  • DIBP (Repr. Cat. 2; R61- Repr. Cat. 3; R62, EU, ESIS, 2009)
  • Bisphenol A (Group 1, DG Environment, 2007)
  • Polyfluoro compounds (Nordström Joensen et al, 2009)
  • Tert Butylphenol (98-54-4) (Group 2, DG Environment, 2007)
  • Dichloraniline (95-76-1)(Group 2, DG Environment, 2007)
  • Diglycidyl bisphenol A(1675-54-3)(Group 2, DG Environment, 2007)
  • Styrene (100-42-5) (Group 1, DG Environment, 2007).

The substances in italics are not included in the exposure calculations in this project. Common to these substances is the fact that they are exclusively identified in textile products, i.e. jackets, mittens and bed linen, and are measured in relatively small concentrations.

3.8 Literature review of endocrine disruptors

Previous surveying projects by the Danish Environmental Protection Agency also identified the following substances suspected of endocrine disrupting effects in products of relevance for 2 year-old children.

  • BBP (in vinyl flooring and modelling wax)
  • Dimethylformamide (68-12-2) (Group 3[11], DG Environment, 2007) (in tents and tunnels for children).

Of these substances, BBP is a focus substance in the exposure calculations included in this project.

Furthermore, two year-old children can be affected by endocrine disruptors from medicinal products and medical devices, which can constitute a considerable exposure. These sources, however, are not included in the exposure calculations for this project, partly because this type of exposure is only expected to affect a small number of children and partly because the exposure is considered to be necessary in all cases in which it occurs.

3.9 (Q)SAR predictions for substances with potential endocrine disrupting effects

Substances included in the cumulative risk assessment are chosen on the basis of prior knowledge of their effects. Animal studies have demonstrated that they have an endocrine disrupting effect.

However, many chemical substances are not tested on animals for their endocrine disrupting effects. We cannot therefore exclude that they have these effects. In recent years, a number of computer models have been developed, which can predict the properties of chemical substances on the basis of their structure ((Q)SAR: (Quantitative) Structure Activity Relationships).

(Q)SAR predictions from two different models have been used to identify whether some of the substances found in the screening, which had not previously been identified as having endocrine disrupting effects, do in fact have them (Jensen et al, 2008)

  • Oestrogen reporter gene activation in in-vitro experiments
  • Antagonism of androgen receptor activation in in-vitro experiments

The QSAR models used predict whether the substances have oestrogen-like or antiandrogenic effects in in-vitro (test tube) experiments, in which it is not possible to imitate the metabolism of chemical substances that occurs in the body. In these models, the substances are characterised as either positive or negative.

A (Q)SAR model is developed on the basis of the results of experiments on concrete chemical substances in the test for which the model is designed. The substances in this test are called the "training set”. The model can then be used to predict the effects of substances that appear similar to the chemicals in the training set. Among other things, the applicability of a model depends on how many different types of substance are tested. The prediction of the model is therefore always accompanied by an assessment of whether the substance, the effect of which is being tested, resembles the substances in the training set enough to be a reliable indicator, i.e. that the predictions of the model lie within its applicability domain. This analysis uses only reliable predictions.

Substances tested in vitro have the same uncertainties associated with this type of data. For example, bio-accessibility, absorption and metabolism are not included in in vitro experiments, but can be of crucial importance in terms of the harmful effects of substances on living organisms. Furthermore, it is not known whether the positively predicted substances have been tested on animals. It is therefore difficult to assess their potential potency and endocrine disrupting effects in humans. These are important parameters that enable prediction of the endocrine disrupting effect of the substances in humans.

The above reservations in terms of in vitro data also apply to (Q)SAR predictions as the models used to predict in vitro effects. There is also an element of uncertainty with (Q)SAR predictions. The model’s sensitivity, i.e. its ability to predict positive results correctly, and specificity, i.e. its ability to predict negative results correctly, are two important parameters to take into consideration when assessing the applicability of (Q)SAR models (see REACH guidelines R6: (Q)SARs and grouping of chemicals). However, there are no hard and fast rules for how high these figures can be – this depends completely on the context in which the models are to be used. Similarly, (Q)SAR model predictions should only be used within the applicability domain. Table 3.3 shows the two models together. Sensitivity and specificity are reached through repeated cross-validation of the models.

Table 3.3 Robustness of the (Q)SAR models

QSAR Model Number of chemical substances in training set Sensitivity Specificity
Oestrogen reporter gene 481 46.4% 94.9%
Androgen receptor antagonism 523 64.4% 84.2%

3.9.1 Procedure

The 177 chemical substances with CAS numbers that were identified in the screening analysis were tested in the latest version of the Danish (Q)SAR database in relation to the two models in the above table. Of the 177 CAS numbers, 22 were not found in the database and are therefore not included in this analysis.

3.9.2 Results

Using the (Q)SAR models, other substances were also identified, which could have endocrine disrupting effects, in addition to the substances already included in the cumulative risk assessment.

Of the 177 substances identified in the screening analysis, we had already included one of them in the cumulative risk assessment for oestrogen-like effects (bisphenol A) and 4 of them in the cumulative risk assessment for antiandrogenic effects (4 phthalates).

A given prediction also provides information on whether the substance was included in the training set, and whether it tested positive or negative. Thus, with some of the substances tested, there were model predictions available for their properties, as well as information on whether they were tested using the in vitro model and its result.

Using the (Q)SAR model, 6 substances were identified as potentially oestrogen-like (Table 3.4). Three of the substances were identified as potential anti-androgens (Table 3.5). Some of the substances were also tested in vitro because they were included in the training set.

3.9.3 Oestrogen-like effects

In the (Q)SAR model for oestrogen-like activity, six substances from the screening analysis tested positive. Three of these also tested positive in vitro and are therefore also included in the training set. In this project, only bisphenol A is included in the cumulative risk assessment for oestrogen-like activity.

Table 3.4. Substances with positive (Q)SAR predictions for oestrogen-like effects in in vitro experiments

CAS no. Name ER activisation in vitro
QSAR prediction
ER activisation in vitro
Test result
80-05-7 bisphenol A Positive Positive
2081-08-5 4,4-ethyldiphenol Positive Positive
106-46-7 1,4-dichlorobenzene Positive Positive
99-30-9 2,6-dichhloro-4-nitroaniline Positive Not tested
827-94-1 2,6-dibromo-4-nitroaniline Positive Not tested
36443-68-2 Irganox 245 Positive Not tested

Bisphenol A is already included in the cumulative risk assessment for oestrogen-like effects. In the screening analysis, 4,4-ethyldiphenol is found in bed linen prior to washing but not after. 2,6-dichloro-4-aniline and 2,6-dichloro-4-nitroaniline are found in jackets. Irganox 245 is found in diapers.

3.9.4 Antiandrogenic effects

In the model for antiandrogenic affects in the in vitro tests, three substances from the screening analysis tested positive. None of the substances were previously included in the cumulative risk assessment for antiandrogenic effects in this project.

Table 3.5. Substances with positive (Q)SAR predictions for anti-androigene effects in in vitro experiments

CAS no. Name Antiandrogenic in vitro
QSAR prediction
Antiandrogenic in vitro
Test result
80-05-7 bisphenol A Positive Positive
2081-08-5 4,4-ethyldiphenol Positive  
52829-07-9 Tinuvin 770 Positive  

In the screening analysis, bisphenol A was found in the plastic parts of children’s pacifiers, although the migration analysis shows no release of the substance from the pacifiers. Bisphenol A is in any case commonly found in foodstuffs. 4,4-ethyldiphenol was detected in bed linen before, but not after, washing. Tinuvin 770 was detected in children’s mittens.

3.9.5 Conclusion on (Q)SAR predictions

QSAR predictions show that in the selected in vitro experiments, many of the 177 chemical substances have, or can be predicted to have endocrine disrupting effects. The identified substances, which are not already included in the quantitative risk analysis, have not been further assessed for endocrine disrupting effects in animals. However, it would seem obvious to proceed in this direction in future analyses of endocrine disruptors.

3.10 Conclusion on the identification of substances with potentially endocrine disrupting effects

In conclusion, the screening analysis, review of relevant literature and the (Q)SAR predictions show that 2 year-old children can be expected to be exposed to a variety of potential endocrine disruptors over and above those chosen as the focus for the quantitative risk assessment in this project. No further risk assessment has been performed for any of the identified substances that were not originally included in the quantitative risk assessment. However, these findings should be taken into consideration in future studies,

3.11 Identified substances with allergenic effects

Thirty-three of the identified substances are classified as R42 (may cause sensitisation by inhalation), or/and as R43 (may cause sensitisation by skin contact), by the EU or have the Danish Environmental Protection Agency (DEPA) advisory classification for these effects.

  • Bisphenol A (EU classification R43)
  • Formaldehyde (EU classification R43)
  • p,p’-Diphenylmethane diisocyanate or Diphenylmethane diisocyanate (EU classification R42/43)
  • 2,4-Diisocyanato-1-methylbenzene (2,4-Diisocyanate toluene) (EU classification R42/43)
  • 2,5-Dichloraniline, 2,3-dichloraniline, or 1,4-dichloraniline (EU classification, R43)
  • Isophorondiisocyanate-1-methylbenzene or similar (EU classification R42/43)
  • Bisphenol A diglycidyl (EU classification R43)
  • Aniline (EU classification R43)
  • Toluene 2,4-Diisocyanate (EU classification R42/43)
  • 1,6-Disocyanatohexane (EU classification R42/43)
  • An unidentified isocyanate (EUclassification R42/43)
  • 2-Mercaptobenzothiazole (EU classification R43)
  • 2,4-bis (1-phenylethyl)-phenol (Danish Environmental Protection Agency (DEPA) advisory classification, R43)
  • Tert. Butylphenol (DEPA advisory classification, R43)
  •  Isocyanatobenzene (DEPA advisory classification, R43)
  • 2-Ethylhexyl fumarate (DEPA advisory classification, R43)
  • 2-Ethylhexyl maleate (DEPA advisory classification, R43)
  •  Oleamide (3-Amino-4-methoxy-N-phenyl-benzamide) (DEPA advisory classification, R43)
  • Melamine (DEPA classification, R43)
  • Kodaflex txib or similar (DEPA advisory classification, R43)
  • Hexadecyldimethylamine (DEPA advisory classification, R43)
  •  2,6-Dibromo-4-nitroaniline or 4,6-Dibromo-2-nitroaniline (DEPA advisory classification, R43)
  •  4-Chloro-2,5-dimethoxy-benzamine or 5-Chloro-2,4-dimethoxy-benzamine (DEPA advisory classification, R43)
  • 1-Methylnapthalene (and isomers) (DEPA advisory classification, R43)
  •  6-Chloro-2,4-dinitroaniline (DEPA advisory classification, R43)
  • 2,6-Dichloro-4-nitroaniline(DEPA advisory classification, R43)
  • Di-p-Tolyl sulfone (DEPA advisory classification, R43)
  • Isocyanatobenzene or 1H-Benzotriazol(DEPA advisory classification, R43)
  • 2-(Methylthio)benzothiazole (DEPA advisory classification, R43)
  • Phenoxybenzamine (DEPA advisory classification, R43)
  •  Salicylic acid benzoyl ester (DEPA advisory classification, R43) (one of the 26 allergen compounds in perfumes and aromas)
  • Limonene (EU classification R43) (one of the 26 allergenic compounds in perfumes and aromas)
  • Linalool (one of the 26 allergenic compounds in perfumes and aromas)

3.12 Literature review of allergens12

Previous surveys undertaken by the Danish Environmental Protection Agency and others1 into chemical substances in consumer products have produced a long list of allergens which can occur in cosmetic products. Below is a list of allergens identified in these surveys. Substance names written in italics have also been identified at screening of the ten product groups represented in this project.

  • 2,2,4-trimethyl-1,3-pentanediol diisobutyrate (TXIB) (R43)
  • 2,6-Dimethoxy Benzoquinone (R43)
  • 2-mercaptobenzothiazole (MBT) (R43)
  • 2-Propenenitrile (R43)
  • 2-Propenoic acid 2 methyl-methyl ester (R43)
  • 4-chloro-3-methylphenol (R43)
  • 4-Hydroxy-3,5-dimethoxy-benzandehyde (R43)
  • 4-Nonylphenol (R43)
  • Aniline (R43)
  • Benzothiazole (MBT) (R43)
  • Benzyl salicylate (2-hydroxybenzoic acid, benzyl ester) (R43)
  • Bisphenol A (R43)
  • Butylphenyl methylpropional (Lillial) (R43)
  • Chlormethyl and methylisothiazolones (Kathon) (R43)
  • Citral (3,7-dimethyl-2,6-octadienal) (R43)
  • D-Limonene (R43)
  • Formaldehyde (R43)
  • Hydroxycitronellal (3,7-Dimethyl-7-hydroxy octanal (R43)
  • IPPD (R43)
  • Isoeugenol (2-Methoxy-4-(1-propenyl)phenol) (R43)
  • Lilial (2-methyl-3-(4-tertbutylbenzyl)propionaldehyde) (R43)
  • Nickel (R43)
  • Nonylphenols (NP) (R43)
  • O-toluenesulfonamide (R43)
  • p-toluenesulfonamide (R43)
  • TXIB= 1,3-Pentanediol, 2,2,4-trimethyl-, diisobutyrate (R43).

Table 3.3 illustrates the types of consumer products in which the identified allergens have been identified.

Table 3.3 The allergens have been identified in the following consumer products.

Consumer products tested in this project Consumer products tested previously
Jackets
Mittens
Pacifiers
Bed linen
Rubber boots
Plasticine
Carpets
Textiles
Clothes
Air fresheners
Electrical and electronic products (computer game joysticks, computer screens, TV’s, transformers)
Toothbrushes
Tents and shelters
Cosmetic products (lip balm, soap, baby oils, massage oils, children’s’ shampoo, body shampoo for children, children’s soap, body lotion for children)
Toys (wooden toys, slimy toys, aromatic toys etc)
Baby changing mats/cushions
Felt-tip pens
Car interior care products
Impregnated textiles
Hobby paints
Books
Children’s make-up sets
Rubber pacifiers

The significance of exposure of 2 year-old children to allergens is not within the scope of this project even though, in general, children’s exposure to these substances should be reduced as much as possible.

3.13 Chemical substances identified in the screening with classification for other effects harmful to health

As can be seen in table 3.2 83 83 substances have been identified with the following general classifications, (according to the List of dangerous substances or The Danish Environmental Protection Agency’s advisory classification). Note that a substance can occur in more than one category:

  • Irritant, Xi (18 substances)
  • Harmful, Xn (25 substances)
  • Toxic, T (9 substances)
  • Very toxic, Tx (3 substances)
  • Dangerous for the environment, N (34 substances)
  • May coause sentitisation by inhalation and/or skin contact, R42 and/or R43 (33 substances)
  • Carcinogenic, Carc (10 substances)
  • Mutagenic, MUT (7 substances)
  • Toxic to reproduction, Rep (11 substances)

A number of products have been classified as irritants (Xi), harmful (Xn), toxic (T), or very toxic (Tx). The current project has not focused on these substances, although they quite probably occur in the products with which 2 year-olds come into contact. Many of the classified substances are either carcinogenic or mutagenic, a fact that is also supported by Danish Environmental Protection Agency surveys of the same target group. The concentrations contained in these products are often very small and it has not been within the scope of this project to determine whether these constitute a health hazard. Instead, the project has focused exclusively on their endocrine disrupting effects.


[9] Group 2: Potential for endocrine-like effect. In vitro data indicates potential for endocrine disruptor effects in intact organisms. Also includes in vivo effects that are, or are not, indirectly endocrine disruptor.

[10] Group 1: Clear indication of endocrine-like effect. At least 1 in vivo study shows a clear indication of an endocrine disruptor effect in an intact organism.

[12] As well as DEPA's earlier surveys of chemical substances in children’s toys, previous tests also include the Danish Consumer Council's test on toys, tests from TÆNK (DCC's magazine) and surveys on consumer products (clothes) undertaken by Greenpeace.

 



Version 1.0 November 2009, © Danish Environmental Protection Agency