Registration Dossier

Endpoint:

monitoring data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Very complete review article considering reliability of each data cited.

Principles of method if other than guideline:

Measured concentrations of the bis(-2-ethylhexyl) phthalate in twelve environmental media were compiled and analyzed succesively in 2003 and updated in 2009. These references constitutes a meta-analysis of available reliable environmental data.

GLP compliance:

not specified

Type of measurement:

background concentration

Media:

other: Surface water, ground water, drinking water, sediments, soil, Air, dust, vegetation, waste water, sludge, rain water and food

Details on sampling:

No data

Details on results:

cf remarks on results for detailled results

Surface water:

In 2003, the calculated mean concentrations for Europe was 0.93 µg/L (n=397). At that time, the detection limits for European data was more than an order of magnitude lower than the lowest Canadian detection limit. The maximum concentration measured in Europe was 50 µg/L. In 2009, the data including also the data of 2003 established an European mean concentration of 0.75 µg/L (n= 1298) and a maximim concentration in Europe of 97.8 µg/L.

Ground water:

In 2003, the database for ground water was considerably more limited compared to that of surface water. The mean concentration for Europe was 0.26 µg/L (n=9 ), which was comparable to the Japan/Asian calculated mean concentration of 0.79 µg/L. In 2009, the update concluded this mean is at 1.7 µg/L (n= 11).

Drinking water:

Although considerably less data were available for the European region, the European maximum concentration was 3.5 µg/L in 2003. In 2009, the mean concentration was established at 0.59 µg/L (n=233).

Sediment:

The mean concentration in sediment was established in 2003 as the highest in Europe and at 4.9 mg/Kg (n=405). In 2009, this value decreased to 4.4 mg/Kg (n= 477).

Soil:

Very little data are available for DEHP measured in soil in 2003. Of the data referenced, DEHP concentrations in soil are higher in Europe with a mean concentration of 48 µg/Kg (n= 3). The maximum reported concentration was at 5100 µg/Kg. In 2009, more values had been generated and the mean concentration decreased to 26 µg/Kg (n= 161).

Air:

In general, measured indoor concentrations were higher than concentrations outdoors in 2003 and still in 2009. The mean indoor air concentration was established at 245 ng/m³ (n=26) in 2003 and 363.6 ng/m³ (n=214) in 2009.

Dust:

In 2003, Europe reports concentrations ranging between 2000 µg/Kg and 4.58x E+06 µg/Kg, with a mean of 662 mg/Kg (n= 55). In 2009, this value was re-estimated to 930 mg/Kg (n= 1110).

Food:

DEHP concentrations measured in food were the most extensive of all the phthalates reported in 2003. So far new data have yet been generated. However, there are insufficient food data to prepare a summary by region. DEHP concentrations measured in the various food groups reveal the highest mean concentration for fats and oil (4.1 µg/g and 3.2 µg/g in 2003 and 2009 respectively). In 2003, the highest maximum concentrations were in fish (32 µg/g) and "other foods" (25 µg/g). It should also be noted that the data have not been separated by year of sampling , although it should be noted that food processing practices may have changed since the the time of sampling. In 2009, further data had been generated but no clear pattern is drawn. However, a clear general increase can be noticed between the two reports. This trend could be explained by the inclusion of old data compared with the report from 2003.

Waster water:

The comparative results of DEHP measured in various waste waters, including industrail effluents and influents, leachates, and storm water have been compiled together. The maximum mean concentration was calculated for Europe at 34.4 µg/L (n= 76) and 30 µg/L (n= 428) in 2003 and 2009 respectively.

Leachate:

In 2009, a mean concentration of 61 µg/L (n=23) was reported for the content of several landfill leachates (at least 20 different landfills across Europe).

Sludge:

The majority of the reported data for sludges and composts are available from Europe and Canada. The maximum mean concentration calculated for Europe was established at 53,000 µg/Kg (n= 62) and at 58,594 µg/Kg (n= 225) in 2003 and 2009 respectively.

Rain water:

The highest calculated mean concentration was established for Europe in 2003 at 14 µg/L (n= 4). The highest maximum concentration was also measured in Europe at 54 µg/L.

In the following tables, the results of both Clark reviews are compiled and summarized:

Medium		Concentration												No. Data points
		Mean		Minimum		Maximum		10 th Percentile		Median		90 th Percentile		No. Data points
		2003	2009	2003	2009	2003	2009	2003	2009	2003	2009	2003	2009	2003	2009
Surface water (µg/L)		0.93	0.75	< 0.008	0,00052	50	97,8	0.018	0.024	0.21	0.3	1.9	2.3	397	1298
Ground water (µg/L)		0.26	1.7	< 0.07	< 0.07	1.4	10.9	0.19	0.31	0.67	1.2	1.1	8.8	9	11
Drinking water (µg/L)		NA	0.59	0.18	< 0.002	3.5	50	NA	0.019	NA	0.18	NA	8.9	NA	233
Sediments (mg/Kg)		4.9	4.4	0.0001	0.0001	487	487	0.019	0.021	0.29	0.28	8.2	8.2	405	477
Soil (µg/Kg)		48	26	4	< 0.5	5100	5100	29	12	50	22	66	75	3	161
Air (ng/m³)
	Outdoor	21.9	15	0.28	0.046	1090	1090	1.3	1.0	17.5	11	126	71	85	203
	Indoor	245	363.6	18	0.3	1046	2400	20	3.9	111	15	398	406	26	214
Dust indoors (mg/Kg)		662	930	2	0.5	4580	29400	36.7	124	471	600	2090	1630	55	1110
vegetation (µg/Kg dry wt.)		NA	127	1200	65	11300	11300	NA	NA	NA	NA	NA	NA	NA	20
Waste water (µg/L)		34.4	30	0.068	< 0.026	1800	4100	0.23	0.25	1.74	6.2	53	64	76	428
Sludge (mg/Kg)		53.1	58.6	0.9	0.002	2600	2600	14	13.5	48	49	160	161	62	225
Rain water (µg/L)		14	2.3	0.0083	0.0083	54	54	0.43	0.42	0.85	0.85	38	29	4	126
Food (µg/g)
	Beverages	0.077	0.044	0.006	<0.00004	1.7	1.7	0.015	0.008	0.043	0.032	0.15	0.12	72	172
	Cereal	0.53	0.53	0.02	0.02	1.7	1.7	0.032	0.032	0.05	0.05	1.3	1.3	5	5
	Dairy (excl. Milk)	1.5	1.4	0.059	0.04	16.8	16.8	0.076	0.07	0.96	0.75	2.5	2.2	107	119
	Eggs	0.21	0.29	< 0.01	< 0.01	0.6	0.6	0.019	0.019	0.12	0.12	0.47	0.47	4	5
	Fat & oils	4.1	3.2	0.7	< 0.053	11.9	11.9	1	0.2	2.4	1.9	4.6	4.7	36	67
	Fish	0.46	0.26	0.00005	0.00005	32	34,1	0.001	0.0002	0.02	0.018	1.3	1.3	64	406
	Fruits	0.03	0.035	< 0.02	< 0.02	0.11	0.12	0.02	0.02	0.002	0.02	0.062	0.07	15	18
	Grains	0.5	2.6	< 0.1	<0.029	1.5	29.3	0.05	0.05	0.14	0.18	1.1	5.1	11	28
	Meat	0.35	0.36	< 0.01	< 0.01	0.8	0.8	0.05	0.05	0.05	0.13	0.75	0.71	27	32
	Milk	0.08	0.076	< 0.005	< 0.002	1.4	1.4	0.01	0.015	0.035	0.03	0.14	0.14	108	168
	Nuts & beans	0.21	0.21	< 0.08	< 0.08	0.8	0.8	0.045	0.045	0.045	0.045	0.27	0.27	6	6
	Other foods	0.28	0.48	< 0.01	< 0.01	25	25	0.005	0.006	0.05	0.08	1.3	1.4	63	87
	Poultry	1.1	4.5	0.05	0.05	2.6	16.9	0.25	0.31	0.9	0.9	2.2	8.8	4	8
	Processed meat	0.94	1.61	< 0.1	< 0.1	4.32	16	0.11	0.14	0.45	0.5	1.9	2.3	25	31
	Vegetables	0.17	1.69	0.0098	0.03	2.2	22.8	0.045	0.045	0.048	0.085	1.1	3.9	84	46
	Infant formula- powder Infant, only for 2009		0.25		< 0.012		0.98		0.006		0.13		0.56		95
	Infant formula- formula-liquid, only for 2009		0.009		< 0.004		0.15		0.006		0.006		0.012		11
	Infant formula - total only for 2003	0.007		< 0.005		0.15		0.006		0.006		0.007		9
	Breast milk	0.062	0.148	0.01	0.00045	0.6	2.92	NA	0.02	0.062	0.06	NA	0.18	10	138
	Baby food	0.12	0.12	0.01	0.01	0.6	4.25	0.039	0.039	0.12	0.12	0.23	0.23	16	16

Conclusions:

The authors of this review compiled and summarized measured concentrations of the DEHP in different compartments in 2003 and in 2009 as an update. Over the time, the authors have updated the figures and showed the reported concentrations vary widely as a result of several factors including analytical error, sample contamination and proximity to a variety of past and present sources. However, for a specific media, the concentrations are within the same range and generally at rather low levels. Nonetheless, It is at this level impossible to conclude generally over a potential increase or decrease of emissions of DEHP in the environment. Further analysis of these meta-data should be undergone per media and further investigation sould be done to check wether no bias have been introduced in the development of this database.

Executive summary:

In these reviews, numerous data sources have been reviewed to determine the ranges and distributions of the DEHP in the environment. These data have meanwhile been compiled in a database. Indeed, on behalf of the Environmental Research Task Group (ERTG) of the Phthalate Esters Panel of the American Chemistry Council (ACC), BEC Technologies Inc. was contracted to update the ACC database containing measured concentrations of phthalate diesters and monoesters in various media.

So far, a first compilation of data was produced by Exxon Mobil Biomedical Sciences Inc. (EMBSI) for five phthalate esters including the test substance in 2003. The data were categorized by EMBSI into regions including Canada, United States, Europe and Japan/Asia. The data were besides categorized by EMBSI in terms of data quality. This database was then regularly updated by including all new reliable data. The last available update was published in 2009.

In this version, the geographic distribution of papers identified for review in this update for the European zone could be summarized as follows (number of papers reviewed shown in parentheses): Italy (7); Spain (5); Germany (4); Netherlands (3); Denmark (2); France (2) Bulgaria (1); Czech Republic (1); Finland (1); Greece (1); Sweden (1); and Switzerland (1). Furthermore, the distribution of papers for which data were added to the ACC database in the current update, by medium, can be summarized as follows (number of papers shown in parentheses): human milk (2), and phthalate diesters in food (9), wastewater (9), drinking water (7), surface water (6), sludge (5), soil (4), sediment (3), air (1), dust (1), groundwater (1), rainwater (1), and vegetation (1).

In the following paragraphs, available data in these reviews are presented per media:

Surface water:

In 2003, the calculated mean concentrations for Europe was 0.93 µg/L (n=397). At that time, the detection limits for European data was more than an order of magnitude lower than the lowest Canadian detection limit. The maximum concentration measured in Europe was 50 µg/L. In 2009, the data including also the data of 2003 established an European mean concentration of 0.75 µg/L (n= 1298) and a maximum concentration in Europe of 97.8 µg/L.

Ground water:

In 2003, the database for ground water was considerably more limited compared to that of surface water. The mean concentration for Europe was 0.26 µg/L (n=9 ), which was comparable to the Japan/Asian calculated mean concentration of 0.79 µg/L. In 2009, the update concluded this mean is at 1.7 µg/L (n= 11).

Drinking water:

Although considerably less data were available for the European region, the European maximum concentration was 3.5 µg/L in 2003. In 2009, the mean concentration was established at 0.59 µg/L (n=233).

Sediment:

The mean concentration in sediment was established in 2003 as the highest in Europe and at 4.9 mg/Kg (n=405). In 2009, this value decreased to 4.4 mg/Kg (n= 477).

Soil:

Very little data are available for DEHP measured in soil in 2003. Of the data referenced, DEHP concentrations in soil are higher in Europe with a mean concentration of 48 µg/Kg (n= 3). The maximum reported concentration was at 5100 µg/Kg. In 2009, more values had been generated and the mean concentration decreased to 26 µg/Kg (n= 161).

Air:

In general, measured indoor concentrations were higher than concentrations outdoors in 2003 and still in 2009. The mean indoor air concentration was established at 245 ng/m³ (n=26) in 2003 and 363.6 ng/m³ (n=214) in 2009.

Dust:

In 2003, Europe reports concentrations ranging between 2000 µg/Kg and 4.58x E+06 µg/Kg, with a mean of 662 mg/Kg (n= 55). In 2009, this value was re-estimated to 930 mg/Kg (n= 1110).

Food:

DEHP concentrations measured in food were the most extensive of all the phthalates reported in 2003. So far new data have yet been generated. However, there are insufficient food data to prepare a summary by region. DEHP concentrations measured in the various food groups reveal the highest mean concentration for fats and oil (4.1 µg/g and 3.2 µg/g in 2003 and 2009 respectively). In 2003, the highest maximum concentrations were in fish (32 µg/g) and "other foods" (25 µg/g). It should also be noted that the data have not been separated by year of sampling , although it should be noted that food processing practices may have changed since the the time of sampling. In 2009, further data had been generated but no clear pattern is drawn. However, a clear general increase can be noticed between the two reports. This trend could be explained by the inclusion of old data compared with the report from 2003.

Waster water:

The comparative results of DEHP measured in various waste waters, including industrail effluents and influents, leachates, and storm water have been compiled together. The maximum mean concentration was calculated for Europe at 34.4 µg/L (n= 76) and 30 µg/L (n= 428) in 2003 and 2009 respectively.

Leachate:

In 2009, a mean concentration of 61 µg/L (n=23) was reported for the content of several landfill leachates (at least 20 different landfills across Europe, mainly domestic).

Sludge:

The majority of the reported data for sludges and composts are available from Europe and Canada. The maximum mean concentration calculated for Europe was established at 53,000 µg/Kg (n= 62) and at 58.6 µg/Kg (n= 225) in 2003 and 2009 respectively.

Rain water:

The highest calculated mean concentration was established for Europe in 2003 at 14 µg/L (n= 4). The highest maximum concentration was also measured in Europe at 54 µg/L.

Reported concentrations of phthalate esters may vary widely, depending on the proximity of the samples to past and present sources. In addition, there are variability in the reported concentrations due to analytical error and sample contamination. The influence of analytical error and contamination on the accuracy and reliability of the recorded values is partially accounted for by using a data quality ranking; however, data were not eliminated due to a lack of information concerning sampling or analytical methods. The overall mean, presented in the summary tables, is a weighted average (weighted by the number of samples) of the mean of each study. Note that the median, 10^thpercentile, and 90^thpercentile values included in the summary tables were calculated using the means of the individual studies and not the individual data points.

Finally, for a specific media, the environmental concentrations are within the same range and generally at rather low levels over the investigated period. Nonetheless, It is at this level impossible to conclude generally over a potential increase or decrease of emissions of DEHP in the environment. Further analysis of these meta-data should be undergone per media and further investigation sould be done to check wether no bias have been introduced in the development of this database.

So far, this meta-analysis of available data is the best documented and reliable source of data for environmetal emissions for Europe. The statistics seem robust and the approach for including data in the database is comprehensive and assumed to be reliable with restrictions, since klimisch 4, not assignable data, are included. Also, the extent of researches and the number of samples for each media are assumed to insure the representativity of these data for the european area. Hence, this study should be considered as reliable with restrictions, a study well documented, meeting generally accepted scientific principles and thus acceptable for assessment.