Registration Dossier

Environmental fate & pathways

Monitoring data

Currently viewing:

Administrative data

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.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Report on update to the phthalate ester concentration database - 2009
Author:
Clark K.
Year:
2009
Bibliographic source:
ACC reference No. PE-143.0-FIN-BEC Amendment 7
Reference Type:
review article or handbook
Title:
Observed concentrations in the environment
Author:
Clark K., Cousins I.T., Mackay D. and Yamada K.
Year:
2003
Bibliographic source:
The Handbook of environmental chemistry, 3, Q, 125-177.

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Study design

Details on sampling:
No data

Results and discussion

Details on results:
cf remarks on results for detailled results

Any other information on results incl. tables

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
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

Applicant's summary and conclusion

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, 10thpercentile, and 90thpercentile 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.