Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

see below

Additional information

PECs at production and processing (1)

 

Exposure scenarios

 

The environmental exposure assessment of DBP will be based on the expected releases of the

substance during the following life cycle stages:

 

I. Production

II. Distribution (e.g. road transport)

IIIa. Processing in polymers

IIIb-1. Formulation in adhesives

IIIb-2. Processing/use of adhesives

IIIc-1. Formulation in printing inks

IIIc-2. Processing/use of printing inks

IIId. Processing of glass fibres

IIIe. Processing of grouting agents

IV. Exterior use of DBP containing products

V. Incineration and disposal of DBP containing products.

 

For most of these life cycle stages local Predicted Environmental Concentrations (PECs) were calculated based on either generic (TGD defaults) or site-specific scenarios. Results are presented in Table 3.1 and Table 3.2 for production and processing, respectively. Regional PECS are calculated to be 0.4 μg/l for water, 89 μg/kg for sediment, 0.006 μg/m3 for air and

0.01 mg/kg for soil.

 

In addition to these estimated PECs also a number of EU monitoring data are available for DBP in various environmental compartments (mainly water and sediment).

 

Table 3.1 Local PECs in the various environmental compartments at production

 

 

Site-spec. A

Site-spec. B

Site-spec. C

PECeffluent, STP (mg/l)

0.06

0.074(in μg/l)

0.09

PECsurface, water (μg/l)

3.6

1

6

PECair (μg/m3)

0.02

0.02

0.02

PECsediment (mg/kg)

0.5

0.1

0.8

PECsoil (mg/kg)

1.1

0.7.10-3

0.7.10-3

PEC oral, fish (μg/kg)

3.7

1.8

3.1

PEC oral, worm (mg/kg)

7.6

0.07

0.06

 

Table3.2  Local PECs in the various environmental compartments at formulation/processing

 

Scenario

IIIa

IIIb-1

III-b2

III-c1

III-c2

III-d

Type of application

Plasticizer in PVC

Adhesive

 

Printing inks

 

Fibres

PEC effluent STP(mg/l)

0.02

0.08

0.02

0.01

4.7.10-4

<2µg/l

PEC surfacewater(µg/l)

2.8

8.9

2.9

2.1

1.1

1

PEC air (µg/m3)

2.4

0.3

0.02

0.05

0.2

1

PEC sediment (mg/kg)

0.4

1.2

0.4

0.3

0.15

0.1

PEC soil (mg/kg)

0.4

1.5

0.4

0.2

0.01

0.003

PEC oral, fish (mg/kg)

0.003

0.008

0.003

0.003

0.002

0.002

PEC oral, worm(mg/kg)

2.5

10.2

2.5

1.5

0.1

0.1

 

(1) according:

European Union Risk Assessment Report dibutyl phthalate, Volume 29, pp. 7 -8 (2003)

Editors: B. G. Hansen, S.J. Munn, R. A/Ianou, F. Berthault, J. de Bruin, M. Luotamo, C. Musset, S. Pakalin, G. Pellegrini, S. Scheen S. Vegro.

Office for Official Publications of the European Communities, ISBN 92—894—1276—3

RISK CHARACTERISATION

General discussion

Table 3.3 and Table 3.4 present the local PEC/PNEC ratios for, respectively, the production and processing stages of DBP. Details will be discussed in Sections 3.3.2 through 3.3.4.

 

Table3.3   Local PEC/PNECs in the various compartments at production

 

PEC/PNEC

Site-spec.A

Site-spec.B

Site-spec.C

STP

0.3

3.4.10-4

0.4

Surfacewater

0.4

0.1

0.6

Sediment

0.4

0.1

0.7

Soil

0.7

3.3.10-4

3.2.10-4

Oral,fish

3.5.10-5

1.7.10-5

3.10-5

Oral,worm

0.07

6.10-4

6.10-4

Pant(air)

2

2

2

Table3.4   Local PEC/PNEC ratios at formulation/processing

 

PEC/PNEC for Scenario

IIIa

IIIb-1

III-b2

III-c1

III-c2

III-d

IIIe

Type of application

Plasticizer softener in PVC

adhesive

 

printing inks

 

fibres

grouting agent

STP

0.08

0.4

0.09

0.05

0.002

0

-.

Surfacewater

0.3

0.9

0.3

0.2

0.1

0.1

0.7(A)1)

0.1(O)

Sediment

0.3

1

0.3

0.2

0.1

0.11

-

Soil

0.2

0.9

0.2

0.1

5.9.10-3

0.002

-

Oral, fish

3.10-5

7.3.10-5

3.10-5

2.5.10-3

1.8.10-5

1.7.10-5

-

Oral, worm

0.02

0.1

0.02

0.01

1.2.10-3

7.4.10-4

-

Plant (air)

236

34

1

5

20

100

-

1)           A=Alna river; O=Oslofjord

PEC/PNEC based on 90 -percentile PEC

3.3.2 Aquatic compartment (incl. sediment)

STP

The PNECmicroorganisms for DBP was set at 220 μg/l. For the risk characterisation this value is compared with the PEC(STO) for the various exposure scenarios. For production and processing all PEC/PNEC ratios were found to be below 1 (conclusion (ii)).

Surface water

The PNEC for surface water was set at 10 μg/l. For the risk characterisation this value is compared with the PEC in surface water for the various exposure scenarios. For production and processing all aquatic PEC/PNEC ratios were found to be below 1 (conclusion (ii)). It should be noted that for scenario IIIe grouting agent the PEC/PNEC based on the maximum (rather than 90 percentile) estimated PEC would amount to 1.5. The current scenario IIIe is based on a Norwegian case and extrapolation to other EU situations is difficult. The general conclusion, however, is that environmental releases of DBP during grouting activities may reach high levels in surface water. Therefore the environmental impact of these kinds of operations should be carefully assessed/monitored. Apart from a few rather old monotoring data (1984) the local and regional measured surface water concentrations were found to be below the PNEC (conclusion (ii)). The same is true for the calculated regional water concentration.

Sediment

The PNEC for sediment is 1.2 mg/kg wwt. As both the PNEC and the PEC were calculated with the equilibrium partitioning method from the water data, the same conclusions as for water can be drawn. In addition, most of the available monitoring data are lower than the PNEC for sediment-dwelling organisms. Only the upper limit of the Furtmann data (1993)* for the river Lippe is higher than the PNEC (PEC/PNEC = 3). Recent marine sediment data (1997) in Denmark indicated that levels (maximum 2.4 mg/kg dwt) very close to the PNEC (fresh water based) can be found. Additional monitoring in marine sediments and identification of emission sources could be relevant. The PEC/PNEC ratio based on a calculated regional PEC sediment is0.3 (conclusion (ii)).

3.3.3 Terrestrial compartment

The PNEC for the terrestrial compartment is 2 mg/kg dw. For the risk characterisation this value is compared with the PEC in soil for the various exposure scenarios. For production and processing all PEC/PNEC ratios were found to be below 1 (conclusion (ii)). Measured local data

and the calculated regional PEC were also found to be below the PNEC(conclusion (ii)).

3.3.4 Atmospheric compartment

The provisional PNEC for the atmospheric compartment is 0.01 μg/m3. A comparison of this PNEC with the calculated and measured local (production and formulation/processing) and regional PECs, shows that all PEC/PNEC ratios are above 1. A chronic fumigation test with

plants has to be conducted(conclusion (i)).

3.3.5 Secondary poisoning

The PNEC oral is 104 mg/kg. For the risk characterisation this value is compared with the PECs in fish and worm for the various exposure scenarios. All PEC/PNEC ratios were found to be far below 1(conclusion (ii)). It should be noted that with the application of a higher BCF-value

based on tests with 14C-labelled DBP, the risks for secondary poisoning would still be low.

Conclusion (i) There is need for further information and/or testing.

This conclusion is reached because:

there is a need for better information to adequately characterise the risks to plants exposed via the atmosphere (the airborne toxicity to plants).

The information requirement is a long-term plant toxicity test.

Conclusion (ii) There is at present no need for further information or testing or risk reduction measures beyond those which are being applied already.

This conclusion applies to effects on the aquatic compartment (including sediment), soil and secondary poisoning.

* For references, see the comprehensive Final Risk Assessment Report that can be obtained from the European Chemicals Bureau: http://ecb.jrc.it

(1) according:

European Union Risk Assessment Report dibutyl phthalate, Volume 29, ppp. 9 -11, 20 (2003)

Editors: B. G. Hansen, S.J. Munn, R. A/Ianou, F. Berthault, J. de Bruin, M. Luotamo, C. Musset, S. Pakalin, G. Pellegrini, S. Scheen S. Vegro.

Office for Official Publications of the European Communities, ISBN 92—894—1276—3