Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.011 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.014 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.02 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.102 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.199 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.1 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

The need for classification has been determined using the Commission Regulation No 286/2011 amending regulation No 1272/2008 (CLP).

 

For DBPP, sufficient acute and chronic information is available for the purpose of classification. Invertebrates, more specifically Daphnia magna are most sensitive to DBPP both after acute and chronic exposure. The 48h EC50 value was 1.4 mg/L (endpoint immobilization) and the chronic 21-day EC10 value was 0.106 mg/L (endpoint survival, as no effects were seen on reproductive success).

 

With regard to biodegradability, substances are regarded ready biodegradable when test results based on oxygen depletion or carbon dioxide generation indicate that 60% of the theoretical maximum is achieved within 10 days from the onset of biodegradation. However, when it concerns a multi-constituent substance, this 10-day window may be waived and multi-constituents can fulfill the criteria when they pass the 28-day level.

 

Here below a summary of the available test results is presented:

 

Test (Reference)

Results

Conclusion per test in function of criteria

OECD301F

(Currenta, 2012)

 

Key study

- 60.9% biodegradation after 28 days (end of test)

->60% biodegradation in 14-day window taking into account day 8 is onset of biodegradation

Readily biodegradable, not meeting 10- window, but window is not absolute requirement as the substance is a multi-constituent.

OECD301C

(Mitsubishi, 2009)

 

Supporting study

- 11% degradation based on BOD measurements 

- 9% degradation based on residual test substance

Not readily biodegradable.

CO2 evolution test

(Saeger and Tucker, 1973)

 

Supporting study

- 36% degradation after 14 days

- 80% degradation after 28 days

- 85% degradation after 48 days

Readily biodegradable, not meeting 10- window, but window is not absolute requirement as the substance is a multi-constituent.

SCAS test

(Saeger and Tucker, 1973)

 

Supporting study

- 95% degradation at loading rate of 3 mg/L

- 52% degradation at loading rate of 13 mg/L

Readily biodegradable as the degradation is > 70% after 28 days at lowest loading rate. However, lowest loading rate can be regarded as a relevant dose.

RDA test

(Saeger and Tucker, 1973)

 

Supporting study

- Half-life of 3 to 4 days

Readily biodegradable.

 

Based on the currently available information with regard to biodegradation, the substance can be regarded as readily biodegradable. All test results are indicative of that fact with the exception of the OECD301C test. The weight of this test, however, was regarded as minimal in this assessment as the combination of the other information indicates the contrary. Additionally, information on biodegradability from a similar substance (tributyl phosphate; CAS xxxx) indicates that the same discrepancy is present in that test package. Also for TBP, the OECD301C test results in contradictory findings in comparison to the rest of the performed tests. The result of the biodegradability assessment for TBP is that TBP is readily biodegradable due to the wealth of additional relevant and reliable data sources.

 

Conclusion of the above mentioned findings is:

- DBPP can be regarded as readily biodegradable;

- Acute aquatic toxicity > 1 mg/L

- Chronic aquatic toxicity > 0.1 mg/L but < 1 mg/L

 

Based on these results, the multi-constituent substance DBPP is to be classified as Aquatic Chronic 3.