Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
310 ng/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
237 ng/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
220 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.18 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:
726 µg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC aqua (freshwater)

Results from acute and chronic tests with fish, invertebrates and algae are available.In accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, an assessment factor of 10 is justified. Based on the results with the most sensitive organism (21 d EC10 in Daphnia magna = 3.1 µg/L) and taking into account the assessment factor 10, a PNECaqua (freshwater) of 310 ng/L was calculated.

PNEC aqua (marine water)

Results from acute and chronic tests with freshwater fish, invertebrates and algae are available.In accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, an assessment factor of 100 is justified. Based on the results with the most sensitive organism (21 d EC10 in Daphnia magna = 3.1 µg/L) and taking into account the assessment factor 100, a PNECaqua (marine water) of 31 ng/L was calculated.

PNEC aqua (intermittent release)

Acute tests with fish, invertebrates and algae are available.In accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, an assessment factor of 100 was applied to the lowest L(E)C50, which was the 72 h ErC50 in Pseudokirchneriella subcapitata of 23.7 µg/L. Thus, the PNEC aqua(Intermittent release) was calculated to be 237 ng/L.

 

PNEC STP

The PNEC STP was based on the 3 h EC50 of 22 mg/L obtained in a respiration inhibition test with activated sludge. Based on the available data, an assessment factor of 100 was applied in accordance with the Guidance in Information requirements and chemical safety assessment, R.10, to calculate the PNEC STP = 220 µg/L.

 

PNEC sediment(freshwater), PNEC sediment (marine waters)

No toxicity tests with sediment dwelling organisms are available.Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment has been calculated with the equilibrium partitioning method using EUSES 2.1.

The following data have been taken into account for calculation:

 

Molecular weight

280.79 g/mol

Melting point

140°C

Vapour pressure

1.9E-04 Pa at 20°C

Water solubility

200 g/L at 20°C

Log Dow

2.33

Koc

58119 L/kg

PNEC Aqua(freshwater)

310 ng/L

PNEC Aqua(marine water)

31 ng/L

 

The calculation resulted in a PNEC sediment(freshwater) of 1.8 mg/kg sediment dw and a PNEC sediment (marine waters) of 0.18 mg/kg sediment dw.

 

PNEC air

The registration substance has a low vapour pressure of 1.9E-04 Pa at 20°C. Based on this no risk for air breathing animals and humans is expected.

 

PNEC Soil

Acute toxicity tests with soil macroorganisms (Eisenia fetida), terrestrial plants (Triticum aestivum, Sinapis alba, Raphanus sativus, Phaseoulus aureus, Lactuca sativa, Avena sativa) and soil microorganism are available. In accordance with the Guidance in Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied to the lowest EC50 value (Lactuca sativa, LC50= 363 mg a.i./kg soil dw).

According to the TGD, the standard soil has an organic matter content of 3.4 % (Fom(standard)) and an organic carbon content of 2 % (Foc(standard)). Since the natural sandy soil used in the study contained an organic carbon content of approximately 1 % (Foc(exp.)) the organic matter content (Fom(exp.)) can be determined in the following way:

                                          Fom (standard,)= 0.034 [kgomx kgsolid-1]

                                          Foc (standard)= 0.02[kgocx kgsolid-1]

                                          Foc (experimental)= 0.01[kgocx kgsolid-1] (approximately)

-> Fom (exp.)= 0.017 [kgomx kgsolid-1]

 

Due to this, the EC50 (exp.)value is converted to the EC50 (standard)value as follows:

                                          EC50 (exp.)= EC50 dwt= 320 mg/kg dwt

                                          Fom (standard)= 0.034 [kgomx kgsolid-1]

                                          Fom (exp.)= 0.017[kgomx kgsolid-1]

-> EC50 (standard)= 726 mg/kg dwt

Thus, the PNEC soil is 726 µg/kg soil dw.

 

Secondary poisoning

The bioaccumulation potential of DOPA-Glycinate is considered to be low. The substance is readily biodegradable, highly water soluble and is therefore not expected to present a significant bioaccumulation risk in the aquatic environment. Due to the physicochemical properties of DOPA-Glycinatemolecules the BCF estimations based on thelog Kow are not considered to be reliable. According to the Guidance on information requirements and chemical safety assessment, chapter R.7a, Log Dow values are considered more realistic for an assessment of bioaccumulation. Log Dow values for the individual constituents of DOPA-Glycinate ranged between -2.37 and 2.33. The predicted BCF in freshwater fish was estimated to be 19.1 L/kg wwt indicating that the substance does not classify as bioaccumulative. There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived.

Conclusion on classification

Based on the acute and chronic toxicity tests in aquatic organisms, DOPA-Glycinate requires classification as hazard category Acute 1 (M factor: 10) and hazard category Chronic 1 (M factor: 1) in accordance with CLP Regulation (EC) No 1272/2008.

According to directive 67/548/EEC, DOPA-Glycinate is classified as R50 “Very toxic to aquatic organisms”.