Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
56 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
560 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
5.6 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.203 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:
0.373 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC values were determined for the registered substance by application of rules provided in ECHA Guidance Chapter R.10 (May 2008).

PNECs for aquatic organisms

One reliable acute study is available for the registered substance on each of the following organisms: algae, invertebrates, fish and microorganisms . The short term toxicity testing were performed according to the OECD guidelines and were GLP compliant (except for the fish). No effects were recorded up to the maximum test concentration of 100 mg/L for tha algee and the fish and an effect on the daphnids gave an 48h EC50 of 56 mg/L. According to the results of the chemical risk assessment, there is no need to further investigate the toxicity of the registered mixture on aquatic organisms therefore no long-term testing was proposed. Therefore the PNEC aqua were derivated using the lowest EC50 of 56mg/L and an AF of 100 for the freshwater and 1000 for the marine water.

No effect was measured on the respiration of the microorganisms from STP at the concentration of 1000 mg/L and therefore an AF of 10 was applied to this value to derive the PNECstp.

In the absence of ecotoxicological data on sediment organisms, provisional PNECs sediment for freshwater and marine waters were calculated using the equilibrium partitioning method.

PNECs for soil organisms

In the absence of ecotoxicological data on soil organisms, a provisional PNEC soil was calculated using the equilibrium partitioning method.

PNEC for predators

No data is available on mammals and birds but secondary poisoning is not expected due to the low bioaccumulation potential of the mixture.

Conclusion on classification

Phosphoric acid, mono- and bis(branched and linear pentyl) esters is an organic complex substance. It is very soluble in water (according to OECD 105) and stable to hydrolysis.

The short-term toxicity of the registered substance to aquatic organisms was investigated according to OECD guidelines. The following toxicity values are available for the substance:

Fish Acute: 96h-LC50 > 100 mg/L (based on nominal test material concentration)

Aquatic invertebrates: 48h-EC50 = 56 mg/L (based on measured test material concentration)

Algae: 72h-ErC50 > 100 mg/L (based on nominal test material concentration)

The lowest acute aquatic toxicity values based on available data ranges between 10 and 100 mg/L. The long-term toxicity of registered substance to aquatic organisms was not investigated. Thus, there are no adequate chronic toxicity data available.

The degradation of the substance was investigated according to OECD Guidelines: The substance was found stable to hydrolysis (according to OECD 111). A reliable study carried out according to OECD Guideline 301B and GLP compliant is available on registered substance. Under the conditions of this study, the registered substance was found not readily biodegradable (45% of biodegradation at Day 28 based on CO2 evolution). Therefore, the substance is considered as not rapidly degradable in aquatic system.

Information on bioaccumulation potential of the submission substance: No fish BCF is available. Log Kow ranges between -2.07 and 0.08 based on experimental or QSAR value for constituents which indicates no potential for bioaccumulation. Experimental value Log Pow for the substance at 22.5°C are: -1.94 for the monoester component and 0.08 for the diester component. Calculated value for Log Pow for the test item (QSAR): -2.07 for the monoester component and -0.235 for the diester component.

CLP Classification proposal It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute aquatic hazard: not classified. Reasoning: lowest E(L) C50 higher than 1 mg/L.

Chronic aquatic hazard: Category 3. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L) C50 value range between 10 and 100 mg/L, non rapidly degradable substance with Log Kow < 4. The determination of M-Factor is not applicable.

DSD Classification proposal

R52/53. Reasoning: lowest acute E(L)C50 value ranges between 10 and 100 mg/L, non readily biodegradable substance with Log Kow < 3.