Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
58.1 µg/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:
113 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
15 mg/kg food
Assessment factor:
300

Additional information

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

Conclusion on classification

The substance is a multi-constituent organic substance which is moderately soluble in water.

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

Fish Acute: 96h-LC50 = 6.104 mg/L (substance itself, WAF)

Aquatic invertebrates: 48h-EC50 = 5.184 mg/L (substance itself, WAF)

Algae: 72h-ErC50 = 5.4 mg/L (substance itself, WAF)

The lowest acute aquatic toxicity values based on available data ranges between 1 and 10 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: A reliable study carried out according to OECD Guideline 301D and GLP compliant is available on registered substance. Under the conditions of this study, the registered substance was found readily biodegradable (72% of biodegradation at Day 28). Therefore, the substance is considered as readily degradable in aquatic system.

Information on bioaccumulation potential of the submission substance: No fish BCF is available. Log Kow range between 2.84 and 4.49 for the substance constituents, which indicates a potential for bioaccumulation.

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 2. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L) C50 value range between 1 and 10 mg/L, rapidly degradable substance with log Kow > 4. The determination of M-Factor is not applicable.

DSD Classification proposal N; R51/53. Reasoning: lowest acute E(L) C50 value range between 1 and 10 mg/L, readily biodegradable substance with log Kow > 3.

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