Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
14.5 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:
28.4 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

The substance is an organic UVCB substance. It is slightly soluble in water (according to OECD 105) and stable to hydrolysis.

The short-term toxicity of the 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 = 2.3 mg/L (based on nominal concentration)

Aquatic invertebrates: 48h-EC50 = 1.1 mg/L (based on geometric mean of measured concentrations)

Algae: 72h-ErC50 > 17 mg/L (based on nominal concentration)

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:

The substance was found stable to hydrolysis. A reliable study carried out according to OECD Guideline 301F and GLP compliant is available on registered substance. Under the conditions of this study, the registered substance was found readily biodegradable (78% of biodegradation at Day 28 based on O2 consumption). Therefore, the substance is considered as rapidly degradable in aquatic system.

Information on bioaccumulation potential of the submission substance:

No fish BCF is available. Log Kow range between 4.6 and 4.8 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.