Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.136 ng/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.011 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.014 ng/L
Assessment factor:
500
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:
45.083 ng/kg sediment dw
Assessment factor:
10
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.508 ng/kg sediment dw
Assessment factor:
10
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:
9.009 ng/kg soil dw
Assessment factor:
10
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

Since the substance is classified as toxic for aquatic organisms, an assessment of the potential hazard of 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) to aquatic, sediment dwelling and terrestrial species was performed. The environmental exposure assessment (see CSR attached to IUCLID section 13) shows that the Risk Characterization Ratio (i. e. PEC/PNEC ratio) in the aquatic, sediment and soil compartment is < 1 and therefore, under the current exposure conditions, 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS No. 107934-68-9) does not pose a risk to the environment. This can be mainly attributed to the self-contained use of the substance, preventing environmental release.

Conclusion on classification

Conclusion on Classification

Biodegradation: 0% after 28 d (OECD 301D)

Bioaccumulation: BCFkL > 5000 L/kg

 

Aquatic acute toxicity

Fish: 96 h, LC50 (Oncorhynchus mykiss): > 6.5 mg/L (measured; OECD 203)

Aquatic invertebrates: 48 h, EC50 (Daphnia magna): 1.1 mg/L (measured; OECD 202)

Aquatic algae: 72 h, EC50 (Desmodesmus subspicatus): > 0.00107mg/L (measured; OECD 201)

 

Aquatic chronic toxicity

Fish: no data

Aquatic invertebrates: 21 d, NOEC (Daphnia magna): 0.0000068 mg/L (measured; OECD 211)

Aquatic algae: 72 h, NOEC (Desmodesmus subspicatus): > = 0.00107mg/L (measured; OECD 201)

 

Classification according to CLP

Based on the data above, 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS No. 107934-68-9) needs to be classified and labeled as environmental hazard Chronic Cat. 1 according to the 7th ATP of Regulation (EC) No. 1272/2008 (CLP) based on the NOEC (21d) of 0.0000068 mg/L for Daphnia magna. 4,4´-(9H-fluoren-9-ylidene)bis(2-chloroaniline) is not considered to be rapidly degradable.

M-factor for acute aquatic toxicity: -

M-factor for chronic aquatic toxicity: 10000