Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
95 ng/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
6.06 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
9.5 ng/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.035 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 mg/kg sediment dw
Assessment factor:
1
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:
0.007 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

The environmental classification of 4,4'-methylenebis(2-chloroaniline) is harmonized according to CLP and DSD. In Annex I of the Dangerous Substance Directive 67/548/EC, 4,4'-methylenebis(2-chloroaniline) is classified as R50/53. In Annex VI of the CLP Regulation (EC) 1272/2008, the substance is classified as H400 (Aquatic Acute 1) and H410 (Aquatic Chronic 1).

This harmonized classification is in accordance with the experimental test results provided in this dossier:

The results of the acute ecotoxicity tests indicated L(E)C50 values below 1 mg/L (for fish and daphnids). Furthermore, in a long-term test with daphnids, mortality and effects on reproduction were observed. In addition, the substance is not readily biodegradable. According to the CLP Regulation (EC) 1272/2008 (Annex I, section 4.1.2.6), 4,4'-methylenebis(2-chloroaniline) should therefore be classified in Acute Category 1 and Chronic Category 1 for the aquatic environment.

According to the Dangerous Substance Directive 67/548/EC (see Annex VI section 5.2.1.2), the substance should be classified with R50 and R53.

Conclusion on classification

The environmental classification of 4,4'-methylenebis(2-chloroaniline) is harmonized according to CLP and DSD. In Annex I of the Dangerous Substance Directive 67/548/EC, 4,4'-methylenebis(2-chloroaniline) is classified as R50/53. In Annex VI of the CLP Regulation (EC) 1272/2008, the substance is classified as H400 (Aquatic Acute 1) and H410 (Aquatic Chronic 1).

This harmonized classification is in accordance with the experimental test results provided in this dossier:

The results of the acute ecotoxicity tests indicated L(E)C50 values below 1 mg/L (for fish and daphnids). Furthermore, in a long-term test with daphnids, mortality and effects on reproduction were observed. In addition, the substance is not readily biodegradable. According to the CLP Regulation (EC) 1272/2008 (Annex I, section 4.1.2.6), 4,4'-methylenebis(2-chloroaniline) should therefore be classified in Acute Category 1 and Chronic Category 1 for the aquatic environment.

According to the Dangerous Substance Directive 67/548/EC (see Annex VI section 5.2.1.2), the substance should be classified with R50 and R53.