Registration Dossier
Registration Dossier
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EC number: 202-918-9 | CAS number: 101-14-4
Ecotoxicological Summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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