Cyclohexanamine, 4,4'-methylenebis[N-(1-methylpropyl)-

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.002 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1.6 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

2.22 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.22 mg/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:

1.07 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

The hazard assessment of this substance in the water compartment was based on the lowest short-term toxicity test results of three taxonomic groups (algae, crustaceans and fish) and the use of assessment factors. As there were neither short-term nor long-term aquatic toxicity test results available for marine organisms, the PNEC for marine water was also derived based on the aquatic fresh water toxicity. The lowest short-term aquatic toxicity of the substance was determined to algal growth (Pseudokirchneriella subcapitata) with EC50 (96 h) value of 0.24 mg/l. Hazard assessment in the STP was derived based on the activated sludge respiration test results (OECD 209) of this substance.

As there was no ecotoxicological data of the substance available for sediment-dwelling organisms or soil organisms, the PNECs for sediments and soil compartment were determined based on the partitioning method by using the PNECs derived for water compartment and the measured adsorption coefficient of the substance (Koc 427 000 L/kg). As Clearlink 1000 is not bioaccumulative no PNECoral was derived.

The classification and labeling of this substance was based on the short-term aquatic toxicity results and the biotic and abiotic biodegradation results of the substance. In addition, the measured BCF factor and partition coefficient were used to evaluate the bioaccumulation potential of this substance. All the studies were conducted according to standard methods and in compliance with GLP.

Conclusion on classification

The following are the available reliable data for Environmental classification of the test substance:

 

Acute Aquatic Toxicity:

Algae: EC50 (Pseudokirchneriella subcapitata,96 h): 0.24 mg/l

Crustacea: EC50 (Daphnia Magna, 48 h): 27 mg/l

Fish: limit test LC50 (Oncorhynchus mykiss, 96 h) > 570 mg/l

Conclusion: Acute aquatic toxicity (based on the lowest of the available toxicity values) is between 0.1 and 1 mg/l. This corresponds to an M-factor of 1.

 

Degradation:

 

Biotic degradation:

2 % degradation in 28 days (BOD); test method OECD 301C.

0 % DOC-elimination in 28 days; test method OECD 301C

 

Abiotic degradation (hydrolysis): Hydrolytically stable, Half-life > 1 year at 25 °C; test method OECD 111

 

Conclusion: not rapidly degradable.

 

Bioaccumulation:

Bioconcentration factor (BCF): 6.1 – 11 L/kg; Species: Fresh water fish (Cyprinus carpio); Method: OECD 305

Log Kow: 1.31

 

Conclusion: Low potential for bioconcentration and bioaccumulation

 

Environmental classification:

 

In accordance with EC Regulation 1272/2008 (CLP):

Acute hazard: Acute 1, M-factor: 1.

Chronic (long term) hazard: Chronic 1, M-factor: 1.

Hazard statement: H410

 

In accordance with DSD (Directive 67/548/EEC):

Dangerous for the Environment: N, R50/53

 

Reasoning:

Acute aquatic toxicity < 1 mg/l and not rapidly degradable.