Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.005 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
180 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
20.53 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:
41.04 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC freshwater, marine waters, and intermittent release was derived based on the data on acute aquatic toxicity and on chronic aquatic toxicity where available following the guidance (GIRCSR Section 10, ECHA 2008). If combination of studies with confirmed EC50 values or NOECs and limit tests was available for one taxonomic groups, preference was given to the data with confirmed (no) effect concentrations. In the absence of a confirmed (no) effect concentration from testing of one of species of the three trophic levels, the lowest confirmed (no) effect concentration of the other species was used to derive the PNEC.

Conclusion on classification

There were no effects observed up to 100 mg/l (nominal) in any acute aquatic toxicity testing. These results do not warrant classsification according to GHS EU implementation. Available chronic NOEC and EC10 values are also > 1 mg/L, thus classification according to CLP_2nd_ATP_Commission_Regulation_EU_No_286_2011 is not warranted.


 


Preliminary PBT Assessment


 


An assessment of the PBT status of the substance has been made using all available data. The information available suggests that the substance does not meet the PBT screening criteria as outlined in Directive 2006/121/EC (Appendix A).


 


Persistence Assessment


 


Biodegradation in water was tested in two ready biodegradability studies according to OECD 301F and one inherent biodegradability study according to OECD 302B. Diaminotoluene, propoxylated showed 23% biodegradability in the first ready biodegradability study (Bayer, 2002) and 9% biodegradability in the second ready biodegradability study (ISOPA, 2003) . In the inherent biodegradability study (OECD302B test), 22% degradation was observed after 27 days. The substance is classified as "not readily biodegradable". The substance exhibits inherent (primary) biodegradability, and therefore is not expected to persist indefinitely in the environment.  The prediction results from quantitative structure-activity relationship models provide additional evidence that neither the parent compounds nor biodegradation daughter products will persist indefinitely in the environment.


However, less than 70% biodegradation was observed in the available screening tests, and predicted biodegradability according to BIOWIN 2, 3, and 6 models is indicative of slow/poor biodegradability; therefore the screening assignment of P has to made, according to ECHA Chapter R11 guidance on PBT assessment.


 


Bioaccumulation Assessment


The BCF values for representative components were predicted to be logBCF =< 0.5 using three QSAR models, well below 3.3. The log KOW can also be used as a screening criterion for bioaccumulative potential (i.e. log Kow </= 4.5). As the calculated log KOW values for representative components of the substance are well below 4.5 and predicted logBCF well blow 3.3, the screening criterion for B/vB criterion is not met. Therefore the screening assignment of not B, not vB is made for the substance.


 


Toxicity Assessment


The acute aquatic effect information for all three trophic levels in freshwater organisms is much higher than the screening criterion of 0.1 mg/l. The available chronic NOEC and EC10 values are well above the definitive T criterion for aquatic organisms (i.e., NOEC < 0.01 mg/L). It can therefore be expected that the substance is not toxic towards aquatic organisms. Furthermore, as the substance is not classified for CMR properties, or as T,R48 or Xn,R48 according to DSD-DPD, a definitive assessment of "not T" can be made for the substance according to definitive PBT criteria of ECHA Ch. R11.


 


Summary and Overall Conclusions on PBT or vPvB Properties


The overall conclusions, based on the present available data, of the preliminary PBT assessment are that the (screening) criteria for PBT/vPvB are not met and that further testing in the scope of the final PBT assessment is not considered to be required.


 


Emission Characterisation


 


The substance is not a PBT/vPvB substance, therefore the emission characterisation does not need to be conducted.