Registration Dossier

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:
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:
0.05 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.005 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:
0.015 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane shows no acute effects towards aquatic organisms of three trophic levels (algae, crustaceans and fish) at least up to concentrations of 100 mg/L (crustaceans and fish) and an ErC50 = 280.9 mg/L. Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane is neither readily biodegradable (27 % in 28 days), nor inherently biodegradable (42 % in 27 days) and the substance is hydrolytically stable at 50 °C at pH 4, 7 and 9. Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane has a low potential to bioaccumulate as reflected by a log Kow = 1.6.

Thus, based on the given substance properties Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane is not classified according to the Dangerous Substances Directive (67/548/EEC) as well as according to Regulation (EC) 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.

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

There is one study (Currenta, 2009) that assessed ready biodegradability within 28 days and gave a degradation of 27 % for Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane. Thus, the substance is not considered to be readily biodegradable" (Currenta, 2009). Furthermore, there is a study (Currenta, 2009) that assessed inherent biodegradability within 27 days, giving a degradation of 42% for Benzenediamine, ar-methyl-, polymer with 2-methyloxirane and oxirane. The substance is considered to be inherently biodegradable, not fulfilling specific criteria. However, it has to be classified as P according to the PBT screening criteria.

 

Bioaccumulation Assessment

In the absence of a measured BCF value, the log KOW can be used as a screening criterion for bioaccumulative potential (i.e. >4.5). As the log KOW of the substance is below 4.5, the B/vB criterion is not met. Therefore the substance is identified as not B.

 

Toxicity Assessment

The acute effect information for all three trophic levels is much higher than the screening criterion of 0.1 mg/l. It can therefore be expected that the substance is not toxic towards aquatic organisms.

 

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.