Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.001 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
6.15 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.615 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
1 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10.33 mg/kg food
Assessment factor:
30

Additional information

Conclusion on classification

CLP

Acute aquatic hazard:

  • Reliable acute toxicity data are available for fish (Dionne, 1995 & 1997), algae (Hoberg, 1996) and crustacea (Putt, 1995). The 48-hourDaphnia magnatest resulted in an EC50of > 1.1 mg/L, whereas an ErC50of > 0.079 mg/L was found in the 72-hour toxicity test onSelenastrum capricornutum(Pseudokirchneriella subcapitata) algae. It was possible to derive a 96-hour EC50for trout and for carp from the available long-term fish tests (Dionne, 1995 & 1997). Respective EC50values are 0.48 mg/L (average, range: 0.35-0.66 mg/L) for rainbow trout (Oncorhynchus mykiss) (Dionne, 1997) and 0.67 mg/L for common carp (Cyprinus carpio) (Dionne, 1995).
  • Based on the fact that the most sensitive species should be taken into account for determination of the aquatic hazard, the classification should be based on the outcome of the algae test. When comparing these test results with the respective criterion (≤ 1 mg/L), it can be concluded that classification of 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. in acute aquatic toxicity Category 1 of CLP Regulation (EC) No. 1272/2008 (amended according to Commission Regulation No 286/2011) is warranted.
  • The relevant M-factor for acute toxicity is 10.

 

Chronic aquatic hazard:

  • Reliable chronic toxicity data are available for the 3 species. The information available for fish (Dionne 1995, 1997) indicates that the lowest toxicity value was detected in rainbow trout with an EC50 of 0.26 mg/L and a NOEC of 0.14 mg/L after 14 days of exposure. A long-term (21d) reproduction study onDaphnia magna(Sacker, 2010) resulted in an EC10 for reproduction of 0.0045 mg/L. In the algae study performed by Hoberg et al. (1996) a NOEC of 0.013 mg/L was determined.
  • Experimental data on biodegradation are available (Kung, 1995; Hartmann, 1990;Commander and Daniel, 2011a; Commander and Daniel, 2011b; Commander et al., 2011). Under standard ready biodegradation test conditions, the test chemical displayed negligible degradation. In the inherent biodegradation tests it was demonstrated that the substance degrades slowly (complete primary degradation within 28 days; 23-37% mineralization after 56-63 days). Therefore, it can be concluded that 1,4 -benzenediamine, N,N'-mixed Ph and tolyl derivs.is inherently biodegradable.
  • Experimental data on bioaccumulation are also available (Tadokoro, 1998; McLaren-Hart, 1998; Vaughan, 2011; Hurd and Vaughan 2011). These studies cover both dietary and waterborne exposure. The results of these studies indicate high bioconcentration factors (> 2000) and a depuration rate of approximately 5 days. In conclusion, based on the currently available information the present substance and its constituents have the potential to bioaccumulate. It is to be noted that further studies are proposed to gain more knowledge on the chemical structure of the accumulated metabolites and thus enable a more accurate calculation of the BCF value.
  • As a consequence of the fact that the substance is not rapidly biodegradable (only inherently) and the chronic toxicity data indicate that relevant effect occur at concentrations below 0.1 mg/L, 1,4-benzenediamine, N,N'-mixed Ph and tolyl derivs. is to be classified as a Chronic Category 1.
  • The relevant M-factor for chronic toxicity is 10, based on the fact that the lowest NOEC (for Daphnia magna) is between > 0.001 and < 0.01 mg/L.

DSD

 

Acute and chronic aquatic hazard:

  • Reliable acute toxicity data are available for fish (Dionne, 1995 & 1997), algae (Hoberg, 1996) and crustacea (Putt, 1995). The 48-hourDaphnia magnatest resulted in an EC50of > 1.1 mg/L, whereas an ErC50of > 0.079 mg/L was found in the 72-hour toxicity test on Selenastrum capricornutum (Pseudokirchneriella subcapitata) algae. It was possible to derive a 96-hour EC50for rainbow trout (Oncorhynchus mykiss) and for carp from the available long-term fish tests. Respective values are 0.48 mg/L (average, range: 0.35 -0.66 mg/L) for trout (Dionne, 1997) and 0.67 mg/L for common carp (Cyprinus carpio) (Dionne, 1995).
  • The experimentally determined Powfor the 3 main constituents of 1,4-benzenediamine, N,N'-mixed Ph and tolyl derivs. (Dix, 2000) range from 3.3 to 4.6.

As a consequence, 1,4-benzenediamine, N,N'-mixed Ph and tolyl derivs. should be classified as R50 (Very toxic to the aquatic environment) and R53 (May cause long-term adverse effects in the aquatic environment) according to the criteria mentioned in section 5 of Annex VI of Directive 67/548 (Dangerous Substances Directive).