Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.28 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.1 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.028 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.001 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Sediment/soil ingestion:

In order to take into account exposure of organisms via sediment/soil ingestion, REACH guidance document R16 recommends applying an additional factor of 10 to the PEC/PNEC ratio for substances with a high log Pow (>5) or for substances with a high adsorption or binding behaviour (e.g. ionisable substances, surface active substances, substances forming covalent bound to sediment components such as e.g. aromatic amines)..The logPow of 2.77 is far below 5, however for the latter type of substances, the adsorption is not triggered by the lipophilicity (i.e. log Kow of the substance) but by other mechanisms.

Based on European risk assessment reports for aromatic amines such as Aniline (European Union, 2004) and 3,4-Dichloroaniline (European Union, 2006), the use of an additional factor of 10 on the PEC/PNEC ratio is however not considered to be applicable for substances of the PPD-type. For Aniline and 3,4-Dichloroanile a large data set for the terrestrial compartment is available:

1. Via sediment/soil ingestion, no significant higher effects have been observed with 3,4-Dichloroaniline and Aniline compared to organisms fed by pore water ingestion. In the table below the relevant results of short term and long term results are shown:

   “pore water” organism  Sediment/soil ingesting organism
 3,4-Dichloroaniline  Lactuva sativa (short term) EC50 = 10 mg/kg d.w. Brassica rapa/Avena sativa (long term) NOAEC = 125 mg/kg d.w. Eisenia fetida (short term) EC50 =130 mg/kg d.w. Eisenia fetida (long term) NOEC = 100 mg/kg d.w 
 Aniline  Lactuva sativa (short term) EC50 = 33 mg/kg d.w. Chironomus riparius (prolonged) NOEC = 37.5 mg/kg d.w Lumbriculus variegates (prolonged) NOEC = 46.5 mg/kg d.w. 

For organisms living from pore water and those who ingest sediment or soil, the effect values are in the same range.

2. The European Risk Assessment Reports for both 3,4-Dichloroaniline and Aniline do not take into account an additional factor of 10 for the calculation of the PEC/PNEC ratio. We therefore consider that the additional factor of 10 should not apply to IPPD.

Conclusion on classification

Classification and labelling according to aquatic toxicity data based on CLP:

Justification for classification or non classification.

Acute classification:

Three acute tests have been performed with fish, daphnia and algae. The effect with the lowest concentration have been observed in an algae study (EC50 (96 h): 0.23 mg/L). Therefore, a classification related to hazard phrase H400 applies.

Chronic classification:

The lowest chronic result was identified in daphnie (21d-NOEC 0.028 mg/L, data from hydrolysis product). The parent substance IPPD is not readily biodegradable but rapidly degradable by hydrolysis. As however the classification is based on a result from the hydrolysis product which is not readily biodegradable and not rapidly degradable by hydrolysis, a classification related to hazard phrase H410 applies.