Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.739 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
7.39 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.074 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.739 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.497 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:
9.95 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Where possible, PNEC calculations have been undertaken using default assessment factors in accordance with ECHA guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration] response for environment.

PNECs were derived from the study with the most sensitive species available for each compartment/endpoint. Acute aquatic effects tests with fish, daphnids and algae showed no significant effects and LC50s were not established. Other than effects on algae, no long-term effects data are available on the registered substance.

 

Conclusion on classification

In determining the classification appropriate to trimellitic anhydride mono-chloride (TMAC), it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below.

Persistence.

Reliable studies are available to demonstrate that trimellitic anhydride mono-chloride (immediately hydrolysed to trimellitic acid under the test conditions) is readily biodegradable regarding results obtained on trimellitic anhydride (source substance).

Trimellitic anhydride mono-chloride may therefore be expected to degrade rapidly, and to be completely mineralised, i.e. converted to CO2and H2O without forming any recalcitrant metabolites. Trimellitic anhydride mono-chloride and its degradation intermediates are therefore non-persistent.

Bioaccumulation.

Log10 Kow values for trimellitic anhydride mono-chloride (QSAR prediction) and its hydrolysis product trimellitic acid (experimental value: log Kow=0.54) are all less than 3.0. The potential for trimellitic acid to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices contaminated with TMAC residues is therefore negligible. The risk that trimellitic anhydride mono-chloride or its derivatives may biomagnify through successive trophic levels of aquatic or terrestrial food chains is consequently also negligible. 

Toxicity

TMAC is a trimellitic anhydride mono-chloride. The first steps that may be predicted in its environmental fate, prior to biodegradation, are its immediate hydrolysis to trimellitic acid followed by conversion to trimellitate salts. Acute aquatic effects tests with fish, daphnids and algae showed no significant effects and LC50s were not established. Other than effects on algae, no long-term effects data are available on the substance itself. These studies demonstrate the low intrinsic toxicity of trimellitate to aquatic biota, and - taking into account its susceptibility to rapid biodegradation - provide assurance that trimellitic anhydride mono-chloride does not present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. 

No classification is triggered based on available data, according to EEC Council Directive 79/831/EEC Annex VI, Part II (D) as described in Commission Directive 93/21/EEC or Regulation (EC) No 1272/2008.