Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.433 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.33 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
43.3 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.433 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2.35 µg/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:
4.45 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC aqua (freshwater), PNEC aqua (marine), PNEC aqua (intermittent release)

There are data from acute toxicity studies in green alga (freshwater), aquatic invertebrates and freshwater fish for 2,4 -Bismaleimidotoluene, but no long-term or reproduction study, nor studies with marine organisms. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied and the PNEC aqua (freshwater) was derived from the 96 h LC50 value of 433 µg/L, determined with zebrafish (Danio rerio), the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 0.433 µg/L.

An assessment factor of 10000 was applied and the PNEC aqua (marine) was derived from the 96 h LC50 value of 433 µg/L, with zebrafish (Danio rerio). This results in a PNECaqua (marine) of 43.3 ng/L. 

An assessment factor of 100 was applied to the lowest LC50, which was the 96 h LC50 = 433 µg/L, with zebrafish (Danio rerio). Thus, the PNECaqua(Intermittent release) was calculated to be 4.33 µg/L. 

PNEC STP

The PNEC STP was based on the EC10 of 1.93 mg/L obtained from a Toxicity to Microorganisms test. Based on the available data, an assessment factor of 10 was applied in accordance with the Guidance in Information requirements and chemical safety assessment, R.10, to calculate the PNEC STP = 0.193 mg/L.

PNEC air

The registration substance has a low vapour pressure of 2.66E-11 Pa at 25°C. Based on this no risk for air breathing animals and humans is expected. 

PNECoral (secondary poisoning)

Bioaccumulation potential has been estimated to be low. There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived. 

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning. 

Conclusion on classification

The most sensitive organism to 2,4 -Bismaleimidotoluene was the zebrafish (Danio rerio). Thus, the lowest acute toxicity value is the 96h LC50 to zebrafish (Danio rerio) of 0.433 mg/L. This value was used for the calculation of PNECs. Based on this results 2,4 -Bismaleimidotoluene needs to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) for acute aquatic toxicity Category 1 "Very toxic to aquatic life" and labelled with the Signalword "Warning". Based on the results from the acute toxicity studies and due to lack of any chronic data 2,4 -Bismaleimidotoluene needs to be classified chronic aquatic toxicity Category 1 according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).