Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Justification for the non-equivalence of the test material to the submission substance identity:

HDI trimer MEKO blocked is always produced and marketed as dissolved in solvent. Thus, the substance is reasonably expected to be handled and used in a form of a mixture of the registered substance in the solvent. The environment is anticipated to be exposed rather to the mixture than to the pure substance. Thus, the testing strategy was designed to take this route of exposure into account and it has been concluded that testing the mixture was more relevant than testing the registered substance as such.

To conclude, ecotoxicological studies were performed on the mixture and as a consequence for endpoint study records, the test material is not ticked when requesting if equivalent to submission substance identity.

Conclusion on classification

Data elements

The registered substance is a poorly water soluble substance. A Log Kow of 1.6 is determined for the registered substance and is an indication of low potential for bioaccumulation which can be used as a BCF data are lacking.

As explained in relevant sections, the ecotoxicological studies were performed on the mixture of the registered substance in the solvent.

The aquatic toxicity dataset is provided here after: Fish: 96h-LC50 = 141.4 mg/L which are attributed to physical effects ; Aquatic Invertebrates: 48h-EC50 > 1.61 mg/L; Algae: 72h-EC50 > 8.1 mg/L. Therefore, acute toxicity is recorded at levels higher than water solubility limit.

The test material was found to degrade up to 9% after 28 days in a screening biodegradation test. The registered substance is thus considered as not readily biodegradable. The hydrolysis study performed on the test material record a half-life of 139 d at pH 7 and 25°C in water and allows concluding that the registered substance does not exhibit any potential for rapid degradation in water.

Reasoning

No hazard classification is requested for the registered substance considering the low potential for acute aquatic toxicity and the low potential for bioaccumulation.