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:
no hazard identified

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 to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Reliable aquatic toxicity tests (all reliability category 1) are available for freshwater algae (Scenedesmus subspicatus), freshwater invertebrates (Daphnia magna, acute), freshwater fish (zebra fish, acute) and sewage treatment plant microorganisms (activated sludge respiration inhibition test, 3 hours). In all these tests, nominal limit concentrations far above the actual water solubility of the submission substance were used (77 or 1000 mg/L). However, no signs of toxicity were observed in any of these tests. Thus, the submission substance was demonstrated to be non-toxic to freshwater organisms at water saturation level.

Thus, judging from these results terrestrial toxicity of the submission substance is unlikely. To ascertain this and in line with REACH guidance R.7c, chapter R.7.11.5, a possible chronic toxicity of the submission substance on earthworm reproduction was assessed. In the reliable (reliability category 1) test performed compliant to GLP no statistically significant effects on mortality, biomass or reproduction of Eisenia fetida were observed up to the highest tested concentration. Thus, the NOEC (56 d; mortality, biomass, reproduction) was determined to be larger or equal to 1000 mg/kg soil dw. In conclusion, taking together nontoxic properties of the submission substance towards aquatic (micro)organisms as well as soil macroorganisms (chronic test), toxicity of the submission substance towards terrestrial organisms can safely be precluded.

Conclusion on classification

As no toxicity for any tested species of algae, aquatic invertebrates, fish, microorganisms, and soil organisms (Eisenia fetida) could be found, no environmental classification is proposed.