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:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.089 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
3.3 mg/kg food
Assessment factor:
30

Additional information

Due to the fact that the substance did not show adverse effects in aquatic toxicity studies with acute and chronic exposure up to the solubility limit, no aquatic PNEC values could be derived. The substance underwent rapid primary degradation in an activated sludge die-away test. If released to the environment, the substance is expected to partition to sediment and soil. Further research is being undertaken on potential toxic effects to organisms living in these compartments, degradation pathways and bioaccumulation properties. In the interim, a PNECsoil has been proposed based on available data from the Environment Canada chemicals regulation programme.

A PNEC for secondary poisoning could be derived from chronic mammalian dietary data in two species with similar NOECs. The standard assessment factor of 30 was applied, but it could be a conservative estimate given the similarities in response in the two test species (rat and dog). As the substance is neither classified for environmental nor for human health endpoints, an exposure assessment is not mandatory according to the REACH legal text and REACH guidance B.8. Version 2.1, December 2011. Therefore an exposure and risk assessment is not performed at this point in time.

Conclusion on classification

Due to the absence of acute and chronic toxicity in aquatic organisms at the solubility limit of the substance in the aquatic environment, a bioconcentration value (BCF) of > 500 in a fish study, and the indication of rapid primary degradation in an activated sludge die away test, the substance is not classified for environmental hazards in accordance with Regulation 1272/2008 and amendments.