Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.05 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.5 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.38 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:
0.247 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.67 mg/kg food
Assessment factor:
300

Additional information

Derivation of PNECs

The PNECaqua(freshwater), PNECaqua(marine water), PNECintermittent release, PNECSTP and PNECoral were derived by application of an assessment factor. This procedure is described in detail in the ECHA REACH Guidance of May 2008, Chapter R.10 ("Characterisation of dose [concentration]-response for environment").

The PNECs for sediments (freshwater and marine water) and soil are derived using the Equilibrium Partitioning Method (EPM) which is in concordance with ECHA REACH Guidance R.10 (“Guidance of Information Requirements and Chemical Safety Assessment, Chapter R.10: Characterisation of dose-response for environment”).The required normalized organic-carbon soil coefficient (Koc) value was predicted via QSAR (Chemservice, 2018).The calculation of the Henry´s Law Constant of the test material was performed by using US-EPA software EPIWIN/HENRYWIN v3.20 (Chemservice, 2018).

Furthermore, no PNEC for the atmospheric compartment (PNECair) has been calculated. It is considered as not relevant based on the chemical structure and intrinsic properties of the test item.

Conclusion on classification

Environmental classification and labelling

Valid experimental results are available for evaluating environmental fate and ecotoxicity. For the test item, short-term data referring to the toxicity to fish, aquatic invertebrates and aquatic algae is available.

The substance showed low biodegradation (Bayliss, 2016) and was assessed to be not readily/rapidly biodegradable. According to QSAR reults the substance has a low potential to bioaccumulate (QSAR Chemservice, 2018).

All obtained effect levels (EL50, LL50) in acute toxicity tests for the three trophic levels (i.e. fish, daphnids and algae) were found to be >50 mg/L (WAF). No acute toxicity has been determined up to the limit of water solubility of < 1mg/L (Fox,2017b). Based upon the obtained experimental results and in reference to Regulation (EC) No 1272/2008, the test item has not to be classified and labelled with respect to environmental hazards.