Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

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

Sediment (freshwater)

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

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

No aquatic toxicity tests are available for HFC 227ea in fish, invertebrates and/or algae. However, data is available from GLP-compliant OECD guideline studies with the structurally similar substances HFC 365mfc and HFC 245fa.

The aquatic PNECs were estimated by considering the lowest value obtained for structural analogues (LC50 > 100 mg/l for HFC 245fa in fish) and dividing it for the default assessment factors of 1000 for freshwater and 100 for intermittent release. As the POD is not indicative of a real LC50, derived PNECs can be considered as very conservative values.

The analogue approach for the HFC category is justified and documented in the position paper "Use if categories approach in environmental hazard assessment of hydrofluorocarbons (HFCs) and hydrochlorofluorocarbons (HCFCs)", attached in the Endpoint Summary in Section 6 of the Technical Dossier (Ecotoxicological Information).

Toxicity to micro-organisms is determined according to an OECD 209 test. The 3-h EC50 of 173.1 mg/L in activated sludge (Voelskow, 1992) will be used in the assessment.

Sediment toxicity: PNEC was estimated via the Equilibrium partitioning method (Guidance IR&CSA, R.10). The Koc of 90.2 L/Kg estimated was used for the estimation of the sediment-water partition coefficient Kp-sed in the equation:

Kp-sed= 0.05 * Koc = 4.51 L/Kg

Ksed-water was calculated in the equation:

Ksed-water = Fwater-sed + F soil-sed * (Kp-sed*2.5) = 0.8 + 0.2 * (4.51*2.5) = 3.06

and used for the PNEC estimation in the equation:

PNECsed = (Ksed-water/1.15) * PNECwater = 0.27 mg/kg w.wt. for fresh water. This PNEC can be converted to the values for dry weight sediment, by dividing for the fraction of solid in the sediments (0.2), to give the reported PNEC.

Terrestrial toxicity: No direct or indirect exposure to HFC 227ea is expected for terrestrial organisms. No PNEC derivation is necessary.

Oral (secondary poisoning): due to the very low bioaccumulation potential of HFC 227ea, no secondary poisoning is to be expected. PNEC derivation is not necessary.

Conclusion on classification

No data are available for HFC 227ea. However, the comparison with other structurally related HFCs showed that no aquatic acute ecotoxicity is to be expected at concentrations ≤ 100 mg/l. Besides, due to the environmental behaviour of those substances, a very low partitioning into the aquatic environment is predictable. Based on all available data on structural analogues for daphnids, fish and algae, HFC 227ea is not classifiable as hazardous to the aquatic environment. As HFC 227ea does not contain Chlorine or Bromine, it is not classifiable as dangerous for the ozone layer. In conclusion, no classification for environmental endpoints is deemed necessary for HFC 227ea under Directive 67/548/EEC and Regulation (EC) No. 1272/2008.