Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.015 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

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:
PNEC soil
PNEC value:
5.43 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Using validated QSAR models from ECOSAR™ v0.99 (U.S. EPA, 2001), the 96-h LC50 in freshwater fish is 246 mg/L, the 48-h LC50 in daphnids is 250 mg/L and the 96-h EC50 in green algae is 150 mg/L (the QMRFs and QPRFs can be found in Annexes 9 to 14). No data are available for micro-organisms, but emission to waste water is not expected.

Conclusion on classification

Initial EU and GHS hazard classification

According to Directive 67/548/EEC, results of validated structure activity relationships and expert judgment may also be taken into account where appropriate with regard to classification and labelling of substances.

Based on all available ecotoxicological data for daphnids, fish and algae, VDF not need to be classified according to Directive 67/548/EEC since the lowest estimated effect concentration is 150 mg/L in green algae. And although VDF is not expected to be readily biodegradable based on results with structural analogues, the substance is not bioaccumulative based on its low log Kow of 1.24.

According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 VDF needs not to be labelled for the same reasons as stated above.

8. PBT AND VPVB ASSESSMENT

8.1. Assessment of PBT/vPvB Properties - Comparison with the Criteria of Annex XIII

An assessment of the PBT status of VDF has been made using all available data. The information available suggests that VDF does not meet the PBT screening criteria as outlined in Directive 2006/121/EC (see Appendix A for the criteria).

8.1.1. Persistence Assessment

No data on biodegradability is available. Information from related gaseous materials (pentafluoroethane and vinylidine chloride) generally showed ≤ 5% degradation (SIDS, 2005 and NITE, 1992) Based on these analogous substances, VDF is not expected to be readily biodegradable (see Annex 4 for the Reporting Format). However, it was demonstrated that indirect photodegradation can contribute significantly to the rapid degradation of VDF in the environment. Furthermore, VDF partition mainly to air and the photodegradation in the atmospheric compartment is expected to be fast (the DT50 of VDF, based on a 12-hr day with an OH radical concentration of 1.5E6 OH/cm3, is 4.7 days). Therefore it can be stated that the P criterion is not met for this substance.

8.1.2. Bioaccumulation Assessment

No measured BCF results are available. The potential for bioaccumulation was therefore assessed on the basis of the log Kow using the program BCFWIN™ v3.00 (U.S. EPA, 2009). The model shows no bioaccumulative potential for VDF (BCF is 3.06 L/kg). Further testing in scope of the PBT assessment is therefore not considered necessary.

8.1.3. Toxicity Assessment

No measured aquatic toxicity data are available for VDF; therefore ECOSAR™ v0.99 (U.S. EPA, 2001) was applied. The calculated acute effect data for all three trophic levels (fish, invertebrates, algae) are much higher than 0.1 mg/l (the lowest calculated effect concentration is a 96-h EC50 of 150 mg/L in green algae). It can therefore be expected that VDF is not potentially toxic towards aquatic organisms. At this moment, there is no reason to expect a CMR classification for VDF, as the substance is not classified as being carcinogenic and there is no evidence that VDF is chronically toxic towards mammals. Therefore, the T-criterion is not fulfilled, and further testing in scope of the PBT assessment is not necessary.

8.1.4. Summary and overall Conclusions on PBT or vPvB Properties

The overall conclusions, based on the present available data, of the preliminary PBT assessment are that the (screening) criteria for PBT/vPvB are not met and that further testing in the scope of the final PBT assessment is not considered to be required.

8.2. Emission Characterisation

VDF is not a PBT/vPvB substance; therefore the emission characterisation does need not to be conducted.