Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.071 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:
0.103 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
43.3 µg/kg food
Assessment factor:
30

Additional information

Aquatic environment

Multiple tests with fish demonstrate a low aquatic toxicity. The lowest 96-hour LC50 value of 210 mg/L is from a study with the freshwater Brachydanio rerio (new name: Danio rerio) conducted under OECD guidelines. Using ECOSAR calculations, algae are assumed to be the most sensitive species. A 96 -h EC50 of 77 mg/l is estimated and this value will be used in the hazard assessment of the substance.

Long-term aquatic tests are not considered necessary, because no significant long-term exposure is expected. Due to the fact that vinyl chloride is a gas, no significant concentrations are present in the fresh water and seawater compartment. This is supported by exposure assessment with EUSES. A regional PEC in fresh surface water of 4.18E-06 mg/L and a regional PEC in seawater of 3.44E-07 mg/L were calculated. The maximal local PEC value that was calculated for fresh water was 3.65E-02 mg/L (for S-PVC production). The maximum local PEC value that was calculated for seawater was 3.65E-03 mg/L (for S-PVC production).

Due to the fact that vinyl chloride is a gas, no significant concentrations are present in the sediment compartment. This is supported by exposure assessment with EUSES. A regional PEC in sediment of 3.74E-05 mg.kg-1 (d.w.) was calculated. The maximal local PEC value that was calculated for sediment was 0.336 mg.kg-1 (d.w.) (for S-PVC production). Since these concentrations are very low, no significant exposure of the sediment compartment is assumed and therefore sediment toxicity tests are not needed.

Terrestrial environment

Due to the fact that vinyl chloride is a gas, no significant concentrations are present in the soil and air compartment. This is supported by exposure assessment with EUSES. A regional PEC in soil of 9.36E-08 mg.kg-1 (d.w.) and a regional PEC in the atmosphere of 3.53E-06 mg/m3 was calculated. The maximal local PEC value that was calculated for soil was 0.042 mg.kg-1 (d.w.) and for air 0.019 mg/m3 (for S-PVC production). Since these concentrations are very low, no significant exposure via the soil and air compartment is assumed and therefore studies on terrestrial organisms are not considered necessary.

In accordance with column 2 of REACH Annex X, the study on birds does not need to be conducted as sufficient reliable data is available from the mammalian data set.

STP

The 84-h EC50 is determined to be 40 mg/l in (domestic) activated sludge, tested in a batch procedure (ATA-assay) (Stuckey, 1980)

Conclusion on classification

Although the calculated 96h-EC50 to algae is 77 mg/l, vinyl chloride is a gas and does not remain in significant concentrations in the aquatic environment. Therefore it can be assumed that vinyl chloride will not constitute a potential long-term and/or delayed danger to the aquatic environment and no classification for environmental hazards is required according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Preliminary PBT assessment

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

Persistence

A closed bottle test (OECD 301D) showed that vinyl chloride is not readily biodegradable. However, as vinyl chloride is a gas at ambient temperature, it can be assumed that the air compartment is the most important compartment for assessment of the persistence. According to the TGD R.7.9.5.1, it may be considered for substances that are a gas under ambient condition, that they are removed from the aquatic compartment via volatilization. In the atmosphere, vinyl chloride degrades via reaction with hydroxyl radicals with a half-life time of approximately 2.3 days; vinyl chloride can therefore be regarded as not persistent.

 

Bioaccumulation

No experimental BCF results are available. The potential for bioaccumulation was therefore assessed on the basis of the log KOWusing the computer program BCFWIN™ (2000). The model shows no bioaccumulative potential for vinyl chloride (3.55 l/kg). Further testing in the scope of the PBT assessment is therefore not deemed necessary.

 

Toxicity

The acute effect information for all three trophic levels is much higher than the screening criterion of 0.1 mg/l. It can therefore be expected that vinyl chloride is not toxic towards aquatic organisms. However, vinyl chloride is classified as a carcinogenic, category 1 and therefore needs to be assigned as being T.

 

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.

 

Emission Characterisation

Vinyl chloride is not a PBT/vPvB substance, therefore the emission characterisation need not to be conducted.