Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7.6 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
6.58 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.76 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
329 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
24 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:
7.2 mg/kg soil dw
Assessment factor:
3
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

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

Additional information

Read-across approach

In the assessment of the ecotoxicity of divanadyl pyrophosphate, a read-across approach is followed based on all information available for inorganic V compounds. This grouping of vanadium compounds for estimating their properties is based on the assumption that properties are likely to be similar or follow a similar pattern as a result of the presence of the common vanadium ion. For most metal-containing compounds, it is indeed the potentially bioavailable metal ion that is liberated (in greater or lesser amounts) upon contact with water that is the moiety of toxicological concern.

This assumption can be considered valid when

i) differences in solubility among V compounds do not affect the results for ecotoxicity,

ii) ecotoxicity is only affected by the vanadium-ion and not by the counter ions, and

iii) there are no important differences in speciation of vanadium in the environment after emissions of the various V compounds.

All reliable data on ecotoxicity vanadium were selected based on soluble V substances or on measured dissolved vanadium concentrations. In assessing the ecotoxicity of metals in the various environmental compartments (aquatic, terrestrial and sediment), it is assumed that toxicity is not controlled by the total concentration of a metal, but by the bioavailable form. No evidence is available on the bioavailable form of vanadium, but for metals, this bioavailable form is generally accepted to be the free metal-ion or oxy-anion in solution. In the absence of speciation data and as a conservative approximation, it can also be assumed that the total soluble vanadium pool is bioavailable.

The reliable ecotoxicity results selected for read-across among vanadium substances are all based on pentavalent V substances (NaVO3, NH4VO3, Na3VO4, V2O5, Ca3(VO4)2and ammonium polyvanadate, (VO)2P2O7), except for one test on toxicity for birds where VOSO4was used. All counter-ions (Na+, NH4+, Ca2+and SO42-) are abundantly present in natural environments and are therefore not expected to cause any toxic effect at the concentration ranges tested.

Vanadium can exist in a multitude of different oxidation states from -2 to +5. However, being a first-row transition element, vanadium has the tendency to exist in high oxidation states (+3, +4 and +5), and vanadium ions will form oxy complexes in aqueous solutions (Cotton and Wilkinson, 1988; Crans et al., 1998). The aqueous chemistry of the metal is complex and involves a wide range of oxygenated species for which stabilities depend mainly on the acidity and oxygen level of receiving waters. Under conditions commonly found in oxic fresh waters (i.e., pH between 5 and 9; redox potential [Eh] between 0.5 and 1 V), the pentavalent forms will be the dominant species in solution (Brookins, 1988; Crans et al., 1998; Takeno, 2005). Tetravalent vanadium also may exist under some specific conditions (e.g. pH<5). It is therefore assumed that upon dissolution of vanadium substances, the environmental conditions control the (redox) speciation of vanadium in water, soil and sediment, regardless of the V compound added.

This is confirmed by redox speciation analysis of dissolved vanadium during transformation/dissolution tests for vanadium metal and 5 vanadium compounds with different oxygenation states (VOSO4, NaVO3, V2O5, V2O3and FeV) according to OECD guidance document 29 (2009). The tests were conducted at a loading of 1 mg/L over 28 days in standard OECD test media at pH 6 and pH 8 under a set of standard laboratory conditions representative of those in standard OECD aquatic ecotoxicity tests. The redox speciation of dissolved vanadium was measured by separating V(IV) and V(V) species by HPLC and analysis via ICP- MS. Regardless of the original redox state of V in the substance, dissolved V is at both pH 6 and 8 dominantly present as pentavalent V (75-97% of all V), with some traces of V(IV) (Table 1 of endpoint summary IUCLID section 5). Recovery of total dissolved V by the measured V(V) and V(IV) was on average 96% and did not differ significantly among the substances tested.

Based on this information, it was concluded that all conditions stated above are met. Therefore, all toxicity data based on soluble V substances (i.e. maximal bioavailability) without concern on toxicity of the counter-ions are used in a read-across approach and all results are expressed based on elemental vanadium concentrations.

Conclusion on classification

In order to evaluate the toxicity of the test substance to aquatic organisms read-across approach to structurally similar vanadium compounds were applied. Both acute and chronic toxicity data for vanadium are available for the three trophic levels. The lowest L(E)C50 for fish, crustacean or algae growth rate is a 48-h EC50 of 0.658 mg V/L (meas., filtered). This value is selected as the acute reference value for classification. The most sensitive long-term EC10/NOEC is the 30-d EC10 of 76 µg V/L (meas.) derived in a two-generation fish test.

For the classification of divanadyl pxrophosphate (CAS no. 65232 -89 -5), the acute and chronic reference values based on the vanadium concentration must be corrected for the molecular weight of divanadyl pyrophosphate (33.1 % V), resulting in 1.99 mg/L for the short-term and 0.2296 mg/L for the long-term effect value.

 

Official classification regarding environmental hazards:

Aquatic compartment

In accordance with Regulation (EC) No 1272/2008 Annex VI Table 3 divanadyl pyrophosphate (CAS no. 65232 -89 -5) is classified as aquatic chronic 2.

 

Self-classification regarding environmental hazards:

Aquatic compartment

According to the criteria outlined in Table 4.1.0(a) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is not to be classified as acutely hazardous to the aquatic environment (Category Acute 1) as the lowest short-term LC/EC50 (corrected) is greater than 1 mg/L.

Long-term toxicity data are available for all three trophic levels; therefore, it is sufficient to classify the substance based on these chronic data only.

- The substance is not rapidly degradable.

- The substance does not significantly bioaccumulate (BCF < 500).

- The available chronic effect value (EC10/NOEC, corrected) is greater than 0.1 mg/L, but less than/equal to 1 mg/L.

According to the criteria outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008), the substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 2).