Lead dinitrate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

6.5 µg/L

Assessment factor:

3

Extrapolation method:

sensitivity distribution

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

3.4 µg/L

Assessment factor:

3

Extrapolation method:

sensitivity distribution

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 µg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

174 mg/kg sediment dw

Assessment factor:

3

Extrapolation method:

sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

164 mg/kg sediment dw

Assessment factor:

3

Extrapolation method:

sensitivity distribution

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

147 mg/kg soil dw

Assessment factor:

2

Extrapolation method:

sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

10.9 mg/kg food

Assessment factor:

6

Additional information

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. For metals, this bioavailable form is generally accepted to be the free metal-ion in solution. In the absence of speciation data and as a conservative approximation, it can also be assumed that the total soluble lead pool is bioavailable. All reliable data on ecotoxicity and environmental fate and behaviour of lead and lead substances were therefore selected based on soluble Pb salts or measured (dissolved) Pb concentration.

 

The reliable ecotoxicity data selected for effects assessment of Pb in the various environmental compartments are derived from tests with soluble Pb salts (lead (di)nitrate, lead carbonate, lead acetate, lead chloride). Since lead is the toxic component and the anions do not contribute to toxicity, all reliable data are grouped together in a read-across approach and the PNEC’s are expressed as μg Pb/L (measured dissolved concentration) or mg Pb/kg. These results can be used for all other Pb compounds without concern on toxicity of the anions.

 

Conclusion on classification

For ERV derivation the general rules according to the ‘Guidance on the application of the CLP criteria (ECHA, 2012)’ have been followed. Therefore, for determining acute/chronic aquatic toxicity for classification purposes data should be generated according to standardised test methods (or from validated and internationally accepted test methods). For acute ERV derivation LC50 values were used, while for chronic ERV derivation NOECs or the equivalent L(E)C10 were used. Unbounded toxicity values were not further considered for ERV derivation.

Furthermore, where 4 or more ecotoxicity data on the same species and endpoint were available, the data were grouped, and the geometric mean used as a representative toxicity value for that species. In other cases (> 4 data points), the lowest representative toxicity value was selected.

For the classification of metals, Transformation/Dissolution is carried out over a pH range. Ideally both T/D and ecotoxicity data are compared at a similar pH since both parameters will vary with pH. Because T/Dp tests are typically performed between pH 5,5 - 8,5, we have 'separated' the toxicity data according to 3 different pH ranges, ie 5,5-6,5/6,5-7,5/7,5-8,5.

- Acute reference values

An overview of the selected high quality species mean/lowest acute toxicity data for the 3 different pH classes is provided inTable96.

Table96: Overview of the selected high quality short-term toxicity data for the individual species (L(E)C₅₀values expressed as µg/L) for the 3 pH classes (lowest values in bold)

Test organism	Standard method	L(E)C50 (µg/L)
		pH: 5.5-6.5	pH: >6.5-7.5	pH: >7.5-8.5
Algae
Pseudokirchnerella subcapitata n Min. Max. Geometric mean/lowest value	OECD 201	6 72.0 364.0 163.7	6 26.6 79.5 37.8	3 20.5 49.6 20.5
Chlorella kessleri n Min. Max. Geometric mean/lowest value	OECD 201[1]	1 388.0 388.0 388.0	/ / / /	/ / / /
Invertebrates
Daphnia magna n Min. Max. Geometric mean/lowest value	OECD 202	/ / / /	/ / / /	3 337.1 364.5 337.1
Ceriodaphnia dubia n Min. Max. Geometric mean/lowest value	EPA-821-R-02-012	3 73.6 655.6 73.6	16 28.8 1,179.6 240.6	20 26.4 3,115.8 300.6
Fish
Oncorhynchus mykiss n Min. Max. Geometric mean/lowest value	OECD 203	/ / / /	1 1,170 1,170 1,170	2 340.5 1,000.0 340.5
Pimephales promelas n Min. Max. Geometric mean/lowest value	OECD 203	4 40.8 810.0 194.2	11 52.0 3,598.0 422.0	21 113.8 3,249.0 602.4

/: no data available

 

- Chronic reference values

An overview of the selected high quality species mean/lowest chronic toxicity data for the 3 different pH classes is provided inTable97.

Table97: Overview of the selected high quality long-term toxicity data for the individual species (L(E)C₁₀/NOEC values expressed as µg/L) for the 3 pH classes (lowest values in bold)

Test organism	Standard method	NOEC/L(E)C10 (µg/L)
		pH: 5.5-6.5	pH: >6.5-7.5	pH: >7.5-8.5
Higher plants
Lemna minor n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 221	1 186.0 186.0 186.0 Root growth rate	1 1,025.0 1,025.0 1,025.0 Root growth rate	3 85.0 348.0 85.0 Root growth rate
Algae
Pseudokirchnerella subcapitata n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 201	6 25.5 190.0 58.0 Growth rate	6 6.1 18.9 9.3 Growth rate	2 6.1 6.2 6.1 Growth rate
Chlorella kessleri n Min. Max. Geometric mean/lowest value	OECD 201[2]	1 120.0 120.0 120.0	/ / / /	/ / / /
Invertebrates
Daphnia magna n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 211	/ / / /	1 9.0 9.0 9.0 Mortality	3 78.0 406.6 78.0 Mortality
Ceriodaphnia dubia n Min. Max. Geometric mean/lowest value Most sensitive endpoint	ASTM n° E1295-01	2 33.3 69.5 33.3 Reproduction	21 1.7 354.9 25.3 Reproduction	16 20.4 107.4 52.2 Reproduction
Fish
Oncorhynchus mykiss n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 204; OECD 210; OECD 212	/ / / /	3 18.9 423.0 18.9 Abnormalities	1 121.0 121.0 121.0 Growth
Cyprinus carpio n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 204; OECD 210; OECD 212	1 17.8 17.8 17.8 Mortality	/ / / /	/ / / /
Lepomis macrochirus n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 204; OECD 210; OECD 212	/ / / /	1 70.0 70.0 70.0 Growth	/ / / /
Salvelinus fontanilis n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 210	/ / / / /	1 39.4 39.4 39.4 Growth	/ / / / /
Salvelinus namaycush n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 210	/ / / / /	1 72.0 72.0 72.0 Mortality	/ / / / /
Salmo salar n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 210	1 48.0 48.0 48.0 Mortality	/ / / /	/ / / /
Ictalurus punctatus n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 210	/ / / / /	2 98.2 100.4 98.2 Growth	/ / / / /
Pimephales promelas n Min. Max. Geometric mean/lowest value Most sensitive endpoint	OECD 204; OECD 210; OECD 212	1 29.3 29.3 29.3 Mortality	7 20.0 1,420.4 94.1 Mortality	3 174.4 1,337.7 174.4 Mortality

/: no data available

A summary of the selected acute and chronic reference values at the different pH’s is provided inTable98.

Table98: Overview of the selected high quality acute and chronic toxicity data for the individual species (expressed as µg dissolved Pb/L) for the 3 pH classes

pH range	Reference values (µg dissolved Pb/L)
	Acute reference value	Chronic reference value
pH 5.5-6.5 pH >6.5-7.5 pH >7.5-8.5	73.6 37.8 20.5	17.8 9.0 6.1

 

The derived reference toxicity data together with transformation dissolution testing and the Unit world model were used to determine the classifications for the various lead grades. Please find the conclusions for the various lead grades which are discussed in more detail in the C&L document in section 13 of the dossier.

 

A TDp 24 h screening test is available for Lead oxide although limited to pH8 information. Given the lower acute toxicity reference values at pH6 (79,4 μg/l) and pH7 (40,6,1 μg/l) and the higher solubility at this pH (> 100 μg/l), it can be deduced/concluded that with the information available, PbO would fail the 24h screening test and should therefore be classified as the soluble Pb ion, corrected for molecular weight, being :

- Under DSD : R50/53,

- Under CLP-2nd ATP : Acute 1 – Chronic 1,

- Under GHS 3rd rev : Acute 1 – Chronic 1,

An acute M factor of 10 is applied based on the lowest acute toxicity reference value (20,5 μg soluble Lead ion/l (at pH 8)), while for the chronic endpoint an M factor 1 is concluded based on a lowest chronic toxicity reference value of 6,1 μg soluble Lead ion/l. The rapidly removing from the water column of the soluble lead ion is confirmed while soluble lead has shown a low bioaccumulation potential.

In line with annex 4 chapter IV.5.3 of the CLP, Metal compounds must be classified by comparing Transformation Dissolution data with toxicity data for the soluble metal ion. The availability of toxicity information on the soluble ion (developed under the Lead metal registration file) makes the requirement for aquatic ecotoxicity tests on Lead oxide redundant.

Transformation Dissolution data in accordance to the OECD protocol are available for Lead oxide but to a limited extend (24h screening test at pH 8 only). There is therefore no need for further developing Transformation Dissolution data on Lead-oxide for the other pH levels, given a default classification of R50-53 or Acute 1-Chronic 1, could be derived.