Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2.4 µg/L
Assessment factor:
2
Extrapolation method:
sensitivity distribution

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.3 µg/L
Assessment factor:
2
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:
186 mg/kg sediment dw
Assessment factor:
3
Extrapolation method:
sensitivity distribution

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
212 mg/kg soil dw
Assessment factor:
1
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 PNECs are expressed as µg Pb/L (measured dissolved concentration) of mg/kg Pb. These results can be used for all other Pb compounds without considering toxicity of the anions.

 

Attached are documents discussing the PNEC derivation for the aquatic, terrestrial, and sediment environments, and secondary poisoning via the terrestrial food chain, which describe the process in detail.

Conclusion on classification

For ERV derivation the general rules according to the ‘Guidance on the application of the CLP criteria' (ECHA, 2015) has been followed. Therefore, the determination of the environmental acute/chronic hazard assessment for Pb is based on data that were generated according to standardised test methods (or from validated and internationally accepted test methods). For acute ERV derivation LC50values were used, while for chronic ERV derivation, NOECs or the equivalent L(E)C10were used. Unbounded toxicity values were not further considered for ERV derivation. Additionally, no marine species were considered. 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.

It is further noted that this substance is included in Regulation (EC) No 1272/2008 Annex VI Table 3.1 under the entry “lead compounds with the exception of those specified elsewhere in this Annex (Index No 082-001-00-6). As such, this harmonised classification is legally binding.

 

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, i.e. 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 in the table below.

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

Higher plants

 

 

 

 

Lemna minor

n

Min.

Max.

Geometric mean/lowest value

OECD n° 221

 

1

373.0

373.0

373.0

 

1

1,674.0

1,674.0

1,674.0

 

2

221.7

482.8

221.7

Algae

 

 

 

 

Pseudokirchnerella subcapitata

n

Min.

Max.

Geometric mean/lowest value

OECD n° 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 n° 201[1]

 

1

388.0

388.0

388.0

 

/

/

/

/

 

/

/

/

/

Invertebrates

 

 

 

 

Daphnia magna

n

Min.

Max.

Geometric mean/lowest value

OECD n° 202

 

/

/

/

/

 

1

280.0

280.0

280.0

 

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 n° 203

 

/

/

/

/

 

8

138

1,170

445.1

 

4

125.0

1,000.0

379.5

Pimephales promelas

n

Min.

Max.

Geometric mean/lowest value

OECD n° 203

 

4

40.8

810.0

194.2

 

11

52.0

3,598.0

422.0

 

21

113.8

3,249.0

602.4

Poecilia reticulata

n

Min.

Max.

Geometric mean/lowest value

OECD n° 203

 

1

1,990.0

1,990.0

1,990.0

 

/

/

/

/

 

/

/

/

/

[1]Sensu stricto, the species Chlorella vulgaris should be used according to the OECD guideline. However, both species belong to the same genus and therefore Chlorella kessleri was selected for classification purposes

/: 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 in the table below.

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 n° 221

 

1

186.0

186.0

186.0

Growth rate

 

1

1,025.0

1,025.0

1,025.0

Growth rate

 

3

85.0

348.0

85.0

Growth rate

Algae

 

 

 

 

Pseudokirchnerella subcapitata

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 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 n° 201[2]

 

1

120.0

120.0

120.0

 

/

/

/

/

 

/

/

/

/

Invertebrates

 

 

 

 

Daphnia magna

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 211

 

/

/

/

/

 

1

9.0

9.0

9.0

Mortality

 

2

30.0

250.0

30.0

Reproduction

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 n° 204; OECD n° 210; OECD n° 212

 

/

/

/

/

 

3

18.9

423.0

18.9

Abnormalities

 

3

55.4

121.0

55.4

Growth

Cyprinus carpio

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 204; OECD n° 210; OECD n° 212

 

1

17.8

17.8

17.8

Mortality

 

/

/

/

/

 

/

/

/

/

Lepomis macrochirus

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 204; OECD n° 210; OECD n° 212

 

/

/

/

/

 

1

70.0

70.0

70.0

Growth

 

/

/

/

/

Salvelinus fontanilis

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 210

 

/

/

/

/

/

 

1

39.4

39.4

39.4

Growth

 

/

/

/

/

/

Salvelinus namaycush

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 210

 

/

/

/

/

/

 

1

72.0

72.0

72.0

Mortality

 

/

/

/

/

/

Salmo salar

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 210

 

1

48.0

48.0

48.0

Mortality

 

/

/

/

/

 

/

/

/

/

Ictalurus punctatus

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 210

 

/

/

/

/

/

 

2

98.2

100.4

98.2

Growth

 

/

/

/

/

/

Pimephales promelas

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD n° 204; OECD n° 210; OECD n° 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

[2]Sensu stricto, the speciesC hlorella vulgaris should be used according to the OECD guideline. However, both species belong to the same genus and therefore Chlorella kessleri was selected for classification purposes

/: no data available

A summary of the selected acute and chronic reference values at the different pHs is provided in the table below.

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

 

In any case, this substance is included in Regulation (EC) No 1272/2008 Annex VI Table 3.1 under the entry “lead compounds with the exception of those specified elsewhere in this Annex (Index No 082-001-00-6). As such, the harmonised classification of Acute 1, Chronic 1 is legally binding.