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Ecotoxicological Summary

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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 PNEC’s 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, 2017) 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 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. 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. The data for the most sensitive endpoint of a given species in a pH band (see below) were selected for grouping (when n = 4 or >4). In other cases (< 4 data points), the lowest representative toxicity value was selected. Finally, the lowest value among all species after grouping of data in the same pH band was selected for an ERV.


 


For the classification of metals, Transformation/Dissolution is carried out over a pH range. Ideally, T/Dp 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 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[1]



 


1


120.0


120.0


120.0



 


/


/


/


/



 


/


/


/


/



Invertebrates



 



 



 



 



Daphnia magna


n


Min.


 


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


 



 


/


/


/


/



 


/


/


/


/



Ictalurus punctatus


n


Min.


Max.


Geometric mean/lowest value


Most sensitive endpoint



 



 


/


/


/


/


/



 


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






[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


 


A summary of the selected acute and chronic reference values at the different pH levels 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



 


 


Classification for Acute Aquatic toxicity: The lowest acute ERV is 20.5 µg/L (pH 8). The dissolved lead ion concentration at the corresponding pH after 7 days was 68.5 µg/L i.e. greater than the acute ERV. Therefore Aq. Acute Cat. 1 is appropriate.



Classification for Chronic Aquatic toxicity: The lowest chronic ERV is 6.1 μg/L; the dissolved lead ion concentration at the corresponding pH after 28 days was 134 µg/L, at 1mg/L loading. An Aquatic Chronic Category 1 classification would therefore seem appropriate. In any case, the lead powder (75μm) failed the screening 24 h T/Dp test, and therefore may be considered as “readily soluble”. According to the relevant classification strategy (Section IV.5.3.2.1 of the ECHA Guidance on the Application of the CLP Criteria (ECHA, 2017)), readily soluble metal compounds are classified on the basis of chronic ERV of the dissolved metal ion: classification as Aquatic Chronic Category 1 is applied where the chronic ERV is ≤0.1 mg/L. In the case of lead metal powder, considered to be readily soluble, Chronic Category 1 would appear appropriate as the lowest chronic ERV is well below 0.1 mg/L.



The conclusions on environmental classification of lead metal powder are further discussed in Section 7.6 of the CSR and in Annex 1 (see section 13.2).



It is further noted that discussions on harmonised environmental classification for lead metal powder were concluded at CARACAL-33; the existing CLP Annex VI entry (human health) for lead metal powder is therefore expected to be updated via a Commission Delegated Regulation, i.e. the 15th ATP to CLP:


 

















082-013-00-1lead powder; [particle diameter < 1 mm]231-100-47439-92-1

Repr. 1A


Lact.


Aquatic Acute 1


Aquatic Chronic 1


H360FD
H362
H400
H410

GHS08
GHS09


Dgr


H360FD H362
H410
 

Repr. 1A; H360D: C ≥ 0,03 %


M=1



M=10