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EC number: 235-252-2
CAS number: 12141-20-7
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. Ale 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.
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.
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, 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):
Geometric mean/lowest value
OECD n° 221
OECD n° 201
OECD n° 201
OECD n° 202
OECD n° 203
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 kessleriwas 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):
Most sensitive endpoint
OECD n° 211
ASTM n° E1295-01
OECD n° 204; OECD n° 210; OECD n° 212
OECD n° 210
Sensu stricto, the speciesChlorella vulgarisshould be used according to the OECD guideline. However, both species belong to the same genus and thereforeChlorella kessleriwas selected for classification purposes
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
Reference values (µg dissolved Pb/L)
Acute reference value
Chronic reference value
The conclusions on environmental classifcation are presented in Section 7.6 of the CSR.
In any case, this substance isincluded 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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