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EC number: 239-290-0
CAS number: 15245-44-0
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.
biodegradation products being Pb ion (46 % of Lead styphnate weight),
therefore the environmental classification needs to be similar.
A precautionary read across approach based on Pb water solubility data
derived from OECD 105 water solubility testing, was used to determine
the environmental hazard classification. In absence of full TDp data on
this compound a temporally reasonable worst case environmental
classifications was derived from the water solubility test results :
· Under DSD : R50/53, with an M factor of 1 (The R53 is automatically
applied by default given the failure of the TDp screening test read
· Under CLP : Acute 1-Chronic 1, with an M factor of 1
This environmental classification recommendation holds all mixtures in
which the compound is used if each of the mixture contains at least 25 %
of the composing material.
In line with annex 4 chapter IV.5.3 of the CLP, Metal compounds must be
classified by comparing Transformation Dissolution data with toxicity
date 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 redundant.
Transformation Dissolution data in accordance to the OECD protocol are
not available for this compound, but water solubility data (saturation
levels at relevant time intervals for the environmental classification)
is available. There is no further need for developing Transformation
Dissolution data given a reasonable worst case read across approach
comparing the water solubility data from the OECD 105 test with the
acute toxicity reference values demonstrates that the compound is
sufficiently soluble to warrant a classification as R50-53 or Acute
1-Chronic 1. Further additional Transformation dissolution testing would
in general not be capable to improve this situation justifying the
requested waiving for TDp data.
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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