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Classification & Labelling & PBT assessment

GHS

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General Information

Implementation:
EU
Remarks:

Justification for Self Classification - Health


 


Lead metal massives (high purity grade) is included in Regulation (EC) No 1272/2008 Annex VI Table 3.1 under the entry “lead massive: [particle diameter ≥1mm]” (Index No 082-014-00-7), agreed in the 9th ATP to CLP. Recital 4 of the 9th ATP indicates a distinction is necessary between the massive form (particle size of ≥1mm) and the powder form (particle size <1mm).


 


The toxicity of lead is generally considered to be mediated through the lead cation; it is manifested in effects on reproductive function but also on other body systems (blood, kidneys, reproductive function, development and the central nervous system).


 


In line with Art. 5(1) of CLP, classification must be based on the form the substance is placed on the market and how it is reasonably expected to be used. Although metallic lead is considered to have a low dermal absorption rate, lead oxide formed on the surface of lead can rub off on the skin becoming systemically available by hand to mouth contact. 


 


Given the systemic availability of the lead ion from metallic lead - which was used to justify the CLH entry - STOT-RE1; H372 is applied in addition to the harmonised classification. No SCL was set for reproductive toxicity for the massive form, thus the GCL of 0.3% applies; similarly, for STOT-RE, no SCL is required.


 


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Justification for Self Classification - Environment


 


No environmental classification is required for massive lead metal.


 


The toxicity of a particular metal in solution, appears to depend primarily on the level of dissolved free metal ions and the physico-chemistry of the environment. The solubility of lead metal was therefore assessed using the data that were generated according to the Transformation/Dissolution Protocol (Annex 10 to the UN GHS).


 


Surface area of the material is a crucial parameter; any variation in surface area tested may cause a significant change in the levels of metals ions released in a given time-window. Thus, particle size or surface area is fixed for the purposes of the transformation test, allowing the comparative classifications to be based solely on the loading level.


 


Normally, the Transformation/Dissolution (T/Dp) data generated would have used the smallest particle size marketed to determine the extent of solubilisation. However, the CLP guidance foresees that there may be cases where data generated for a particular metal powder are not considered as suitable for classification of the massive forms. For example, powders that have been produced by a special process and which cannot be formed by the massive metal should not be used for the hazard assessment of the massive form. Under these circumstances, classification of the massive should be based on tests that were conducted with a more representative particle size or surface area, if such data are available.


 


As this is the case with lead metal (see Section 2 of the report in Annex I to the CSR), T/Dp test data was generated on both powder (75µm) and massive (using a surface equivalent to a spherical particle diameter of 1 mm) forms of lead metal.


 


Transformation/Dissolution tests were conducted on non-aged Pb in the massive form using a surface equivalent to a spherical particle diameter of 1 mm at 1, 10 and 100 mg/L dosing, corresponding to respective surfaces loadings of 0.529, 5.286, 52.863 mm2/L. 7- and 28-day Transformation/Dissolution tests were conducted at pH 6 (CIMM, 2009), pH 7 (CIMM, 2012) and pH 8 (CIMM, 2017). The results are summarised in the following table:


 
















































 



pH 6


(µg soluble Pb/L)



pH 7


(µg soluble Pb/L)



pH 8


(µg soluble Pb/L)


 



Lead massive: Acute T/Dp testing results after 7 days



 



 



 



1 mg/L loading



5.1



2.0



0.28



10 mg/L loading



43.1



10



3.14



100 mg/L loading



428.9



109



29.99



Lead massive: Chronic T/Dp testing results after 28 days



 



 



 



1 mg/L loading


 



14.2


 



2.0


 



0.66



 


REACH requires the material being tested “as placed on the market”; the massive Pb material used for the original T/Dp testing was however carefully polished eliminating any potential transfer barrier. This pre-treatment of the sample would normally have eliminated the patina formed during normal storage and may have impacted the dissolution properties. The representativity of the tested non-aged material for real market conditions may therefore be questioned. The T/Dp test at pH 6 was therefore repeated with an aged sample (according to more normal market conditions), which resulted in the following results:


 


For 7-day T/Dp (“acute”):



  • 567 µg dissolved Pb/L at 100 mg/L dosing

  • 6 µg dissolved Pb/L at 1 mg/L dosing


 


For 28-day T/Dp (“chronic”):



  • 15 µg soluble Pb/L at 1 mg/L dosing


 


The results for the aged sample are comparable with those for the non-aged sample indicating a lack of effect of the potential passivation layer.


 


Conclusions


Lead in massive form clearly demonstrates significantly reduced solubility at 7- and 28-days compared to Pb metal powder at 7- and 28- days at the same loading, and compared to the 24-hour screening T/Dp test results for powder at equivalent loading. (See CSR Section 3.1.4 for 24-hour screening and 7- and 28-day full T/Dp data on Pb metal powder.) Lead metal in massive form is not considered readily soluble.


 


For the purpose of classification there is still no scientific consensus on how evidence of rapid removal should be used for metals, therefore it is assumed that any evidence for this phenomenon for lead metal cannot be used.


 


Classificaton for Acute Aquatic toxicity: It is appropriate to use the 7-day T/Dp data of the Pb-ion released from a Pb metal massive sample at 1 mg/L loading derived for the equivalent pH ranges to compare with the acute toxicity ERVs of the Pb-ion in solution). Following the criteria illustrated in the ECHA guidance results in the following conclusions:


 


































pH range



Acute reference value


(µg dissolved Pb/L)



Release of Pb from Pb-massive after 7 days at 1mg/L loading


(µg dissolved Pb/L)



Release >Acute ERV?



Classified as Acute 1?



pH 5.5-6.5



73.6



5.1


No

No



pH >6.5-7.5



37.8



2.0


No

No



pH >7.5-8.5



20.5



0.28



No



No



 


Classification for Chronic Aquatic toxicity: It is appropriate to use the 28-day T/Dp data of the Pb-ion released from a Pb metal massive sample at 1 mg/L loading derived for the equivalent pH ranges to compare with the chronic toxicity ERVs of the Pb-ion in solution. Following the criteria illustrated in the ECHA guidance results in the following conclusions:


 


































pH range



Chronic reference value


(µg dissolved Pb/L)



Release of Pb from Pb-massive after 28 days at 1mg/L loading


(µg dissolved Pb/L)



Release >Chronic ERV?



Classified as Chronic 2?



pH 5.5-6.5



17.8



14.2



No



No



pH >6.5-7.5



9.0



2.0



No



No



pH >7.5-8.5



6.1



0.66



No



No



 


Comparing toxicity and dissolution at an equivalent pH band, at no pH is the dissolved fraction from the 28-day T/Dp testing at 1 mg/L loading of lead metal massive HIGHER than the chronic ERV of the most sensitive species. Therefore, lead metal in massive does not require classification for acute or chronic (long-term) aquatic hazards according to CLP criteria; as Pb metal in massive form is not classified Acute 1 or Chronic 1, the assignment of M-factors is not applicable.


 


More detailed information to explain the environmetal non-classification of Pb metal in massive form is provided in Section 13: "Annex 1 C&L Lead".


 


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Labelling derogation


 


A derogation from labelling requirements exists for metals in massive form. Such metals do not require a label according to Annex 1 to the CLP Regulation if they do not present a hazard to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market, although classified as hazardous in accordance with the criteria of that Annex.

Related composition

Related composition:
lead metal massives (high purity grade)

Classificationopen allclose all

Explosives
Reason for no classification:
data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data conclusive but not sufficient for classification
Aerosols
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
hazard class not assessed
Oxidising gases
Reason for no classification:
data conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
data conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
data conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
data conclusive but not sufficient for classification
Skin corrosion / irritation
Reason for no classification:
data conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
data conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
data conclusive but not sufficient for classification
Skin sensitisation
Reason for no classification:
data conclusive but not sufficient for classification
Aspiration hazard
Reason for no classification:
data conclusive but not sufficient for classification
Reproductive toxicity
Hazard category:
Repr. 1A
Hazard statement:
H360: May damage fertility or the unborn child <state specific effect if known > <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Specific effect:
H360FD: May damage fertility. May damage the unborn child.
Effects on or via lactation
Hazard category:
Effect on or via lactation
Hazard statement:
H362: May cause harm to breast-fed children.
Germ cell mutagenicity
Reason for no classification:
data conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - single (STOT-SE)
Reason for no classification:
data conclusive but not sufficient for classification
Affected organs:
other:
1. Specific target organ toxicity - repeated (STOT-RE)
Hazard category:
STOT Rep. Exp. 1
Hazard statement:
H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Affected organs:
other: Causes damage to central nervous system, blood and kidneys through prolonged or repeated exposure by inhalation or ingestion
Route of exposure:
inhalation
oral
Hazardous to the aquatic environment (acute / short-term)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (long-term)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the ozone layer
Reason for no classification:
data conclusive but not sufficient for classification

Labelling

Signal word:
Danger

Hazard pictogram

GHS08: health hazard

Hazard statements

H360: May damage fertility or the unborn child <state specific effect if known > <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H360FD: May damage fertility. May damage the unborn child.
H362: May cause harm to breast-fed children.
H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Causes damage to central nervous system, blood and kidneys through prolonged or repeated exposure by inhalation or ingestion

Notes