Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

GHS

General Information

Name:
orange lead
Implementation:
EU
Type of classification:
self-classification
Remarks:

This substance is included in Annex VI, Table 3.1 of Commission Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures, under the entry “lead compounds with the exception of those specified elsewhere in this Annex” (Index No 082-001-00-6). As such this entry is legally binding and must there be cited on both the label and SDS. However, for hazard classes not covered by Annex VI, the manufacturer or importer is required to self-classify the substance in accordance with the criteria described in the guidance on CLP. Endpoints marked by an asterisk (*) in Annex VI denote a minimum classification; manufacturers and importers must classify in a more severe hazard category in cases where they have further information which shows this is more appropriate.


Classification - Health


The basis of the original human health classifications is unknown. However, the CSR includes self-classification that, based on industry’s analysis of current data, proposes CHANGES TO THE EU CLASSIFICATION.


Based upon supporting data referenced in the REACH Registration dossier, the minimum classification of STOT-RE 2 is changed to STOT-RE 1, as human evidence exists for repeat dose effects on CNS, kidney and haematological (blood) systems. It is proposed that the existing SCL of ≥0.5% is maintained for STOT-RE1.


Multiple studies have now demonstrated that a number of soluble lead compounds can induce cancer in different species of test animals. Given the large doses of soluble lead compounds required to induce tumours in animals, only compounds with significant bioavailability will likely elicit a carcinogenic response. The bioavailability of most high-production-volume lead compounds is not known, but the sparingly soluble nature of some of the compounds under consideration does not equate with limited bioavailability under the acidic conditions of the stomach. For example, both lead oxide and lead carbonate exhibit high bioavailability in animal feeding studies and when tested in in vitro gastric simulation systems. While not all lead compounds may exhibit high bioavailability, extension of Carc. 2 (CLP) classification to most inorganic lead compounds can be considered unless there is evidence that limited bioavailability of a specific substance obviates cancer risk. Thus Carc. 2; H351: Suspected of causing cancer is added.


In addition, as lead may be transferred from mother to child in breast milk it is proposed that an additional hazard statement “H362: May cause harm to breast-fed children” be assigned.


It should be noted that Industry believes that data are available that support removal of classification Acute Tox. 4 (oral); H302: Harmful if swallowed and Acute Tox. 4 (inhalation); H332: Harmful if inhaled. These existing classifications for lead compounds are not supported by the read-across data. Acute toxicity is not observed in animals after oral exposures up to the limit values of acute toxicity testing for seven different inorganic lead compounds. Lead oxide, predicted to yield similar deposition patterns in the lung and comparable systemic uptake, is also not acutely toxic. Three similar compounds are lacking in dermal toxicity and in irritancy properties for the skin or eyes. Although toxic under chronic exposure situations, the acute toxicity of orange lead is predicted to be quite low and does not require classification.


It is noted, however, that removal of the harmonised classification for acute toxicity can only be undertaken by making a proposal to ECHA to be discussed at RAC and the classification officially changed via an Adaption to Technical Progress.


This situation is also the case for the harmonised classification Repro. 1A; H360Df, evidence of impact upon human male fertility indicates consideration of Repr. Cat. 2 being changed to Repr. Cat. 1A under CLP.


Classification - Environment


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). such, the harmonised classification of Acute 1, Chronic 1 is legally binding. The basis of the original environmental classifications is unknown. However, no change to the existing EU environmental classifications is proposed. M factors have been assigned for both acute and chronic effects to the aquatic environment:



  • Aquatic Acute 1; M-factor = 10

  • Aquatic Chronic 1; M-factor = 1.


NB Pb compound M factors may be reviewed in light of the Pb metal ENV CLH debate which is still ongoing at the time of writing.

Related composition

Related composition:
Orange Lead

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:
hazard class not applicable
Aerosols
Reason for no classification:
hazard class not applicable
Reason for no classification:
hazard class not assessed
Oxidising gases
Reason for no classification:
hazard class not applicable
Gases under pressure
Reason for no classification:
hazard class not applicable
Flammable liquids
Reason for no classification:
hazard class not applicable
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:
hazard class not applicable
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:
hazard class not applicable
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 conclusive but not sufficient for classification
Acute toxicity - oral
Hazard category:
Acute Tox. 4
Hazard statement:
H302: Harmful if swallowed.
Acute toxicity - dermal
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - inhalation
Hazard category:
Acute Tox. 4
Hazard statement:
H332: Harmful if inhaled.
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:
H360Df: May damage the unborn child. Suspected of damaging fertility.
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
Hazard category:
Carc. 2
Hazard statement:
H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
Route of exposure:
oral
1. Specific target organ toxicity - single (STOT-SE)
Reason for no classification:
data conclusive but not sufficient for classification
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>.
System:
central nervous system
Affected organs:
blood
kidney
other: central nervous system
1.
Concentration range (%):
>= 2.5
Hazard categories:
Repr. 2
2.
Concentration range (%):
>= 0.5
Hazard categories:
STOT Rep. Exp. 1
Hazardous to the aquatic environment (acute / short-term)
Hazard category:
Aquatic Acute 1
Hazard statement:
H400: Very toxic to aquatic life.
Hazardous to the aquatic environment (long-term)
Hazard category:
Aquatic Chronic 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
M-Factor acute:
10
M-Factor chronic:
1
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
GHS07: exclamation mark
GHS09: environment

Hazard statements

H302: Harmful if swallowed.
H332: Harmful if inhaled.
H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
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>.
H360Df: May damage the unborn child. Suspected of damaging fertility.
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>.
H372: Causes damage to central nervous system, blood and kidneys through prolonged or repeated exposure by inhalation or ingestion.
H410: Very toxic to aquatic life with long lasting effects.

Notes