Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Nickel Sulphamate
Implementation:
EU
Remarks:
  • Ni sulphamate has not previously been classified for acute oral or inhalation toxicity in the EU. However, a recently completed OECD-guideline compliant study reported an oral LD50=1098 mg/kg Ni sulphamate. Based on this newly generated data, Ni sulphamate now has a harmonized classification as Acute Tox. 4; H302 according to the 14th ATP to the CLP Regulation. In addition, a comprehensive read-across assessment was recently completed based on bioaccessibility data in synthetic lung fluids of various nickel compounds combined in vivo verification data for three source nickel substances. The bioaccessibility-based paradigm presented in a summary document in Section 7.2.2 and Appendix B2 of the CSR enables grouping of target Ni substances for classification purposes according to bioaccessibility in interstitial fluid as demonstrated. The outcome of this assessment indicates that Ni sulphamate should be read-across from Ni sulphate for acute inhalation toxicity. Therefore, application of this read-across paradigm suggests that Ni sulphamate should be classified as Acute Tox 4.; H332. This nickel sulphamate classification profile reflectsa newly harmonized (according to the 14th ATP to the CLP) acute oral classification of Acute Tox. 4; H302 and an acute inhalation self-classification of Acute Tox. 4; H332.
  • In the Labelling section, the hazard pictogram GHS08 (health hazard), associated with the respiratory sensitization 1 classification, overrides the hazard pictogram GHS07 (exclamation mark) for skin sensitization 1 according to the Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008.

Related composition

Related composition:
Composition 8

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
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 lacking
Desensitized explosives
Reason for no classification:
data lacking
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
Hazard category:
Resp. Sens. 1
Hazard statement:
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Skin sensitisation
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Hazard category:
Repr. 1B
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:
Perinatal mortality
Effects on or via lactation
Reason for no classification:
data conclusive but not sufficient for classification
Germ cell mutagenicity
Hazard category:
Muta. 2
Hazard statement:
H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Carcinogenicity
Hazard category:
Carc. 1A
Hazard statement:
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Route of exposure:
Inhalation
1. Specific target organ toxicity - single
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated
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:
Lungs
Route of exposure:
Inhalation
1.
Concentration range (%):
>= 0.01
Hazard categories:
Skin Sens. 1
2.
Concentration range (%):
>= 1
Hazard categories:
STOT Rep. Exp. 1
3.
Concentration range (%):
>= 0.1 - < 1
Hazard categories:
STOT Rep. Exp. 2
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:
1
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

GHS07: exclamation mark
GHS08: health hazard
GHS09: environment

Hazard statements

H302: Harmful if swallowed.
H332: Harmful if inhaled.
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes 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>.
Perinatal mortality
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>.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H317: May cause an allergic skin reaction.
H410: Very toxic to aquatic life with long lasting effects.

Notes

Note H