Registration Dossier

Classification & Labelling & PBT assessment

GHS

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General Information

Remarks:
  • CARCINOGENICITY
    Nickel metal carries a classification as a suspect carcinogen. It is classified as a Category 2; H351 carcinogen under GHS and CLP; and Group 2B carcinogen (possible human carcinogen) by IARC (1990). These classifications were based on the lack of human evidence of carcinogenicity, but the presence of positive results for tumor induction in animals after injection or intratracheal instillation. In the late 1990s, the lack of a robust inhalation study lead the EU to mandate the conduct of such a study (conclusion (i); European Union Risk Assessment for Nickel, 2008-2009). The recent animal study by relevant route of exposure (inhalation) showing no increased respiratory cancer risk for nickel metal powder supersedes the results from injection/instillation studies and indicates that no carcinogen classification is warranted for nickel metal (Oller et al., 2008). A summary describing all relevant information regarding the classification of Ni metal for carcinogenicity has been included under Section 7.7 of this IUCLID and is in Appendix B2.
  • ENVIRONMENT
    Justification for the aquatic toxicity classification of Ni metal powder and no classification for nickel metal massives is provided in Section 6 IUCLID (∑ Ecotoxicological Information/Conclusions on Classification/Environmental Classification Justification) and in Section 7.6 of CSR.

Related composition

Related composition:
Composition 119
Composition 81

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
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
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Reason for no classification:
data conclusive but not sufficient for classification
Effects on or via lactation
Reason for no classification:
data lacking
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:
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
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)
Hazard category:
Aquatic Chronic 3
Hazard statement:
H412: Harmful to aquatic life with long lasting effects.
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

Hazard statements

H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
Inhalation Only
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>.
Inhalation Only
H317: May cause an allergic skin reaction.
H412: Harmful to aquatic life with long lasting effects.

Notes