Registration Dossier

Classification & Labelling & PBT assessment

GHS

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General Information

Implementation:
EU
Remarks:
  • Nickel dihydroxide is classified for acute oral toxicity as Acute Tox. 4; H302 under the 1st ATP to the CLP. A recently completed in vivo acute oral toxicity study concluded Ni dihydroxide has an LD50=5,000 mg/kg suggesting it should not be classified for this endpoint. However, an older study already exists in which the results correspond to the current harmonized classification, thus the harmonized classification continues to be reflected in this file.
  • Recently generated data suggest that Ni dihydroxide should not be classified for 3 endpoints for which a harmonized classification currently exists according to the 1st ATP to the CLP. While no actual changes to any of these classifications are being proposed within this registration file, the background information is included below and within each endpoint's respective summary.
  • Dermal Irritation. A recently completed in vivo dermal irritation study concluded Ni dihydroxide was not an irritant suggesting it should not be classified for this endpoint.
  • Dermal Sensitization. Ni dihydroxide is currently classified as a dermal sensitizer (Skin Sens. 1; H317) according to the 1st ATP to the CLP Regulation. However, the results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate that Ni dihydroxide releases significantly less nickel (II) ion compared to nickel substances known to be skin sensitizers, including nickel sulphate and nickel metal. This suggests that nickel dihydroxide may not be a skin sensitizer. However, the bioaccessibility method has not yet been validated in vivo so the classification for skin sensitization can be read-across from nickel sulphate or nickel oxide, since both are classified as skin sensitizers. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3 in the accompanying CSR.
  • Reproductive Toxicity. A comprehensive read-across program based on bioaccessibility data in synthetic fluids and in vivo acute oral toxicity data has been conducted on a series of Ni substances including Ni dihydroxide. The results of this program suggest that Ni dihydroxide should not be classified as Repr. 1B; H360D. While no change to the existing classification is proposed within this registration file, a complete summary of the testing program including results and discussion are provided in Section 7.8 of IUCLID and as Appendix B1 in this CSR.

Related composition

Related composition:
Composition 16
Composition 10

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
Hazard category:
Skin Irrit. 2
Hazard statement:
H315: Causes skin irritation.
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
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

H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
H350i-Inhalation route only
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
H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
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>.
Respiratory effects only
H332: Harmful if inhaled.
H302: Harmful if swallowed.
H315: Causes skin irritation.
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