Nickel dihydroxide

GHS

General Information

Implementation:

EU

Type of classification:

harmonised classification

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:

Nickel dihydroxide

Nickel dihydroxide - LE composition 1

Classification

Physical hazards

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 lacking

Desensitized explosives

Reason for no classification:

data lacking

Health hazards

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:

H360D: May damage the unborn child.

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:

H350i: May cause cancer by inhalation.

Route of exposure:

inhalation

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>.

Affected organs:

lungs

Route of exposure:

inhalation

Environmental hazards

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

H350i: May cause cancer by inhalation.

H360D: May damage the unborn child.

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.