Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
Pentanickel octahydroxide carbonate Self-Classification
Implementation:
EU
Remarks:
The self-classification of Pentanickel octahydroxide carbonate is read across from Nickel Hydroxycarbonate (235-715-9) due to the similarities between the two substances. The following statements apply to pentanickel octahydroxide carbonate.
Ni hydroxycarbonate currently carries a minimum classification as Acute Tox 4;H332 for acute inhalation toxicity in the EU. Section 1.2.1 of the CLP Regulations states that a minimum classification "shall be applied if none of the following conditions are fulfilled:...the manufacturer or importer has access to data or other information as specified in Part 1 of Annex I that lead to classification in a more severe category compared to the minimum classification. Classification in the more severe category must then be applied". The findings of a recently completed OECD-guideline compliant study suggest that a gender-specific anion effect may be causing increased toxicity in males as compared to females. Although the LC50 in females was greater than the highest dose tested (2.09 mg/L), the LC50 of 0.24 mg/L in males should be carried forward as a conservative approach to classification. This indicates that a more stringent classification of Acute Tox. 2:H330 is warranted. In accordance with the rules set by the CLP Regulation, the minimum classification has been changed to Acute Tox. 2:H330 for the Nickel Hydroxycarbonate Self-Classification profile (CAS # 12607-70-4), while the harmonized classifications can be found in Nickel Hydroxycarbonate (CAS # 12607-70-4) within this registration file. A complete summary of the testing program including results and discussion are provided in Section 7.2.2 of IUCLID.
Ni hydroxycarbonate is currently classified as Skin Irrit. 2;H315 according to the 1st ATP to the CLP. However, the results of a recently completed guideline-based, GLP study do not meet the classification criteria for this endpoint. 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 7.3.1.
Ni hydroxycarbonate is not currently classified as for eye irritation according to the 1st ATP to the CLP Regulation. However, a review of the updated CLP classfication criteria resulted in the determination of self-classification of Ni hydroxycarbonate as an eye irritant (Eye Irrit. 2; H319). Therefore, the GHS self-classification profile for nickel hydroxycarbonate (CAS # 12607-70-4) within this registration file reflects this classification. A complete summary of the testing program including results and discussion are provided in Section 7.3.2 of IUCLID and Section 5.3.2 in the accompanying CSR.
Ni hydroxycarbonate 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 hydroxycarbonate releases less nickel (II) ion compared to water soluble nickel substances known to be skin sensitizers (including nickel sulphate and nickel chloride), but releases similar amounts of nickel ion to nickel metal, which is also a known skin sensitizer. This suggests that nickel hydroxycarbonate is probably a skin sensitizer but with lesser potency than water soluble nickel compounds like nickel sulphate. Although the bioaccessibility method has not yet been validated in vivo, the classification for skin sensitization for nickel hydroxycarbonate is appropriate to be read-across from nickel sulphate or nickel since both are skin sensitizers. An explanation of the rationale and methodology is provided in Section 7.4.1 of IUCLID and as Appendix B3 of the CSR.
In the Labelling section, the hazard pictogram GHS06 (skull and crossbones), associated with the change in Acute Inhalation Toxicity classification, overrides the hazard pictogram GHS07 (exclamation mark) according to the Guidance on Labelling and Packaging in accordance with Regulation (EC) No 1272/2008. Therefore, in accordance with the CLP, only the hazard pictogram GHS06 is included in this IUCLID file and the associated Chemical Safety Report.
Please note that the REACH registration for nickel hydroxycarbonate (CAS # 12607-70-4) does not include nickel carbonate (CAS # 3333-67-3), as it is neither manufactured nor imported since large-scale production of pure nickel carbonate is not viable. See IUCLID Section 1.4, Substance Identification attachement document or Appendix E1 of the CSR for additional information.

Related composition

Related composition:
Composition 1
Composition 2
Composition 3

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. 2
Hazard statement:
H330: Fatal if inhaled.
Skin corrosion / irritation
Hazard category:
Skin Irrit. 2
Hazard statement:
H315: Causes skin irritation.
Serious eye damage / eye irritation
Hazard category:
Eye Irrit. 2
Hazard statement:
H319: Causes serious eye irritation.
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 lethality; Developmental effects
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

GHS06: skull and crossbones
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>.
Route of exposure: Inhalation
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>.
Specific effect: Developmental
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 organ: Lungs; Route of exposure: Inhalation
H330: Fatal if inhaled.
H302: Harmful if swallowed.
H315: Causes skin irritation.
H319: Causes serious eye 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