Registration Dossier

Classification & Labelling & PBT assessment

GHS

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General Information

Implementation:
EU
Remarks:
  • Ni oxide is currently classified as a dermal sensitizer (Skin Sens. 1; H317) according to the 1st ATP to the CLP Regulation. The results of a comprehensive bioaccessibility testing program evaluating release of Ni ion in synthetic sweat from various Ni compounds indicate that green nickel oxide releases significantly less nickel (II) ion compared to nickel substances known to be skin sensitizers, including nickel sulphate and nickel metal, suggesting very low or no sensitization potency. In this same testing black nickel oxide released significantly more than both green nickel oxide and nickel dihydroxide, with black nickel oxide releasing similar amounts to nickel metal. A comprehensive summary on this topic is provided in Section 7.4.1 of IUCLID and as Appendix B3. The bioaccessibility data for black nickel oxide suggest that it may be a skin sensitizer and therefore the current classification of nickel oxide as a skin sensitizer in the CLP is supported. The bioaccessibility data for green nickel oxide suggest that it may not be a skin sensitizer. This is supported by earlier results in a Guinea pig GMPT test that were positive for nickel sulphate and negative for green nickel oxide. Since the bioaccessibility method has not yet been validated in vivo for skin sensitization no change to the existing classification for green nickel oxide is proposed within this registration file.
  • Ni oxide is currently classified as Aquatic Chronic 4 (H413: May cause long lasting harmful effects to aquatic life) according to the 1st ATP to the CLP Regulation. However, a recent study evaluating the transformation and dissolution of green Ni oxide using the T/D Protocol (OECD, 2001) found it to be essentially unreactive. The results of the study indicate that the net concentration change in total dissolved Ni for the seven- and 28 day test at 1 mg/L loading at pH 6 and at pH 8 was less than the pH 6 acute, pH 8 acute, and chronic Ecotoxicity Reference Values (ERVs) for Ni (120 µg Ni/L at pH 6, 68 µg Ni/L at pH 8, and 2.4 µg Ni/L, respectively). Specifically, dissolved Ni concentrations were 0.23 µg Ni/L and < 0.1 µg Ni/L at pH 6 and pH 8, respectively. The 10 and 100 mg/L loadings for the seven-day tests at pH 6 and 8 exhibited similar sub µg/L values of total dissolved Ni, which were all below the respective ERVs. Since the total dissolved Ni concentrations for the 7-day acute tests for all loadings and the 28-day chronic test were all significantly less than the respective Ni ERVs, the green Ni oxide would not classify under the GHS.
  • Another recent study evaluating the transformation and dissolution of black Ni oxide using the T/D Protocol (OECD, 2001) suggests that a more stringent classification would be appropriate. The results of the study indicate that the net concentration changes in total dissolved Ni for the seven day test at the 1 mg/L loading at pH 6 was 82.8 µg Ni/L and 11.7 µg Ni/L at pH 8. These dissolved Ni concentrations were less than the pH 6 acute and pH 8 acute Ecotoxicity Reference Values (ERVs) for Ni (120 µg Ni/L at pH 6, and 68 µg Ni/L at pH 8, respectively). Based on these results, the black Ni oxide would not classify as Aquatic Chronic 1 (H410: Very toxic to aquatic life with long lasting effects). The 10 mg/L loading was not tested at either pH 6 or 8, but extrapolation of the 1 mg/L loading rate results to a loading rate of 10 mg/L suggests that dissolution at 10 mg/L would exceed the acute ERVs (i.e., assuming that a 10-fold difference in dissolved Ni would accompany the difference in loading rate from 1 to 10 mg/L, dissolved Ni concentrations of approximately 830 µg Ni/L at pH 6 and 120 µg Ni/L at pH 8 would be expected). Exceedance of ERVs at the 10 mg/L loading rate would result in an appropriate classification for black Ni oxide as Aquatic Chronic 2 (H411: Toxic to aquatic life with long lasting effects).
  • While no change to the existing classification is proposed within this registration file, the results of the T/D P testing on green NiO and black NiO can be found in Section 5.6 of IUCLID.

Related composition

Related composition:
Composition 27
Composition 2
Composition 7

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 conclusive but not sufficient for classification
Germ cell mutagenicity
Reason for no classification:
data conclusive but not sufficient for classification
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)
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (long-term)
Hazard category:
Aquatic Chronic 4
Hazard statement:
H413: May cause long lasting harmful effects to aquatic life.
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

H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes 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.
H413: May cause long lasting harmful effects to aquatic life.

Notes