Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
respiratory sensitisation, other
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
other: K3/K4 studies
Rationale for reliability incl. deficiencies:
other: See Remarks
Remarks:
Though K3/K4 studies were evaluated and scored for reliability, robust summaries and unique IUCLID endpoint study records were not developed for such. Rather, a summary table of K3 and K4 studies evaluated and scored for this endpoint is provided in the field, “Any other information on results and table” for informational purposes.

Data source

Reference
Reference Type:
publication
Title:
Surface area- and mass-based comparison of fine and ultrafine nickel oxide lung toxicity and augmentation of allergic response in an ovalbumin asthma model
Author:
Roach KA, Anderson SE, Stefaniak AB, Shane HL, Kodali V, Kashon M, Roberts JR
Year:
2019
Bibliographic source:
Inhalation Toxicology 31(8):299-324

Materials and methods

Test material

Constituent 1
Reference substance name:
Nickel oxide
EC Number:
234-323-5
EC Name:
Nickel oxide
Cas Number:
11099-02-8
Molecular formula:
NiO
IUPAC Name:
Nickel(II) oxide

Results and discussion

Any other information on results incl. tables

Data Source

Study Design and Findings

Reliability

Roach et al. (2019). Surface area- and mass-based comparison of fine and ultrafine nickel oxide lung toxicity and augmentation of allergic response in an ovalbumin asthma model. Inhalation Toxicology; 31(8):299-324.  This study investigated the respiratory sensitisation of fine nickel oxide (181 nm) using the ovalbumin asthma model. Groups of mice were treated with nickel oxide via a single oropharyngeal aspiration at treatments of 0 (control) and 40 µg, followed by a sensitisation exposure to ovalbumin on days 1 and 10 and a challenge exposure on days 19 and 28. The lung function was assessed following the second challenge. Evidence of sensitisation to nickel oxide was observed on day 14 and 29 post-sensitisation through an increase in serum IgE levels. During histopathological analysis, inflammatory cell infiltration, macrophage accumulation and vacuolation was observed in the lungs of animals treated with nickel oxide.  K3: Does not meet important study design criteria. Only one nickel dose tested.  

Applicant's summary and conclusion

Executive summary:

Studies were rated by an independent reviewer.