Registration Dossier

Administrative data

Endpoint:
immunotoxicity
Type of information:
other: K3/K4 Studies
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
other: K3/K4
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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 tables" for informational purposes.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Metal-induced diffuse lung disease
Author:
Fontenot AP, Amicosante M
Year:
2008
Bibliographic source:
Semin Respir Crit Care Med. 29(6):662-9.

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nickel (Ni)

Results and discussion

Any other information on results incl. tables

 Data Source  Study Design and Findings  Reliability
Fontenot AP, Amicosante M. 2008. Metal-induced diffuse lung disease. Semin Respir Crit Care Med. 29(6):662-9.   The authors present a review of metal-induced diffuse parenchymal lung disease, of which a very brief summary of occupational observations and immunological mechanistic findings are presented K4: secondary literature source (review) 

Applicant's summary and conclusion

Executive summary:

Study rated by an independent reviewer.