Iron ores, agglomerates

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

other: Expert Review

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Review document

Data source

Reference

Reference Type:

grey literature

Title:

Unnamed

Year:

2010

Materials and methods

Endpoint addressed:

repeated dose toxicity: inhalation

Test material

Test material information

Constituent 1

Reference substance name:

iron oxide

IUPAC Name:

iron oxide

Details on test material:

as stated in the document

Method

Details on study design:

Review

Results and discussion

Results:

Prolonged inhalation of pure iron and iron compounds may produce a benign pneumoconiosis without impairment of lung morphology, function or symptoms. Prolonged inhalation of high levels of mixed welding dusts and fumes may also cause pulmonary fibrosis.

Applicant's summary and conclusion

Executive summary:

This paper evaluated the scientific literature on the effects of prolonged inhalation of iron or iron compounds and, specifically, any association between these exposures and the development of siderosis or pulmonary fibrosis. It considered whether these two conditions require iron and iron compounds to be classified as causing specific target organ toxicity (STOT) – repeated exposure under the CLP regulation criteria. The only group of workers exposed to pure iron or iron oxides appear to be silver polishers who are exposed to pure ferric oxide. They have been shown to accumulate iron in their lungs without health consequences. The animal data on inhalation and instillation of iron oxide also demonstrates that iron does not produce lung fibrosis. Most publications and reviews of these conditions discuss the consequences of prolonged high exposures to mixed dust or to welding fumes, a complex mixture of iron and other metal particles and a variety of gases derived from the process. Prolonged inhalation of high levels of these mixed dusts and fumes may cause siderosis (a benign pneumoconiosis) but also may cause pulmonary fibrosis, sometimes called siderofibrosis, which may lead to restriction in lung capacity. It is not known specifically which components of the complex mix of gases and fumes are responsible for the development of fibrosis. Using a weight of evidence approach to this human and animal literature the authors concluded that the prolonged inhalation of pure iron and iron compounds may produce a benign pneumoconiosis without impairment of lung morphology, function or symptoms. Therefore the conditions occurring after the prolonged inhalation high levels of iron or iron compounds as placed on the market do not meet the criteria for classification under either REACH or CLP.