Iron oxide

Repeated dose toxicity: other routes

Administrative data

Endpoint:

short-term repeated dose toxicity: other route

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Pulmonary toxicity study. Iron(II)Oxide belongs to the iron oxides family and presents comparable physico chemical properties, leading to similar behaviour for the all members of the iron oxide substances. In particular, based on affinity of the chemical structure, Iron Oxide (Fe3O4) and Iron(III)Oxide (Fe2O3) are selected to support read across for the Iron(II)Oxide dossier. Full justification paper is provided in the current Summary Section.

Data source

Reference

Reference 1

Title:

No information

Author:

Hubbs A et al. (2005), Abrasive blasting agents: designing studies to evaluate relative risk, J.Toxicol. Environ. Health, Part A, 68, 999-1016

Reference 2

Title:

No information

Author:

Hubbs AF et al. (2001), Comparative toxicity of 6 abrasive blasting agents, Toxicol. Sci. 61, 135-143

Materials and methods

Principles of method if other than guideline:

ME-Freetext: For intratracheal administration, rats were briefly anesthetized. Due to the limited amount of available specular hematit, 4 rats were each exposed to 0.3 ml of the 33.3 mg/ml suspension of speculat hematite (10mg/rat). The exposure duration was 4 weeks after instillation. A 0.3 ml volume of the particle suspension or vehicle (phosphate-buffered saline) was administered via the trachea using a 20-gauge 4-inch ball tipped animal feeding needle. 4 weeks after exposure, the rats were killed and bronchoalveloar fluid was (BAFL) was obtained. The BALF cell counts and differentials were performed on a cell counter. The polymorphonuclear leucocyte (PMN) designation excudes alveloar macrophages but includes some lymphocytes. An aliquot of first BAL fluid was removed for analysis of lactate dehydrogenase (LDH) activity. LDH activity was determined spectrophotometrically.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Diiron trioxide

EC Number:

215-168-2

EC Name:

Diiron trioxide

Cas Number:

1309-37-1

Molecular formula:

Fe2O3

IUPAC Name:

diiron trioxide

Constituent 2

Reference substance name:

Iron(III)oxide

IUPAC Name:

Iron(III)oxide

Details on test material:

IUCLID4 Test substance: other TS: specular hematite (98-99% Fe2O3)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

other: intratracheal instillation

Vehicle:

other: phosphate buffered saline

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

4 weeks exposure

Frequency of treatment:

single instillation

Doses / concentrations

Remarks:

Doses / Concentrations:
2.5 or 10 mg in 0.3 ml phosphate buffered saline

No. of animals per sex per dose:

4

Control animals:

yes

Details on study design:

Post-exposure period: 4 weeks

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

RS-Freetext:
Hematite did not significantly increase the activity of LDH and  
polymorphonuclear leukocytes in BAL-fluid