Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: DNA single strand breaks
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: detailed publication available

Data source

Reference
Title:
No information
Author:
Garry S, Nesslany F, Aliouat E, Haguenoer JM, Marzin D (2003). Hematite (Fe2O3) enhances benzo(a)pyrene genotoxicity in endotracheally treated rat, as determined by comet assay. Mutation Res 538, 19-29.

Materials and methods

Principles of method if other than guideline:
Animals: 12 Male OFA Sprague-Dawley rats in 4 groups of 3 Procedure: Animals were anesthesized by i.p, injection Treatment was performed by intratracheal instillation of a suspension of iron oxide, benzopyrene or a mixture of both. The control group was treated with the vehicle (saline) only. Dose: Iron oxide and BaP : ~3.75 mg/kg or the sum of these 24 hours after treatment animals were killed and cells isolated (alveolar macrophages, lung cells, peripheral lymphocytes, hepatocytes) Parameters: alkaline single cell electrophoresis (Comet Assay; 100 cells per slide)
GLP compliance:
not specified
Type of assay:
other: Comet assay

Test material

Constituent 1
Chemical structure
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
Details on test material:
IUCLID4 Test substance: other TS: Fe2O3 (purity 99%, Particle size 1µm)

TS-Freetext:
Fe2O3
particle size: 1µm
purity: 99%

no further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
other: endotracheal instillation
Duration of treatment / exposure:
24 hours
Frequency of treatment:
single dose
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
3.75 mg/kg bw
Basis:

No. of animals per sex per dose:
3

Examinations

Tissues and cell types examined:
four cell types (alveolar macrophags, lung cells, peripheral lymphocytes, hepatocytes)

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

RS-Freetext:
No damage was observed in cells from the four investigated organs in rats
treated with iron oxide alone, while a statistically significant increase in DNA damage was observed compared with control animals in all tested cell types of rats treated with benzo[a]pyrene alone or in association with hematite.

Applicant's summary and conclusion

Executive summary:

method: comet assay

result: negative

Categories Display