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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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