Registration Dossier
Registration Dossier
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EC number: 701-090-0 | CAS number: -
Genetic toxicity: in vivo
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
- 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
Constituent 1
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
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