Registration Dossier
Registration Dossier
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EC number: 235-487-0 | CAS number: 12251-53-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Evaluation of genotoxic effects of oral exposure to Aluminum oxide nanomaterials in rat bone marrow
- Author:
- Balasubramanyam, A. et al.
- Year:
- 2 009
- Bibliographic source:
- Mutation Research 676(1-2):41-47
- Reference Type:
- publication
- Title:
- In vivo genotoxicity assessment of aluminium oxide nanomaterials in rat peripheral blood cells using the comet assay and micronucleus test
- Author:
- Balasubramanyam, A. et al.
- Year:
- 2 009
- Bibliographic source:
- Mutagenesis 24(3):245–251
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- limited information on study design and results
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Aluminium oxide
- EC Number:
- 215-691-6
- EC Name:
- Aluminium oxide
- Cas Number:
- 1344-28-1
- Molecular formula:
- Al2O3
- IUPAC Name:
- dialuminium trioxide
- Details on test material:
- - Name of test material (as cited in study report): aluminium oxide
- Analytical purity: >90%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: National Institute of Nutrition, Hyderabad, India
- Weight at study initiation: 90–100 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 60 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Tween 80 in double distilled water
- Doses:
- Sighting study: 5, 50, 300 and 2000 mg/kg bw
Main study: 2000 mg/kg bw - No. of animals per sex per dose:
- Sighting study: 1
Main study: 5 - Control animals:
- no
Results and discussion
- Preliminary study:
- Sighting study: No mortality and/or clinical signs of intoxication were observed in single rats treated at 5, 50, 300 and 2000 mg Al2O3/kg bw, respectively.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in rats treated at 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 (rat) of Al2O3 (both bulk material and nanosized particles) is above 2000 mg/kg bw.
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