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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only a short report available; nonetheless, the study is important for the determination of an LD50 for the substance.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Single oral application by gavage, post observation time: 14 days, test substance was applicated in water
GLP compliance:
not specified
Remarks:
The study was performed before the adoption of GLP principles
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): alpha-Fe2O3, ferric oxide
- Molecular formula (if other than submission substance): Fe2O3
- Analytical purity: 96.2%
-Density: 5 g/ml

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5 g/ml
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
no data
Statistics:
no data

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality observed among the rats
Clinical signs:
no abnormalities detected
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results iron(III) oxide (Fe2O3) is practically non toxic, because no mortality or abnormalities were observed in 10 rats exposed orally to 10000 mg/kg bw.
Executive summary:

In an acute oral toxicity study, male Wistar rats were given a single oral dose of alpha-Fe2O3 in water at a dose of  10000  mg/kg bw (limit test); the treatment was followed by 14 days of observation. No control animals were used in this study. No mortality and clinical abnormalities were observed. The study yielded an oral LD50 of > 10000 mg/kg bw for male rats. Ferric oxide is practically non toxic based on the results of this study, and classification and labelling for acute oral toxicity is not required.