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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Mill scale is mainly and primarily composed of high-purity iron oxides (on average above 65%, i.e. FeO, Fe2O3, Fe3O4). Besides, other metal oxides and spinels, elements, and trace compounds such as oil residues <1% for all the uses except for batteries and Melting charge for which <3% can be found in the mill scale. More information on the justification of read across can be found in the attached document in the endpoint summaries of section 7.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
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

Constituent 1
Reference substance name:
iron(III) oxide
IUPAC Name:
iron(III) oxide
Constituent 2
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:
- 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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.

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 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.

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